Senate Funding Bill Improves Research Funding, Punts on FDA

The Senate this week passed an appropriations package that includes funding for Labor, Health and Human Services, Education, and Related Agencies that would provide a $2 billion increase in funding to the National Institutes of Health (NIH) in 2019. That increase is in addition to $10 million in appropriations, authorized by the 21st Century Cures Act, for the Regenerative Medicine Innovation Project, which funds clinical research to further the field of regenerative medicine.

The House is expected to vote on the bill next week, then it will await the president’s signature. For the first time in 22 years, it is possible that Congress will pass the two largest appropriations bills before the fiscal year actually starts on October 1, which would be good news for ASGCT members who rely on NIH funding to support their research.

Of concern however, this appropriations bill also includes a continuing resolution for several other departments and agencies, including the FDA, which will receive flat line funding through December 7, 2018 if the bill is passed as-is.

If the FDA is funded for an additional two months by a continuing resolution, the agency will need to spend its budget on activities that were part of the 2018 work plan. Both the House and Senate Appropriations Committee bills would allocate $20 million in new funds for investment and innovation of treatments for rare diseases and a $5 million increase to fully fund the Oncology Center for Excellence, so delaying this funding could delay progress relevant to the gene therapy field.

Of note, the Senate appropriations bill would provide $149 million more in FDA funding than the House bill. ASGCT supports consistent, strong funding of the FDA to support these measures, as well as the ongoing work of the FDA in regulating the development of safe and effective gene and cell therapies.