Opinion: Georgia's Congressional delegation can lead the way on correcting 'pill penalty'

Opinion: Georgia's Congressional delegation can lead the way on correcting 'pill penalty'

Maria Thacker Goethe President and CEO, Georgia Life Sciences: May 1, 2025

EPIC Act offers commonsense fix to 'pill penalty' problem


Georgia is home to a thriving life sciences sector, with groundbreaking research and innovation happening across the state. From the laboratories at Emory University to biotech firms in Atlanta and beyond, our state plays a vital role in developing the next generation of medical treatments. But a flaw in federal policy is putting that progress at risk—and unless Congress acts now, patients and businesses alike will pay the price.


The problem is known as the "pill penalty," an unintended consequence of the Inflation Reduction Act (IRA). While the IRA was designed to lower drug costs, it included a provision that discourages investment in small-molecule drugs—the pills and capsules that make up over 90% of prescriptions in the U.S. Unlike biologic drugs, which are administered via injection or infusion and have 13 years before they are subject to Medicare price controls, small-molecule medicines face price controls after just nine years. That four-year difference may seem minor, but in the high-risk world of drug development, it has a major impact.


This disparity is already reshaping the research landscape. A recent analysis by Vital Transformation found that early-stage investment in small-molecule medicines has plummeted by more than 70% since the IRA became law, with companies deprioritizing entire areas of drug development. The result? Fewer innovative treatments for conditions like cancer, heart disease, and mental illness—diseases that affect millions of Georgians.


While the White House issued an Executive Order on April 15 to address the pill penalty, a permanent fix is needed through Congressional action. The Ensuring Pathways to Innovative Cures (EPIC) Act (H.R. 1492) offers a commonsense fix. It levels the playing field by giving small-molecule medicines the same 13-year exemption period as biologics. This change would restore incentives for drug companies to invest in critical pill-based treatments while maintaining the IRA’s broader goals of affordability and access.


Georgia needs a leader in Congress to take up this fight―to ensure patients have access to innovative therapies and to ensure that our bioscience community continues to thrive. Our state’s Congressional delegation is perfect for the job, with a track record of protecting patients’ access to care.


Beyond its impact on patients, the EPIC Act is also critical for Georgia’s economy. According to the Georgia Department of Economic Development, the life sciences industry contributes billions to our state’s economy and supports over 75,000 high-paying jobs. This sector is growing rapidly, but continued investment depends on smart policies that encourage research and development.


The good news is that fixing this problem doesn’t require a massive overhaul—just a simple correction to ensure fairness in drug development timelines. The EPIC Act is a targeted solution that preserves the IRA’s intent while ensuring continued medical breakthroughs. Congressman Buddy Carter has a well-earned reputation as a leader in health policy and a tireless champion for patients. By stepping up on the EPIC Act, he can set the stage for the rest of Georgia’s delegation to follow his lead.


The choice is clear: we can either allow the pill penalty to stifle innovation and limit patient access to new treatments, or we can fix it and keep Georgia at the forefront of medical research. The Georgia delegation has the opportunity to lead on this critical issue, and we urge them to seize it. Georgia’s patients, researchers, and life sciences industry are counting on it.

By Maria Thacker Goethe July 28, 2025
By: Clary Estes “Small companies are the lifeblood of the industry and a lot of what they do, and what they’re experiencing, greatly affects the industry as a whole,” said Chad Wessel, Director of Industry Analysis at the Biotechnology Innovation Organization (BIO). He spoke with Bio.News in an interview about BIO’s 2025 report, “ The State of Emerging Biotech Companies: Investment, Deal, and Pipeline Trends ,” focused on the biotech industry from the early-stage perspective. As researchers found, the current landscape is challenging, but there are still opportunities. “In the last couple years, we’ve had a little bit of a contraction of the industry. During COVID, we kind of had this sugar rush for the industry,” said Wessel. “A lot of companies were being created. A lot of money was being thrown out there. A lot more companies were being funded. And in the last couple of years, there has been a little bit more of a correction, and we’re seeing funding levels going down to what we’ve seen prior to COVID.” “But when you add on other challenges, like the political landscape and everything, it is leaning towards a very challenging environment for a lot of companies,” he continued. Bearish venture capital “In venture capital, yes, you have a lot of money, but it’s going to fewer companies at higher average amounts,” explained Wessel. “It’s creating this competitive haves and have-nots type marketplace or environment. So it just makes it a lot more competitive and more challenging to raise funds.” Instead of finding new opportunities, venture capitalists are investing more in companies they are already working with. As the BIO report found, the amount of new series A-1 investment rounds into biopharma remained flat between 2023 and 2024, while the number of U.S. companies receiving their first series A-1 tranche went from 102 to 100. This is in comparison to 181 in 2021, reflecting the COVID influx to emerging biotechs. Comparatively, as the BIO report found, the average amount for A-1 transactions in the U.S. saw a remarkable increase of 700% in the last 15 years, with the average amount raised sitting at $60 million in 2024. The rest of the world stayed relatively steady in comparison to the U.S.’s persistent growth. And with the more bearish tendencies of investors, Wessel and team observed an interesting trend. “2024 was the first year that clinical programs actually raised more venture dollars than pre-clinical, which hasn’t happened in a while,” said Wessel. “I think the last time that happened was in 2018. This ties into some of the information that we’ve heard anecdotally, which is that a lot of VC firms are focusing on the companies that they currently have in their portfolio, rather than adding new companies.” Licensing and deals dip It is not too surprising, then, that as investors shore up what they already have in the pipelines, the R&D pipeline and licensing have slowed somewhat. As the BIO report observed, long-term growth in the R&D pipeline continues with an overall growth of 145% since 2010. Yet, the 2024 expansion rate (4.6%) subsided slightly, trailing the 5-year average of 6.7%. “The growth has slowed on new programs, and more of those programs are being licensed with larger companies,” explained Wessel. “There are fewer options for big companies to backfill their pipeline with products because a lot of them are already out.” The data also shows a notable slowing of the R&D typically done by large biopharma companies. “The areas that are not licensed out as much are the ones with some of the higher patient populations and subsequently the ones that are not being run by small companies,” said Wessel. “These are areas like endocrine and cardiovascular diseases, which are areas where there are a lot of things like type 2 diabetes, psoriasis , high blood pressure, etc. Those all have a lot of burden on the healthcare sector or the patient population, and those aren’t really being worked on that much by smaller companies.” Comparatively – and also not surprisingly – oncology has stayed at the top of the clinical pipeline, along with neurology and infectious disease. “Same thing with licensing,” said Wessel. “While there are deals that are still happening, the upfront amount is lower currently than it has been in years past, and most of the value is tied up into milestone payments, which may or may not happen.” This is also being felt when it comes to new companies going public, which has been an oft-discussed challenge in the biotech industry for the last few years. “The IPO market has still been challenging,” Wessel says. “We went from having 40 companies a year going public, down to 15 in 2023, and now we’re back up in 2025, but it’s still down from the pre-COVID era timeframe.” Biopharma layoffs Another notable characteristic of this year’s biopharma landscape has been uptick in layoffs. “Sometimes it’s just the nature of the economy. But the amount that we’ve seen in the last few years is quite a bit higher,” said Wessel. “To counter that, we don’t really have a way of measuring job creation, but we do know it’s happening. We just are unable to put a value on that.” The BIO report found that layoff announcements ticked up to 65 during Q1 of 2025. While two points lower than Q1 of the previous year, this still marks a jump from 2024’s Q2, Q3, and Q4, which saw the number of layoff announcements at 41, 54, and 46, respectively. All in all, Wessel noted, the biotech industry is still in a bit of a holding period when it comes to trying to navigate the coming months. “It’s too early to be able to say much about the coming years for the industry based on these numbers,” he said. “It takes a little time for reality to kind of catch up for multiple reasons. But what I can say is that we do know that companies are reducing their pipelines. We do know that companies are laying off individuals. We do know that companies are having a challenge of raising funds and continue doing their best to try to maintain operations as long as they can until they can get funds.” “We know the challenge is out there, but we’re going to have to kind of wait and see a little bit on the data side of things to understand how everything is going to catch up going forward.” Source: https://bio.news/bioeconomy/bio-2025-state-of-emerging-biotechs-report-market-trends/?mkt_tok=NDkwLUVIWi05OTkAAAGb7m5php-rTOf0a_GTaj5pj7Zl-HlpVM25WtyVvCYudM82a9GKjoazUg9sqU66hlAbhqbEuYvcX3C4EqfBG7Q
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