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Industry Blasts Kennedy — Sponsored Riders to FDA User Fee Reauthorization

Industry groups are up in arms over a proposal by Sen. Edward Kennedy (D-Mass.) to add regulatory riders to a pending drug user-fee reauthorization, arguing that these efforts are unnecessary and would undermine patient care.

Kennedy recently introduced legislation to give the Food and Drug Administration the authority to regulate laboratory tests, and he is about to introduce a bill that would give the agency regulatory authority over drug compounding.

Kennedy wants to add both bills to legislation reauthorizing the Prescription Drug User Fee Act, various Congressional and other sources said. Congress, industry and the agency are anxious to reauthorize these fees because of the central role they play in ensuring timely and effective drug application reviews.

Without the fees — an estimated $300 million to $400 million in the agency’s fiscal 2008 budget — the FDA may be forced to lay off a few hundred drug reviewers, which could delay new drug applications for years, said Marc Scheineson, a former FDA associate commissioner who’s now a partner at the law and lobbying firm Alston & Bird.

Because the reauthorization is considered must-pass legislation, some outside groups, such as the Washington Legal Foundation and the International Academy of Compounding Pharmacists, are worried about the prospect of Kennedy’s riders passing.

The IACP is joining several other pharmacy groups in drafting a letter to Kennedy detailing their concerns. The coalition likely will send their letter today.

The bill on compounding — a process by which pharmacists use bulk ingredients to customize some drugs for specific patients — would turn authority for regulating the practice over to the FDA, according to a discussion draft obtained by CongressNow.

This is “the wrong approach,” said L.D. King, IACP’s executive director. The states already regulate these products, and adding additional regulations would “disrupt the practice of medicine.” The bill “federalizes the regulation of compounding in a way we don’t think serves patients, physicians or pharmacists,” a group spokesman said.

Meanwhile, the WLF is concerned with the Laboratory Test Improvement Act, introduced by Kennedy and Sen. Gordon Smith (R-Ore.) on March 1. “The bill concerning laboratory-developed tests is frightening,” said Rich Samp, the WLF’s chief counsel. “It goes way beyond anything that FDA is proposing to do — and FDA’s actions have been heavily criticized by the laboratory industry.”

The bill would mandate all providers of laboratory tests provide the FDA with evidence verifying their analytical and clinical validity. That information would then be compiled in a database that would be publicly available.

But these tests already are regulated by the Clinical Laboratory Improvement Amendments, Samp said. The new regulations would “cripple the ability of laboratories to rapidly develop new tests in response to new health care challenges.”

Kennedy argues that new regulations are necessary. Current regulations do not ensure that all of these tests are performed accurately or that they have any clinical meaning, according to a summary of his bill.

“Our goal is to ensure the quality of clinical tests used everyday in hospitals and doctors’ offices across the country,” Kennedy said in a statement issued when the bill was introduced. “Physicians often base medical decisions on the results of such tests, and patients deserve confidence that they will not be wrongly diagnosed or given the wrong pill because of a faulty test.”

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