FDA's Drug Safety and Risk Management Advisory Committee will be a tougher venue for drug sponsors during the next four years - long-time consumer advocate Sidney Wolfe recently was named a permanent committee member.

Wolfe's committee term runs from Aug. 8, 2008, to May 31, 2012.

Wolfe, a highly visible pharma gadfly, has headed Public Citizen's Health Research Group for 36 years. From that platform, he has brought a substantial number of drug and other product safety issues to public attention.

He earned a MacArthur Foundation "genius award" in 1990. The accolade recognized his ability to use the political/media/regulatory system to question the safety and use of pharmaceuticals.

While advisory committees operate as a group when convened by FDA, Wolfe offers a pointed example of how one individual can impact a meeting.

In May, he participated as temporary voting member in the joint meeting of the Drug Safety and Anesthetic and Life Support Drugs committees on Cephalon's Fentora . The company is seeking expanded approval of the fentanyl buccal tablet for management of breakthrough pain in patients who already are receiving and tolerant to around-the-clock opioid treatment for underlying chronic pain. The firm submitted an sNDA for the expanded indication with a revised risk-management plan.

The sponsor hoped the committees would help it win support for what is now a prevalent off-label use of the product.

But instead, it encountered a virtual inquisition about how the company had lost control of a drug of abuse in the marketplace. (¹ 'The Pink Sheet,' May 12, 2008, p. 3). And now, the sponsor faces the task of showing FDA it can cut back existing use in the market.

Wolfe played a significant role in setting the tone 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 learned of Wolfe's participation only a few days before the meeting. His participation may be unsurprising, but still challenging, for a number of companies in just the next few months.

Upcoming drug safety panel issues

Pain Therapeutics and Alpharma have opioid pain-management products ( Remoxy RT and Embeda ) scheduled for a joint meeting of the Anesthetic and Drug Safety Committees, Nov. 13-14. That meeting could be a reprise of the Fentora meeting and offers the advisory committee further opportunity to encourage FDA to move toward tougher post-market controls on abusable pain-management products.

In December, the drug safety panel will meet together with the Pulmonary Drugs and the Pediatric Drugs committees on a class of products that reaches a much wider patient population: asthmatics using beta agonist inhalers. The advisors will discuss of the safety of long acting beta-2 agonists salmeterol and formeterol, which are ingredients in a number of major products ( Serevent , Advair , Symbicort and Foradil ) from GlaxoSmithKline, AstraZeneca and Novartis.

With the growing importance of post-marketing surveillance and Risk Evaluation and Management Strategies, FDA is likely to consult increasingly with both the drug safety panel and its individual members on a variety of issues.

The panel's role and clout in the current environment were underscored by Bruce Burlington in a July FDC/Windhover audioconference entitled "The Road to FDA Approval: Advisory Committee Survival Strategies."

For advisory committees in general, some companies "came in focused on one narrow aspect of what they thought the issue was, and they totally missed the issue that was in front of the public from the mass media, that the patient advocacy groups and individuals were going to bring to light in the open public hearing, that the government was worried about, that the academic community was worried about, and as a direct consequence it has turned into a fiasco for the company," the former Wyeth VP and former FDA official commented.

And more specifically, he urged companies that "come before Drug Safety and Risk Management to pay attention to the title of the advisory committee - if you come to drug safety and you don't even present a risk-management plan, you've clearly missed that big story."

- Cole Werble (c.werble@elsevier.com)

A Seat At The Drug Safety Table: Public Citizen’s Wolfe Joins FDA Advisory Committee

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