According to an article in last week's
The Washington Post, orphan drugs accounted for 11 of the 30 new drug approvals in 2011. This represents the highest percentage in the last thirty years. Specifically, last year saw new drug treatments for lupus and Hodgkin's lymphoma for the first time in 50 years and 30 years, respectively.
The
Orphan Drug Act defines a "rare disease or condition" as one that affects less than 200,000 people in the United States, or one that affects more than 200,000 people in the United States but there is no reasonable expectation that the costs of developing and making available the drug will be recovered from its sale in the US.
See
21 U.S.C. § 360bb. Applicants may petition FDA to give a particular drug orphan drug status. If FDA determines the drug meets the criteria required for orphan drug status, the applicant may enjoy the following benefits: (1) seven years of market exclusivity, (2) tax credits, (3) no user fees, (4) help on the costs of clinical testing, and (5) a shorter review period.
Another reason for the increase in orphan drug approvals appears to be the looming expiration of numerous patents covering more traditional ailments. EvaluatePharma Ltd., a London research firm, notes that the patents of drugs generating around $250 billion in annual sales are set to expire in 2016. With the expectation that generic versions of these drugs will flood the market, innovator drug companies are hoping the orphan drug market, where there are often fewer treatment options, can provide replacement revenue. Even with smaller numbers of patients taking these drugs, they often demand higher prices. Some drugs cost in the hundreds of thousands of dollars for a year's worth of treatment.
Kader Arif, the lead Acta negotiator in the European Parliament, says Acta potentially cuts access to lifesaving generic drugs and restricts online freedom
The French MEP who resigned his position in charge of negotiating the international Anti-Counterfeiting Trade Agreement (Acta) has said it "goes too far" by potentially cutting access to lifesaving generic drugs and restricting internet freedom.
In an exclusive interview with the Guardian, Kader Arif – a member of the European parliament's international trade group, who was the lead negotiator over Acta – said that despite talks over the agreement having begun in 2007, "the European parliament, which represents the rights of the people, had no access to this mandate, neither had it information of the position defended by the commission or the demands of the other parties to the agreement".
Arif resigned in protest on 26 January as the EU signed the treaty, saying that he wished to "denounce in the strongest manner the process that led to the signing of this agreement: no association of civil society [and] lack of transparency from the beginning".
He said that it now threatens online freedom, access to the use of generic versions of drugs for treating illnesses, and could potentially mean that someone crossing a border who has a single song or film on their computer could face criminal charges.
Asked what he thought European citizens should do, Mr Arif said: "Showing that there is interest and concern about this agreement is the best way of creating a real public debate, which was never possible until now because of the lack of transparency on this dossier. Especially if the timeframe is short, raising awareness of members of parliament will be crucial. And because Acta is a mixed agreement, it will have to be ratified both by the European parliament and by every member state of the union, so there is also an opportunity to organise debates at the national level."
He says that it is now impossible to renegotiate the agreement because the 11 key parties to it concluded their discussions on 1 October 2011: "the European commission negotiated it on behalf of the EU, on the basis of a mandate given by the member states in 2007."
That means, he says, that "at this stage one can only accept or reject the agreement – no change of the text is possible. If the right wing of the European parliament had not imposed such a tight calendar, the members of the European parliament could have drafted an interim report, which would have put conditionalities to the ratification of the agreement, by giving recommendations to the commission and member states on how to implement it. But this is no longer a feasible option."
"The title of this agreement is misleading, because it's not only about counterfeiting, it's about the violation of intellectual property rights," he told the Guardian. "There is a major difference between these two concepts."
Acta
has triggered public protests in a number of European and other countries, as well as online attacks by the hacking collective Anonymous. The US, EU member states, Australia, New Zealand, Canada, Japan and a number of other countries have signed it, although none has yet ratified it in national legislation.
The agreement would create an international framework and set of standards for a voluntary legal regime to enforce intellectual property rights across national boundaries.
Arif said one example illustrates this difference particularly well – the case of generic medicines. "Generic medicines are not counterfeited medicines; they are not the fake version of a drug; they are a generic version of a drug, produced either because the patent on the original drug has expired, or because a country has to put in place public health policies," he said.
A number of countries such as India and African nations have sought to use generic versions of drugs for infections such as HIV, which has often been resisted by pharmaceutical companies. Under Acta, Arif fears such countries would not have the same freedom to determine their own actions.
"There are international agreements,
such as the Trips agreement, which foresees this last possibility," he said. "They're particularly important for developing countries which cannot afford to pay for patented HIV drugs, for example.
"The problem with Acta is that, by focusing on the fight against violation of intellectual property rights in general, it treats a generic drug just as a counterfeited drug. This means the patent holder can stop the shipping of the drugs to a developing country, seize the cargo and even order the destruction of the drugs as a preventive measure."
He thinks that is a key flaw: "Acta also limits the flexibilities listed in the Trips agreements to support developing countries in need of generic drugs. When the question of finding the right equilibrium between protection of intellectual property rights and protection of final users is so crucial, Acta appears to be very unbalanced in favour of patent holders. This is one of the major problems with the agreement."
Internet freedoms could also be under threat if Acta is ratified in its present form, he says. "The chapter on internet is particularly worrying as some experts consider it reintroduces the concept of liability of internet providers, which is clearly excluded in the European legislation." That could make ISPs, who provide internet access, liable for users' illicit file-sharing.
Arif also expressed concern that there could be more intrusive checks at borders to fight counterfeiting.
"I see a great risk concerning checks at borders, and the agreement foresees criminal sanctions against people using counterfeited products as a commercial activity," he said.
"This is relevant for the trade of fake shoes or bags for example, but what about data downloaded from the internet? If a customs officer considers that you may set up a commercial activity just by having one movie or one song on your computer, which is true in theory, you could face criminal sanctions.
"I don't want people to have their laptops or MP3 players searched at borders, there needs to be a clearer distinction between normal citizens and counterfeiters which trade fake products as a commercial activity. Acta goes too far."
The
text of the finalised treaty (PDF) has now been made public, and the European commission has begun to try to explain how Acta would work. It has also published a document called
10 Myths about Acta, asserting that the public was informed "since the launch of the negotiations"; that it is drafted "in very flexible terms" and that "safeguards and exceptions under EU law or under the Trips agreement remain fully preserved".
It also insists that "Acta is about tackling large-scale illegal activity … there is a provision on Acta specifically exempting travellers from checks if the infringing goods are of a non-commercial nature and not part of large-scale trafficking".
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It isn't often that a prescription product repurposed on the street then returns to the clinic. But that's just what's happening with ketamine, sold as a generic and by Pfizer (
$PFE) under the brand names Ketalar and Ketaject (and illegally as Special K). Studies testing the injectable against depression are yielding some dramatic results, described by patients in language familiar to recreational users.
Researchers from the National Institute for Mental Health and from Houston's Ben Taub General Hospital have administered ketamine to severely depressed patients with almost instantaneous results, NPR reports. Yale scientists have pinpointed a potential explanation: Ketamine appears to affect glutamate in the brain, triggering new connections among brain cells.
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"I feel that something's lifted or feel that I've never been depressed in my life," was how NIMH researcher Carlos Zarate described his ketamine patients' reactions. "And it was a different experience from feeling high. This was feeling that something has been removed." One Ben Taub study patient, who believes she got ketamine, not placebo, said she went home feeling "no more fogginess, no more heaviness." Both of them reactions that
LA Weekly
deemed obvious. "Any raver could have told you this," the paper said.
Ketamine has serious potential side effects, including hallucinations during its infusion--and, not insignificantly, addiction. But unlike drugs already approved as antidepressants, the injectable appears to work quickly, a big advantage for patients in crisis. Further study is on the way; the Ben Taub researchers say that if their trial shows that ketamine outperforms a placebo, they plan to conduct a longer-term study to determine whether its effects could be long-lasting.
- see the blog
post at NPR
- get
more, also from NPR
- see the
LA Weekly
post
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Important news for women using oral birth control products. Pfizer is recalling about one million packets of birth control pills in the United States because they may not contain enough contraceptive to prevent pregnancy.
"As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy," according to a Pfizer statement on
the U.S. Food and Drug Administration website.
Monthly doses contain 28 tablets total... 21 with contraceptive and 7 sugar pills. The pharamceutical company discovered that some of their blister packs had too many active tablets, some had too few and some had the tablets out-of-order.
Related:
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The recall involves 14 lots of Lo/Ovral-28 tablets and 14 lots of Norgestrel and Ethinyl Estradiol tablets.
Pfizer said the mix-up poses no health threat to women, but it urges those taking the affected products to "begin using a non-hormonal form of contraception immediately."
A company spokesperson told The Associated Press that the problem is the result of both mechanical error and a failure on the packaging line during visual inspections.
The pills in question were distributed nationwide.
Lot numbers of affected packs of Lo/Ovral®-28 (norgestrel and ethinyl estradiol)Tablets and Norgestrel and Ethinyl Estradiol Tablets (generic) follow on the table below:
| NDC |
Product |
Lot |
Expiration |
Configuration/Count |
|---|---|---|---|---|
| 24090-801-84 | LO/OVRAL® 28 | E15678 | 08/31/2013 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | E15679 | 08/31/2013 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | E15686 | 08/31/2013 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | E15687 | 01/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | E15690 | 01/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | E15698 | 01/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | E15700 | 02/28/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | E80434 | 07/31/2013 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | E80438 | 08/31/2013 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | F36908 | 02/28/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | F36909 | 02/28/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | F43915 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | F43926 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-801-84 | LO/OVRAL® 28 | F43927 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | E15677 | 08/31/2013 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | E15704 | 01/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | E15706 | 01/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | E80440 | 08/31/2013 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F16388 | 01/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F16390 | 02/28/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F22132 | 02/28/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F31330 | 02/28/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F36911 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F36913 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F43924 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F43925 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F43934 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
| 24090-961-84 | Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg | F53238 | 03/31/2014 | 6 Pilpacks® of 28 tablets each |
http://www.fda.gov/Safety/Recalls/ucm289770.htm
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