Epic Act Reintroduced

March 4, 2025

Addressing the Pill Penalty - A Bipartisan Effort to Boost Small molecule Drug Innovation

The Ensuring Pathways to Innovative Cures (EPIC) Act (H.R. 1492), has been reintroduced. It’s a bipartisan bill that would address the harmful “pill penalty” created by the Inflation Reduction Act (IRA). Introduced by Representatives Greg Murphy (R-NC), Don Davis (D-NC) and Richard Hudson (R-NC), this legislation seeks to correct a provision of the law that disincentivizes the development of small molecule drugs and equalizes the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program.  


Small molecule drugs make up well over 90% of all prescriptions and two-thirds of new drug approvals annually. Yet, under the IRA, they face stricter price-setting timelines - 9 years versus 13 years for biologics – before being subject to federal drug price setting. Numerous pharmaceutical companies have adjusted their R&D pipelines away from small molecule drugs due to the onerous IRA provision. 


Indeed, a new analysis by research firm Vital Transformation found that R&D spends on small molecules has dropped by 70% in the two years since 2021 when the IRA was first introduced. Further, biologics R&D funding was 10 times larger than small molecules in the first six months of 2024, despite the latter being the most common and convenient treatment option for patients. 



A just released report by the Center for Life Sciences Innovation at the Information Technology & Innovation Foundation (ITIF) underscores even more emphatically  the need to pass the EPIC Act and provide an incentive and resources to companies to reinvest in future small-molecule projects. 

RECENT ARTICLES

April 24, 2025
Prenuptial Patenting: Responsible Engagement with Engineering Firms
April 24, 2025
PharmOptima, a Poratge, Michigan-based preclinical contract research organization (CRO) is advancing drug discovery through its comprehensive suite of services. Specializing in in-vivo ADME/PK, ocular research, as well as regulated large and small molecule bioanalytical and ligand binding services, PharmOptima supports clients in optimizing drug development programs efficiently and effectively. With a staff averaging 11 years of industry experience and multiple individuals with advanced degrees, PharmOptima also boasts one of the most capable and engaging teams in the industry. The company collaborates with board-certified veterinary ophthalmologist Dr. Ryan Boyd, further enhancing its ocular research capabilities. PharmOptima's team of experts is dedicated to providing high-quality services to the pharmaceutical biotechnology industries. Looking ahead, PharmOptima scientists will be presenting posters at the 2025 The Association for Research in Vision and Ophthalmology (ARVO) conference, showcasing their latest research and innovations in ocular drug development. For more information visit www.pharmoptima.com .
April 24, 2025
Two bills, HB 4332 and HB 4333 were recently re-introduced that would prohibit pathogen gain-of-function (GoF) research. Given that the House is now Republican-led raises concerns for MichBio and others that the legislation might gain traction due to misinformation over biosafety and pandemic origins. MichBio opposes such broad legislative bans as they risk undermining critical scientific progress, public health preparedness, and economic innovation. GoF research has been instrumental in developing life-saving therapies and vaccines. For instance, viral vector-based gene therapies, such as Sarepta's Elevidys for Duchenne muscular dystrophy, and oncolytic virotherapies like Amgen's Imlygic for melanoma, rely on genetically modified viruses to deliver therapeutic genes or selectively destroy cancer cells. These advancements stem from GoF methodologies that enhance viral capabilities for therapeutic purposes. Moreover, GoF research has played a pivotal role in vaccine development. Examples like the AstraZeneca and Janssen COVID-19 vaccines and Merck's ERVEBO vaccine against Ebola employs a genetically modified virus to confer protection, underscore the public health benefits derived from GoF studies. ​ Contrary to concerns that GoF research operates without sufficient oversight, multiple layers of regulation are in place. Since 2017, the U.S. Department of Health and Human Services has implemented a framework to evaluate and guide funding decisions for GoF research, particularly those involving potential pandemic pathogens. This framework includes stringent safety protocols, risk assessments, and ethical reviews. ​ MichBio is most concerned that any legislative bans that broadly define and prohibit GoF research risk stifling innovation across various scientific fields. Such bans could inadvertently encompass research in virology, microbiology, molecular biology, and synthetic biology—disciplines vital for developing new therapies, sustainable agricultural practices, and environmental remediation technologies. ​ In turn, state-level bans on GoF research could have detrimental effects on local economies and academic institutions. Such a ban could impede research critical to understanding and combating diseases, leading to a loss of federal and philanthropic funding. This could hamper the growth of the Michigan's biotech and biomedical sectors. ​  MichBio advocates for a balanced approach that reinforces existing oversight mechanisms and fosters transparent, responsible research practices essential to safeguard both public health and scientific progress.