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On September 20, the House Energy & Commerce Oversight and Investigations Subcommittee will explore how the drug price controls in the Inflation Reduction Act (IRA) will limit innovation and access to medicine – with testimony from a Biotechnology Innovation Organization (BIO) Board member.
The hearing, At What Cost: Oversight of How the IRA’s Price Setting Scheme Means Fewer Cures for Patients, will feature testimony from John F. Crowley, Chairman of Amicus Therapeutics and BIO Board Vice Chair. The focus will be on how the implementation of the price controls by Centers for Medicare and Medicaid Services (CMS) “will result in fewer lifesaving cures and treatments and negative outcomes for patients.”
“The IRA’s Price Negotiation Program is not an arms-length negotiation. In fact, the price setting process is not consistent with commonly accepted definitions of ‘negotiation.’ The maximum price for a selected drug is statutorily capped at 25% to 60% below the non-Federal average manufacturer price (market price). Beyond that price ceiling, the Secretary has broad discretion in setting a price and may use practically any information deemed relevant to determine the price that will be paid for a select drug. A unique feature of the ‘negotiations’ is that manufacturers must agree to accept that price before negotiations begin,” explains the hearing memo.
“[T]he penalties for refusing to negotiate and to agree in advance to accept CMS’s price setting determination are extremely punitive.”
BIO opposes price controls
BIO has long opposed the drug price controls in the law and CMS’ guidance and handling of the process, which the organization says will inhibit investment and innovation.
John F. Crowley is expected to testify to this point. Crowley is CEO of Amicus Therapeutics, which researches therapies for rare diseases including Batten and Pompe, a rare and severe neuromuscular disorder afflicting two of his children. A Navy combat veteran, he also promotes veterans’ access to care.
He will testify on BIO’s behalf to explain how the IRA’s price controls would make life-saving cures, like the ones he developed, impossible.
Hearing from real-life patients and advocates will be very impactful, says Aiken Hackett, BIO’s VP of Federal Government Relations.
We’ll be watching his testimony closely – stay tuned for a recap on September 21.
