I think that you could argue that Thalidomide is an imminent hazard as it was used for morning sickness and the rates of deformity was 50%. In addition even a single tablet taken during a specific time frame caused the birth defects. Thus unlike Vioxx and some other drugs the toxicity was with acute use and had a very high risk of occurring and was not primarily with chronic use.

Also birth defects in babies gets a lot more attention than old people dying.

I am unfamiliar with Mer-29.

That language leaves a universe of interpretation. I wonder if 60s thalidomide or MER-29, which definitively entailed fraud on FDA but were also not removed for that reason, would be barred from marketing under existing regulations.

Contained in THIS SORT are all of the Pharmalot articles that contain the words “FDA” and “Fraud” within the same article. There are 64 articles dating back to February 2007.

I haven’t drawn any conclusions, this is just raw information.

“Provided, That if the Secretary (or in his absence the officer acting as Secretary) finds that there is an imminent hazard to the public health, he may suspend the approval of such application immediately, and give the applicant prompt notice of his action and afford the applicant the opportunity for an expedited hearing under this subsection”

This is the crux. I can understand why these particular drugs might not be considered imminent dangers.

It’s become worse since then. Now the burden is so high for removing a drug for safety that we probably couldn’t withdraw Vioxx now.

Salmon

Given the phrasing re: “due notice” and “opportunity for hearing,” it sounds to me that there remains a good deal of wriggle room, at least in actual practice.

Indeed, we know that in the case of drugs like Rezulin, Baycol, fen-phen, and others, all sorts of misrepresentations were made to FDA–acts of commission and omission. Eventually these drugs were, indeed, withdrawn. But not until a process that dragged on for years, and often through events that were instigated by forces outside FDA or by mavericks acting within the agency in concert with outside forces.

“The Secretary shall, after due notice and opportunity for hearing to the applicant, withdraw approval of an application with respect to any drug under this section if the Secretary finds that the application contains any untrue statement of a material fact”

http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVDrugsandDevices/ucm108125.htm

Sorry about getting the refs wrong.

“An applicant also may be requested under existing regulatory procedures to recall products affected by the wrongful acts, or otherwise lacking adequate assurance of safety, effectiveness, or quality.”

So that is the “nuclear option” which, as above, almost never happens.

The policy as conveyed by Kessler in this 1991 document was in response to the generic drugs scandal, primarily involving bribery.

As I read the document, there is no automatic withdrawal of approval for marketing a product (drug or device) if fraud or bribery has occurred.

Rather, the FDA seems is reserving a range of options, including withdrawal.

As we’ve seen from a range of cases, actual withdrawal of permission to market appears to be very rare. Instead, we have the usual CIAs, warnings, etc..

So, in sum, I believe Jaynesday is correct that even the most heinous fraud does not necessarily compromise marketing a drug or device–which, indeed, almost never happens.

Spam: It happens.

Oh well — Namaste