Outgoing GSK chief speaks on FDA approvals

LONDON GlaxoSmithKline chief executive officer Jean-Pierre Garnier recently said that he does not foresee the Food and Drug Administration softening its position on drug approvals, according to published reports.

Garnier, who will be stepping down from the company next week at its annual meeting, said, “This is not a pendulum, society wants to avoid risk. We have to tease out the rare side effects earlier.”

Garnier added that the FDA has raised the bar and companies must adapt by shifting drug development priorities and conducting trials on targeted sub-populations to better realize rare side effects prior to regulatory submission.

Other senior industry personnel suggest the U.S. election has had a strong impact on the FDA’s position on new drugs and Garnier believes “the market will get reconstituted” with a new focus on so-called “progressive blockbusters,” which will ultimately reduce drug development costs by eliminating false negative results sooner.

In regard to his stepping down, Garnier confessed in an interview with the Financial Times that he wishes he had done things differently with GSK’s diabetes drug Avandia, in terms of releasing data earlier on about the risks of the drug to increase the risk of a heart attack.

In April, the FDA issued a warning to the company for not reporting safety results on Avandia. Avandia received the prominent, “Black Box” warning label last year and the FDA said that between 2001 and 2007 GSK neglected to update the agency on over 10 ongoing studies of Avandia, as required by regulations. The FDA acknowledges that information from those studies was included and disclosed in other notices to the government; however, the FDA categorizes the omissions as “serious,” saying that the omissions “may be symptomatic of underlying post-market reporting failures.”