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.