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Pending FDA Reauthorization Bill Could Be Far-reaching

With a crucial drug-safety law set to expire Sept. 30, lawmakers are writing legislation that not only would reauthorize essential Food and Drug Administration user fees, but also could expand the clout of the powerful regulatory agency.

The FDA relies on industry fees, which account for nearly 25 percent of its budget, to ensure timely reviews of drug applications and to handle the agency’s burgeoning workload. The fee’s reauthorization is a priority for many lawmakers, including Sen. Edward Kennedy (D-Mass.) and Mike Enzi (R-Wyo.), the chairman and ranking member of the Health, Education, Labor and Pensions Committee, respectively.

The lawmakers said they back renewing the user fees. “This program has been a great success in speeding safe and effective new drugs to patients, and Congress has a responsibility to act quickly to renew it,” Kennedy and Enzi said in a statement in January.

Without the fees — an estimated $300 million to $400 million in the agency’s fiscal 2008 budget — the FDA may be forced to lay off a few hundred drug reviewers, which could delay new drug applications for years, said Marc Scheineson, a former FDA associate commissioner who’s now a partner at the law and lobbying firm Alston & Bird.

That makes reauthorization of the Prescription Drug User Fee Act a top priority for both the government and the drug industry — and also makes both sides likely to accept various riders as part of the PDUFA reauthorization. Potentially dozens of riders “could be added to this train,” including language giving the FDA the authority to regulate the tobacco industry, Scheineson said.

High on the list of potential add-ons is an expansion of the FDA’s drug review authority. Kennedy is ready to attach to PDUFA a bill he authored, the Enhancing Drug Safety and Innovation Act, former Hill aides and agency staff said.

That bill, S.484, would require companies to take additional steps to ensure safety to get their drugs approved. For instance, new product applications would need to include risk evaluation and mitigation strategies. The bill also would allocate user fees to increase the FDA’s drug safety efforts, create tighter rules for how companies test their drugs for efficacy and limit conflicts of interest in agency advisory committees.

In the meantime, Rep. Henry Waxman (D-Calif.), who chairs the House Oversight and Government Reform Committee, also is writing legislation that will serve as a companion to S.484, a Waxman aide told CongressNow. But Waxman has yet to decide whether to add his legislation to PDUFA reauthorization, the aide said.

The Senate is planning a markup of a PDUFA reauthorization at the end of March, with the goal of getting the bill on the president’s desk by the August recess, said Alexander Vachon, an industry consultant and former Republican staffer on the Senate Finance Committee. “The Senate is on an incredibly aggressive schedule,” Vachon said.

What the Kennedy bill, and likely the Waxman bill, will not include is controversial language establishing a separate agency office to address drug safety.

A competing bill, S.468, sponsored by Sens. Chuck Grassley (R-Iowa) and Chris Dodd (D-Conn.), proposes a new office that would report directly to the FDA commissioner on safety issues. That office, the Center for Postmarket Evaluation and Research for Drugs and Biologics, has been the focal point for a bitter dispute between advocacy groups who say the center is necessary to ensure the independence of agency drug reviewers and industry officials who argue that an additional level of management is unnecessary.

Separately, Kennedy is considering language that would speed up the introduction of generic versions of biologic products into the market, and a provision that would limit compounding, said Scott Gottlieb, a resident fellow at the American Enterprise Institute and a former FDA deputy commissioner.

Biologics are products, such as vaccines and antitoxins, made from living organisms and used to treat or prevent diseases. Compounding involves pharmacists using bulk ingredients to customize some drugs for specific patients.

Speeding the introduction of generic versions of biologics would make them more readily available at lower prices to consumers, but would also ramp up competition for existing manufacturers.

Kennedy’s office did not return calls seeking comment.

The question, Scheineson said, is, “How much stuff will they be forced to swallow?” If lawmakers go too far for industry’s tastes, he said, they will either work to strike the offending language before it is introduced or try to get Members to make changes during markup.

Industry has responded to this push by making the point that a bill loaded down with too many unrelated items is less likely to become law before the fees expire, an industry insider said.

While industry officials believe additional drug-safety measures likely are to be added, they are balking at the biologics proposal. These cheaper products, which the industry calls “follow-on” biologics, present safety, complexity and other questions that are better addressed through hearings, markups and other means than being added into PDUFA reauthorization.

So far, lawmakers’ responses have been mixed, but as more briefings are held, industry believes it is getting more support to exclude biologics from reauthorization, the source said.

For its part, the FDA itself will soon send its own recommendations on reauthorizing PDUFA to Congress, including proposed legislative language, Vachon added. The FDA is also expected to testify before the House Energy and Commerce Committee in early March about its handling of previous drug safety issues.

The agency has been under fire from lawmakers such as the Iowa Senator for its handling of drugs such as the antibiotic Ketek (or telithromycin) made by sanofi-aventis. These lawmakers have accused the FDA of using faulty data to approve the drug and withholding their concerns about this information from an agency advisory panel.

The FDA has been asked by Energy and Commerce Chairman John Dingell (D-Mich.) to provide, by Feb. 28, information about its handling of both pre-market review and post-market surveillance of Ketek, according to a Feb. 16 letter.

The FDA could not be reached for comment.

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