WASHINGTON DC – The Health, Education, Labor, and Pensions (HELP) Committee favorably voted out three bills authored by Senator Casey (D-PA), bringing them one step closer to becoming law.
S. 1878, the Advancing Hope Act, was authored by Senator Casey and Senator Johnny Isakson (R-GA). This bill will extend an important program to incentivize the development of new drugs to treat rare pediatric diseases (affecting fewer than 200,000 children). The pediatric priority review program became law in 2012 and was based on legislation authored by Senator Casey, the Creating Hope Act. The bipartisan proposal was approved by the Committee by an overwhelming majority, and will extend the program through 2022. Drug sponsors whose products are designated by the Food and Drug Administration (FDA) as “rare pediatric disease products” will have until 2027 to claim a voucher. The current program has already awarded six vouchers for new drugs to treat rare pediatric conditions, including diseases such as lysosomal acid lipase deficiency, which has only been reported in about 50 people.
Senator Casey also teamed with Senator Isakson on S. 1767, the Combination Products Regulatory Fairness Act, which will provide important certainty for combination product sponsors without weakening the FDA’s regulatory authority. The bill’s main component is an agreement between the FDA and a combination product sponsor to guide the sponsor as it conducts premarket testing and works to get FDA approval or clearance to market the combination product.
Finally, Senator Casey worked with Senator Richard Burr (R-NC) to introduce S. 2055, the Medical Countermeasures Innovation Act, which makes targeted improvements to the Pandemic and All-Hazards Act (PAHPA) that the two Senators reauthorized in 2013 to address preparedness for public health threats, from anthrax and pandemic influenza to Ebola and Zika. The bill also includes a new provision modeled after Senator Casey’s Advancing Hope Act, to create a similar incentive for the development of material threat medical countermeasures, the most dangerous biosecurity threats for which we have few or no available medical countermeasures.
“We made necessary progress in moving important legislation forward that will help foster innovation and promote drug development for important unmet needs,” said Sen. Casey. “In particular, with the Advancing Hope Act, the bill does exactly what the title says: it advances hope for children living with rare and often devastating diseases.”
Senator Casey also spoke about the importance of a robust budget for the National Institutes of Health (NIH), and is a cosponsor of an amendment offered by Senator Warren to provide an additional $5 billion per year in mandatory funding for the NIH. Senator Warren’s amendment did not come to a vote.
The bills are a part of the HELP Committee’s innovation agenda and are expected to be packaged together with other measures for consideration on the Senate Floor later this year. “My hope is that we will come to a bipartisan agreement on NIH funding as a part of this innovation agenda,” said Casey, “We made important steps forward, but we cannot truly be committed to innovation without supporting basic medical research. “