Policy experts have challenged pharmaceutical industry claims about the negative impact of Medicare's Drug Price Negotiation Program on innovation, presenting new evidence at a National Institute for Health Care Management Foundation webinar.
A comprehensive analysis of FDA drug approvals has revealed that smaller biotech companies, not large pharmaceutical corporations, are the primary drivers of drug innovation. The study, conducted by the Foundation for Research on Equal Opportunity (FREOPP), examined 428 FDA drug approvals from 2013 to 2022, analyzing data from over 4,000 companies.
Small Biotech Companies Lead Innovation
Research findings show that emerging companies, defined as those earning less than $500 million in revenue, originated 52% of new drugs, significantly outperforming large pharmaceutical companies, which contributed only 36%. This trend has strengthened in recent years, with 75% of emerging company discoveries in 2022 being marketed independently without big pharma partnerships.
"The implication is that a policy like the IRA is sensible in that it helps to save on Medicare spending without targeting the most efficient and most productive part of the innovation ecosystem," stated Gregg Girvan, MPP, a FREOPP fellow.
Improving the Current Framework
While supporting the overall direction of the Medicare Drug Price Negotiation Program, experts suggested potential improvements. These include:
- Aligning eligibility timing for small-molecule drugs and biologics
- Eliminating the excise tax penalty for non-participation
- Fostering more collaborative price negotiations between CMS and pharmaceutical companies
International Reference Pricing Considerations
The concept of international reference pricing, previously proposed under the "Most Favored Nation" policy, received attention as a potential mechanism for distributing drug development costs more equitably across developed nations. However, recent political developments suggest this approach may not be pursued in the immediate future.
Patent Reform Challenges
The pharmaceutical patent system faces ongoing scrutiny, particularly regarding patent thickets that delay generic competition. Adalimumab (Humira), with over 100 patents and $22 billion in 2020 revenue, exemplifies the current challenges in the system.
A recent setback occurred when the U.S. Patent and Trademark Office withdrew a proposed rule that would have addressed patent thickets and potentially accelerated generic drug market entry. The rule had received bipartisan support from Senators Peter Welch, Mike Braun, and Amy Klobuchar, who emphasized its potential to reduce patent holder gamesmanship and promote market innovation.
The withdrawal of this patent reform initiative, cited due to "resource constraints," represents a significant setback in efforts to increase competition and reduce drug prices through patent system reform.
