Two recent articles this past week highlight issues that question the validity of FDA approval of new drugs. This is on the heels of the spotlight on Big Pharma’s efforts to circumvent the Hatch-Waxman provisions designed to encourage generic company challenges to weak drug patents, and alleged abuse of the citizen petition process. In sum, one might be left wondering if the politics (read $) of new drugs and Big Pharma have overshadowed legitimate government functions of approving safe drugs and preserving patent rights for only the truly innovative.
The New York Times reported Monday that scientific advisors to the review process may have conflicts of interest that may jeopardize the integrity of the approval process. According to the article, critics have “complained for years” that those who sit on FDA approval boards often have “deep financial ties to drug makers.” The FDA often relies heavily on advisory boards for making decisions regarding drug approval. As a result, advisory board recommendations can have great influence on both the approval of the drug, and the stock price of the company that manufactures the drug. According to the FDA, however, finding qualified scientific advisors without financial ties is not as easy as it sounds.
Regardless, the FDA is currently debating new rules that would serve a policing function for who can sit on advisory boards. One proposed mechanism would be to exclude advisors who are paid directly by drug maker’s marketing departments. That seems to be a fair start.
Reuters, in an article posted last Friday, reports results of a somewhat alarming survey conducted by the “liberal-leaning Union of Concerned Scientists.” The study reports that about 15% of FDA scientists say they have been “wrongly asked to withhold or alter information or their conclusions in agency documents.” 17% said that they had been asked to report incomplete, inaccurate or misleading information to the public, industry, or other government officials. Perhaps most surprising, a stunning 40% said they feared retaliation if they “voiced concern about product safety in public.” While these numbers are indeed unsettling, one has to wonder whether there is any basis in FDA spokeswoman Susan Bro’s comments that the survey was a “counter-productive exercise based on leading questions and innuendo.”
Regardless, in light of Big Pharma’s recent practices of marketing branded drugs as generics (so-called “authorized generics”), paying generic manufacturers to stay out of the market during infringement litigation (”reverse payments”), and the alleged misuse of citizen’s petitions by drug manufacturers, my view would be that the FDA would be best served by keeping its nose clean while the ruckus dies down.
Posted July 27th, 2006 by Nicole Tepe in
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On Thursday, Pfizer announced that it plans to introduce a generic version of its antidepressant Zoloft in the United States as soon as a rival generic hits the market, which could be as early as Saturday (in what is known as the sale of an “authorized generic”). The patent on Zoloft expires in two days.
Pfizer spokesman Paul Fitzhenry confirmed that Pfizer’s Greenstone unit is ready to launch a generic version of Zoloft, also known by its active ingredient sertraline, “if and when others release” their generic versions of the drug.
A generic company that is first to break a branded drug’s patent is awarded a 180-day period of exclusivity over other generics. But an authorized generic can compete in this period. “Generic companies are aggravated because it means they don’t get a 180-day period of market exclusivity,” said Ira Loss, an analyst at Washington Analysis.
Teva inherited the rights to generic Zoloft through its acquisition of Ivax Corp. earlier this year. Ivax received Food and Drug Administration approval in December 2004 to sell a generic version of Zoloft after the patent expires, and 180 days of marketing exclusivity upon launch. However, the exclusivity period does not apply to authorized generics.
By launching their own generic products, branded companies hope to hang on to a bigger portion of sales from the drugs they developed and discourage generic companies from making aggressive, early patent challenges. Generic companies, however, say they are not deterred.
As more blockbuster drugs lose patent protection, greater attention has become focused on the practice of branded drug makers allowing “authorized generics,” or unbranded versions of branded drugs they control, to compete with dedicated generic drug makers. Over the next five years, brand-name prescription drugs representing about $50 billion in annual sales are scheduled to lose patent protection.
Teva downplayed the news, probably still stinging from Merck’s decision last week to sell its generic Zocor at prices well below other generic competitors, made through special deals with health care companies. (Teva has the 180-day exclusivity period for Zocor which went off-patent last Friday). Pfizer has not announced whether or not it will follow the same pricing strategy as Merck did for Zocor. If it does, do you think the FDA will stand up and take notice and put an end to these bad days for the generics?
Posted June 29th, 2006 by Karlyn in
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Maybe it’s the cold weather and the gloom of February, but cupid did not bestow any Valentine’s day gifts on the biotech industry for the month of February.
“Although the biotech industry managed to hold its own during much of the month with the Burrill Select Index up slightly into the final weekend of February, the news that Biogen Idec (BIIB) and partner, Elan PLC (ELN) were pulling from the market their new drug for multiple sclerosis, Tysabri, not only gutted the value of both companies immediately, but also dampened the performance of other publicly traded biopharmaceutical firms,” noted G. Steven Burrill, CEO of Burrill & Company, a San Francisco based life sciences merchant bank. The Burrill Biotech Select Index ended February down 2%, compared to the NASDAQ, down less than 1% and the DJIA, up nearly 3% for the month.
“The news about Tysabri couldn’t have come at a worse time, following as it did in the footsteps of tremendous controversy surrounding the use of COX-2 inhibitors,” said Burrill. “Less than two weeks after the FDA expert advisory panel voted in favor of allowing the arthritis painkiller Vioxx and other COX- 2 inhibitors to remain available on the market under strict conditions, Biogen Idec and Elan make the announcement that physicians should suspend dosing of Tysabri until further notice … investors were taken completely off guard,” he explained.
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Posted March 14th, 2005 by Karlyn in
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