Is FDA “Crushing” Biotech?
Is FDA’s foot-dragging making the U.S. less globally competitive? That’s what Senator Scott Brown recently suggestedat the Biotechnology Industry Organization’s (BIO) 12th annual CEO Biotech Conference in Boston. The Massachusetts Republican was obviously preaching to the choir in a state where biotech is a big part of the economy, but his outlook is shared by many in industry who see the agency’s risk-averse demands for increasing amounts of clinical data, as well as arduous post-approval monitoring, as unnecessary burdens on innovation.
There’s some truth behind those charges. This past month, executives at Orexigen threw up their hands in their struggle to bring the weight loss drug Contrave to market. They have met with FDA’s Division of Metabolic and Endocrinologic Products in hopes of establishing a clear path that would allay concerns about potential cardiovascular risks and get the drug to market, but instead met with frustration. Orexigen proposed a study of 12,000 to 15,000 patients; FDA instead demanded a trial of 60,000 to 100,000, which the company called neither “necessary or feasible.” The company sought approval in patient with reduced risk for heart problems, and FDA demurred.
Moreover, Orexigen was stymied by the slow pace of government when it comes to regulation: FDA has planned a general advisory committee meeting for next year to discuss how cardiovascular risks should be assessed for weight loss drugs, after which it may change its requirements. That means all bets could be off next year--something the company understandably didn’t want to make a huge investment ahead of. Even if you believe that the risk/reward ratio for weight-loss drugs argues for extremely stringent safety requirements, playing a game where the rules can retroactively change clearly poses a major obstacle. Orexigen has scrapped plans for U.S. approval and is instead going through a dispute resolution process while pursuing approval for Contrave in Europe and elsewhere.
Eli Lilly, Amylin, and Alkermes may also find something in Brown’s argument that “we’re losing out to a lot of what’s happening overseas": The companies just won European approval for the diabetes drug Bydureon while studies designed to meet FDA’s demand for more data drag on.
But FDA’s counter-argument is that it is the length of clinical trials that make up the bulk of delays rather than review times. The Boston Herald quotes an FDA spokesperson as saying “The FDA’s times to drug approval are faster than its European counterpart...I don’t know how we’re losing out to overseas if we’re approving them faster than they do in Europe.” But that faster approval time counts the time in review, not the time of clinical trials, which in some cases are more stringent in the U.S.
BIO is working on a proposal for FDA reform that it plans to unveil at its annual Convention, taking place this week. As I write, I don’t know what the proposal will entail, but BIO President Jim Greenwood has given some hints. According to a report in the Boston Globe, he said that it is the trade group’s mission to “change the formal legal mission statement of the FDA.’’“The FDA understands that if they approve a product that’s not safe or effective, that’s a failure, and we agree with that. But it’s not deemed a failure if people die because they took too long to approve a product.’’ That’s an ominous note on which to launch a reform campaign--who else might be blamed for things they could have done but didn’t?--but it’ll interesting to see what the trade group comes up with.
-Karl ThielRead the BioPharm Executive online newsletter June 2011.
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