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A House subcommittee advanced a bill to reauthorize the Rare Pediatric Priority Review Voucher (PPRV)—and the story of two young siblings fighting muscular dystrophy explains why. Also: BIO recently urged the Supreme Court to take a case that could have an impact on patents. (626 words, 3 minutes, 7 seconds) |
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House subcommittee advances Rare Pediatric Priority Review Voucher reauthorization (updated) |
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The story of two children fighting muscular dystrophy illustrates the need to reauthorize the Rare Pediatric Priority Review Voucher (PPRV), House Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-WA) said yesterday.
What happened: While marking up 23 bills yesterday, E&C’s Health Subcommittee approved H.R. 7384 to extend the PPRV program, which incentivizes R&D by awarding vouchers to companies who receive approval of pediatric rare disease drugs. These vouchers can be used to expedite subsequent drug approvals.
One family’s story: Peter and Maggie Dion were healthy at birth, Chair McMorris Rodgers said. “Peter loved to fish for tuna with his dad. Maggie enjoyed dance and running with her mom, Everything changed when Peter was almost 10 and was struggling to climb up a set of stairs.”
“Peter was diagnosed with a form of muscular dystrophy,” she continued. “Later that year, his then-six-year-old sister Maggie was also diagnosed with the same disease. This type of muscular dystrophy is a rapidly progressive muscle wasting disease, and there is currently no cure.”
Why it matters: “Without the Rare Pediatric Disease Priority Review Voucher Program, Maggie and Peter’s parents say their chances of getting treatments for their kids becomes almost impossible,” Chair McMorris Rodgers said.
BIO’s view: BIO was pleased to see legislation to reauthorize the PPRV for six years pass with a bipartisan vote. As Members of Congress on both sides of the aisle shared, the PPRV is a critical tool in incentivizing the development of treatments for rare pediatric diseases.
What’s next: BIO urges Congress to pass the legislation before it expires on Sept. 30, the end of the fiscal year.
This article has been updated to address the details of the PPRV program.
Watch highlights: |
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More Health News: Bio.News: Awareness is a major weapon in the war against arthritis
“Kathleen Torkarski’s young daughter started experiencing pain and swelling in her ankles and feet six years ago. … The difficulty in obtaining Grace’s diagnosis is one indication that doctors need to be more aware of arthritis. The public also needs to know more about symptoms, risks, treatments, and patients’ needs. Policymakers should be aware that patient access to medicine can be improved through legislation, including pharmacy benefit manager (PBM) reform.” |
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BIO urges Supreme Court ruling to protect patents |
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A lawyer claiming whistleblower status (even though he’s sharing public information) threatens to weaken patent protections, BIO explains in an amicus brief urging the U.S. Supreme Court to take the case. Why it matters: “Innovation in biotech—and other fields—relies on predictable patent enforcement. If the argument in this case is accepted, a wave of ‘parasitic’ suits could generate uncertainty and reduce the investment that enables biotech innovators to bring patients the drugs they need,” says Hans Sauer, BIO’s VP for Intellectual Property.
The case: After successfully challenging a drug patent by Valeant (now Bausch Health) in a U.S. Patent Office review, a lawyer maintains the proceedings were unknown to the federal government, so he qualifies as a False Claims Act (FCA) whistleblower, eligible to seek hundreds of millions in damages.
The FCA was amended in 2010 to prevent “‘parasitic’ lawsuits that merely repackaged information about fraud that had already been made public,” according to Law360. Still, the Ninth Circuit Federal Court has accepted the claim.
BIO’s brief: Unless overturned, “the Ninth Circuit’s ruling will have significant consequences in the pharmaceutical industry and beyond,” encouraging “an onslaught of new parasitic FCA suits,” says BIO’s brief. Anyone “will be able to allege that he or she has identified some purported inconsistency between any number of otherwise public documents.”
BIO’s view: “Our legal framework is clearly designed to prevent this kind of unneeded risk for patent holders,” Sauer explains.
Read more in Bio.News. |
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President Biden’s Friday: Speaking at the National Museum of African American History and Culture and meeting with the Divine Nine, a group of historically Black sororities and fraternities, during a week of outreach to Black voters, per NPR.
What’s Happening on Capitol Hill: Enjoy the weekend. |
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