A team of researchers composed mainly of Yale faculty and recent alumni has concluded that the U.S. Food and Drug Administration remains the fastest jurisdictional drug-regulating agency in the world when it comes to reviewing and approving new medications.
The study, published in the New England Journal of Medicine on April 6, was an update to a larger project conducted several years earlier, in which the researchers compared the FDA’s review and approval times to those of the European Medicines Agency and Health Canada. The original study found that the FDA reviews and approves drugs about 60 days earlier than similar agencies.
“When you look into various areas of therapeutics, this speed tends to be consistent,” said Nicholas Downing MED ’14, one of the authors on the original 2012 study and a current resident at Brigham and Women’s Hospital.
In the first study, Downing and Yale School of Medicine professor Joseph Ross compared review and approval times between the FDA and comparable agencies in Europe and Canada between 2001 and 2010. The 2017 study is an extension of that one, and compares the EMA to the FDA using data from 2011 to 2015.
To reach its conclusion, the team used the FDA’s and the EMA’s publicly available databases of drug approval, Downing explained. First, the researchers identified a number of drugs approved in both Europe and the Americas. They eliminated several categories of drugs that are considered diagnostic agents, and therefore not drugs per EMA classifications, but are categorized as drugs by the FDA.
The EMA generates European Public Assessment Reports of all drugs it approves, according to Downing. These reviews contain a timeline of events starting with a drug application submission to the EMA and culminating in the approval decision. The researchers used this information to understand review times, as the entire process from submission to approval is outlined in these public reports.
For the FDA however, the information was harder to come by. The U.S. agency does not produce similar summary reviews. It does, however, make letters between the agency and drug companies public, and in these letters the necessary information about submission and approval dates can be found, Downing said.
Downing was prompted to investigate the FDA’s review times by the Prescription Drug User Fee Act, a law passed by Congress in 1992 that allowed the FDA to charge drug manufacturers a fee in order to fund the approval process. According to FDA press officer Sandy Walsh, the PDUFA was created in response to what was seen as a lag in the FDA’s approval times.
The FDA used the funds generated by the PDUFA to increase staff and to expedite the bureaucratic process, among other things.
During the PDUFA’s reauthorization process, which takes place every five years, the regulatory review times come under great scrutiny. Because of this, Downing said he and the other researchers involved in the study wanted to provide a benchmark for understanding the FDA’s review times.
“[PDUFA] reversed the lag in drug approvals that prompted its creation, providing Americans with more rapid access to safe and effective new drugs and biologics,” Walsh said. “Today, almost two-thirds of new active substances approved in the world market are launched first in the United States.”
According to Ross, the study helps contextualize political and industry pressure to push for faster FDA approvals, since the FDA is already moving quickly in comparison to analogous agencies. Legislators can therefore use the study to inform their decisions about the review process.
Both Ross and Downing noted that the study looked exclusively at the speeds of the review times — not the outcomes of the agency reviews.
“Speed is only one component of the review process,” Downing said. “We don’t really know if the FDA should be going faster or slower. All we know that it is faster, which is important as PDUFA is being reconsidered.”