ViroPharma Sues FDA Over Generic Decision
1 CommentBy Ed Silverman // December 19th, 2008 // 11:49 am
An interesting battle has been playing out between the little biotech and the agency over a 2006 decision to allow a different standard for permitting generic versions of it Vancocin antibiotic, which is used to treat gastrointestinal infections. And the latest twist has ViroPharma filing a lawsuit yesterday against the FDA and the Department of Health and Human Services to force the agency to turn over its files on its controversial decision.
The ruckus began in March 2006 when the FDA’s Office of Generic Drugs responded to an inquiry from Infinium Capital, a Canadian investment firm, about agency standards for allowing generic Vancocin. Dale Conner, the director of the OGD’s division of bioequivalence, wrote an Infinium broker that in vivo, or human studies, would no longer be required. Instead, a rapid dissolution test would suffice. The firm subsequently released a report indicating generic versions may appear sooner than previously expected, hurting ViroPharma stock.
For its part, ViroPharma later complained the OGD similarly informed still others, including a would-be generic rival, of its decision, but was itself never informed. Ever since, the biotech has been locked in a contentious battle with the FDA to learn how the decision was made, arguing that the lower standard could harm patients, not only its own bottom line, and may have violated FDA procedures. (here is its May 2006 petition to the FDA that copiously details its version of events).
Earlier this week, the FDA released a draft guidance for establishing bioequivalence for Vancocin, suggesting that its earlier decision did not hold up, but also issued another requirement that ViroPharma contends is puzzling and inequitable. “Faced with its own data that do not support OGD’s March 2006 bioequivalence approach, FDA was forced to modify its rationale yet again, and now proposes that a generic copy does not need to demonstrate rapid dissolution,” Tom Doyle, the biotech’s vp of strategic initiatives, says in a statement, “and now proposes that a generic copy does not need to demonstrate rapid dissolution, and adds yet another standard, Q1/Q2 sameness, for which there are more questions than answers.”
MyPharmalotID
My, my…
Corruption within the FDA and HHS just goes on and on.
1. You can see it in how the FDA and HHS handled VaxGen and their next-generation anthrax contract. For a real eyeopener regarding VaxGen’s major competition and the whole environment at the time, look at this article:
http://rawstory.com/news/2007/Wellconnected_drug_company_obtained_anthrax_vaccine_0529.html
If the SEC had been awake, they could have looked into how VaxGen traded on the OTC in the days before the announcement was made that the government was terminating VaxGen’s contract for a new anthrax vaccine). Who in the FDA and/or HHS and/or industry leaked word to Wall Street??? The GAO concluded that the government played a role in the demise of the contract, but of course, it then was too late to save VaxGen or the new vaccine. To this date, nothing has been heard from the HHS OIG or the FDA regarding any investigation into the matter.
2. Look at how the FDA handled the Provenge Advisory Committee on March 29, 2997, and the aftermath of that travesty. We still have yet to hear from the HHS OIG, Dan Levinson, in the matter of Drs. Scher’s and Hussain’s conflicts of interest and what part they might have played in the delay of Provenge approval. (Provenge is a therapy for prostate cancer.) That Schering-Plough signed a $440M deal with Novacea 3 weeks after the FDA called for more data, and that Dr. Scher was the co-lead on the phase 3 trials for Asentar, Novacea’s lead drug for prostate cancer, at the time of the Provenge AC meeting, frankly, stinks to High Heaven. Hello? Anyone home at the HHS OIG?
3. And then we have the tale in this Pharmalot article, where OGD leaked word to a Canadian financial house, allowing it and their clients to short the stock before any announcement was made. Where is the HHS OIG on this? Where is the SEC?
In general, where is our government???!!!
It would appear that Washington is sorely in need of adult supervision. What passes for government oversight, it appears, is nothing more than children playing at work.
More sadness in America. A government in total disarray. Totally dysfunctional!!!!