Challenges, Changes, Commitments

The Three Cs could be taxing on FDA resources as the new Congress brings stiffer oversight and leadership revisions to the agency
Feb 01, 2011


Jill Wechsler
One of the last acts of Congress in 2010 was to approve sweeping food safety legislation. The new law provides FDA with more authority to recall and monitor food products, boosts its inspection force, and strengthens its capacity to halt unsafe imports.

But this may be the last time for a while that the legislators bolster FDA's oversight capabilities or authorize added resources. With Republicans taking over the House last month and increasing their clout in the Senate, Congressional leaders are looking to cut federal spending and to aggressively examine administration health policies and regulatory programs. FDA is a clear target as agency critics zero in on an apparent slowdown in new drug approvals and the agency's difficulties in keeping violative products off the market.

Similar legislation to bolster drug safety, moreover, is not likely to move forward in the near future. House Democrats have proposed a bill that strengthens FDA enforcement tools for drugs and biologics, including mandatory recall authority, stiffer civil and criminal penalties, and authority to subpoena records related to drug violations. But there's not likely to be any action on the measure before 2012, when Congress will consider new FDA policies to add on to must-pass legislation renewing prescription drug user fees.

Probing FDA

Meanwhile, new Republican committee chairmen in the House are preparing for extensive oversight hearings on health reform and industry regulation. The head of the House Committee on Oversight and Government Reform, Darrell Issa (R-Calif.), has called FDA a "broken bureaucracy" and put the agency on his priority investigation list. Issa was highly critical of FDA officials and pharma executives at hearings before this committee last year on delays in drug recalls by Johnson & Johnson's McNeil unit. Now as panel chairman, he plans to hold FDA officials accountable for such regulatory lapses.

Similarly, House Energy and Commerce Committee (E&C) chairman Fred Upton (R-Mich.) is preparing to scrutinize the administration's health reform legislation, along with "job-killing regulations" that block technological innovation, and wasteful programs that warrant budget cuts. Upton will be supported by Reps. Joe Pitts (R-Pa.) and Mike Burgess (R-Texas), who head the panel's Health subcommittee, as well as the E&C subcommittee on oversight and investigations, now chaired by Rep. Cliff Stearns of Florida.

Legislators from both sides of the aisle also are paying close attention to FDA's progress in creating an approval pathway for biosimilars and in interpreting the controversial 12 year data exclusivity provision. A flurry of letters to FDA commissioner Margaret Hamburg from key members of the House E&C Committee and the Senate Health Committee point out that the law's provision on data exclusivity—not to be confused with market exclusivity—does not prevent a sponsor from obtaining another 12 years of exclusivity for a "next-generation" version of a reference product, provided it has been sufficiently changed or improved to gain FDA approval as a new drug. Generics makers object that this will permit patent "evergreening" based on minor tweaks in therapies, but innovators maintain that only important product changes will lead to new—not additional—exclusivity.