Senate Republicans support including a funding increase with its health care innovation package for NIH, but not for FDA.

The Senate Health, Education, Labor and Pensions Committee does not yet have any additional dollars attached to the package, which would be combined with the House's 21^st Century Cures legislation, but it appears negotiations will continue to create them.

HELP Committee Chairman Lamar Alexander, R-Tenn., said during a March 9 mark-up he supports a "surge" in funding for NIH and wants to work with Democrats to reach an agreement that will coincide with the entire package reaching the Senate floor.

Alexander said after the hearing that he felt FDA should seek an increase through gradual appropriations increases rather than take a piece of the surge for NIH.

He said FDA's funding issue is a "different kettle of fish" than NIH in part because it is mainly personnel-related.

"We're going to have to work our way through what we want to do, how much we want to spend on the surge in funding for the National Institutes of Health and how to pay for it," Alexander said during the hearing. "We all know that that won't succeed unless we have a bipartisan consensus on that."

Democrats reiterated that without a funding agreement that included FDA as well as NIH, the health care innovation package would not move beyond the Senate floor.

HELP Committee Ranking Member Patty Murray, D-Wash., said while members can continue working on other aspects of the package, the committee needs to "secure sustained investments in the NIH and the FDA."

Sen. Elizabeth Warren, D-Mass., had noted the same concern known during a prior mark-up of other components of the innovation bill ([A#14160209005]).

FDA officials made it clear during debate on the Cures legislation in 2015 that it needed additional funding for the proposed changes otherwise existing items may be cut ([A#14150603005]).

Given Republican reluctance to provide significant increases to FDA's budget, the Senate package could wind up being an unfunded mandate.

FDA's fiscal year 2017 budget request includes a small increase that consisting mostly of theoretical user fees ([A#00160215006]).

Differing NIH Funding Proposals

Alexander suggested creating an innovation projects fund for NIH that would allow money to go to items like President Obama's Precision Medicine Initiative and Vice President Joe Biden's Cancer Moonshot. He did not commit to a specific amount for the increase.

Warren, on the other hand, proposed adding $5bn per year in funding over the next 10 years to be divided between NIH and FDA based on each's agency's annual discretionary appropriations amount.

She made the proposal as an amendment to one of the bills considered during the mark-up, but withdrew it so as not to force a vote. Warren said she wanted to allow funding conversations to continue.

"What we are looking for is … something that is sustainable over time," Warren said.

But her proposal was criticized for not having an adequate offset.

Alexander said the HELP Committee will have a tougher time coming up with offsets for any funding increase, in part because the pay-fors that the House used in the Cures bill (including sale of oil from the Strategic Petroleum Reserve) were "stolen" during negotiations for the FY 2016 omnibus appropriations bill.

FDA received a substantial increase in the omnibus legislation ([A#14151216002]).

Voucher Program Expansion Advances

The funding question was the only significant debate as the HELP Committee moved seven bills to the Senate floor, including several that would extend and expand FDA's priority review voucher program (see table below).

The final mark-up for the package is scheduled for April 6.

A list of bills to be considered during that meeting has not been released. Alexander said about 20 different bipartisan ideas remain under consideration and that a proposal to deal with drug pricing issues is expected as an amendment to one of the bills that will be brought forward.

Congress has been working on the pricing issue for several months amid anger over sudden and dramatic increases to the cost of some prescription drugs.

FDA may find a role in Congress' solution to the problem through its approval system for generic drugs ([A#14160202002]).

Overall, however, the Senate package has not included items that were in the House counterpart, including allowing the summary review of applications and creating a limited population approval pathway for antibiotics ([A#00160125014]).

Seven More Bills Join Innovation Initiative
The Senate HELP Committee moved seven bills to the floor as part of its health care innovation initiative to join the original seven bills moved out of committee in February.
Title and Sponsors	Description
Advancing Hope Act of 2015 (S. 1878) – Sens. Casey, D-Pa., Isakson, R-Ga., Brown, D-Ohio, Kirk, R-Ill.	Extends the pediatric rare disease priority review voucher program and makes sickle cell and pediatric cancers eligible diseases
Advancing Breakthrough Medical Devices for Patients Act of 2015 (S. 1077) – Sens. Burr, R-N.C., Bennet, D-Colo., Hatch, R-Utah, Donnelly, D-Ind.	Requires FDA to establish a program to expedite development and allow priority review of breakthrough medical devices
Medical Electronic Data Technology Enhancement for Consumer's Health Act (S. 1101) – Sens. Bennet and Hatch	Excludes software for electronic records and similar uses from regulation by FDA as a medical device
Medical Countermeasures Innovation Act of 2015 (S. 2055) – Sens. Burr, Casey, Isakson, and Roberts, R-Kan.	Creates a priority review voucher for medication countermeasures that are for a material threat and requires a report each month after enactment on why FDA's animal rule guidance is not final
Combination Products Innovation Act of 2015 (S. 1767) – Sens. Isakson, Casey, Donnelly, and Roberts	Requires FDA to designate a center to review combination product applications when they arrive, review them as a single application where possible, and ensure center coordination during the review
Patient Focused Impact Assessment Act (S. 1597) – Sens. Klobuchar, D-Minn., and Wicker, R-Ms.	FDA must publish an assessment of patient engagement when a drug approval package is released and release guidance on collaboration between patients, advocacy groups and industry for drug development
Adding Zika to the Priority Review Voucher Program (S. 2512) – Sens. Franken, D-Minn., Nelson, D-Fla., Isakson and Brown	Would add Zika virus to the list of diseases eligible for the tropical disease priority review voucher program

FDA Wouldn't Get Funding Boost As Part Of Senate GOP Innovation Bill

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