RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > Senate Committee Advances FDA User Fee Reauthorization Bill

Senate Committee Advances FDA User Fee Reauthorization Bill

Posted 11 May 2017 | By Zachary Brennan 

Senate Committee Advances FDA User Fee Reauthorization Bill

The Senate Committee on Health, Education, Labor & Pensions on Thursday advanced by a vote of 21-2 a bill that would reauthorize the pharmaceutical, medical device, generic drug and biosimilar user fee agreements that expire at the end of September.

Two additional amendments were added to the latest version of the bill, one from Sens. Orrin Hatch (R-UT), Michael Bennet (D-CO), Richard Burr (R-NC), and Bob Casey (D-PA) on expanded access to drugs and one from Sens. Al Franken (D-MN) and Susan Collins (R-ME) on generic drugs and competition.

Another amendment on allowing drug imports from Canada from Sen. Bernie Sanders (D-VT), who lamented the pharmaceutical industry’s control of Congress on Thursday, was tabled and is expected to be taken up on the Senate floor at a later point. A prescription drug cost hearing is also expected to be held by the committee in the coming weeks.

Hatch Amendment

The first amendment, discussed at the hearing by Hatch, requires newly confirmed US Food and Drug Administration (FDA) commissioner Scott Gottlieb to work with the National Institutes of Health, patients and other stakeholders to convene a public meeting and issue a report on clinical trial inclusion and exclusion criteria to inform new FDA guidance.

That guidance "shall address methodological approaches that a manufacturer or sponsor of an investigation of a new drug may take to—(i) broaden eligibility criteria for clinical trials, especially with respect to drugs for the treatment of serious and life-threatening conditions or diseases for which there is an unmet medical need; and (ii) develop eligibility criteria for, and increase trial recruitment to clinical trials so that enrollment in such trials more accurately reflects the patients most likely to receive the drug."

Under the Hatch amendment, FDA also will have to issue guidance or regulations "to streamline the institutional review board review for individual pediatric and adult patient expanded access" protocols.

In addition, the amendment would strike a section in the federal Food, Drug and Cosmetic Act that requires a licensed physician to determine that the person "has no comparable or satisfactory alternative therapy available to diagnose, monitor, or treat the disease or condition involved, and that the probable risk to the person from the investigational drug or investigational device is not greater than the probable risk from the disease or condition."

Franken and Collins Amendment

Collins, meanwhile, said her amendment will foster a more competitive generic drug marketplace and sets a timeframe for FDA to review generic drugs with inadequate competition within eight months, which the agency took action on in March 2016.

She added that the amendment will also improve the visibility of FDA’s generic drug backlog, offer more transparency on average approval times and expand communications to improve the quality of generic drug applications on the front end.

The amendment will "improve FDA’s ability to know when drugs are exiting the market so we know when shortages" are occurring, Collins noted.

In addition to the two amendments and user fee agreements, the bill also features provisions on over-the-counter hearing aids, improving the existing processes and standards for domestic and foreign medical device establishment inspections, facilitating more international harmonization, ensuring device accessories are appropriately classified and authorizing FDA, under certain conditions, to approve or clear an imaging device or an imaging device enhancement for use with a contrast agent in a new indication.

The committee on Thursday also advanced the RAISE Family Caregivers Act (S.1028), which will help develop a strategy to coordinate federal programs to better support millions of Americans who are caregivers for a family member. 


S.934 - FDA Reauthorization Act of 2017


© 2022 Regulatory Affairs Professionals Society.