Washington Editor

WASHINGTON - FDA Commissioner Andrew von Eschenbach on Friday offered strong reassurances to the public and Congress that industry supplements to the agency's annual budget come with no strings attached.

"This is a fee for service," he said. "No one is buying the FDA." His comments opened a meeting on renewing the Prescription Drug User Fee Act (PDUFA), during which agency officials outlined the industry-negotiated package on what will be its fourth iteration and received public feedback on the proposal for $393 million in user fees during each of the next five government fiscal years. After a further public comment period, the FDA will forward its final PDUFA IV draft to members of Congress, many of whom may want to slice up the recommendation and insert broader oversight powers, given their wont to continuously level conflict-of-interest charges against the regulatory body and the industry.

Clearly, von Eschenbach sought to use his platform to stress the importance of user fees for maintaining and improving the agency's current capabilities, while also deflecting and neutralizing criticisms of the program. To underscore his theme, he emphasized the importance of an adequate budget comprised of both appropriated dollars and user fees to ensure that the FDA remains a bridge to getting new drugs to patients rather than a barrier.

"There should be no confusion about the FDA and who in fact the FDA serves, and what in fact our purpose and functions are all about," von Eschenbach said. He added that protecting and promoting public health is "the only reason why we're here, and it's the only purpose for which our resources will be utilized, regardless of their source."

A number of patient advocates spoke generally in favor of the agreement on PDUFA IV and warned Congress of the consequences of using a heavy hand in the renewal process.

Amy Comstock, CEO of Parkinson's Action Network, spoke of her organization's worries that "safety concerns will trump speed" despite the higher risk tolerance of some patients groups. She added that ultimately a climate that's too risk averse "will slow down getting drugs to market."

That theme was echoed by Jeff Allen, director of policy for Friends of Cancer Research, who also urged congressional appropriators to allocate more federal funds to the FDA's budget.

The agency and its PDUFA proposal didn't wholly avoid criticism, though.

Kim Witczak blamed her husband's suicide on the use of an antidepressant whose serious side effects were allegedly hidden from regulators, and said that the user fee system seems to promote conflicts of interest "from the get-go." She voiced support for a proposition floating around Capitol Hill that would allow Congress to disperse PDUFA-generated funds, thereby obviating accusations of undue industry sway. She also expressed support for legislation that would move the FDA's post-approval safety office outside its drug approval division.

"The true clinical trial exists in the real world," Witczak said, "when millions of Americans get a drug."

Bill Vaughan, a senior policy analyst with Consumers Union, said consumer and patient groups should have a louder voice during the next PDUFA negotiation in five years. He also advocated that more resources should be directed toward post-approval safety than the $30 million per year proposed in the current draft. Better defined safety goals would improve this system, he added, and also help ensure that safety consciousness doesn't slow drug development and approval timelines.

"What we want," Vaughan said, "is an agency that can walk and chew gum at the same time."

The FDA first publicized the industry-negotiated PDUFA recommendation last month, a proposal that includes increased fees to account in part for more post-approval safety oversight work, workload growth and escalating staff costs. A related fee-for-service item included in the request is aimed at collecting funds from companies requiring FDA review of direct-to-consumer advertising. (See BioWorld Today, Jan. 12, 2007.)

Congressional debate on PDUFA IV will take place this spring, and a final version is expected to pass early this summer to give the FDA an appropriate cushion for calculating staff funding ahead of the next government fiscal year that begins Oct. 1.

Biosimilar Bill Reintroduced

It's back.

Lawmakers last week reintroduced legislation on follow-on biologicals, a subject of intense industrywide interest, which would allow the FDA to approve abbreviated applications for such products if they are considered comparable or interchangeable with pioneer versions. The measure would give the agency discretion to determine whether there are clinically meaningful differences between follow-ons and original biologicals, as well as prudence on mandating clinical studies on a case-by-case basis.

But such language doesn't satisfy critics at the Biotechnology Industry Organization in Washington.

Amit Sachdev, BIO's executive vice president for health, said the group has "been consistent for some time" on several points: All follow-ons need clinical studies, and there should be some period of market exclusivity to preserve innovation. The bill, he told BioWorld Today, fails to meet either of those standards.

Called the "Access to Life Saving Medicine Act of 2007," H.R. 1038, its principal sponsors include Rep. Henry Waxman (D-Calif.) and Sens. Charles Schumer (D-N.Y.) and Hillary Rodham Clinton (D-N.Y.). They first introduced the bill late last summer. (See BioWorld Today, Oct. 3, 2006.)

Proponents lauded the eventual savings that abbreviated approval pathways for follow-ons could provide. According to the St. Louis-based pharmacy benefits management firm Express Scripts Inc., they could save U.S. plan sponsors and patients $71 billion over a decade, with $3.5 billion in savings during the first year. The analysis, based on a review of biotech drugs for multiple sclerosis, anemia, growth hormone deficiencies and diabetes, used a 25 percent discount off the branded equivalent medicine.

But Sachdev called such projections "substantially exaggerated," noting a number of flaws in the analysis: It uses a fully interchangeable construct for follow-ons, which the FDA has indicated isn't possible; it ignores existing patent protections; and it assumes no competition from next-generation biologicals.

Thomas Resurfaces In The District

Recently retired congressman Bill Thomas (R-Calif.), who was elected to the House in 1979, joined the American Enterprise Institute, a think tank based inside the Beltway. Formerly the chairman of the House Ways and Means Committee, in his new appointment as a visiting fellow he will study health care policy and other issues related to the legislative and political processes.