New drugs are often launched in the United States before other countries, leading some to believe that the speed of regulators’ reviews is the main driver for this difference. But a new study by researchers at the School of Public Health challenges this notion.
The study, published in Health Affairs, found that when a pharmaceutical company submits a review plays a larger role in determining how soon patients gain access to a new medication, than the length of a medication’s regulatory review.
According to Olivier Wouters, an associate professor of health services, policy and practice at SPH and an author on the paper, people who critique regulatory bodies view them as “unnecessary red tape that prevents new drugs from reaching patients quicker.”
But the study found that regulatory bodies are relatively similar in their review timelines, and they “operate pretty much at equal speed,” Wouters said.
The findings suggest that “cross-national differences in drug availability are largely about whether and when drug companies submit applications to each regulator, not only about how quickly regulators review applications,” Wei wrote.
The researchers identified all of the new drugs that were approved by the Food and Drug Administration or European Medicines Agency from 2014 to 2018 and tracked their submissions to regulators in the United States, the European Union, Canada, Japan and Australia through 2022.
In addition to submission timing, the researchers also studied the impact of a drug’s therapeutic value on how quickly companies pursued approval in different countries.
For Wouters, the “most interesting” finding of the research was that companies tend to submit drugs that provide more therapeutic benefit “a lot sooner, and so those are made available much sooner in all the countries (they) looked at” compared to drugs with a lower therapeutic value.
According to Wouters, the drugs’ therapeutic values were determined using assessments from regulatory bodies of different countries.
Olivier Wouters, an associate professor of health services, policy and practice at SPH, told The Herald that the study found that regulatory bodies are relatively similar in their review timelines.
Wei explained that patients “should be cautious about interpreting should be cautious about interpreting later authorization as ‘slower regulators.’”
“A large part of the gap occurs before regulatory review even begins, because drug companies prioritize submitting to certain regulators based on commercial strategies,” she wrote.
Longer review times and additional regulatory requests can help “allow for proper scrutiny of the evidence and follow-up on important analyses,” Kaley Hayes, associate director of health services, policy and practice, wrote in an email to The Herald.
Hayes, who was not involved in the study, explained that longer reviews help ensure that there is as much solid evidence for the drug’s safety as possible before it is released to consumers.
“But long review times can sometimes result from administrative issues or other delays that aren’t related to the content or review of the safety information,” she added.
When it comes to therapies that are more urgent, “there are pathways that help to prioritize speed of review when there are few to no available options on the market,” Hayes explained, pointing to the FDA’s priority review and accelerated approval pathways.
For Wouters, it’s important to consider the therapeutic value of drug products when having debates about the availability of drugs in different countries.
“I was quite pleased to see that really important medical advances are reaching patients and healthcare systems much sooner than ones that offer less therapeutic value,” he said.
Amrita Rajpal is a senior staff writer covering science and research.
