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FDA’s letter to GSK warns Big Pharma to get its act together and start reporting all adverse event information or suffer the consequences of fines and criminal proceedings.

In his In Vivo blog, Micheal McCaughan suggests that the warning letter sent to GlaxoSmithKline (GSK) about its diabetes drug Avandia is more than just bad news for the company, but a warning for other biopharmaceutical companies as well.

After inspecting the firm’s post-market adverse event reporting procedures and discovering that GSK has not filed all the necessary reports on Avandia, the FDA issued a strongly worded letter, addressed to the firm’s CEO Jean-Pierre Garnier. Since the Food, Drug and Cosmetics act is a “strict liability” statute, top executives — starting with the CEO — can be held criminally accountable for violations they knew nothing about.

McCaughan says this is the key section in the letter:

FDA’s inspection revealed that your firm lacked appropriate knowledge of the studies associated with Avandia, resulting in the reporting deficiencies noted. Absent a clear explanation of the extent and cause of these deficiencies and an adequate plan to correct them, we are concerned that similar deficiencies in the postmarket reporting for your firm’s other FDA-approved drugs may exist . We expect that your corrective actions will include a comprehensive evaluation of your firm’s reporting of postmarketing studies for all drug products for which your firm holds an approved application.

McCaughan goes on to say: “The warning letter should be a must read for all biopharma companies with products on the market (and all companies who hope to be so lucky as to have products some day). The letter does indeed add to GSK’s headaches, but for the rest of the industry it should serve as notice that the agency is likely to do a lot more enforcement of postmarketing study reporting requirements in the months and years ahead.

“Congress, remember, has just handed FDA new enforcement authority over postmarketing trials, in the form of the ability to mandate Phase IV studies — and fine sponsors who fail to live up to their commitments.

“In the new world of post-marketing oversight and regulation,” he adds, “expect the agency to make sure that every company gets that message loud and clear.”

Post-marketing adverse events are what we, the public, are all too familiar with. That’s when we usually hear about drug problems — headlines citing injuries, deaths and massive lawsuits, or worse, learning that someone we know or love is a victim.

The FDA’s record on ensuring that prerelease drug testing is thoroughly done before drugs reach the market has been less than stellar in recent years. Many clinical trials showing that a drug had problems were kept from the FDA and the public. Most new drugs are released on the public after being tested with less than 1000 to 3000 carefully chosen patients. This is why the FDA admits that the real tests of a new drug only occur after their release to the public and is why post-marketing disclosures are so important.

That is why it is so critical that post-marketing adverse effects are reported promptly. But post-marketing muscle has been flabby as well, with drugs causing hundreds or even thousands of adverse events before the FDA acts.

Post-marketing inspection and reporting is at least as important as prerelease clinical trials and testing, because no program can possibly cover every possible scenario that could and will exist in the real world. Post-marketing vigilance is critical, and we’re glad to see the FDA stepping up to the plate to get the attention of Big Pharma, and exercising the new muscle given to it by Congress last year in changes to the FD&C Act.
We just hope that the FDA is not just making a show but are serious about this and will take affirmative action if GSK doesn’t immediately correct the problem.

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