May 15, 2012 by MassDevice
Over the angry protests of consumer groups, Congress is moving rapidly – and in bipartisan fashion – to give drug and medical device companies an easier path to Food and Drug Administration approval for some products in exchange for sharply higher user fees to fund the agency.
The five-year user fee reauthorization bill, which includes new fees on companies working to bring generic drugs and biologic products to market, passed the House Energy and Commerce Committee by a unanimous 46-0 vote Thursday. The legislation, which previously passed the Senate Health Education Labor and Pensions committee, will raise over $3 billion from industry over the next five years – about twice as much as was raised over the last five years.
But the fees come with a price: In sections of the bill that deal with regulations at the agency, Congress plans to give companies working on drugs for life-threatening conditions an easier pathway to accelerated approval, a classification created in the early 1990s during the AIDS crisis. Accelerated approval, which is based on so-called surrogate markers that are likely to lead to better outcomes, postpones definitive clinical trials proving effectiveness until after the drug hits the market.
“It allows smaller trials with surrogate markers which may or may not affect the ultimate outcome,” said Michael Carome, deputy director of Public Citizen’s Health Research Group, the nation’s leading drug safety group. “They’re pushing the envelope to gee the FDA to use the process more and more.”
The device industry achieves its major goals in the bill through subtraction. The fast-moving legislation eliminates a new clinical trial requirement for follow-on devices, which can avoid efficacy testing if the new device is deemed a minor change from previously approved devices. The industry has been plagued by recalls in recent years where follow-on devices like metal-on-metal artificial hips and some implanted cardio-defibrillators had to be recalled.
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