sexta-feira, 13 de julho de 2007

Mais força para o FDA com a maioria democrata na Câmara dos Deputados dos EUA

A vitória do Partido Democrata em 2006 provocará aumento do controle pelo FDA do processo regulatório e, maior preocupação com a segurança dos medicamentos em uso. Mas, um ponto importante será a regulação do marketing direto com o consumidor. Há um ponto duvidoso: a aprovação de genéricos de produtos biotecnológicos, um assunto polêmico sem uma conclusão clara e contundente, como a favorável aos genéricos da "química fina". Abaixo, reportagem do The Wall Street Journal.
House Acts to Boost FDA Powers; Biotech Fight Looms By ANNA WILDE MATHEWSJuly 12, 2007; Page A2 WASHINGTON -- The House passed legislation that would bolster the powers of the Food and Drug Administration, but the vote sets up a confrontation with the Senate over whether to create a pathway for generic versions of biotechnology drugs. The House FDA bill, approved 403-16, mostly parallels a bill that passed the Senate in May. Both versions would devote more money to monitoring the safety of marketed drugs and increase the agency's authority over medications that raise safety concerns. The agency would have the clear ability to order follow-up studies, restrict distribution and enforce changes to the medications' labels. The bills don't grant the FDA the power to force a moratorium on direct-to-consumer advertising, a tough restriction that was discussed earlier, though the agency would be able to levy fines for false and misleading promotions. A compromise version of the two measures is expected to be completed in the next few months -- perhaps before the August recess -- because the legislation renews industry fees that fund much of the FDA's work. Both the House and Senate versions would also force drug companies to make public information from many clinical trials. But there is a key divide between the Senate and House bills: the Senate will include language that creates a pathway for the FDA to approve copycat versions of biotech drugs, and the House bill doesn't address the issue. The Senate provisions reflect an agreement among a group of key senators including Democrat Edward Kennedy of Massachusetts and Republican Michael Enzi of Wyoming, the health-committee leaders. Mr. Kennedy has said he will introduce that compromise, which was reached after the Senate passed its FDA bill, as part of the proceedings of the bicameral conference committee that will resolve differences between the House and Senate proposals. A key question is whether House leaders, including Energy and Commerce Committee Chairman John Dingell, a Michigan Democrat, will be willing to accept the move. Different House members have introduced divergent bills, but the Energy and Commerce Committee hasn't moved forward with any of them. In an interview yesterday, Mr. Dingell signaled that he will oppose inclusion of the copycat biotech-drug language in a final bill. He said he supports a pathway for such drugs, but has safety concerns as well as questions about whether science is advanced enough to verify a copy's similarity to the original medication. "There's really no record to justify that kind of action" in the House, which hasn't yet fully debated a bill, he said. The issue is extremely important for the generics and biotech industries, and it has been the focus of extensive lobbying. Currently, the FDA doesn't have the power to approve generic versions of most biotech drugs, which have become some of the most important, and expensive, treatments. Generics makers will prod for inclusion of the Senate generic-biotech language. Biotech makers, though, are expected to push for the House to consider its own bill, which could stall the change.A spokesman for the Biotechnology Industry Organization said "it's a complex issue, and it deserves full and deliberate consideration."A spokeswoman for the Generic Pharmaceutical Association said in an email that the group is "cautiously optimistic" that the copycat-biotech provisions will be in the final FDA legislation.

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