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Bipartisan legislation reintroduced in the House on Feb. 21 would encourage the development of small-molecule drugs by eliminating the “pill penalty” in the Inflation Reduction Act (IRA).
The IRA arbitrarily gives small molecule drugs only nine years of total protection from price controls, while biologics can be exempt for 13 years. The Ensuring Pathways to Innovative Cures (EPIC) Act (H.R. 1492) would correct this unscientific approach that discourages the development of small molecule drugs—typically oral drugs that are easier for patients to take.
Reps. Gregory Murphy, M.D. (R-NC), Don Davis (D-NC), and Richard Hudson (R-NC) reintroduced the EPIC Act based on a bill that was introduced in the previous Congress.
BIO President & CEO John F. Crowley thanked Reps. Murphy, Davis, and Hudson for introducing the new bill, saying the IRA currently prevents science from determining the direction of innovations in drug development.
“For decades small molecule medicines that come in a pill or tablet have been recognized for improving patient adherence, being easier to take, and more broadly accessible to those who need them. As a result, hundreds of such therapies have been developed,” Crowley said. “Today, instead of building on years of biomedical progress, some innovator companies and investors are now being forced to pull away.”
The full text of the proposed EPIC Act is here. It was introduced and referred to the House Energy & Commerce and Ways and Means committees on Feb. 21.
The need for IRA mitigation
In announcing the introduction of the EPIC Act, Rep. Murphy noted the need to correct the IRA’s disincentives for drug development.
“Unfortunately, the Inflation Reduction Act’s price-fixing scheme destroys research and development, reducing treatment options for patients,” he said.
BIO has listed mitigation of the IRA’s negative impact on innovation of new treatments as one of its top priorities for the current Congress. Another measure in this vein is the ORPHAN Cures Act, introduced in the House on Jan. 28 by Rep. Davis, who is backing the EPIC Act, and Rep. John Joyce, M.D. (R-PA). The ORPHAN Cures Act would enable faster drug discovery by granting exemptions from the drug price “negotiation” process for rare disease drugs approved for a second rare disease.
The IRA currently encourages the development of orphan drugs for rare diseases by giving these drugs exemptions from drug price “negotiations,” but only if the drugs are approved for a single indication. Investigating whether new drugs could treat a second indication has proven to be an effective way to speed drug development and has led to many new treatments.
“That’s why BIO strongly supports the ORPHAN Cures Act, which would amend the IRA and ensure the continuation of essential research and development of new medicines for patients with rare diseases,” Crowley said after the ORPHAN Cures Act was introduced.
