FDA user-fee extension breezes through Senate committee

A Senate committee easily passed a bipartisan bill to reauthorize the FDA's ability to collect user fees from drug and device makers.

The Senate's Committee on Health, Education, Labor & Pensions voted 21-2 during a markup hearing to approve the bipartisan Food and Drug Administration User Fee Reauthorization Act. The bill would reauthorize the FDA's four user-fee agreements that renew the agency's authority to collect fees from the makers of prescription brand drugs, medical devices, generic drugs and biosimilars.

The act, which Congress has been working on for more than a year, calls for more than $400 million in additional user fees that would allow the FDA to hire more staff and speed up approvals. The user fees account for a quarter of the FDA's overall funding, or $8 billion to $9 billion over five years.

Legislators face a narrowing window to pass the reauthorization bill. The agency would have to lay off more than 5,000 employees if the agreements are not reauthorized before the end of September. A reauthorization delay also would postpone the review of many drugs and devices.

Device and drug manufacturers could benefit from a more defined review process and streamline operations, supporters argue, while critics claim that the rising fees disproportionately affect smaller companies that cannot accommodate the fee hike.

Jim Shehan, head of FDA regulatory practice at Lowenstein Sandler, expects the act to pass in both the U.S. House of Representatives and Senate.

"If it doesn't go through, the whole FDA approval method will grind to a halt," he said.

The committee added several amendments to the bill, including one from Sens. Susan Collins (R-Maine) and Al Franken (D-Minn.) that aims to increase more competition in the drug marketplace and another from Sens. Orrin Hatch (R-Utah), Bob Casey (D-Penn.), Richard Burr (R-N.C.) and Michael Bennet (D-Colo.) to expand access to drugs.

"Increasing generic drug competition is key to lowering prescription drug prices and reducing healthcare costs overall," Collins said during Thursday's hearing. There are several bills moving through Congress aimed at reducing barriers to generics entering the market.

The Collins/Franken amendment sets a timeframe of no more than eight months for the FDA to prioritize the review of new drugs introduced into uncompetitive markets. It also improves the visibility of the backlog of priority review applications, provides additional resources and communication to improve the quality of applications when they are submitted, and enhances the FDA's ability to discern potential drug shortages by bolstering its capacity to track drug trends, Collins said.

The Hatch amendment requires the FDA, the National Institute on Health and other stakeholders to assemble a public meeting to discuss the potential barriers for patients to participate in clinical trials. There are often a lack of available treatments for rare diseases because there aren't enough willing participants for clinical trials, according to Hatch.

The committee voted to table an amendment proposed by Sen. Bernie Sanders (D-Vt.) that would allow drugs to be imported from Canada.

In addition, the bill also features 20-plus provisions addressing drug importation and counterfeiting, over-the-counter hearing aids, properly classifying device accessories, refining the medical device inspection process via risk-based review, and improving communication about abuse-deterrent opioid products, among others.

"You never know with (President Donald) Trump, but I would be surprised if I were to see a veto," Shehan said.