Before heading home for President’s Day recess, Members of Congress made progress on a few priorities for the biotech industry. Of note, the House introduced a bill to reauthorize PPRV, the Rare Pediatric Disease Priority Review Voucher Program (PPRV). Additionally, a hearing covered vaccine safety systems and compensation claims.
Here’s what happened before the President’s Day recess.
House introduces bill to reauthorize PPRV
On February 15, Members of Congress introduced H.R. 7384, the Creating Hope Reauthorization Act of 2024.
The bill would reauthorize the Rare Pediatric Disease Priority Review Voucher Program (PPRV). The program incentivizes the development of novel therapies to treat pediatric rare diseases. PPRV awards “priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. Under this program, a sponsor who receives an approval for a drug or biologic for a ‘rare pediatric disease’ may qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product,” explains the U.S. Food and Drug Administration (FDA).
The current program expires Sept. 30, 2024. If not reauthorized prior to Sept. 30, FDA may only award a voucher for an approved rare pediatric disease product application if the sponsor received rare pediatric disease designation by Sept. 30. After Sept. 30, 2026, FDA may not award any vouchers.
The Biotechnology Innovation Organization (BIO) applauded the introduction of the bill to reauthorize PPRV.
“The PPRV program provides critical incentives to promote R&D for drugs to treat rare diseases impacting children across the country,” said BIO Interim CEO Rachel King. “Rare diseases, by definition, impact a small percentage of the patient population. The costs of drug development paired with the risk involved of bringing a successful drug to market can often discourage investment in the rare disease space. This is especially true for rare diseases unique to children.”
Rep. Michael McCaul (R-TX) introduced the bill. The co-leads include Reps. Anna Eshoo (D-CA), Gus Bilirakis (R-FL), Nannette Barragan (D-CA), Michael Burgess, M.D. (R-TX), and Lori Trahan (D-MA).
Members of Congress discuss vaccine safety systems, compensation
Meanwhile, on February 15, the House Oversight Subcommittee on the Coronavirus Pandemic held a hearing, “Assessing America’s Vaccine Safety Systems.” The hearing featured testimony from:
- Daniel Jernigan, M.D., M.P.H., Director of the National Center for Emerging and Zoonotic Infectious Diseases and the Centers for Disease Control and Prevention (CDC);
- Peter Marks, M.D., Ph.D., Director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA); and,
- Commander George Reed Grimes, M.D., M.P.H., Director of the Division of Injury Compensation Programs at the Health Resources and Services Administration (HRSA).
Currently, patients who experience harmful vaccine side effects may receive up to $500,000 in compensation for vaccines covered under the U.S. Vaccine Injury Compensation Program (VICP). The VICP was created in the 1980s to help instill greater public confidence in vaccines and safety monitoring systems. Covered vaccines include many routine vaccines for all age groups, such as influenza, MMR (measles, mumps, rubella), HPV, and polio.
COVID-19 vaccines, however, are not covered by VICP. They are covered by the Countermeasures Injury Compensation Program (CICP), which pays much lower compensation, Subcommittee Chair Brad Wenstrup (R-OH) explained.
“Because COVID-19 vaccines were purchased and distributed by the Federal government under the Public Readiness and Emergency Preparedness (PREP) Act, they are covered under CICP. Whereas most other widely distributed vaccines are covered under VICP,” he said in his opening statement. “As of January 2024, CICP has only compensated 11 claims out of the more than 12,000 that have been filed for COVID-19 vaccines. Because of its design, CICP payouts are also significantly smaller than VICP—an average of about 3,700 dollars compared with almost 500,000 dollars in VICP.”
“It appears that CICP may not be designed or equipped to handle a vaccine that was so widely distributed—and mandated for many—as COVID-19 vaccines were,” he continued.
Other Members of Congress, including Rep. Mariannette Miller-Meeks, MD (R-IA), agreed.
“The CICP was not designed for a pandemic as large as the COVID-19 pandemic,” she said. This has led to a backlog in COVID-19 vaccine compensation claims.
Why vaccine safety systems, compensation are important
Additionally, new vaccines, such as those to protect against RSV and dengue, also require congressional action. CICP or VICP do not cover these vaccines
“We wouldn’t be able to expect people to line up and get vaccinated during the next pandemic if they feel they are abandoned,” said Rep. Wenstrup.
Vaccines have been saving lives since the cowpox vaccine in 1796. However, misinformation has led to “a startling decline in immunization,” said Rep. Debbie Dingell (D-MI). She urged “constructive reforms that enhance community engagement and strengthen the vaccine systems.”
BIO supports adding COVID-19, RSV, and Dengue fever vaccines to the VICP.
