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.
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.
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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