jueves, 8 de junio de 2017

FDA Law Blog: User Fee Reauthorization Moves One Step Closer to Reality with House Committee Passage

FDA Law Blog: User Fee Reauthorization Moves One Step Closer to Reality with House Committee Passage

Posted: 08 Jun 2017 05:16 AM PDT
By Kurt R. Karst –

On June 8, 2017, after a long mark-up session, the House Energy and Commerce Committee unanimously (54-0) passed H.R. 2430, the FDA Reauthorization Act of 2017 (“FDARA”). The Senate version of the bill, S. 934, passed out of the Health, Education, Labor, and Pensions Committee last month (see our previous post here).  Both bills would, in enacted, reauthorize an alphabet soup of user fee programs that fund much of FDA’s operations, including PDUFA, GDUFA, BsUFA, and MDUFA.

During the House Energy and Commerce Committee mark-up session, several amendments were added to the bill that passed out of the House Energy and Commerce Subcommittee on Health in May. Those amendments include:

  • An amendment from Reps. Ryan Costello (R-PN) and Scott Peters (D-CA) on medical device servicing;
  • An amendment from Reps. Ryan Costello (R-PN) and Scott Peters (D-CA) concerning FDA’s review process for medical imaging devices with contrast agents;
  • An amendment from Rep. Mimi Walters (R-CA) concerning a process for medical device manufacturers to request that FDA reclassify accessories based on their intended use;
  • An amendment from Rep. Jan Schakowsky (D-IL) establishing a voluntary pilot project to gather timely and reliable information on medical device safety and effectiveness; and
  • sense-of-Congress amendment by Rep. Schakowsky (D-IL) urging the Department of Health and Human Services to work with Congress to take administrative actions and enact legislation to lower the costs of prescription drugs by increasing generic and biosimilar competition and preventing anticompetitive behavior.
Chairman Greg Walden (R-OR) also offered a package of technical corrections that passed.  Among other things, the package of technical corrections amends provisions included in the Health Subcommittee version of H.R. 2430 concerning Competitive Generic Therapies and a new 180-day exclusivity regime (see our previous post here). 

Several other amendments failed to garner the votes necessary for inclusion in the user fee reauthorization bill. Those proposed amendments include the Pharmaceutical Information Exchange Act, which seeks to “improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers,” a revised version of Rep. Morgan Griffith’s (R-VA) Medical Product Communications Act concerning off-label use, and an amendment from Rep. Peter Welch (D-VT) concerning drug importation.  Rep. Welch also offered the Fair Access for Safe and Timely Generics Act concerning Risk Evaluation and Mitigation Strategies, but withdrew the amendment after debate.

H.R. 2430 will now move to the House Floor where further changes may be made to the bill. Differences between the House and Senate versions of FDARA will need to be ironed out before the bill can be sent to the President for his signature.  

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