The Price Control Debate: Protecting Patient Access and Future Innovation
Patients need access to affordable medicines today. They also need continued investment in the treatments and cures of tomorrow.
These goals are deeply connected. Yet, too often, discussions about drug pricing treat them as if they’re in conflict.
As policymakers look for ways to address healthcare costs, price controls have emerged as an increasingly suggested policy solution. From the Medicare Drug Price Negotiation Program under the Inflation Reduction Act (IRA), to State Prescription Drug Affordability Boards (PDABs), to renewed interest in Most Favored Nation (MFN) pricing, these proposals are reshaping the conversation around how medicines are valued and paid for.
The intent behind these policies is straightforward: lower the cost of medicines. But the evidence is raising harder questions about what gets lost in the process — and who ultimately bears the cost.
Innovation Doesn't Happen Overnight
Every new medicine represents years of scientific research, investment, and risk-taking. The United States has long been a global leader in biopharmaceutical innovation because it has fostered an environment that encourages companies to pursue difficult scientific challenges. The result has been hundreds of new medicines that have transformed care across cancer, diabetes, cardiovascular disease, and rare conditions — over 390 in the last five years alone.
Policies that alter the economic framework supporting that innovation influence what research moves forward, where investment flows, and which future medicines reach patients.
New research from Vital Transformations shows that follow-on orphan oncology studies declined 14% following the IRA’s introduction.
New research from Vital Transformation adds important insights to this conversation. An analysis of FDA-approved medicines and more than 1,100 secondary indication development programs found that the share of follow-on orphan oncology studies declined 14% following the IRA’s introduction.
The IRA has particularly impacted the development of small molecule oncology medicines, with secondary studies declining 37% and lead indication approvals declining 27% since its introduction. Small molecule drugs include the pills and capsules patients take at home, often among the most convenient and affordable treatments available.
Under the IRA’s so-called “pill penalty,” small molecule drugs face government price controls four years earlier than biologics, and the research data is beginning to reflect that pressure.
The findings raise a critical question: if the policy landscape continues pursuing price controls, what does that mean for the treatments patients are still waiting for?
At a time when patients are waiting for breakthroughs in some of healthcare's most challenging diseases, even modest reductions in research activity deserve careful consideration.
Duane Schulthess
CEO of Vital Transformation
Beyond Washington
The debate is no longer limited to federal policy.
Across the country, states have established or are considering PDABs — politically appointed boards that can review medicine affordability and, in some states, set upper payment limits on selected therapies. Despite the name, PDABs neither lower out-of-pocket costs for patients, nor require potential savings to be shared directly with patients.
Patient and provider organizations have expressed concern that government price-setting mechanisms could interfere with treatment decisions that physicians make in consultation with their patients.
As price-setting efforts continue to expand, policymakers should carefully consider both their intended benefits and their potential consequences.
A New Chapter in the Debate
Most recently, attention has turned to Most Favored Nation pricing proposals, which tie U.S. medicine prices to prices in other countries.
While the specifics of these proposals continue to evolve, the broader discussion underscores an important principle: policies designed to address affordability should also preserve the conditions necessary for continued medical innovation.
Patients benefit when both priorities are considered together.
Where Sanofi Stands
Improving affordability and encouraging innovation should not be viewed as competing objectives.
Patients deserve access to treatments today, but they also deserve the possibility of future breakthroughs. Achieving both requires policies that support broad and affordable access to medicines while preserving incentives for research and development.
Mike Penn
Head of U.S. Reimbursement and Public Policy at Sanofi
The emerging evidence from Vital Transformation highlights why this balance matters. As policymakers evaluate approaches to drug affordability, reforms should be designed to address current cost pressures without unintentionally discouraging future research, particularly in areas of high unmet need.
Sanofi supports specific reforms at both the federal and state level to address these concerns, including changes to the “pill penalty” impacting small molecule drug development, protections for post-approval research, and guardrails to keep rare disease innovation from being caught in the crossfire.
The drug pricing debate is often framed around today's costs. But it is equally important to consider tomorrow's innovations and holistic impact on patients. The best solutions will be those that help patients access the medicines they need today while preserving the scientific progress that will improve and extend lives in the years ahead.
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