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CLSA Wire

Legislative Update from DC: FDA User Fees; ACA Repeal & Replace; Briefing on Cost & Value
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July 27, 2017

PDUFA/MDUFA

On July 12, the House of Representatives passed the FDA Reauthorization Act of 2017 (FDARA), the legislation needed to renew the FDA’s prescription drug (PDUFA) and medical device (MDUFA) user fee programs. The bill was passed by voice vote under suspension of the rules, and now awaits action in the Senate. The Senate leadership announced that they will stay in session and delay August Recess until the 3rd week of August, allowing them additional time to vote on the reauthorization bill. The FDA’s current authority to collect user fees expires on Sept. 30, however, the FDA has announced that they will not be issuing pink slips (reduction in force notices – or, RIFs) due to the high degree of confidence that the legislation will be enacted before the authorization lapse. CLSA is pleased that the user fee package passed by the House includes several provisions of importance to the life sciences sector, including a provision to improve medical device facility inspections. We continue to urge our California senators to support the bill when it is brought before the Senate for a vote.

ACA Repeal & Replace

After the House of Representatives passed a bill to repeal and replace the Affordable Care Act (ACA) in May, the Senate has worked for the past several months to advance its own version of such legislation and garner enough support to pass, amidst a divided Republican conference.

In the early morning hours of July 28, the Senate voted on a pared down – or “skinny” – bill to repeal and replace the ACA. The measure – called the Health Care Freedom Act – failed in a 49 to 51 vote, with Republican Senators Susan Collins (R-Maine), John McCain (R-Arizona), and Lisa Murkowski (R-Maine) crossing party lines to oppose the measure. (All Democratic senators opposed.) Moments beforehand, Sen. Patty Murray (D-Wash.) offered a motion to commit and send the bill back to the Health, Education, Labor and Pensions Committee (HELP) for further work – this vote also failed, by a vote of 48 to 52.

At press time, and in light of these votes, it is unclear what next steps Congress will take to repeal-and-replace or reform the ACA.

Notably, there remains strong support for a repeal of the medical device excise tax, which had been included in several versions of the various House and Senate repeal-and-replace bills. CLSA remains supportive of a full repeal of the medical device tax and is communicating with our California delegation to underscore our support for a swift and full repeal of the medical device tax.

Congressional Briefing: The Cost and Value of Prescription Medicines

On July 13, CLSA and 8 other state and regional life sciences associations hosted a congressional briefing on the cost and value of prescription medicines in the healthcare system. Speakers included Aaron Vandervelde (Berkeley Research Group), Mark Fendrick, MD (University of Michigan), and Jeanne Haggerty (BIO). The discussion was focused around the complexities surrounding the current drug pricing ecosystem, and explored factors for consideration in moving toward a value-based healthcare system.

CLSA’s Protect Access and Innovation public affairs campaign offers additional resources to help illustrate the value of medical innovation, including an infographic on The Complicated Way We Pay for Medicine.

Questions? Please contact Adam Lotspike, CLSA’s Associate Director of Federal Government Relations (Alotspike@califesciences.org).