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A busy day on Capitol Hill advances legislation on PBMs and preventive care, and brings important discussions on antimicrobial resistance. Meanwhile, BIO tells the Biden administration why Bayh-Dole cannot be used for drug price controls. (587 words, 2 minutes, 56 seconds)
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House committees advance legislation on PBMs, preventive care |
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Yesterday was a busy day on Capitol Hill. Two House committees advanced health care--one regulating pharmacy benefit managers (PBMs) and another aiming to better measure the true value of preventive care, while a third committee discussed the need to support new antimicrobials.
Here's what happened. During the House Oversight & Investigations Committee mark-up, H.R. 6283, the Delinking Revenue from Unfair Gouging (DRUG) Act was approved by 20-11. This legislation would limit PBM revenues to fair-market service fees and prohibit them from charging health plans more than they pay pharmacies. It would also prevent PBMs from steering beneficiaries to pharmacies owned by the PBM.
What they're saying. During the hearing, Chair James Comer (R-KY) mentioned BIO’s support in urging passage. Ranking Member Jamie Raskin (D-MD) promised additional PBM disclosure legislation. Watch highlights: |
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Also yesterday, the Budget Committee approved H.R. 766, the Preventative Health Savings Act, by 30-0. H.R. 766 would require the Congressional Budget Office to use a 30-year time frame (instead of the current 10 years) when assessing savings provided by legislation on preventive health care. The bill’s long-term view more accurately measures the benefits of one-off treatments, like new cell and gene therapies, in reducing future costs, explained sponsor Rep. Michael Burgess, M.D. (R-TX), in an opinion column yesterday.
What’s next: H.R. 6283 and H.R. 766 await consideration by the full House.
Meanwhile, antimicrobials got airtime: During a Ways & Means Committee hearing on drug shortages, Rep. Drew Ferguson (R-GA) stressed the importance of the PASTEUR Act to support new antimicrobial R&D. Witness Dr. Stephen Schondelmeyer of the University of Minnesota agreed, noting current risks because our existing supply of antimicrobials is produced in China. Watch:
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NIST wants to use Bayh-Dole for price controls – here's BIO's response |
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The Bayh-Dole Act is intended to enable innovation, and the “march-in” rights clause cannot be used for price controls, BIO explains in comments to the Biden administration.
What’s happening: The National Institute of Standards and Technology (NIST) proposes using march-in rights as a “back door” for drug price controls. NIST is considering giving patents of drugs developed with federal funding to a third party if the drug price is deemed too high.
The Bayh-Dole Act, which allows patenting of research that receives federal funding, has enabled remarkable biotech advances. The government can “march in” and give away patents in very specific circumstances, but using march-in rights for price controls is against the law’s scope and intention, BIO explains.
NIST’s proposal would undermine Bayh-Dole’s objectives,BIO explains: - Uncertainty about patent ownership will discourage the private sector partnerships that enable the commercialization of federally funded inventions.
- March-in rights just won’t work for price controls because patents obtained through federal research are rarely directly linked with commercialized products.
- NIST’s proposal “rests on incorrect interpretations” of Bayh-Dole.
- The proposal would “disrupt settled expectations,” ignoring the history of past federal decisions.
The proposal would create confusion as it “fails to account for the complexity of marketing and distribution of products in a wide range of manufacturing and service industries,” BIO says.
BIO’s view: “The ambiguities and uncertainty in the draft framework, if adopted, would create unacceptable commercial risks and uncertainty for potential private sector partners, which, in turn, would chill (if not substantially eliminate) interest from the private sector in forming the partnerships necessary to commercialize products and services based on federally funded inventions,” BIO explains. |
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