Consumers Lose in Latest FDA User Fee Bill; COI Restraints Disappear

May 12, 2012
By

Over the angry protests of consumer groups, Congress is moving rapidly – and in bipartisan fashion – to give drug and medical device companies an easier path to Food and Drug Administration approval for some products in exchange for sharply higher user fees to fund the agency.

The five-year user fee reauthorization bill, which includes new fees on companies working to bring generic drugs and biologic products to market, passed the House Energy and Commerce Committee by a unanimous 46-0 vote Thursday. The legislation, which previously passed the Senate Health Education Labor and Pensions committee, will raise over $3 billion from industry over the next five years – about twice as much as was raised over the last five years.

But the fees come with a price: In sections of the bill that deal with regulations at the agency, Congress plans to give companies working on drugs for life-threatening conditions an easier pathway to accelerated approval, a classification created in the early 1990s during the AIDS crisis. Accelerated approval, which is based on so-called surrogate markers that are likely to lead to better outcomes, postpones definitive clinical trials proving effectiveness until after the drug hits the market.

“It allows smaller trials with surrogate markers which may or may not affect the ultimate outcome,” said Michael Carome, deputy director of Public Citizen’s Health Research Group, the nation’s leading drug safety group. “They’re pushing the envelope to gee the FDA to use the process more and more.”

The device industry achieves its major goals in the bill through subtraction. The fast-moving legislation eliminates a new clinical trial requirement for follow-on devices, which can avoid efficacy testing if the new device is deemed a minor change from previously approved devices. The industry has been plagued by recalls in recent years where follow-on devices like metal-on-metal artificial hips and some implanted cardio-defibrillators had to be recalled.

The Institute of Medicine in a report released last summer called for a complete overhaul of follow-on device regulations, known as the 510(k) process. Editorials in leading medical journals said the 510(k) approval process should never used for devices whose failure would pose an immediate risk to health, which would include virtually all orthopedic and cardiovascular devices.

“Industry heavily lobbied both sides of the aisle to get provisions favorable to industry,” said Carome said. “They were very successful.”

Both the Pharmaceutical Research and Manufacturers of America and the Advanced Medical Technology Association (AdvaMed), which represents the device industry, issued statements on Thursday praising the bill, even though it will sharply raise their fees. “The agreement includes a number of groundbreaking accountability and transparency measures that, combined with enhanced resources for FDA, will help increase the predictability, consistency and efficiency of the agency’s stringent review process,” said Stephen Ubl, president of AdvaMed. “This translates into more timely access to life-changing treatments.”

The legislation reflects a sharp reversal in tone from the last time Congress passed a user fee reauthorization bill. In 2007, in the wake of Merck’s Vioxx scandal, where tens of thousands of people died after taking a minor pain medication, Congress passed legislation that gave the FDA new powers to force companies to closely monitor potentially dangerous drugs after they came on the market.

The 2007 reauthorization bill also limited the agency’s use of scientists with financial conflicts of interest on its advisory committees, whose recommendations on specific products are almost always followed by FDA officials. That limitation was eliminated in the bill that passed the House Thursday.

The legislation contains a few measures that will enhance the FDA’s ability to monitor product safety. It imposes a 120-day deadline for the agency to issue a medical device bar-coding system that will enable companies to track their products for carrying out recalls when necessary.

And it includes devices in the FDA’s adverse event electronic tracking system, which can be used to identify unsafe products. The Sentinel system, which is still under construction and will eventually include 100 million individual health records, was originally designed to track only drugs.

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3 Responses to Consumers Lose in Latest FDA User Fee Bill; COI Restraints Disappear

  1. Steven Grossman on May 14, 2012 at 6:41 am

    Merrill—As always, smart, focused analysis in support of your points. Whether harm will actually result–indeed, whether anything bad has been created–is more nuanced and ultimately only time will tell. Nothing produced by a political process is ever all-good or all-bad.

    If companies things this legislation “fixes” their problems, I think they will be disappointed. The first responsibility for greater productivity in medical product development lies with the companies and not FDA, a point I discuss in a blog column “Medical Innovation: The Dream of More Cures and More Industry Success” at http://www.fdamatters.com/?p=1821.

    But as industry produces more sophisticated products based on more sophisticated evidence, FDA is trying hard–without the resources it needs–to stay on top of scientific advances and provide appropriate regulatory structures and advice.

    Unfortunately, when it falls behind, almost everyone gets a “no” out of sheer precaution. A little more flexibility is important for the agency and is not necessarily a bad things. I talk in more detail on this point at “Safety and Efficacy Standards: Innovative Approaches to Radical Ideas” at http://www.fdamatters.com/?p=1889.

    None of the PDUFA changes exist in a vacuum and overall, I think they will lead to a more efficient and effective process for review of drugs and devices and the tracking of safety. There are certainly a few provisions I wish had been written differently or omitted, but the balance is more favorable than not.

    Agree to disagree? With best regards, Steven

    • GoozNews on May 15, 2012 at 4:33 am

      What do you mean if “industry produces more sophisticated products based on more sophisticated evidence.” The legislation has lots of flowery language about expanding accelerated approval to accommodate new biomarkers. But there is only one bottom line for a biomarker. Does reducing or increasing its presence in the body accurately predict a better outcome? And will that better outcome be confirmed by post-marketing trials completed in a timely manner? If by “more sophisticated evidence” you mean we don’t really know if the biomarker is an accurate predictor of better results; and if the FDA and industry continue their poor track record in requiring companies receiving accelerated approval for new drugs to complete post-marketing trials, then it seems to me the law, on balance, is an unfavorable outcome for consumers . . . and public health.

  2. Abbey Meyers on May 14, 2012 at 7:13 am

    Merrill, I agree with you 100% about the dangers posed by the new User Fee bill. The drug and device industries lay back waiting for the next User Fee bill to begin its travels through Congress, and they get their congressional pals to add amendments that will help companies achieve faster and less expensive marketing approvals.

    The United States already has the quickest drug approval process in the industrialized world. Inevitably, speeding the approval process beyond what it is now will put the American public at risk for ineffective or unsafe drugs and devices. But the insiders will get richer faster, and that’s who pays the lobbyists.

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