Senate Set to Vote on PDUFA Reauthorization This Week

Later this week -- possibly as early as tomorrow -- a bipartisan majority in the United States Senate is expected to vote in favor of S. 3187, the Food and Drug Administration Safety and Innovation Act, which among other things, reauthorizes the Prescription Drug User Fee Act of 1992. MPT readers will, of course, be familiar with PDUFA and what it does. But in an article published in yesterday's Washington Times, I called it "arguably the most important piece of health care legislation [most people have] never heard of."

Before PDUFA, FDA typically took two years or more to evaluate new drugs -- that's after they already had been through some 10 or so years of clinical testing. The net effect was that American patients were often the last to benefit from important medical breakthroughs. Since 1992, the PDUFA user fees have enabled FDA to hire new medical reviewers and improve its scientific capacity. More important, the average drug-approval period was cut in half, to just more than a year.

As I wrote in the Times:

"Ideally, individual firms should not have to pay user fees to fund regulatory oversight that is ostensibly for the public's benefit. But in an era of tighter federal budgets, Congress has given the FDA more and more responsibilities but not the additional revenue to fund them. Without PDUFA, the FDA's budget shortfall would mean fewer new medicines reaching the patients who need them. Reauthorizing the user fees is a second-best choice, but in the face of a slow economy and pressure to reduce the federal budget deficit, it seems to be the best available option."

As a libertarian, I generally oppose efforts to give the government more money. But let's face it: given all the responsibilities Congress has given the FDA, if we starve that federal agency of resources, we'd only be shooting ourselves in the foot. I'd prefer that FDA have far less power and fewer regulatory authorities. But until that day comes, we are better off with an agency that has sufficient resources to review medical products in a timely fashion.

The Food and Drug Administration Safety and Innovation Act (FDASIA -- let's pronounce it Fudd-Asia) not only reauthorizes the user fees for prescription drugs, but it also reauthorizes the medical device user fees first introduced in 2002, and it establishes new user fees to fund FDA review activities for generic drugs and biosimilars. But what is especially noteworthy about this year's reauthorization, known to insiders as PDUFA V, is that it incorporates very few additional "Christmas Tree" amendments - measures unrelated to the primary purpose of a bill that are added to "must pass" legislation.

Prior PDUFA reauthorizations, typified by 1997's Food and Drug Administration Modernization Act (FDAMA) and 2007's Food and Drug Administration Amendments Act (FDAAA), included dozens of amendments to the statutes regulating drugs, medical devices, and even foods. FDAAA, for example, introduced new advisory committee conflicts of interest rules, gave the FDA new post-approval recall authority, established a public database of clinical trials, and even changed the way the agency regulates the safety of pet food.

This year, congressional leaders succeeded in getting relatively clean bills reported out of the House Energy and Commerce Committee and Senate Health, Education, Labor & Pension Committee. It's not that the bills don't incorporate a few non-user fee related items. They do. But for the most part, this handful of additional items will help to streamline the drug and device approval processes by expanding eligibility for the Accelerated Approval pathway, permitting FDA to expedite the testing and review of "breakthrough therapies," and requiring the agency to solicit the views of actual patients when assessing the safety and benefits of medical products.

Other provisions provide incentives for the development of new antibiotics and orphan drugs.The bills also permanently reauthorize the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA), which give FDA the authority to require pediatric testing of already approved drugs (which I oppose) and give companies that do pediatric testing an additional six months of market exclusivity (which I support).

One provision would also instruct FDA to issue a long-awaited guidance document clarifying the rights of drug and device manufacturers when promoting their products on the Internet (an issue I wrote about here). And the bills even soften the harshest effects of the FDAAA conflict of interest rules.

Arguably, the worst aspect of the House and Senate bills are one provision requiring the FDA to consider stronger warning labels on sunlamps and tanning beds and another intended to address the drug shortage problem that MPT contributors have written about here, here, and here. It's not that I think the drug shortage problem needs to be addressed, though. I just happen to think that the drug shortage provisions of the FDASIA will do extraordinarily little to solve the underlying problem.

All in all, this bill may be about as good as we could expect. So, it'll be a good day when the Senate and House pass the legislation, and when President Obama signs it into law.

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