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There has been a significant increase in attention aimed towards the business practices of pharmacy benefit managers (PBMs) on Capitol Hill. On Sept. 19, the House Committee on Oversight and Accountability held a hearing focused on the pricing practices of PBMs entitled, “The Role of Pharmacy Benefit Managers in Prescription Drug Markets Part II: Not What the Doctor Ordered.”
The House Energy & Commerce Committee has been, and will continue to be, busy with activity focused on PBMs and the entire healthcare landscape. The Health Subcommittee held a hearing yesterday, September 19, entitled “Examining Policies to Improve Seniors’ Access to Innovative Drugs, Medical Devices, and Technology” focused on a slate of legislation intended to improve access to treatments, medical devices and technology. Both PBMs and Medicare Part D were topics of discussion.
Additionally, the “Lower Costs, More Transparency Act” was introduced earlier this month, led by Rep. McMorris Rodgers (R-WA), Rep. Pallone (D-NJ), Rep. Smith (R-MO) and Rep. Foxx (R-VA). For a summary of the bill from the Energy & Commerce Committee, click here. Additionally, the Congressional Budget Office (CBO) estimates that it would cost $10.2 billion
The House Energy & Commerce Health Subcommittee also held a hearing entitled, “Examining Policies to Improve Seniors’ Access to Innovative Drugs, Medical Devices and Technology” on Sept. 19. The Subcommittee had a busy day, also considering about 25 legislative proposals.
Today, the House Energy & Commerce Committee will hold a hearing entitled, “At What Cost: Oversight of How the IRA's Price Setting Scheme Means Fewer Cures for Patients.” We expect testimony from life sciences executives to be contributed at the hearing.
As a reminder, the Centers for Medicare and Medicaid Services (CMS) will hold Patient-focused listening sessions for the selected medications, with a different session date set for each of the ten medications. They are expected to randomly select 20 from the range of entities who apply to contribute with an opportunity to submit written comments if not selected to present in person. For more information on the listening sessions and the submission process, click here.
Also related to the Inflation Reduction Act (IRA), Senators Menendez (D-NJ) and Blackburn (R-TN) introduced the “Maintaining Investments in New Innovation Act” or “MINI Act”. This legislation would specifically render new drugs that incorporate or utilize a genetically-targeted technology to be treated as large molecules from the perspective of the IRA’s price provisions.
On the topic of Artificial Intelligence, Senator Cassidy (R-LA), the Ranking Member of the Senate Health, Education, Labor and Pensions (HELP) Committee, released a white paper focused on the role of Congress in the emergence of AI. The white paper includes a variety of questions associated with medical innovation, medical ethics and protecting patients. Comments in response to the questions in the white paper are due this Friday, September 22. This follows a hearing by the Senate Committee on Commerce, Science & Transportation entitled, “The Need for Transparency in Artificial Intelligence”.
Further, Sen. Cassidy (R-LA) delivered remarks on the pricing provisions of the IRA.
Please contact Ian McLaughlin, VP of Government Affairs at BioNJ, at IMcLaughlin@BioNJ.org, with any thoughts related to the Senate HELP Committee’s engagement of AI.
The Federal Trade Commission (FTC) issued a policy statement signaling that companies that manufacture and sell brand-name drugs may face legal action if they improperly list patents in the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations”, also referred to as the “Orange Book.” The FTC announced that it will be investigating improper Orange Book listings that might inhibit competition derived from generic drugs. On a related note, a bill has been introduced that would target intellectual property policy. The “Medication Affordability and Patent Integrity Act” was introduced by Senators Hassan (D-NH), Braun (R-IN), and Reps. Kuster (NH-02), and Harshbarger (TN-01). On the topic of intellectual property, the Bayh-Dole Coalition held a briefing on Capitol Hill entitled, “Faces of American Innovation” based on the report that the group recently released.
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