With 40% of Americans struggling to afford prescription drugs and many rationing or delaying the initiation of lifesaving drugs, it is clear that something has gone terribly wrong. The goal of medical research and development (R&D) is to discover, develop, and deliver tools that address urgent public health needs, but high prices prevent American patients from accessing the medicines essential to their care. In other regions of the world with limited or devastated resources, the access crisis is even more acute: certain important diseases are completely neglected by the market, while the drugs that exist are priced out of reach.

For decades, pharmaceutical companies have argued that drug prices should be set high because bringing new drugs to market is incredibly expensive. Yet the key evidence behind this claim remains a closely guarded secret. Pharmaceutical companies keep the public in the dark about the true cost of drug development. The Pharmaceutical Research Transparency Act of 2022, a new bill recently introduced in the House and Senate, aims to correct this information asymmetry. This would allow the public to access crucial information on R&D costs and to know more clearly if the price of medicines is fair.

It’s the final stages of the R&D process that pharmaceutical companies typically describe as the most expensive part – especially clinical trials, which get new products out of the lab and provide crucial evidence of their safety and efficacy for consumers. real patients. Yet detailed information on the costs of clinical trials is not publicly available.

The Pharmaceutical Research Transparency Act would tackle this long-standing problem in two ways. First, it would create a public database of detailed, disaggregated clinical trial cost data for all drugs under FDA review. Drugmakers, government labs, universities and other entities that sponsor these trials would then be required to submit these cost data within one year of the trials being completed. Second, the law would require drugmakers to report disaggregated clinical trial costs in their annual securities filings. Together, these elements would significantly increase public knowledge of clinical trial costs and overall R&D expenditures.

The law would build on a 2007 federal law that requires researchers to publicly register and report clinical trial results to ClinicalTrials.gov, a public website operated by the NIH. Although not perfect, ClinicalTrials.gov has been a major victory for public health, facilitating knowledge sharing, helping to avoid costly and inefficient duplication of research, and curbing dangerous “picking” of data by pharmaceutical companies, which previously hid major safety and efficacy issues. Similarly, mandating the disclosure of clinical trial cost data would make it harder for pharmaceutical companies to use hidden data to justify setting unaffordable prices for therapies.

What little we currently know about R&D spending—revealed by recent congressional surveys, for example—suggests that pharmaceutical companies are exaggerating their true R&D spending. The revenues of pharmaceutical companies are increasingly being “reinvested” in executive compensation, share buybacks and dividends rather than in R&D.

Sharing the actual costs of clinical trials would bring many benefits. Cost transparency would allow purchasers of health technologies to question claims about the pharmaceutical industry’s need to recoup R&D costs through high prices. Ultimately, when cost transparency is combined with the ability to negotiate prices, buyers can negotiate more effectively for fair prices. Cost transparency will be essential for negotiating Medicare drug prices — a very popular proposal currently being debated in Congress — to have the desired impact on cost savings. It would also serve non-profit groups like Doctors Without Borders that purchase drugs for use in humanitarian operations and advocate for equitable global access to medical innovations. Disclosure of clinical trial costs would also strengthen alternative models of R&D, such as public and philanthropic drug discovery, by refining estimates of the true costs of late-stage clinical research. Currently, these costs are generally estimated, based on opaque data from limited self-reporting by pharmaceutical companies. (More in-depth and exceptionally transparent data on clinical trial costs are shared by nonprofit developers such as the Drugs for Neglected Diseases Initiative, but they fund only a tiny fraction of trials.)

If Congress does not act, the Biden administration can, without waiting for Congress. The United States is the largest funder of biomedical research in the world, with taxpayers’ money not only providing the fundamental scientific foundation on which most R&D is based, but playing a major and often underestimated role in late-stage development of new health technologies, including testing. biologics and gene therapies. The National Institutes of Health (NIH) alone spends billions each year on clinical trials, but does not currently disclose detailed, disaggregated cost data. In short, the US government holds a huge, mostly untapped reservoir of useful data on the true costs of clinical trials. And it has a responsibility to the public to provide full and clear accountability for how public money is spent.

We, along with many other groups committed to lowering drug prices and aligning medical innovation with public health needs, recently called on the Department of Health and Human Services (HHS) and its agencies, including including the NIH, to disclose the costs of all clinical trials they fund or conduct in a detailed and disaggregated manner. Such disclosure is within the legal authority of the agency. Yet the response we received from HHS was boilerplate, expressing no specific plan or intention to share cost data. HHS, NIH and President Biden should embrace the proactive disclosure of trial cost data we called for in our letter. Any candidate for the vacant position of NIH director should make this reform a priority.

Amid the ongoing pandemic, as the U.S. government continues to invest billions more to develop tools to fight COVID-19 and other infectious threats, transparency and accountability in discovery and drug development have never been more important – both to the American public and the global community as a whole. Disclosure of clinical trial costs is an essential next step to ensure fair prices for medicines, fair public returns on public investments in R&D, and fair and equitable access to the fruits of scientific progress.

Ava Alkon, PhD, MPH is Policy Advisor for Médecins Sans Frontières/Médecins Sans Frontières (MSF) USA. Christopher Morten, JD, PhD is an associate clinical professor of law at Columbia Law School and director of Columbia’s Science, Health, and Information Clinic. He is also a Visiting Fellow of the Global Health Justice Partnership at Yale Law School. MSF USA has ordered a key report on clinical trial cost transparency by Dr. Morten and the NYU Technology Law & Policy Clinic, which published in August 2020. MSF then published a complementary advocacy briefing in January 2021 calling for this reform. Reshma Ramachandran, MD, MPP is a family physician and member of the Yale National Clinician Scholars Program. She leads efforts on drug pricing and FDA policy for the national nonprofit organization Doctors for America.