May 11, 2022
Prescription Drug User Fee Act (PDUFA)

Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ), Ranking Member Cathy McMorris Rodgers (R-WA), Health Subcommittee Chairwoman Anna G. Eshoo (D-CA) and Health Subcommittee Ranking Member Brett Guthrie (R-KY) unveiled a comprehensive legislative package to reauthorize the Food and Drug Administration (FDA) user fee agreements. BioNJ is pleased that Chairman Pallone and the Committee recognize the importance of timely reauthorization and are working together to develop a bill that will have a positive impact on Patients. This year marks the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA). The user fee program was created to authorize the Food and Drug Administration (FDA) to collect user fees from biopharmaceutical companies to supplement its funding and review and approve innovative products faster and more efficiently. Thanks to PDUFA, the United States is the world leader in the development of biomedical products. The Energy & Commerce House Subcommittee has shared that they are planning on a vote “next week,” with the goal of sending the bill to President Biden for signature before August.

Learn more about PDUFA here.
Please find the legislative text here.
Please find the House Energy and Commerce's press release here.
Please find BIO's statement here.
Senate Subcommittee Holds Hearing on PBM Practices 

U.S. Senator Richard Blumenthal (D-Conn.), Chair of the Subcommittee on Consumer Protection, Product Safety and Data Security, convened a hearing to examine practices of Pharmacy Benefit Managers (PBMs) on May 5, 2022. The hearing examined steps Congress can take to increase transparency in drug prices, require PBMs to operate fairly and ensure the Federal Trade Commission has the authority it needs to stop unfair practices in the prescription drug market.

PBMs are “part of a broken drug supply chain,” said Sen. Blumenthal, noting his priority is lowering the cost of prescription drugs. Sen. Blackburn criticized the Centers for Medicare and Medicaid Services (CMS) for delaying the final policy on pharmacy price concessions at the point of sale to January 1, 2024, saying it gives PBMs “another year to play games.”  

BIO recently provided comments to the Federal Trade Commission’s Solicitation for Public Comments on the Business Practices of Pharmacy Benefit Managers and Their Impact on Independent Pharmacies and Consumers.

Please find BIO’s comments here.
Click here to view the hearing.
Bayh-Dole Coalition on the Threat to Innovation and Small Business

The Bayh-Dole Coalition hosted a webinar to educate on the potential impact of marching-in solely on the basis of price. The Bayh-Dole Act of 1980 enables academic research institutions, federal laboratories and small companies to own inventions made with federal funding so that they can be developed into useful products. As previously shared, BioNJ recently joined with more than 65 other groups and individuals in signing on to the Bayh-Dole Coalition letter to the U.S. Department of Health and Human Services Secretary Becerra opposing the most recent march-in petition on Xtandi. The Bayh-Dole Act does not sanction marching-in because critics do not like the price of a successfully commercialized product that arose from a federally funded invention. The purpose of the Bayh-Dole Act is to incentivize the commercialization of technologies developed from federally funded inventions. Under Bayh-Dole, approximately 70% of academic patent licenses go to small companies. These companies must secure venture funding to operate. The recent webinar hosted by the Coalition explains the threat to small company innovation.

Please click here to read an informative article by Joe Allen, Executive Director of the Bayh-Dole Coalition.

Click here to watch the Bayh-Dole webinar.
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BioNJ is the voice of New Jersey’s life sciences sector in Trenton and Washington. BioNJ’s Public Policy Support Series sponsorship opportunities are still available for 2022. Help ensure BioNJ continues to deliver our message of improved Patient access and enhanced innovation through a Public Policy Support Series Sponsorship.  

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