Jill Wechsler
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One of the last acts of the 111th US Congress 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 increases its ability to halt unsafe
imports. But the law may be the last piece of legislation to expand the agency's authority and resources for some time. With
Republicans now holding a majority in the House of Representatives and gaining clout in the Senate, Congress is talking about
severe federal budget cuts and curbs on government regulators. New Republican committee chairs in the House are preparing
to grill Obama administration officials about the high cost of healthcare reform and antibusiness regulatory policies. A clear
target is the slow-down in new drug approvals at FDA and the agency's difficulties in keeping violative products off the market.
In fact, there's strong speculation that Republicans won't provide the $1.4 billion over five years (part of the approved
food-safety bill) needed to hire some 2000 additional FDA inspectors to expand the agency's oversight of food growers and
processors. Even without a budget increase, the new legislation authorizes FDA to mandate recalls, require food companies
to assess risks, and establish new rules for food importers. But it's unlikely that a similar drug-safety measure sponsored
by House Democrats will gain traction on Capitol Hill in the coming year. Former House Energy & Commerce Committee Chairman
John Dingell (D-MI) has long backed legislation that gives FDA additional enforcement tools over drugs, including mandatory
recall authority, more stiff civil and criminal penalties, and authority to subpoena manufacturer records. As with the food
safety-bill, Dingell's measure would increase foreign and domestic inspections, strengthen import controls, and enhance plant
registration requirements. The best chance of action won't arise until 2012 when Congress has to enact legislation to renew
the prescription-drug user-fee program.
Probing FDA
Meanwhile, FDA and other federal regulatory agencies face a hostile Congress. The new chairman of the House Committee on Oversight
and Government Reform, Darrell Issa (R-CA), considers FDA a "broken bureaucracy" according to his website, and has included
the agency on his investigation hit-list. Issa was highly critical of agency officials and pharma executives at hearings before
his committee last year on delays in drug recalls by Johnson & Johnson's (J&J) McNeil Consumer Products unit. Now as panel
chairman, Issa plans to hold FDA officials accountable for such regulatory lapses. In December 2010, Issa sent FDA Commissioner
Margaret Hamburg a letter questioning the agency's oversight of a J&J contract manufacturer—and of contract drug-manufacturing
practices in general. Issa also will have an eye on how FDA implements the new food-safety law and its growing involvement
in tobacco regulation. The agency's Office of Criminal Investigations (OCI) may draw scrutiny following strong criticism last
year by Congress' Government Accountability Office (GAO).
In Washington this month
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Similarly, House Energy and Commerce (E&C) Committee Chairman Fred Upton (R-MI) plans to probe the costs and impact of the
administration's healthcare reform legislation, along with what he calls on his website "job-killing regulations" that block
technological innovation and wasteful programs that warrant budget cuts. FDA programs and policies will be fodder for the
E&C health subcommittee, which is headed by Reps. Joe Pitts (R-PA) and Mike Burgess (R-TX). In addition, the E&C subcommittee
on oversight and investigations, now under Chairman Cliff Stearns (R-FL), may continue to analyze drug regulatory problems,
such as FDA's handling of heparin contamination and its failure to adequately monitor foreign drug production.
