Stakeholders Optimistic Bill Will Establish IRA Drug Negotiation Equality for Biologics and Small Molecules

The Impact of the Inflation Reduction Act on Drug Price Negotiations

Equalizing Negotiation Periods

As discussions continue between the Biden Administration and pharmaceutical companies regarding Medicare price negotiations for the initial 10 drugs impacted by the Inflation Reduction Act, a bipartisan bill aims to address the law’s “pill penalty.” This penalty results in small molecules losing four years of exclusivity compared to biologics, creating a significant disparity in negotiation periods.

Under the Inflation Reduction Act, biologics are granted a 13-year grace period following approval, while small molecules only receive nine years. This discrepancy has been criticized by industry stakeholders and lawmakers for hindering investment and innovation, ultimately affecting patients who rely on these essential medications.

The EPIC Act: A Solution to the Disparity

Introduced by Rep. Greg Murphy, the Ensuring Pathways to Innovative Cures (EPIC) Act aims to address the imbalance in negotiation periods between biologics and small molecules under the IRA’s Drug Price Negotiation Program. The legislation seeks to promote continued research and development investments in small molecule drugs, leveling the playing field for all types of medications.

Incubate, a lobbying group advocating for venture capital firms in the life sciences, supports the EPIC Act as a means to rectify the small molecule penalty imposed by the IRA. By aligning negotiation periods for all drugs, the bill aims to encourage sustained innovation and investment in critical therapies.

Implications for Pharma Companies and Patients

Pharmaceutical companies developing small molecule drugs have expressed concerns about the reduced grace period before price negotiations, leading to potential pauses in clinical trials and research pursuits. The EPIC Act is seen as a positive step towards ensuring that life-saving products reach patients without penalizing innovators.

Fitch Ratings has warned that the IRA’s pricing program may deter investments in small molecule drugs, shifting focus towards biologics with longer negotiation periods. The Congressional Budget Office estimates a potential reduction in drug introductions due to the IRA provisions, highlighting the need for legislative adjustments to support innovation in the pharmaceutical industry.

Advocating for Change

Non-profit organizations like No Patients Left Behind are calling for a reevaluation of the IRA’s impact on drug classes to advocate for a legislative fix that ensures fair negotiation periods for all medications. With stakeholders across the industry emphasizing the need for equitable policies, there is growing momentum to address the disparities created by the Inflation Reduction Act.

Author: Greg Slabodkin


Read More of this Story at – 2024-02-29 05:04:36

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  1. Your article helped me a lot, is there any more related content? Thanks!

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