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Executive Summary

Amendment defunding Planned Parenthood is one ACA repeal refugee that could hitch a ride with user fee bill, which would be 'problematic,' to say the least, for Democrats.




An issue that could sink the US FDA user fee package already has emerged, a product of Republicans' failed bid to repeal and replace the Affordable Care Act (ACA).

Rep. Diana DeGette, D-Colo., said March 29 that she already has heard that defunding Planned Parenthood could wind up as one of the amendments lawmakers try to attach to the legislation.

The move "would be problematic," DeGette said during a talk at the National Press Club which focused on the future of health care reform efforts.

The user fee package, which should include reauthorizations of the prescription drug, medical device, generic drug and biosimilar programs, is considered must-pass legislation since FDA would need lay off staff and slow product reviews if Congress does not renew the programs. That status means it likely will attract amendments attempting to make health care and other policy changes. (Also see "US Healthcare Bill's Failure Could Have Unpleasant Ripple Effects For Pharma" - Pink Sheet, 26 Mar, 2017.)

Among them could be language from the ACA repeal-and-replace legislation that failed to pass the House which would have prohibited federal Medicaid funding from Planned Parenthood clinics for one year. (Also see "GOP Action To Push Through ACA-Replace Bill Threatens Device Tax Repeal" - Medtech Insight, 9 Mar, 2017.)

Attaching that provision to the user fee bill almost surely would hamper the legislation's prospects for enactment. Not only would it likely not draw any Democratic votes in the House, but also could spark a filibuster in the Senate.

 Diana DeGette



That could further delay passage – or worse-case scenario, even kill -- a bill already behind its typical legislative schedule. Either would be devastating to FDA. A delay beyond July likely would force the agency to send notices to those employees who could be laid off if the bill is not passed by Oct. 1. No reauthorization would cripple its ability to perform many of its vital functions. (Also see "Obamacare Repeal May Be Delaying User Fee Bill, Rep. DeGette Says" - Pink Sheet, 8 Feb, 2017.)

The White House appears to consider user fees more important for FDA than previous administrations. President Trump's FY 2018 budget blueprint significantly increases fee revenue as a way to control increases in budget authority. (Also see "Trump's Budget Outline Threatens User Fee Agreements" - Pink Sheet, 16 Mar, 2017.)

Trump also proposed a budget cut for the remainder of FY 2017, potentially using the same philosophy. (Also see "US FDA Faces Hiring Slowdown, Funding Cuts In Trump's FY 17 Plan" - Pink Sheet, 28 Mar, 2017.)

Amendment Could Clear Way For Others

Still, it seems unlikely that such an amendment could wind up in floor versions of the user fee bill, even if it is proposed. Many Republicans understand the importance of the bill to FDA and may reserve amendment slots for issues with broad support.

On the other side of the coin, if Democrats were able to put forward an amendment on drug pricing, that could force a tough vote for many Republicans.

Sen. Lamar Alexander, R-Tenn., who chairs the Senate Health, Education, Labor and Pensions Committee, already has said that amendments should be germane and bipartisan in order to ensure the bill moves as quickly as possible. (Also see "FDA User Fee Hearing Hijacked By US Health Care Reform Arguments" - Pink Sheet, 21 Mar, 2017.)

But DeGette said, "The larger conversation about do you use [the user fee bill] as a vehicle to try to move other types of legislation, that's still happening and I don't think it's been resolved in any way."

Beating back a problematic amendment also could exhaust concerned Democrats and clear an easier path for other less controversial issues to be added. The OPEN Act, which would offer exclusivity for drugs repurposed for rare diseases, could see its chances improved, (Also see "Rare Disease OPEN-ing In PDUFA Possible For Drug Repurposing Advocates" - Pink Sheet, 2 Mar, 2017.) along with other regulatory reforms and innovator incentives.

Cures Model Could Advance ACA Reform

DeGette also indicated that bipartisan conversations about potential fixes to ACA have restarted, although she wants a much broader approach to any changes.

A number of Republicans were talking with her about changes before the presidential election, but they stopped after Trump won. But she said after the American Health Care Act was pulled from the House for a lack of votes, conversations began anew. DeGette said most of the Republicans she has talked with are on the Energy and Commerce Committee, of which she is a member.

But DeGette also made clear that serious bipartisan talks will not include repealing the existing law.

"Conversations are happening, but we're not going to have the conversation about repeal," she said. "We're going to have the conversation about improve."

DeGette also suggested that both parties craft ACA reform legislation using the model that she and Rep. Fred Upton, R-Mich., employed with the 2016 21st Century Cures legislation.

"It's going to take thoughtful bipartisan discussion that might take longer than some people want, but you know, that's how you get good legislation that actually works when you're dealing with complex issues," DeGette said.

She and Upton spent more than a year holding round-table discussions and hearings on pertinent issues before the Cures bill took shape. (Also see "To Congress, From Pharma: Love, Hate And Fresh Ideas For 21st Century Cures" - Pink Sheet, 23 Mar, 2015.)

The final product was unanimously passed by the Energy and Commerce Committee (Also see "21st Century Cures Now A Partially Funded Mandate For FDA" - Pink Sheet, 21 May, 2015.) and then overwhelmingly cleared the full House. (Also see "Cures Excitement May Wane While Senate Works" - Pink Sheet, 10 Jul, 2015.)

The Senate spent more than a year developing companion legislation and the final product was enacted in late 2016. (Also see "Woodcock, Califf Give Thumbs Up To Certain 21st Century Cures Provisions" - Pink Sheet, 14 Dec, 2016.)

"This sounds simple, but all of these issues are highly technical," DeGette said. "Addressing them will require consulting regularly and up front with experts who can guide us to policies that will create more stability in the marketplace without eliminating vital consumer protections."

DeGette and colleagues now may have an opportunity to take a slower approach. Trump said after the GOP pulled its bill that the administration was moving on to other issues.

 Diana DeGette

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