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the laser-focused motivation they once had to complete clinical trials which might end up reflecting badly on their cash cows. The FDA hasn’t often exercised authority to revoke accelerated approvals. But commissioner Margaret Hamburg did make one of those tough calls last November when Roche’s bevacizumab (Avastin) lost its clearance as a breast cancer treatment.
Essentially, there’s a risk here that the FDA could end up letting a lot of sketchy drugs onto the market, forcing it to later make painful and embarrassing recalls when the evidence becomes more clear-cut. And while enthusiasts of new biomarkers may be right about their value some of the time, there are bound to cases where some supposedly compelling biomarker turns out to mean little. Researchers have seen plenty of cases, for example, of cancer drugs that appear to shrink tumors which don’t end up helping people live longer.
The bill, known as House Bill 4132, which I took time to read in all its boring glory, doesn’t include any specifics about what kinds of data will be necessary to satisfy “accelerated approval” standards at the FDA. That’s wise, because those decisions will have to be made on a case-by-case basis, by the FDA, companies, and researchers—not Congress. If this bill is passed, the details—and the details are really all that matter—will be hashed out in a million little decisions made between the FDA and companies over the years to come.
Still, Maraganore says passage of the bill would make a big difference in one key respect—it would boost the confidence of investors in biotech. And he says the FDA has been willing to work on a variety of reform proposals, including this one. “They have gone a long way to work with industry to think about the proposals that are now in front of Congress,” Maraganore says. “There is a solid working relationship between industry and the FDA on thinking about what’s the right thing for patients.”
There are a number of smallish ideas tucked into the bill that also make some sense. In the Senate version of the FDA reform bill, known as TREAT, there’s language that would call for the FDA to hire a “chief innovation officer” who would be charged with identifying “promising new scientific and regulatory approaches” to help speed up drug development and regulatory reviews.
Every year, lots of bills get introduced that go nowhere, but this year there’s an incentive to get things done, as the Prescription Drug User Fee Act (PDUFA) V—a key piece of legislation that provides the FDA with industry user fees it needs to function—expires at the end of September. It’s entirely possible that the ideas contained in the FAST and TREAT bills could get rolled into the broader PDUFA reauthorization bill, which has to pass to essentially keep the FDA operating.
I’ve already gone on my soapbox with “Five Things Industry Can Do to Support True FDA Reform and Restore Public Confidence.” I don’t think these bills are going to come close to solving all that ails the drug development industrial complex, but they are reasonable. I’d love to hear your thoughts about what kind of impact this legislation could have.
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