How Senate Republican leaders are hoping to ease rules on regenerative therapies
Senate Republican leaders think FDA is unnecessarily impeding the development of regenerative medicines, and they want to use the 21st Century Cures Act as a vehicle to reduce regulatory requirements to market cell- and tissue-based therapies.
Sen. Majority Leader Mitch McConnell (R-Ky.) and Health, Education, Labor and Pensions (HELP) Committee Chairman Sen. Lamar Alexander (R-Tenn.) are leading the effort.
McConnell signaled his support for both 21st Century Cures and for regenerative medicine the day before the Senate closed down for the elections, and Alexander has promised that the full Senate will be given an opportunity to vote on the Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act (S. 2689) in 21st Century Cures legislation.
When it was introduced in March, S. 2689 raised alarm bells at FDA, NIH and at biopharmaceutical companies because it would substantially lower approval standards.
Because of these concerns, Alexander did not include S. 2689 in the package of bills presented to the HELP Committee