Senate, House Calling on FDA to Address Biosimilars, Drug Shortages

July 31, 2015

The Senate and House Appropriations Committees are calling on the FDA to issue guidance on biosimilars standards and work with industry to prevent drug shortages as part of their fiscal 2016 funding bills.

The Senate bill, S. 1800, and an accompanying report, S. Rept. 114-82, directs the FDA to provide a timeline for finalizing and publishing all pending biosimilars guidances. The House bill, H.R.3049, and accompanying report, H. Rept. 114-2014, show less patience, directing the agency to release guidance on biosimilar naming and interchangeability no later than Nov. 30.

Both committees also highlight concerns over drug shortages, directing the FDA to issue reports on its efforts to maintain adequate supply.

The House and Senate panels also want the FDA to report to Congress on when it will complete its review of proposed active pharmaceutical ingredients for use by compounding pharmacists.

The House bill and report include a laundry list of other tasks the committee would like the FDA to address in the coming fiscal year. Among these are finalizing the proposed rule on labeling changes for drugs and biologicals and issuing a rule revising the monograph on over-the-counter cough and cold product labeling for children. The committee also is proposing a provision that would prohibit the FDA from using funds for any rule that allows prescription drugs or biologicals to be distributed without labeling inserts.

On compounding, the House panel calls for the FDA to provide guidance on how pharmacists can fulfill requests for “office use” compounding before receiving a patient-specific prescription. It also directs the agency to finalize off-label guidance within 60 days of enactment of the appropriations bill.

User Fees

Lawmakers in the House are also concerned about financial management of the FDA’s user fee programs and would require the commissioner to submit monthly reports on fees collected, agency obligations and proposed uses for the balance. The panel also urges the agency to consider waiving, exempting or reducing GDUFA facility fees for small generics makers.

The House committee also urges the FDA to address off-label guidance, drug compounding, pharmacy compounding and antibiotics development.

Tasks targeted by the Senate committee include increasing the use of in silico and in vitro clinical trials — studies that use advanced computer modeling and patient specimens, respectively — to support NDAs and encouraging development of and broad access to naloxone products.

The Senate report also directs the FDA to use funds provided for the China Safety Initiative to support “robust funding for onsite verification support and integration of results in FDA inspection planning.”

No dates have been scheduled for floor votes in the House and Senate. Following floor votes, lawmakers will meet in conference committee to hammer out differences in the two bills.

Read the Senate bill and report here: www.fdanews.com/072015-senate-appropriations.pdf and www.fdanews.com/072815-SRpt114-82.pdf.    The House bill and report are here: www.fdanews.com/06-24-15-appropriations-bill.pdf  and www.fdanews.com/072815-HRpt114-205.pdf. — Jonathon Shacat