Monday, March 5, 2012

News and Events - 06 Mar 2012




05.03.2012 23:58:00

FROM THE ECONOMIST INTELLIGENCE UNIT


Greece's austerity measures are once again hitting the country's pharma industry, as cost-containment tightens.

The pain is far from over for pharma companies in Greece, as new cost-containment measures for the sector come into force. As part of its efforts to cut spending in the wake of its latest EU bailout, parliament has passed a new law limiting drug spending by the country's social insurance funds to ˆ2.88bn (US$3.8bn this year. The industry itself will be liable for any overspend.

The new law also makes it a criminal offence for doctors to prescribe drugs by brand rather than generic name. This draconian measure will apply to the top ten therapeutic classes from April 1st, and then to all drugs on the reimbursement list from June 1st. The country's reimbursement scheme will only cover the generic cost, with any additional cost to be covered by the patient. In addition, doctors will be fined if they fail to prescribe via the new electronic prescription system, while pharmacy opening hours will be extended.

The aim of these measures is to slice ˆ1bn off the country's drugs bill this year.
In December 2011, while Greece was negotiating its latest bailout, the EU and IMF reportedly asked for drug spending to be reduced to 1% of GDP. The Greek National Organisation for Medicines declared this goal was unrealistic. If the latest measures do succeed in cutting spend to ˆ2.88bn, then that will amount of around 1.4% of Greece's projected ˆ199bn in GDP this year.

The government also wants to raise the market share of generic drugs, which is currently one of the lowest in Europe at around 16% by volume in 2009, according to the
European Federation of Pharmaceutical Industries and Associations . Critics attribute this low share to the minimal difference between generic and branded drug prices, as well as incentives in the pharmacy sector which favoured more expensive drugs. The government has already moved to limit pharmacy profit margins to a flat fee, a measure that is expected to cut the number of pharmacies by 30% over the next few years.

These and other measures have already proved highly controversial. In May 2010, in the wake of previous austerity measures, pharma prices were cut by a weighted average of 21.5%, prompting protests from pharmaceutical producers. Two Danish pharmaceutical companies, Novo Nordisk and Leo Pharma, withdrew a number of their products from the Greek market (they reversed this action only after the government eased the price-cuts slightly .

Despite this, the government introduced a new referencing pricing system in September aligning Greek prices with the average of the three lowest-priced EU countries. The effect was to cut prices by a further 20%.  
As a result, Greece now has some of the lowest pharma prices in Europe, a fact that has prompted a huge parallel trade with other EU markets. Moreover, many hospitals have failed to pay for the drugs they have received, with debts to pharma companies deepening every month.

This latest announcement will lead to more controversy and further deter launches in the pharma sector. The government is clearly prepared for that, however. According to Pharma Times, ministers have in any case been contemplating banning new drug launches until such drugs have been accepted for reimbursement in 8-10 other EU countries. Though that measure would probably exclude cancer drugs, the main losers would be Greek patients.

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04.03.2012 21:59:00

via
pharmatimes.com

Greece's parliament has passed major new pharmaceutical cost-containment legislation which will require drugmakers to cover, each quarter, any overspending on the strict limits which the bill sets for the national drugs bill.

The new law - which passed on a 213-58 vote, with a number of deputies abstaining - states that overall drugs spending by Greece's social insurance funds must not exceed 2.88 billion euros for this year.

The legislation also mandates that, from April 1, clinicians must prescribe medicines from the 10 most-widely used therapeutic classes by generic name only, and from June 1 this requirement will apply to all products on Greece's positive reimbursement list. The funds will reimburse at the level of the cheapest product in each class, and any cost difference between this and the product supplied will have to be paid for by the patient.
Moreover, "inappropriate" prescribing - ie, of medicines by other than their generic name, and not of the cheapest product available - will now be classed as a criminal offence, according to local reports.
Generics currently account for just 18% of the pharmaceutical market in Greece, one of the lowest levels in the European Union (EU , and the latest measures aim to bring this up to the EU average of 50%. Health Minister Andreas Loverdos - who says he intends to slice a massive one billion euros off the nation's drug spending in a single year - has condemned a "coalition of interests" for allegedly attempting to cast doubts on the quality and safety of generics with the aim of hindering their wider uptake in Greece; however, counterfeit drugs are a significantly greater problem for Greece than for other EU nations.

The new law also seeks to save money by mandating the use of computerised prescriptions, with the imposition of a 1-euro fine on doctors for each hand-written prescription, and deregulation of pharmacy opening hours.
The legislation constitutes a requirement by the EU, the European Central Bank (ECB and the International Monetary Fund (IMF - Greece's "troika" of creditors - for agreeing a second bailout of 130 billion euros for Greece.
It is also reported that Yiannis Tounta, president of Greece's National Organisation of Medicines (EOF has been in talks with the troika concerning moves to delay the introduction into Greece of innovative new medicines until the products have been accepted for reimbursement by 8-10 other EU member states. Cancer drugs would be excluded from the proposals.
Commenting on the new legislation, analysts at IHS Global Inslght say that the requirement for pharmaceutical companies to pay back any spending above the stated limit in each quarter is "very negative." This is especially so given that many multinational and Greek drugmakers are owed considerable amounts, by the public hospitals in particular, and that the multinationals which have been paid in Greek government bonds have seen their value plummet, they note.

• A number of decrees concerning implementation of some of the major measures contained within the cost-containment legislation are expected to be announced shortly.

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05.03.2012 18:02:00
News and Announcements updated



05.03.2012 16:42:37
Reuters - One of the pledges of the Obama administration's healthcare overhaul was to enable cheaper copies of expensive biotech drugs, but the savings may not be as deep or come as quickly as hoped.



05.03.2012 7:24:11
Reuters - India's Lupin Ltd has received the U.S. Food and Drug Administration's approval for the generic version of Geodon capsules used to treat schizophrenia, the drugmaker said on Monday.

Saturday, March 3, 2012

News and Events - 04 Mar 2012




02.03.2012 11:04:00

DOMINIC COYLE

Blockbuster drugs coming off patent will knock a major hole in our export figures and tax revenues

PHARMACEUTICALS HAVE been a driving force for Ireland’s export success in recent years. Even through the darkest days of our financial collapse and recession, the sector, dominated by the large multinational players, continued to deliver export growth and a glimmer of hope of economic recovery.

However, the most recent trade figures point to a looming problem for the Government. Reporting a 9 per cent fall in exports in December, the Central Statistics Office was unusually frank and detailed in stating that “a substantial part of the decline in the value of exports was due to a high value product in the chemicals and related products sector coming off patent”.

The drug is Lipitor, Pfizer’s blockbuster cholesterol lowering therapy and the world’s best-selling drug in recent years, accounting for revenues of $10.7 billion in 2010. Pfizer’s Cork plant produces 100 per cent of the company’s global requirements for the active pharmaceutical ingredient in the drug and a significant portion of the finished tablets.

Coming off patent will knock a major hole in the future revenues Pfizer can expect to get from the drug as generic competition kicks in. As a rule, loss of patent protection can hit the value of sales by anything between 40 and 70 per cent over time – and not much time at that.

For Ireland, the concern in the December figures was that, for now, generic competition to Lipitor is limited. If that was enough to skew the export figures so dramatically, the worry is what damage future, more intense competition will do to our trade balance.

And Lipitor is just one of a number of key drugs in which Ireland has a commercial interest and which are coming off patent. Chris van Egeraat, a lecturer in economic geography at NUI Maynooth, says seven of the 10 largest-selling drugs worldwide which are losing patent protection are currently produced in Ireland. They include the best-selling drug worldwide in 2010 after Lipitor; Sanofi/Bristol Myers Squibb’s blood clotting treatment Plavix, with sales of $9.43 billion. It comes off patent in May.

Globally, it is estimated that as much as $100 billion in sales will be lost to drug companies between 2009 and 2014 as a result of drugs coming off patent. Expected pipeline delivery in terms of market revenue over the same time amounts to about $30 billion, Dr van Egeraat says.

While he doesn’t expect the loss of patents to lead to huge imminent job losses, it does highlight the ambition of the Government’s new Action Plan for Jobs, which has targeted the health and life sciences sector for significant growth in the coming years to help reach the Government’s 100,000 job target.

However, loss of market sales will clearly impact on trade figures and tax revenues. The Irish Pharmaceutical Healthcare Association (IPHA notes that the pharmaceuticals sector accounts for roughly half of all exports and is the largest contributor to corporation tax, accounting for roughly 50 per cent of the ˆ3.5 billion collected last year.

In employment terms, IPHA president and Pfizer country manager David Gallagher says that about 25,000 people are employed directly in the industry, with a roughly similar number working in related sectors. He notes that pharmaceuticals has been more resilient than other sectors of the economy during recent “economically challenging times”.

The message is pointed, especially at a time when the sector is locked in a dispute with the Government over access to market for its new drugs and the contribution it can make to savings in the health budget sought by the State.

David Gallagher noted recently that an increasing number of innovative medicines are currently not being reimbursed by the Department of Health, despite being approved by regulators and meeting health technology assessments.

He recently accused the department of acting in bad faith by refusing to approve drugs for reimbursement as provided for under the industry’s current pricing agreement with the Department, even though the industry had delivered savings of about ˆ540 million over the past five years, a figure he says equates to a 20 per cent cut.

Even before the latest row, the IPHA said the delay between approval and market access had jumped by over 50 per cent to 157 days in recent years, and only 64 per cent of drugs that received market authorisation in the EU between 2007 and 2009 were made available to patients here.

Matt Moran, director of Ibec group PharmaChem Ireland, said Government policy “needs to urgently recognise the very serious challenges facing the industry”.

“A number of blockbuster drugs are coming off patent and healthcare spending in Ireland has been cut by ˆ600 million in the last five years,” he said. “The future success of the sector must not be taken for granted.”

In a speech last year, Gallagher said further price concessions were “simply untenable”, citing preliminary 2011 figures pointing to a 5.2 per cent decline in the value of the Irish market. “There is a limit to the amount which can be taken out of a market without its effective operation and employment being jeopardised,” he said.

Ireland is not alone. The commercial prospects for big pharma were also thrown into sharp focus with a report on the UK’s pharmaceuticals price regulation scheme, which reported collective industry losses of ?142 million in 2009 despite rising sales.

For its part, the Department of Health needs to find cuts in its budget. In a recent report on pharma pricing, the Economic and Social Research Institute (ESRI said that drug costs account for about 17.5 per cent of public health expenditure in Ireland, up from 14 per cent in 2000.

In 2009, the ESRI says, spending per head of population in Ireland on pharmaceuticals was “amongst the highest in the OECD”.

It is understood the Department of Health is targeting a saving of about ˆ112 million from the drugs bill – either in terms of pricing and access for new medicines or pricing of generics.

The ESRI report recommended a number of approaches. These included pricing drugs on the basis of the lowest cost in a basket of European markets rather than the average, and more regular price updates to capture the impact of falling prices earlier.

The industry says that, despite the small physical size of the Irish market, such a move would be negative in two ways. First, Ireland is itself a component of pricing baskets in eight other larger EU markets. A “match the lowest” price here will inevitably further eat into prices in other more important markets.

Secondly, the industry points to Ireland’s importance as a base of operations for most of the main players in the sector. An increasingly adversarial approach with the State will only damage the prospects for future investment, they say, with one industry source saying the recent approach of the department to market access for new drugs was creating a very poor impression in a number of important boardrooms State-side.

The seriousness with which the pharmaceutical sector views the current price negotiations in Ireland – where eight of the top 10 global players have operations – is highlighted by the engagement of some of the industry’s leading figures with the Government.

The chief executive of one major global player has made a point of briefly visiting Ireland next week. The message in his first visit to the State will not be lost on ministers. The following week, leading executives from another top 10 drug manufacturers gather in Dublin for a meeting at which the attitude of the State to the sector is certain to figure.

On the Government’s side, there is concern too at any adverse impact on such a major employer and contributor to the exchequer. Taoiseach Enda Kenny has recently engaged directly in private meetings with top industry figures here to assure them of the Government’s support despite the ongoing budgetary squeeze.

For their part, the drug companies say that current pricing pressures are restricting innovations. Without adequate compensation, they say, companies simply will not be able to invest in new products given the costs involved and the risk of failure.

This isn’t unique to Ireland. Reporting annual results earlier this month, Bayer chief executive Marijn Dekkers expressed concern “about the side-effects” of health service reforms taking place around the world “because the money we earn from today’s medicines pays for the development of tomorrow’s medicines”.

Pointing to the ˆ2 billion research and development cost of Xarelto, a new drug developed with Johnson Johnson to prevent blood clotting, he said: “We need innovative pharmaceuticals more than ever, because so many known diseases still cannot be treated adequately, or at all, with medicines.”

But that’s part of the problem for the major pharmaceutical companies. Many of the easy treatment areas are now well catered for. A good portion of the drugs that do so are shortly coming off patent and are easily accessible to generic competition.

The opportunities of the future lie in increasingly niche conditions or very high risk areas such as oncology and, especially, neurology. Added to this is the move to biologics and the trend towards more personalised medicines.

The challenge is evident in the fact that, last year, the US drug regulator, the Food and Drug Administration, licensed just a handful of new pharmaceutical therapies. Getting this more select group of drugs to as many markets as possible is increasingly critical for big pharma.

The age of the blockbuster is fading, along with the fat profit margins it offered. That presents major issues for the sector. Over time, through consolidation and acquisition, they have grown into massive unwieldy entities with poorly directed research failing to deliver sufficient pipeline.

In recent years, much effort has been devoted to streamlining operations and increasing productivity, especially on the research side. Thousands of jobs have been shed worldwide, and greater emphasis placed on outsourcing much of the early-stage RD work.

A case in point is Elan’s prospective Alzheimer’s treatment bapineuzumab. Originally developed by the company in association with Wyeth, it is now controlled by Pfizer (which acquired Wyeth to fill a perceived weakness in its biopharmaceuticals operations and Johnson Johnson, which bought an 18.4 per cent stake in Elan in 2009 in a deal valued at $1 billion. Its interest was driven largely by the Irish company’s pipeline – particularly bapineuzumab which is seen as one of the more promising candidates to address a disease with limited treatment options at present and which reports critical Phase III trial data later this year.

The second focus is on developing new markets. But that presents its own problems, not least with business practices that have reflected poorly on the industry.

Several of the largest drug companies have been implicated in an ongoing legal action in Serbia in which a group of 10 doctors and drug company officials were charged with taking, or offering, more than ˆ500,000 in bribes to use specific products. While all deny guilt in this case, an examination of US Securities and Exchange Commission (SEC filings by the world’s top 10 drug companies has found that eight of them recently warned of potential costs related to charges of corruption in overseas markets.

Life is unlikely to get any easier for the sector over the coming two or three years. That raises the stakes in the ongoing price negotiations. The new accord was due to come into force yesterday and, as the leaked Commission assessment this week illustrated, pressure on the Government to deliver the necessary savings to ensure their budgetary projections is only likely to intensify.

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02.03.2012 15:00:00

by
Charles J. Raubicheck


Thumbnail image for Thumbnail image for FDA logo.jpg
FDA Commissioner Margaret Hamburg has announced Elizabeth ("Liz" Dickinson was appointed as the Chief Counsel of FDA, effective March 12, 2012.

The new Chief Counsel has had a long and distinguished career at FDA since she joined the agency in 1994. She has principally served as legal counsel to FDA's Center for Drug Evaluation and Research, providing advice in such key areas as Hatch-Waxman generic drug approvals, pediatric exclusivity and orphan drugs. She has also worked closely with the Department of Justice representing FDA in many court cases. Liz is well respected by both her colleagues at FDA and outside lawyers representing companies in FDA-regulated industries.

Among the imminent issues that Liz will face at FDA include generic drug user fees, drug shortages, and regulations/guidances for the Agency's implementation of new statutes on food safety and tobacco products.

Liz received her B.A. in Economics from the University of Massachusetts, and her J.D. from Northeastern University. She clerked for Judge William B. Bryant at the U.S. District Court for the District of Columbia.

Mark Raza will continue to serve as the Acting Principal Deputy Chief Counsel.

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02.03.2012 12:25:25
Generics focus to shift towards difficult to produce drugs, specialist products and biosimilars



03.03.2012 9:34:00

The European Commission
said it ended an antitrust probe into
GlaxoSmithKline Plc (GSK over possible collusion to keep cheaper copies of medicines off the market after a complaint against the company was withdrawn.

“The Commission examined whether there may have been violation of EU competition law by GlaxoSmithKline,” Antoine Colombani, a spokesman for the regulator, said in an e- mail. The case involving generic-drug producer Synthon BV concerned “possible anticompetitive agreements or concerted practices in order to delay or exclude generic competition,” he said. Colombani declined to elaborate on Synthon’s role in the probe.

The announcement comes a day after European Union regulators
dropped a similar probe into
AstraZeneca Plc (AZN , the U.K.’s second-biggest drugmaker, and
Takeda Pharmaceutical Co. (4502 ’s Nycomed unit over possible collusion to keep cheaper copies of medicines off the market. That case was brought to a halt because of a lack of evidence.

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03.03.2012 0:02:00
Drug Approval Listing

Thursday, March 1, 2012

News and Events - 02 Mar 2012




29.02.2012 0:58:00

Media_https1reutersme_fqkpq

By Aleksandar Vasovic and Ben Hirschler
BELGRADE | Wed Feb 29, 2012 3:13am IST
(Reuters - According to a signal from the electronic tag around his ankle, Nenad Borojevic last left his apartment building at 6.25 p.m. on January 10. It was the festive season in Serbia; the capital was enjoying the lull between Orthodox Christmas and New Year.

Police said Borojevic, a doctor, headed to Kosutnjak park, a popular wooded area in Belgrade dotted with restaurants and criss-crossed by jogging paths.

Borojevic had been one of Serbia's most eminent doctors, a director of the Institute for Oncology and Radiology. Now he was due in court in five days to face charges brought by the public prosecutor that he had taken bribes from international drug companies as incentives to use their products. The electronic tag was a condition of his 500,000 euro ($660,000 bail.

The next day, around noon, a passer-by found Borojevic hanging from a tree on a nylon rope five millimeters thick. Police found a suicide note in the mailbox of his wife, from whom he was separated. It had been sent from a local post office. "I couldn't take it anymore," it said.

Borojevic's story, some of which emerges here for the first time, is a particularly gruesome example of what even people in the global drugs business concede is a growing problem: bribery and corruption in emerging markets. The 51-year-old cancer specialist was one of a group of 10 Serbia-based doctors and drug company officials charged in 2010 with taking, or offering, more than 500,000 euros in bribes to persuade the medics to use specific products. The doctors are alleged to have personally gained from the choice of medicines used; the drug company representatives with illegally offering the incentives.

In recent years, Big Pharma has forked out billions of dollars to settle scandals involving improper promotion of medicines in the United States. Now bribes paid to foreign doctors and other state employees are shaping up as the next major legal liability threat for the industry. A Reuters examination of U.S. Securities and Exchange Commission (SEC filings by the world's top 10 drug companies has found that eight of them recently warned of potential costs related to charges of corruption in overseas markets.

One factor driving the trend is a search for new business. Companies whose profit margins have been squeezed in the developed world are increasingly turning to thinly regulated emerging markets for growth. At the same time, U.S. and European governments are toughening up on bribes paid by companies overseas. The U.S. Foreign Corrupt Practices Act and Britain's new Bribery Act, which came into force last July, are both targeting drugs companies for special scrutiny, providing new impetus for the industry to clean up its act.

"There's clearly a legal risk from violating laws with the current drive into emerging markets, so mis-selling cases in these markets could become a significant legal threat for the industry," said Chris Stirling, European sector leader for pharmaceuticals at KPMG in London. "The business practices in these countries are very different from the sort you find in Western Europe and the United States."

Borojevic's suicide - police have ruled out foul play - means certain aspects of his case, which is being investigated at a national level, may never be known. The trial of the other men and women in the group is continuing. All the defendants have pleaded not guilty, though one of the six drug company representatives involved agreed a plea bargain and another turned witness for the prosecution.

Emerging markets to drive pharma growth: link.reuters.com/ryw76s

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OPERATION CRAB

The probe of Borojevic, which police called Operation Crab, started with a tip-off in March 2007, according to a police source involved in the investigation.

At a later point, police received information from a former mistress of one of the accused, the investigator said, declining to name her. "After they broke up, she came to us and recited everything - names, places, contacts, how they operated, how much everyone received and from whom, when and where," said the investigator. "She even gave us some concrete evidence which helped us a great deal."

Some of Serbia's tabloid media said the informant was a former Serbian model, Katarina Rebraca, who herself, in a separate case, had in April 2010 faced charges of embezzling funds at a breast cancer charity she ran. Borojevic, the doctor, had been called as a witness for the prosecution against her, although he died before testifying.

Rebraca declined to comment. Her lawyer, Dragan Mrakovic, said: "It is not in the best interest of my client to give any information whatsoever" about the Borojevic case. "This has nothing to do with my client's case, nor does my client have anything to do with the pharmaceutical corruption case."

The informant led police to a rented apartment in Medakovic, a neighborhood of communist-era apartment blocks and family homes in Belgrade. Here a group of doctors and drugs company sales representatives would allegedly meet and hold "raunchy, loud parties with Belgrade babes, three or four times a week," said the police investigator. It was not possible to confirm who had rented the apartment.

In June 2010 police arrested Borojevic: the charges against him and four colleagues included running a criminal conspiracy in cancer drugs from 2007 to 2009. The indictment said that the alleged scheme, whereby drug company representatives gave inducements to the doctors to use their companies' products, had increased sales of a number of generic chemotherapy medicines as well as branded cancer medicines including Roche Holding AG's Avastin and Erbitux, made by Merck KGaA of Germany.

For Borojevic, the alleged gains were significant, especially in a country whose GDP per capita the IMF puts at just $6,500 a year. In total, he was accused of receiving a total of 11.2 million dinars ($138,000 in kickbacks from drug companies.

Officials at drugs companies AstraZeneca Plc, Sanofi SA and Actavis confirmed they were served in July and August 2011 with criminal indictments related to allegedly improper payments to physicians including Borojevic at his state-run institute, and said they had filed certain procedural objections. Icelandic pharmaceutical company Actavis gave the most expansive statement: "The allegations include bribery of state officials in order to obtain preferential status when it comes to the sale of oncology products in Serbia," said the company, which moved its headquarters to Zug, Switzerland in 2011.

All declined further comment on the proceedings. Also charged with alleged bribery in the case were representatives of Roche, Merck KGaA and PharmaSwiss - a unit of Canada's Valeant Pharmaceuticals International Inc - all of whom declined to comment.

REPS TAKE THE RAP

In one instance, the police allege, Borojevic and his colleague Zoran Bekic, head of the Institute for Oncology and Radiology's pediatric oncology ward, received 95,000 euros from Goran Orlic, a representative for Actavis. Orlic allegedly paid the men for inside information about its business plans.

The Actavis representative received immunity from prosecution in exchange for his testimony ahead of the trial, the court said in a statement. Actavis said Orlic left the company in 2009. Neither Bekic, the pediatrician, or his lawyer would comment. Orlic could not be reached.

Another of those charged was Merck KGaA's representative, Jasmina Gutovic. She reached a plea bargain with prosecutors and admitted giving bribes, according to the judge who heard her case. While Gutovic was convicted, the court will not say what punishment she received while the rest of the case is being heard. Merck KGaA confirmed she left the company in June 2011 and she could not be reached for comment.

The indictment against Borojevic also states that he and colleagues did a deal with unnamed drug company sales staff to develop "new therapeutic applications" using their companies' drugs, as a way of further boosting sales of the products. In the months before his death, Borojevic was portrayed in Serbian media as a poisoner of children, based on suggestions in the media that he had overprescribed.

Borojevic was released on bail in November 2011. He repeatedly denied all the charges against him, saying he was the victim of a media witch hunt. "Nothing is true from the indictment," he said in a statement in May 2011.

His lawyer, Strahinja Kastratovic, said that the day before Borojevic killed himself, he had learned the apartment he had bought with his estranged wife would be seized by the court. "He said, 'I can't take this anymore, I don't know how to fight this or against whom I'm supposed to be fighting,'" said Kastratovic. He declined to elaborate.

TEMPTATIONS INCREASE

Corruption is rife in Serbia, which is ranked 86th out of 183 countries in Berlin-based Transparency International's corruption perceptions index. The drugs business is particularly exposed to corruption, Transparency International says: pharmaceuticals create vast opportunities for graft across both rich and poor countries. Its 2011 Bribe Payers' Index ranks pharmaceuticals and healthcare 13th out of 19 industries on probity - a lower ranking than defense firms, though above mining and construction.

"There are a number of classic red flags for bribery that indicate the pharma sector is particularly vulnerable," says Robert Barrington, TI's director of external affairs. These include a tradition of gifts and hospitality, a lack of transparency over pricing and the need for regulatory approval in everything.

In many parts of the world lavish gifts such as all-expenses-paid trips to resorts and golf days remain common, even though the industry has reined in such hospitality in the United States.

Temptations may increase as companies move into the developing world. IMS Health, which analyses pharmaceutical industry trends, says 17 key emerging markets will account for around 63 percent of worldwide growth in prescription drug sales between 2010 and 2015.

"It is almost guaranteed that every multinational pharmaceutical company is going to end up with these issues and is going to have to go through a painful experience," says one in-house lawyer at a major U.S. drugmaker. "Frankly, the odds are stacked against companies."

'NOT ETHICAL, BUT UNIVERSAL'

The Serbian charges and claims of corruption extend beyond Borojevic and his colleagues. In his defense, Borojevic always insisted that he could not approve drug purchases alone, but passed on recommendations to the state-run Department of Health Insurance. That itself is the target of other, unrelated corruption charges brought by the public prosecutor against its former head, Svetlana Vukajlovic, who has been in pre-trial detention since September 2011.

An example from another Balkan country, Greece, underlines how ingrained such practices can be. Earlier this month, London-based Smith & Nephew Plc, Europe's biggest maker of artificial knees and hips, agreed to pay $22 million to settle SEC allegations that it bribed doctors in Greece to use its products. Among documents the SEC released as part of the dossier was a note jotted down in 1999 by an unnamed in-house lawyer for the company.

"Pay surgeon to use prod(uct ," it read. "Not legal or ethic; but universal."

In that case, the company's Greek distributor sent an email to the firm's U.S.-based head of international sales seeking to maintain access to one of the slush funds used to pay doctors to buy S&N products: "I absolutely need this fund to promote my sales with surgeons, at a time when competition offers substantially higher rates," he wrote. The fund's "only reason for being is the need for cash incentives, a real pain in the neck but an unavoidable fact of Greek life."

S&N CEO Olivier Bohuon, who took office in 2011, long after the alleged bribery occurred, said the company had moved on but the episode showed the need to remain vigilant.

Over the past year eight of the world's top 10 drugmakers - Pfizer Inc, Novartis AG, Merck & Co Inc, Sanofi, AstraZeneca, GlaxoSmithKline Plc, Johnson & Johnson and Eli Lilly & Co - have all warned that they may face liabilities related to charges of corruption in numerous overseas markets.

Investigations into potential wrongdoing by pharmaceutical firms cover activities in countries including Argentina, Brazil, Canada, China, Germany, Italy, Poland, Russia and Saudi Arabia, according to company filings. They also involve possible improper conduct of clinical trials, which are increasingly being run in lower-cost Asian or East European countries.

(For a report, see link.reuters.com/kyp76s .

'JUST SAY NO'

One reason such cases are surfacing now is the renewed vigor with which U.S. officials have enforced its foreign corruption law since November 2009. That's when U.S. assistant attorney-general Lanny Breuer told a pharmaceutical conference: "We will be intensely focused on rooting out foreign bribery in your industry."

The 1977 Foreign Corrupt Practices Act makes it illegal for U.S. companies and foreign firms whose stock is traded in the United States to bribe government officials in foreign countries. Officials at the U.S. SEC and Department of Justice (DOJ declined to say if they planned to follow the Serbian probe with their own investigations.

Some drug firms have already started to come clean. In the first case of its kind, Johnson & Johnson settled for $78 million with U.S. and British authorities in April last year, after disclosing voluntarily to U.S. authorities back in 2007 that it had made payments to doctors in Poland, Romania and Greece who chose to use J&J medicines and surgical implants.

Pfizer, which in 2004 became the first pharmaceutical company to volunteer information about past wrongdoings to the DOJ and the SEC, is likely to be the next big firm to settle. The world's biggest drugmaker, it reached an agreement in principle with U.S. authorities towards the end of last year and is set to finalize a deal during the first half of 2012, according to people familiar with the discussions.

Under U.S. and British law, the onus is on a corporation to report improper behavior by either its own staff or outside contractors. In some cases, this has already meant radical change. AstraZeneca, for example, said last May it was ending all payments to doctors attending international scientific and medical congresses.

"I know that this is not easy," Chief Executive David Brennan told a conference at the time. "I know from my own experience as a sales representative, you will encounter people who will ask for gifts, or other inducements. And they will threaten to take their business elsewhere, if you don't acquiesce. But we have made it clear that our sales force have to say no."

(Aleksandar Vasovic reported from Belgrade, Ben Hirschler from London; Edited by Sara Ledwith and Simon Robinson

(For PDF: link.reuters.com/xaz76s

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01.03.2012 21:52:09

Three bellwether trials against drug manufacturer Merck & Co. are scheduled to take place this year. Opening statements for two consolidated
Fosamax lawsuits are expected to begin today in the New Jersey state court.

Two women, Jo Ann Sessner and Ameila Flores, claim they developed osteonecrosis of the jaw (ONJ after taking Fosamax. Osteonecrosis is a painful condition which causes the jaw bone to decay requiring surgery to remove portions of it.

Merck maintains that Fosamax did not cause Sessner and Flores to suffer jaw injuries. According to a statement released by the company’s legal counsel, “Unfortunately, both plaintiffs had medical problems that cause people to develop jaw problems regardless of whether they were taking Fosamax.”

Fosamax was introduced by Merck and approved by the Food and Drug Administration in October 1995 for the treatment of osteoporosis, a chronic condition which causes bones to become brittle and weak leading to possible breakage. It is included in a class of bone strengthening medications known as bisphosphonates. Prior to the release of a generic, Fosamax generated more than $3 billion in 2010.

An increased number of reported problems associated with bisphosphonate drugs such as Fosamax, Boniva®, and Reclast® caused the Food and Drug Administration to issue a bisphosphonate warning and later require manufacturers to update warning labels.

Currently Merck faces more than 1,000 Fosamax side effects lawsuits filed by women who have taken Fosamax for the treatment of osteoporosis. The lawsuits allege that Fosamax causes adverse side effects such as osteonecrosis of the jaw and atypical
femur fracture injuries when taken for long periods of time, usually 12 months or more.

All
femur fracture lawsuits have been consolidated in the U.S. District Court for the District of New Jersey while jaw decay lawsuits have been consolidated in the U.S. District Court for the Southern District of New York.

http://consumer-drug-report.com/content/fosamax-jaw-decay-lawsuits-opening-statements-be-heard#comments



28.02.2012 22:18:19
Sildalis (Sildenafil citrate & Tadalafil Sildalis combined with tadalafil and sildenafil citrate goes to work for typical sexual problems.Sildalis power packed with tadalafil and Sildenafil citrate it can handle the most severe problem of erectile dysfunction so that you can be the extra stroge for your mistress.Sildalis slither up to her without a worry and perform with complete confidence with tadalafil and Sildenafil citrate of fire power.The sildalis tablet is administered orally to treat erectile dysfunction and impotency in men. Red film coated rectangular shaped tablets packed in a pocket size blister strip of 6 tablets comes in tadalafil 20mg and Sildenafil citrate 100mg. Most man who used sildalis had the ability to do better for an extended amount of time without concerns about losing their erections. This tablet provides a prolonged effect compared to the standard ed tablets in market. As a result sexual arousal in harsh, prolonged erection for maximum sexual performance. Composition each film coated tablet contains : Tadalafil 20mg Sildenafil citrate equivalent to sildenafil 100mg how to use: For best results, take 1 tablet of sildalis at least 20 minutes if not one hour before the planned sexual intercourse. Do not consume more than 1 tablet in a day and always consult your doctor and pharmacist before beginning the course. Always check the patient information leaflet provided by your pharmacist with your supply and also each time you order refill, to ensure that you are fully aware about the efficacy and various contra indications of tadalafil and slidenafil citrate. When in doubt or in need of clarification, consult your doctor or pharmacist before taking your dose. Side effects: Immediately notify your doctor or any medical practitioner if suffering from dizziness, vertigo, flushing, hyperacidity & heartburn, stomach upsets, diarrhea, nasal stuffiness, drop in blood pressure and vision problems such as blurriness, light sensitivity, blue/green color vision discrimination loss etc.. These side effects are by no means comprehensive or cover other complications which may occur. Report any unusual condition to your doctor after taking this drug for an expert opinion. If your doctor has given his green signal for you to be put on this drug, he must have carefully weighed the benefits gained against the risk of side effects involved. So please do not indulge in self medication and consult your doctor. However most people hardly experience any side effects of this drug. Sildalis tablet : √ this sildalis tablets provide a longer effect than normal ed tablets available in the market. √ the effect of sildalis tablet keeps up 'till 15 hours. √ sildalis is simply taken orally with water or juice. √ sildalis cures erectile dysfunction √ sildalis increases sex drive and libido √ sildalis makes you feel confident Dose : take 1 tablet of sildalis at least 10 minutes if not one hour before the planned sexual intercourse. Do not consume more than 1 tablet in a day or as directed by the physician. Presentation : red film coated rectangular shaped tablets packed in a pocket size blister strip of 6 tablets



01.03.2012 14:45:00

BRUSSELS (Dow Jones --The European Commission said Thursday it has closed an antitrust investigation into possible deals between pharmaceutical companies AstraZeneca PLC (AZN and Nycomed SCA after finding no wrongdoing.

"The investigation focused on suspected individual or joint action to delay the market entry of generic medicines," the commission, which has antitrust powers in the European Union, said in a statement. "Such behavior if established would have been contrary to EU antitrust rules that prohibit restrictive business practices and the abuse of a dominant market position," it said.

The commission's antitrust authorities have in recent years specifically targeted the pharmaceutical sector to ensure companies don't restrict competition from generic drugs to the detriment of patients. The efforts are part of governmental efforts in Europe and elsewhere to cut drug prices across the board to limit spiraling health-care costs.

Ensuring the free flow of generics is considered necessary to help bring down medication costs by as much as 80%, allowing governments and state health insurers to save billions of euros.

-By Alessandro Torello, Dow Jones Newswires; +32 2 741 14 88;
alessandro.torello@dowjones.com

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01.03.2012 22:22:00
Drug Approval Listing



01.03.2012 17:24:09
Four operating companies will provide integrated solutions across various treatment delivery platforms: branded pharmaceuticals, generic drugs, medical devices and services CHADDS FORD, Pa., March 1, 2012 -- Endo (Nasdaq: ENDP , a diversified...



28.02.2012 22:10:24
Generic Super P Force The team of our company proposes a wide assortment of Sildigra Super Power to our valuable clients. These capsules have the composition of sildenafil citrate and dapoxetine. Offered in seal packaged packaging, these can be availed at competitive rates. In order to maintain safety, these capsules should be taken after discuss with doctor. Our capsules are highly efficient to keep an erection for a longer period of time. Side effects: Both active agent's sildenafil and dapoxetine may create certain adverse reactions in the consumer. But as with any other drugs you may not observe them on yourself. If you should witness certain untypical symptoms on yourself, please consult your doctor. To the common side effects of sildenafil belong: sneezing headache dyspepsia prolonged erections photophobia visual changes dyspepsia palpitations The rather rare side effects of sildenafil are: severe hypotension increase intraocular pressure priapism Dapoxetine adverse reactions are: nausea diarrhea dizziness headache



01.03.2012 5:49:43
Less than one month after Pfizer recalled nearly 1 million packages of faulty birth control pills, Glenmark Generics has recalled its version of the oral contraceptives because of a packaging error that landed the pills in the wrong order. The India-based drug company has warned that seven lots of norgestimate and ethinyl estradiol tablets distributed to U.S. pharmacies between Sept. 21 and Dec. 30, 2011, "could leave women without adequate contraception, and at risk for unintended pregnancy." "Select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date visible only on the outer pouch," the company said in a statement released Friday, explaining the packaging error.

News and Events - 29 Feb 2012




28.02.2012 17:59:33

The Food and Drug Administration (FDA has had to face dealing with a growing number of prescription drug shortages caused by various reasons. The health regulating agency issued a
consumer update on its website stating that possible reasons for the shortages may be caused by manufacturing or quality problems, delays, or discontinuations of the drug. When there is a drug shortage, the FDA works with the drug manufacturer to work out the issue and often asks generic drug makers to increase productions.

A
letter of concern was issued to manufacturers in short supply of prescription drugs. The letter was issued on October 31, 2011 and stated that the number of drug shortages has nearly tripled within 5 years. In 2005, there were 61 drug shortages and that number increased to 178 in 2010. About 54% of these drugs shortages were caused by manufacturing problems and the FDA warns that these issues should be taken care of immediately so as to not jeopardize the patient’s health.

There are multiple reasons for drug shortages such as the following:

Interruptions or other adjustments in manufacturing

Delays in obtaining dire raw materials

Manufacturing complications causing supply disruptions

Import suspensions

Unforeseen rises in demand

Many of the drugs in short supply are used to treat life threating conditions such as cancer and anesthesia and are typically the only type on the market. This has raised much attention causing the Obama administration to get involved. An
executive order by the Obama administration was also issued on October 31, 2011.The FDA has taken multiple approaches to dealing with the increase in drug shortages including issuing a letter of concern to the manufacturers of these critical drugs in short supply, increasing staff resources to avoid drug shortages, supporting legislation which will require manufacturers to report drug shortages, and much more.

http://consumer-drug-report.com/content/fda-deals-prescription-drug-shortages#comments



27.02.2012 15:00:00

by
Brian J. Malkin


Thumbnail image for Thumbnail image for Thumbnail image for Generic Labeling.jpg
On February 22-24, the Generic Pharmaceutical Association ("GPhA" held its
Annual Meeting in Orlando, Florida to a first-time, sold-out crowd of approximately 625 attendees. During the public sessions to which this blog refers, representatives from the generic industry along with guest speakers such as FDA Commissioner Margaret A. Hamburg, M.D., addressed a variety of issues facing generic drug manufacturers in the upcoming year and years to come. Key topics throughout the conference included drug shortages, biosimilars, and challenges to survival of generic industry despite the promise of the user fees from the Generic Drug User Fee Act ("GDUFA" to shorten abbreviated new drug application ("ANDA" review times. This is part one of a two-part series.

Hamburg said that she had hoped to announce a new director for the Office of Generic Drugs ("OGD" . In the meantime, a big OGD focus will be gearing up to effectively utilize the $299 million per year user fees (to be adjusted by need and inflation with the goal to shorten review times from a mean of 30+ months to 10 months. One of the challenges will be addressing the need to conduct overseas inspections now that approximately 40% U.S. generic drugs are imported and 80% U.S. generic drugs utilize imported active pharmaceutical ingredients. FDA also hopes to streamline the review process by issuing single response letters rather than multiple deficiencies, resulting in less review cycles.

According to Hamburg, the generic drug industry must continue to demonstrate therapeutic equivalence and equality to maintain that generics are as good as innovator products. Hamburg explained that the OGD will continue to address new scientific topics, such as bioequivalence for inhalation products, and hopes to tackle additional issues surrounding more complex dosage forms. In turn, Hamburg asked the generic industry to help support studies on generic drugs to address key patient concerns and to invest generally in high quality production to reduce drug shortages. Hamburg warned GPhA's members that currently there are more drug shortages attributed to generics, which could lead to a public misperception that generic drugs are not as good. Hamburg also discussed internal changes made within FDA to reduce drug shortages after President Barack Obama's Executive Order in October 2011, which has resulted in 195 shortages prevented in 2011. The generic drug industry can help, Hamburg said, by providing early notification of potential shortages. Hamburg also briefly discussed FDA's new biosimilar guidances and FDA's biosimilars statistics to date: 35 pre-investigational new drug ("IND" application meeting requests, 21 pre-IND meetings, and 9 in-house INDs.

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2012-02-28 08:18:25
Inadvertent prescription of gelatin-containing oral medication: Its acceptability to patientsA significant proportion of vegetarians and other patients with dietary preferences borne out of cultural/religious practices are unwittingly consuming animal gelatin in prescribed medicines, reveals research published online in Postgraduate Medical Journal. The findings prompt the authors to call for more comprehensive labeling of drug content and for vegetarian alternatives to animal gelatin to be used in manufacture. The active component of a medicine accounts for relatively little of the content; most is made up of "excipients," which include binders/fillers, disintegrants, lubricants, sweeteners, and coating agents. Gelatin is a commonly used coating agent, but is also used as a thickener in liquid and semisolid medicines, particularly in generic (non-branded medicines. The researchers surveyed 500 patients being treated for urinary/urological disorders in Manchester, a culturally diverse city in the north west of England. Previous research has shown that many specialist urology drugs contain gelatin, while roughly one in four Mancunians is of non-white ethnicity. The researchers wanted to know about the prevalence of dietary restrictions; the willingness to take medicines containing animal content; the preparedness to ask about the content of drugs; and the proportion refusing to take drugs they knew contained ingredients derived from animals. Two hundred patients stated they were not supposed to eat animal products. Over half (283; 56.5% were taking medicines, 75 of whom were taking a total of 87 different drugs. Most (88%; 176 of the 200 patients following a restricted diet said they would prefer to take medicines containing only vegetable products, only one in 10 said this didn't matter to them. Among the 176 with a stated preference, more than half (100; just under 57% said they would take a drug containing an animal product, if no other alternative was available. But the remainder (43% said they would not knowingly do so. Yet only one in five of those with a stated preference would have asked their doctor or pharmacist if the drug's content flouted their dietary requirements/beliefs. And half of the 49 men, who had been prescribed medicines containing gelatin, were taking these drugs in contravention of their stated dietary preference. "We already know that doctors are fairly ignorant about the issue of excipients in medication," write the authors, who conclude that their findings pose ethical quandaries for the entire profession. Around 10 million people were prescribed specialist urinary/urological drugs in 2009 in the UK, but this category of drugs accounts for only the 14th commonest class of prescription, they say. "[Gelatin content] is almost certainly a much bigger issue for the 860 million non-urological preparations prescribed in the UK each year, whose excipient content is not easily identified," they caution. Clearer content labeling, the adoption of a vegetarian symbol as is done for foodstuffs, and changes in the manufacturing process could all help patients make informed choices as well as promoting best practice in medical care, they suggest. --- On the Net:



28.02.2012 17:18:00

By Ben Hirschler 

   LONDON, Feb 28 (Reuters - How to measure medical corruption? Tuan Anh Nguyen, a researcher at Hanoi University of Pharmacy, believes informal payments to doctors are "a dominant factor" in high prices of the older off-patent drugs that make up the lion's share of prescriptions in many emerging markets. 

   After interviewing doctors, pharmaceutical companies, government officials and pharmacists in both the private and state hospital sectors, he concluded in a study published last year that around 40 percent of the drugs' price in Vietnam is typically spent on offering financial inducements to doctors. 

   "When I talk to colleagues in some other Asian countries they say the situation is the same," he told Reuters.

   His investigation broke down the different legal and illegal components that contribute to the cost of drugs in Vietnam, and found 40 to 60 percent of the final price could be spent to induce prescribers to use particular medicines, and to persuade procurement officers inside hospitals to buy them. The biggest share went to doctors. 

   Nguyen said the problem was worse with generic medicines sold by Asian companies, although his study did not name any firms. In Vietnam the price of these is sometimes even higher than that of the original branded product, in order to recoup payments made to doctors by drug companies trading these medicines. 

   But Western drug firms are not immune: pharmaceutical company representatives who spoke to Nguyen reported that doctors typically expect a commission of about 15 percent from European drug makers; the figure they look for from Asian producers is nearer 40 percent. 

   The study, which was presented at the International Conference for Improving Medicines in Antalya, Turkey, last October, found multinational companies tend to prohibit bribes, officially at least, although pressure to achieve sales targets often means representatives ignore this and give money to prescribers. 

   At other times, multinationals pay for one-off benefits like luxury holidays that would be prohibited under anti-kickback rules adopted by the drug industry in the United States. 

   Doctors surveyed said they took the cash and non-cash offers to make up for low salaries, and it was common for commissions from the pharmaceutical industry to become the main source of income for some physicians, leaving those reputable doctors who are determined to stay "clean" out in the cold. 

   It's a situation one foreign drug salesman says has turned the system upside down: "Now, the worse the doctors, the more money they have. It's ridiculous."  

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27.02.2012 23:30:00
Drug Approval Listing



27.02.2012 20:02:28
MONDAY, Feb. 27 -- A second company has issued a voluntary recall of birth control pills because of a packaging error that could lead to incorrect dosing and expose women to unintended pregnancies. Glenmark Generics Inc. said the seven lots of...



27.02.2012 18:17:37
As employee benefit budgets remain tight, employers are adopting plan design changes that reduce drug benefit coverage and improve pricing, according to the Pharmacy Benefit Management Institute.



27.02.2012 18:17:37
Catalyst Health Solutions Inc said it will buy Walgreen Co's pharmacy benefits management unit for about $525 million in cash, a deal that might spur more consolidation before big generic drug launches that could boost the business.