The heparin scandal has intensified scrutiny of how FDA regulates the growing volume of imported drugs and pharmaceutical ingredients. Questions about the efficacy of popular cholesterol and diabetes treatments have prompted charges of insufficient premarket testing and lax oversight. And FDA's slow response to evidence of research fraud for Sanofi-Aventis's (Paris) antibiotic "Ketek" (telithromycin) prompted Congressional leaders to call for more effective enforcement of clinical research requirements.
FDA officials feel the heat. Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), told the House Appropriations subcommittee in February that FDA is "an agency under assault" and that continued attacks make it more difficult to attract and retain the scientists the agency needs. Former CDER Director Carl Peck echoed Woodcock's remarks at the annual meeting of the Food and Drug Law Institute (FDLI) in March. He described FDA as operating in a "guerilla environment" created by "ambitious politicians, media competing for headlines, and opportunistic academics." The latest "roadside bomb," said Peck, was a widely cited study published in The New England Journal of Medicine indicating that new drugs approved close to user fee deadlines are less safe than those approved without such time pressures.
Although this report appeared as one more piece of evidence that drug companies are thrusting unsafe products onto the market because of ineffective regulatory oversight, FDA says it's not true. CDER Deputy Director Douglas Throckmorton claimed that agency approval and withdrawal data is "considerably different" from what the study reported and that it's common to approve drug applications within two months of a review deadline. FDA plans to submit its own analysis to the Journal, but even a strong refutation is unlikely to make front-page news.
FDA has difficulty meeting the high expectations of all its constituencies because of an ever-expanding portfolio of oversight and regulatory responsibilities. The agency's depleted resources and decimated work force are other problems. The need to establish a host of new rules and policies to implement FDAAA makes matters worse, at least for the short run. And pressure to beef up CDER's postapproval surveillance operations has increased strain on the new-drug approval process.