FDA User Fee Legislation Heads Toward Finish Line


Applied Clinical Trials

House & Senate leaders aim to resolve the many differences by end of June.

Legislation to reauthorize Food and Drug Administration user fee programs sailed through the House and Senate last month, setting the stage for leading legislators to resolve their differences and agree on a compromise measure. Much of the work will be tackled by Committee staffers who have been laboring over the legislative details for months. The aim is to bring the House and Senate leaders together in about two weeks to hash out the final language.

There are many differences between the two bills, but most are expected to be resolved fairly easily. Both bills reauthorize user fees for drugs and biologics and medical devices and establish new fee programs for generic drugs and biosimilars. The measures contain similar provisions for expediting the development and approval of critical new therapies and treatments for rare diseases. And they drop the long-time requirement that FDA inspect drug manufacturers every two years, permitting a risk-based approach instead.

Although the two bills propose to enhance pharmaceutical supply chain security, there are notable differences in the specifics for registering drug establishments, deterring counterfeit drugs, halting illegal imports, and addressing drug shortages. The bills also vary in how they provide incentives for the development of new anti-infective drugs and loosen conflict-of-interest rules governing advisory committees.

A notable difference in the Senate bill (S. 3187) is a “place holder” for establishing a drug track-and-trace system. Other unique provisions encourage third-party drug inspections, require reports on the inclusion of subgroups in clinical trials and prevent innovator firms from blocking generic drug maker access to drugs covered by postmarket limited distribution programs. The Senate measure also strengthens protections for FDA whistleblowers and requirements governing public registration of clinical trials. And there’s sure to be debate over a late provision that stiffens controls on hydrocodone-containing pain meds.

The House bill (H.R. 5657), in turn, makes it easier for sponsors to modify REMS (risk evaluation and mitigation strategies) and for FDA to block and destroy adulterated and counterfeit products. It enhances access to generic drugs by speeding up FDA review of petitions and providing for forfeiture of 180-day exclusivity under certain conditions. These provisions are important because more generics translates into reduced federal outlays for medicines, which makes the legislation a money-saver that meets federal deficit reduction requirements.

Among other things, the conferees will have to agree on what to call the bill –the FDA Safety and Innovation Act (FDASIA) proposed by the Senate or the FDA Reform Act (FDARA), as in the House. Backers of the legislation aim to send a final bill to the White House by the end of June – and avoid getting tangled up in new health reform proposals sure to erupt from the Supreme Court decision on the Affordable Care Act.

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