Betting That Biotech Will Bring the FDA to Heel? Don’t Count On It

Xconomy National — 

When Minnesota Democrat Al Franken and Massachusetts Republican Scott Brown line up on the same side of an issue, my first guess would usually be that it’s to vote on some meaningless resolution in favor of apple pie.

Or, like now, it could be a sign that a controversial, potentially transformative piece of legislation is brewing.

Some strange political bedfellows are sending signals that big things are cooking this week as the Biotechnology Industry Organization (BIO) kicks off its annual convention in Washington, D.C. The biotech industry has plenty on its agenda to discuss every year—patent reforms, tax breaks, Medicare, rules for generic drugs, etc.—but this year some especially meaty issues are on the plate. Word is that BIO has been working behind the scenes on a series of pro-industry legislative proposals that take aim at the Food and Drug Administration, the agency with the power to make or break companies developing innovative new medical products.

BIO president Jim Greenwood, a former Republican member of Congress from Pennsylvania, hinted last week at what’s coming at a meeting in Boston. According to a report in the Boston Globe, he told biotech CEOs in Boston that the industry group wants to “change the formal legal mission statement of the FDA.” He added: “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.” Brown, at the same conference in front of home-state biotech leaders, accused the FDA of “throwing a wet blanket” on innovative new drug discovery, according to the Globe. Franken joined the fray, issuing a press release urging the FDA to consider input from his medical device industry constituents in Minnesota before making changes to a common regulatory approval process for medical devices.

I don’t know yet what will be in BIO’s proposals, or how deep and broad a coalition Greenwood has assembled to push this new agenda through the partisan crossfire on Capitol Hill. I do know that a couple biotech CEOs familiar with the plan are impressed, and even a bit optimistic. While biotech is a privileged special interest group that often gets its way—remember the 12-year market exclusivity gift to makers of innovative biologics in last year’s health reform?—this sounds like a major uphill battle.

The issues between the FDA and companies that make new drugs, devices, and diagnostics are complex, and don’t lend themselves to debates on the Sunday morning talk shows. The FDA, operating under laws that have been on the books for decades, is charged with ensuring new drugs and devices are safe and effective enough to be sold on the U.S. market. The agency, like a good referee at the Super Bowl, is invisible when it does a good job. But there is hell to pay when … Next Page »

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