Senate Democrats Call for FDA, NIH Funding Boost as Other Bills Emerge

Posted 04 March 2016 By Zachary Brennan

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Sens. Elizabeth Warren (D-MA) and Patty Murray (D-WA) on Thursday introduced a bill that would provide $5 billion per year in new funding for the Food and Drug Administration (FDA) and National Institutes of Health (NIH).

The boost in funds for FDA and NIH, backed by the Health, Education, Labor & Pensions (HELP) Committee Democrats, comes almost a month after the committee, still looking to pass companion legislation to the House-passed 21st Century Cures bill, advanced seven bills that call on FDA to speed reviews of new treatments for rare diseases, reduce “unnecessary burdens in device evaluations and streamlining the review process for clinical trials” and help the CDC better track the epidemiology of neurological diseases, among other bills.

The HELP Committee will also discuss five other bills next Wednesday: The Advancing Hope Act of 2015 (S. 1878), the Medical Electronic Data Technology Enhancement for Consumers Health (MEDTECH) Act (S. 1101), the Medical Countermeasures Innovation Act of 2015, which offers another priority review voucher program for developing new medical countermeasures (S. 2055), the Combination Products Innovation Act of 2015 (S.1767) and the Advancing Breakthrough Medical Devices for Patients Act of 2015 (S.1077).

And two new bills have also been added: S. 1597, Patient Focused Impact Assessment Act of 2015, which would require the package of information published by FDA upon approval of a new drug to include documentation of efforts to assess patient engagement; and S. 2512, which would add the Zika virus to the potential disease areas that are incentivized for new research with the tropical disease priority review voucher program.

Democrats’ New Bill

The swath of bills up for further discussion does not include the newly introduced National Biomedical Research Act, which would create a “Biomedical Innovation Fund,” designed to provide investments in biomedical research to support Vice President Joe Biden's National “Cancer Moonshot,” the Precision Medicine Initiative, grants for emerging scientists and other research aiming to accelerate the development and approval of new drugs, improve prevention and increase the understanding of life-threatening diseases.

Senate Democrats say the new funding will help NIH, which currently rejects nine of 11 grant proposals, which is below the 1/3 rate called for by agency leaders.

"Any package of innovation bills coming out of the HELP Committee must include significant increases in funding for NIH and FDA. Anything less is just lip service,” Sen. Warren said.

Opioids Bill

The bills coming out of the HELP committee and the fight over additional funding come as other senators battle over how to pay for an opioid bill that looks to combat prescription drug and heroin abuse, in addition to increasing the availability of naloxone, a drug to treat overdose.

Senate Republicans late Wednesday blocked $600 million in additional funding for the bill, but then majority leader Mitch McConnell (R-KY) said late Thursday he wouldn’t block the bill, though Democrats have protested the number of amendments they can add to the legislation. Senators will conduct a procedural vote on Monday at 5:30 p.m., with 60 votes needed to advance it.

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Categories: Drugs, Medical Devices, Government affairs, Preclinical, Regulatory strategy, Regulatory intelligence, News, US, FDA

Tags: opioids, device regulation bill, pharmaceutical bill, FDA funding

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