Senate Vote on Revised User Fee Package Planned for This Week

The Senate plans to debate and vote on an omnibus FDA user fee bill this week, after lawmakers substituted a new bill for the prior reauthorization package and began discussing it on Thursday.

Sens. Tom Harkin (Iowa) and Mike Enzi (Wyo.), the top Democrat and Republican on the Senate Health, Education, Labor, & Pensions (HELP) Committee, released late Tuesday the new FDA Safety and Innovation Act, S. 3187, which replaces the prior user fee bill, S. 2516, and expands it in several key areas.

For example, the new version of the bill requires HHS to request a report on a risk-based regulatory strategy for health technology software, including medical mobile applications, before the FDA can finalize guidance on medical apps. HHS must also convene a working group on the subject. Draft guidance issued last fall was criticized as being too vague and too bogged down in technical language to be useful (D&DL, Oct. 24, 2011).

The bill also would require the FDA to work with international regulatory bodies to develop universally acceptable international study standards to foster submissions of global clinical trials data. The language seeks to reduce duplicative clinical and preclinical studies by devicemakers and encourages multiple regulatory filings using the same trials.

S. 3187 would also direct the FDA to develop strategies for getting patient feedback during the review process, a point industry negotiators pushed during talks with the FDA last year.

Senate Majority Leader Harry Reid (D-Nev.) told reporters Tuesday he was prepared to file procedural motions to begin consideration of the bill this week. Meanwhile, lawmakers in the House still could vote on their version of the user fee bill by the end of the month. Congressional leaders hope to have the bill on President Barack Obama’s desk and signed into law before the July 4 holiday (D&DL, May 14).

Additional changes to the Senate bill are expected before it hits the floor this week.

Lawmakers have already reached agreement on several other FDA reforms that are included in the bill. These measures would:

• Ease investigational device exemption authorization;
• Withdraw the FDA’s controversial guidance on submitting 510(k) revisions;
• Reauthorize third-party reviews and
  inspections;
• Eliminate a requirement that devicemakers submitting de novo applications first be denied a 510(k);
• Extend the Sentinel postmarket monitoring program to include devices; and
• Ease financial conflict-of-interest rules to allow advisory committee vacancies to be filled more easily.

View S. 3187 at www.fdanews.com/ext/files/05-17-12-PDUFA.pdf. — David Pittman, Elizabeth Orr

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