FTC Launches Inquiry into Pharmacy Benefit Manager Practices |
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The Federal Trade Commission (FTC) announced that it will launch an inquiry into the industry of pharmacy benefit managers (PBMs), requiring information and records surrounding their business practices. This inquiry is intended to build on the significant public record developed in response to the request for information about PBMs that the agency launched on Feb. 24, 2022, in which more than 24,000 public comments were received. The agency’s inquiry will scrutinize the impact of vertically integrated pharmacy benefit managers on the access and affordability of prescription drugs. As part of this inquiry, the FTC will send compulsory orders to the six largest pharmacy benefit managers: CVS Caremark; Express Scripts, Inc.; OptumRx, Inc.; Humana, Inc.; Prime Therapeutics LLC; and MedImpact Healthcare Systems, Inc. “Although many people have never heard of pharmacy benefit managers, these powerful middlemen have enormous influence over the U.S. prescription drug system,” said Federal Trade Commission Chair Lina M. Khan. “This study will shine a light on these companies’ practices and their impact on pharmacies, payers, doctors and Patients.”
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BioNJ Honors New Jersey Health Commissioner Persichelli |
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On June 9, BioNJ held its Annual Dinner Meeting and Innovation Celebration which featured the presentation of the 2022 Annual Dr. Sol J. Barer Award for Vision, Innovation and Leadership to New Jersey Health Commissioner, the Honorable Judith M. Persichilli, by Dr. Sol J. Barer himself.
"We are elated to honor Commissioner Persichilli with the 2022 Dr. Sol J. Barer Award for Vision, Innovation and Leadership for her tireless work on behalf of Patients, leading the State’s response to the COVID-19 pandemic and improving New Jersey’s health care system," said BioNJ President and CEO Debbie Hart. "Commissioner Persichilli has proven time and time again her commitment to the residents of New Jersey by diligently working to protect our communities from the spread of the coronavirus, while enhancing the overall health of New Jerseyans.”
Click here for a video honoring Commissioner Persichilli.
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S2829 (Vitale), which requires the hiring of a vendor to manage a Medicaid Multi-State Pooling Supplemental Rebate Agreement and associated uniform Preferred Drug List, was introduced and referred to the Senate Health, Human Services and Senior Citizens Committee on June 13. It is the companion bill to A3159 (McKeon) which was originally introduced in February as part of the Governor's Prescription Drug Affordability Package. A3159 was released in March with unanimous support from the Assembly Financial Institutions and Insurance Committee, but did not receive consideration in the Assembly Health Committee in late May along with the other bills in the package.
There has been no additional movement on the Governor’s bill package or A1747/S329, legislation to create a Prescription Drug Affordability Board (PDAB), since the May 24 hearing of the Assembly Health Committee. The Assembly bills await a hearing in Assembly Appropriations, while the Senate companions remain in Senate Budget.
BioNJ continues to oppose a PDAB as the wrong way to address Patient out-of-pocket costs. A1747/S329 would allow for government to set price controls for prescription treatments and does not guarantee any savings for those New Jerseyans facing high out-of-pocket drug costs. BioNJ supports transparency across the entire supply chain, as proposed in A2840. BioNJ continues to seek amendments that would enhance and enable data collection and compliance, eliminate anti-competitive disclosure and reduce the risk of delayed access for Patients, while still allowing for meaningful transparency. The advance notification language in this bill would potentially delay launch of a drug for 60 days, essentially delaying Patient access to a new innovative medicine.
S1794 (Stanley, Conaway, Benson), legislation that places certain requirements regarding the use of prior authorization of health benefits on carriers and utilization review entities acting on behalf of carriers, was released by unanimous vote out of Senate Commerce Committee. The bill prohibits the use of a step therapy protocol if it is not in the best interest of the Patient and also establishes requirements regarding the prior authorization of certain medications. BioNJ supports A1255/S1794 and its intent to improve Patient access to medicines. S1794 is on second reading in the Senate, while the Assembly companion (A1255) was second referenced to Assembly Financial Institutions and Insurance Committee.
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The House of Representatives passed H.R. 7667, the Food & Drug Amendments Act of 2022, with a vote of 392-28. The legislation reauthorizes the Prescription Drug User Fee Act (PDUFA), the Generic Drug User Fee Act (GDUFA), the Biosimilar User Fee Act (BsUFA) and the Medical Device User Fee Act (MDUFA). During the debate last week, Energy & Commerce Committee Chairman Frank Pallone expressed appreciation for the strong bipartisan efforts to develop the package. The Senate Health, Education, Labor, and Pensions (HELP) Committee met yesterday to mark up its version of the FDA user fee reauthorization legislation “Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDASLA Act”, S. 4348)”. We will provide more details on amendments as they become available. The plan is for the House and Senate to conference the bills with the goal of final passage before September 30 to ensure timely reauthorization of the user fee programs. |
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U.S. Representative Adrian Smith, the Ranking Republican on the House Trade Subcommittee, recently introduced a resolution of inquiry seeking information from the administration on the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. The agreement would allow the world to infringe on the intellectual property behind COVID-19 vaccines and therapeutics. House Resolution 1169, Requesting the President to transmit certain information to the House of Representatives relating to the proposed waiver of intellectual property commitments under the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights, specifically requests for information that demonstrates that the proposed waiver will increase global supply and delivery of COVID-19 vaccines; will accelerate the end of the COVID-19 pandemic; or the People’s Republic of China will not obtain access to patents or other intellectual property related to COVID-19 vaccines even if expressly excluded from the proposed TRIPS waiver.
Click here for a letter by members of the House Committee on Ways and Means to Ambassador Tai concerning the administration’s failure to consult with Congress on the TRIPS negotiations.
Click here for a bipartisan letter led by Reps. LaHood and Panetta providing actions the administration can and should take to ensure global access to vaccines.
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We Need Your Help: Support BioNJ Policy and Advocacy Efforts |
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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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Thank You to Our Public Policy Sponsors |
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