FDA Faces Internal Changes and Challenges - Pharmaceutical Technology

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FDA Faces Internal Changes and Challenges
Food-safety, transparency, and counterfeit-drug growth will tax agency resources.


Pharmaceutical Technology
Volume 35, Issue 2, pp. 26-30


Jill Wechsler
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
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.


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