FDA Has a New Guard Dog: He’s a Wolfe

The election is near and Washington is rife with chatter about who will go where in the next administration.

But FDA made a Washington appointment in early August that will have as much (if not more) impact on many drug sponsors for the next four years than many of the more visible and high-profile appointments expected in the health field.

On August 8, FDA made long-time consumer advocate and pharma gadfly Sidney Wolfe (above) a permanent four-year member of the Drug Safety & Risk Management Advisory Committee. His term began August 8 and lasts through May 31, 2012. The information was only recently posted publicly by the agency.

Wolfe has headed Public Citizen's Health Research Group for 36 years. There are only a handful of products during that period with safety issues, where the issues were not brought to the public attention by Wolfe. He earned a MacArthur genius award in 1990 acknowledging his ability to use the political/media/regulatory system to question the safety and use of pharmaceuticals.

How much impact can one person have on an advisory committee ?

Ask Cephalon, which faced Wolfe at a May advisory committee looking into an expanded indication for Fentora. What the sponsor hoped would turn into an important expanded use for the product turned instead into an inquisition about how the company had lost control of a drug of abuse in the marketplace. Far from getting an expanded indication, the sponsor faces the task of showing FDA that it can cut back existing use in the market.

Wolfe played a significant role in setting the tone and timber of the Fentora advisory committee. He urged FDA to use its new post-market control powers to increase control of use of the drug for approved patient populations.

Cephalon did not know that Wolfe would be part of that review until three days before the meeting was scheduled. He was an unpleasant surprise for the sponsor. It might not be much better for companies prepared for sessions with him; and, at least five sponsors have upcoming dates with him in the next two months.

Pain Therapeutics and Alpharma have opioid pain management products (Remoxy RT and Embeda) scheduled for a joint meeting of the Anesthetic & Life Support Advisory Committee and Drug Safety & Risk Management Advisory Committee on Nov. 13-14. That meeting could be a reprise of the Fentora meeting and offers the advisory committee a further opportunity to encourage FDA to move toward tougher post-market controls on abusable pain management products. It could help set the tone for the post-market for the wide range of pain drugs and formulations in development.

In December, the drug safety advisory committee will be meeting with the Pulmonary Drugs Advisory Committee and the Pediatric Drugs Advisory Committee on a class of products that reaches a much wider patient population: asthmatics using beta agonist inhalers. The advisory committees have two days set aside for discussion of the safety of long acting beta-2 agonists (salmeterol and formeterol). The ingredients appear in a number of major products (Serevent, Advair, Symbicort and Foradil) from GSK, AstraZeneca and Novartis.

From his advisory committee post, Wolfe will be able to push for more active post-marketing monitoring and control programs across the broad gamut of drug classes. FDA calls in the drug safety committee for joint meetings across drug classes. Wolfe won't be restricted to any narrow single class of product.

That leads to one final thought about where he may be asked to offer his opinions in the near future. Wolfe's resume shows an early interest in the cellular mechanisms of blood clotting. It will be interesting to see if FDA asks either the drug safety committee or Wolfe as a visiting advisory committee member to bring that knowledge to upcoming reviews as new anti-clotting compounds come up for approval .

Eli Lilly better hope that, if there is an advisory committee for prasugrel next February, FDA does not turn loose its new Wolfe.