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

6/27/11Follow @xconomy

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 the FDA screws up. Elected officials howled when scientists discovered dangerous risks from cardiac stents, the pain reliever Vioxx, and the diabetes drug Avandia years after the FDA had given the green light, and companies had already made billions in sales.

I’m sure it was painful for FDA officials to be hauled in front of Congress to explain those decisions, and be accused rightly or wrongly of being an industry lapdog, with TV cameras recording every minute. So it shouldn’t be any surprise that since those debacles the FDA has been especially careful about approving new products.

Huge amounts of money are at stake when the pendulum swings toward caution. Despite spending a breathtaking amount of money on R&D—about $65 billion last year—the pharma and biotech industry were only to win the FDA’s blessing for a paltry 21 new drug approved drugs last year. Complaints have been rising for months now from venture capitalists and biotech executives, who say the FDA has raised the bar for new drug approvals to ridiculous heights that are discouraging investment in life sciences innovation.

The medical device industry has been particularly aggressive, complaining that the FDA’s caution has created a process that’s painfully slow, costly, and unpredictable. Regulation has become such a roadblock, the med-device industry says, that new products are almost universally being tested and marketed first in Europe now, a situation that threatens U.S. standing as the No. 1 medical technology innovator in the world. The industry and its investors have argued that unless the FDA lightens up, lots of high-paying, desirable jobs will be sent packing overseas.

It’s never a good time to be getting labeled as a “job-killing” regulatory agency, especially in a time of high unemployment and economic anxiety. So I can see how the FDA might be feeling the heat from a pro-industry legislative agenda. In this environment, FDA officials have been saying some surprising things about how they view their own role. “We must assure that our oversight doesn’t stifle innovation, but rather encourages innovation while maintaining a commitment to safety and effectiveness upon which Americans rely and that other countries follow,” said Jeff Shuren, who runs the FDA medical device review office, in February remarks posted on the FDA website.

Despite the FDA’s conciliatory posture, I’m still skeptical that these pro-industry proposals will be enacted as the new law of the land. The public doesn’t pay attention to the cost, expense, and regulatory rigmarole of new drug development. People do know that new drugs hit them hard in the pocketbook, especially seniors on fixed incomes. It’s way too easy for some elected official, from either party, to score political points by accusing Big Pharma of trying to loosen up the regulatory rules so it can push risky new products on people to boost profits.

The debate over the proper role of the FDA in regulating pharmaceuticals and new medical devices is a healthy one, and one that should take on a higher public profile. But I just can’t help but think the industry could overreach here. If you were to boil down its position to a bumper sticker, it would probably be something like “let’s create a science-based regulatory balance between benefit and risk.” The other side’s position, meanwhile, could be stripped down to “keep unsafe drugs off the market.”

The situation reminds me of a headline the folks at The Onion wrote in a great historical satire of the 20th century, called “Our Dumb Century.” They crystallized the 1980 presidential election, and the complex debate over energy independence, with nothing more than a couple of mug shots and captions. There was Jimmy Carter’s smiling mug over the headline “let’s talk better mileage.” Next to that was Ronald Reagan saying “kill the bastards.”

Biotechies, with their advanced degrees and belief in fact-based reasoning, would serve themselves well if they remember who won that election.

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