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Washington DC, June 21, 2007—The House Committee on Energy and Commerce today began mark-up on several bills on FDA pharmaceutical regulation. A new study by the Competitive Enterprise Institute explains why Congress is likely to bungle reform.
"There is growing momentum for Congressional action to address several perceived drug safety problems, but all of the proposals under consideration would harm, not improve, patient safety by making it more difficult to get promising new drugs approved by the FDA and into the hands of doctors and patients," explain study authors Henry I. Miller and Gregory Conko, fellows of the Competitive Enterprise Institute.
"These ill-conceived policies would also increase the already astronomical costs of bringing these medicines to market, raise prices, and reduce incentives for developers to undertake experimental projects," the authors predict.
Congressional reform bills aim to make the FDA drug approval process slower and more heavily regulated, worsening the agency's already slow and costly drug approval process. "Contrary to perceptions, FDA has actually become more cautious and slower to approve new medicines during the past decade," write Miller and Conko. "Patients are already waiting too long for live-saving drugs to make it through regulatory red tape. The American public is literally dying for real reform."
Instead of forcing FDA to be more risk averse, Congress should acknowledge that no medicines are risk-free and hold the agency accountable for approval delays. "FDA’s senior and mid-level managers should be made more accountable—especially for scientifically dubious policies and needless delays in getting new drugs, vaccines and medical devices to the patients who need them," conclude Miller and Conko.
Miller is research fellow at Stanford University’s Hoover Institution and an adjunct fellow of the Competitive Enterprise Institute. Conko is a senior fellow at CEI.
Read the full study: Dying for FDA Reform,  by Henry I. Miller and Gregory Conko.
Read other CEI publications on health and safety issues.