Timing is everything. Why the US gets some drugs faster than other countries
Researchers find that differences in drug availability are driven more by when companies submit drugs for approval than review speed, especially for medicines that offer little added benefit to patients.
As Washington debates how to rein in soaring prescription drug prices, including proposals that would tie U.S. prices to those paid abroad, a new study led by researchers at the Brown University School of Public Health is challenging the long-held assumption about why Americans get new medicines sooner than patients in other countries.
For years, drug companies and industry allies have argued that the U.S. gets faster and wider access because its government moves quicker than foreign regulators, but the new analysis suggests the U.S. advantage in drug access is driven less by faster government review and more by when companies apply for review and the type of drugs they submit.
The study, published in Health Affairs, looked at every new prescription drug approved between 2014 and 2018 in the U.S., and Europe, and then tracked submission delays and review times for these products across regulators in Canada, Japan and Australia through the end of 2022. The analysis assessed the speed of the review process and the timing of submissions for approval, with results broken down by drug characteristics, including therapeutic value of the drugs.
Specifically, the researchers explored whether different patterns in submission and review times emerged for drugs that offered little added medical benefit over drugs that were already on the market.
“Some commentators have argued that foreign regulators take too long to review drugs and should do more to ensure timely access to new therapies, often pointing to limited availability of new cancer therapies in Europe and other rich markets relative to what’s on the market in the United States, as evidence that regulatory red tape is getting in the way of timely patient access,” said lead author Irene Papanicolas, a professor of health services, policy and practice at the Brown University School of Public Health. “Where we're coming at this from is saying that broader availability of new medicines is generally a great thing — we want patients to get access to new meds — but not all new medications are equally important from a medical standpoint.”
In fact, what stood out most was how companies handled drugs that provide little therapeutic advantage over existing treatments, which the authors referred to as “low-value” drugs in their analysis. The researchers found these drugs were typically submitted to U.S. regulators months or even years before companies sought approval in other high-income countries, giving Americans earlier and wider access to expensive drugs that may not significantly improve patient outcomes.
The findings likely reflect a mix of business incentives and policy choices, according to the research team which along with Papanicolas and other Brown co-authors Olivier Wouters and Tania Sawaya also includes health policy experts from Vanderbilt University and the London School of Economics and Political Science.
The U.S. is the world’s largest drug market, and manufacturers can generally set prices freely when a drug launches. In contrast, many other countries evaluate how much a new drug improves health compared with existing treatments and use that information to negotiate prices or limit coverage, said Wouters, an associate professor in the Department of Health Services, Policy, and Practice.
“There are many drugs that enter the U.S. market that frankly aren’t much better than what’s already available,” Wouters said. “Companies generally seem to submit these lower-value products for approval earlier in the United States than in other markets. This may reflect the fact that governments in other countries tend to drive a tougher bargain than U.S. payers, which could influence companies’ decisions about where and when to seek approval.”
The study also showed that drugs offering clear medical benefits over existing treatments tended to reach most high-income countries at roughly the same time. This is because drugmakers typically submit those products for approval simultaneously across the high-income countries the researchers looked at. The Food and Drug Administration was only slightly faster than its counterparts abroad in approving the drugs by a few weeks or a month on average, the researchers said.
“Historically, yes, the U.S. gets more new drugs and gets them faster than other countries but a lot of what is driving this pattern aren’t the drugs that have this meaningful therapeutic gain for patients,” Papanicolas said. “Everybody's getting those important new drugs quickly.”
Overall, the study helps add nuance to the question of why the U.S. spends far more on prescription drugs than other high-income countries without consistently better health outcomes. It also paints a more complicated picture as policymakers debate proposals such as the “most favored nation” approach, to bring down drug spending, which proposes linking U.S. drug prices to those paid in peer countries.
“It's not clear how this is going to work,” Papanicolas said. “How will the US authorities handle products that haven’t yet been marketed abroad? Will the policy affect where and when companies decide to submit drugs abroad? No one really knows yet.”
Journal
Health Affairs
Article Title
Review Times For New Drugs And Submission Delays Among The FDA And 4 International Regulators, 2014–22
Article Publication Date
2-Feb-2026
