Lawmakers To Release Proposals To Extend FDA's User Fee Programs

TOPIC ALERT:

Leaders of a House health subcommittee and Senate health committee this week are releasing the so-called "chairman's mark" of legislative proposals to reauthorize FDA's prescription drug and medical device user fee programs, which are scheduled to expire in September, Politico reports.

The House Energy and Commerce Subcommittee on Health and the Senate Health, Education, Labor and Pensions Committee are expected to pass the measures, which include provisions to boost antibiotic and medical device approval and safety policies (Norman, Politico, 4/25). They also would combat prescription drug misuse and expand protections against generic version of biotech drugs (National Journal, 4/24).

Challenges To Overcome in House, Senate Proposals

Although the proposals have garnered adequate bipartisan support, several sticking points remain with federal officials, consumer groups and the industry, according to CQ HealthBeat. For instance, FDA officials have expressed concern about a provision in the House health subcommittee's draft proposal, which is slated for markup on Thursday (Adams, CQ HealthBeat, 4/24).

The GOP-sponsored provision seeks to add language about the economic effects of the agency's approval decisions to FDA's mission statement to facilitate public access to safe, new medical products (Politico, 4/25).

FDA says the proposed language would spur lawsuits and be difficult to enforce because it is not equipped to make such economic assessments. FDA also opposes two other proposals that would require the agency to establish an official registry of legitimate online pharmacy websites and accelerate manufacturing changes for certain drugs that are in short supply (CQ HealthBeat, 4/24).

Meanwhile, the Senate HELP committee draft proposal -- which the panel is slated to mark up on Wednesday -- has drawn opposition from the medical device industry.

On Tuesday, AdvaMed CEO Steven Ubl expressed concern about language that would allow FDA to independently determine whether a medical device can be used by other companies to obtain approval.

The industry also is likely to oppose a possible amendment by Sen. Jeff Merkley (D-Ore.) that would permit FDA to reject devices based on earlier products with flaws (McCarthy, National Journal, 4/24).

Lawmakers say they are hopeful of resolving the issues in a bipartisan way during upcoming hearings. However, the legislative process is expected to be time-consuming as the measures are among the "must-pass bills" this year that give Congress the chance to include potentially controversial health-related amendments, CQ HealthBeat notes (CQ HealthBeat, 4/24).


to share your thoughts on this article.