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FDA review process faster than in other countries, med student reports in NEJM

Yale Medicine Magazine, 2012 - Autumn


Somewhere between his board examinations and his wedding this spring, medical student Nicholas Downing found time to be the lead author on a paper published in a prestigious clinical journal. The paper, published online in May and in print in June in The New England Journal of Medicine, challenges criticism that the Food and Drug Administration’s (FDA) drug review process is too slow. According to the paper, the FDA approved drugs faster on average than peer agencies in Europe and Canada between 2001 and 2010.

“It’s a huge accomplishment,” said Joseph Ross, M.D., M.H.S. ’06, assistant professor of medicine and senior author of the paper.

And it’s not Downing’s first publication. He also published a paper in April in Archives of Internal Medicine describing how a pharmaceutical company used reformulations to dominate the market for fenofibrate, a drug given to treat high cholesterol levels, for over a decade despite numerous generic formulations of the drug.

Downing, an American citizen, grew up in London and attended Harvard, graduating in 2007 with a degree in chemistry. He then worked for three years at McKinsey & Company, an international management consulting firm. As a business analyst and engagement manager, Downing worked mostly with pharmaceutical companies and, to a lesser extent, with hospitals. “I didn’t really understand the clinical and human side of medicine,” he said, “and that was kind of a stimulus that got me interested in exploring what a medical career could look like.

“Medicine is not immune to market forces,” he said, but added that few people understand both “the realities of business … (and) the nuances and human side of clinical medicine.”

During his first year at Yale, Downing approached Ross and Harlan Krumholz, M.D., the Harold H. Hines Jr. Professor of Medicine (cardiology) and professor of investigative medicine and of public health (health policy), and the director of the Robert Wood Johnson Foundation Clinical Scholars Program, about a summer research project. Ross and Krumholz were interested in research about the pharmaceutical industry, and Downing had business experience in pharmaceuticals—the perfect partnership.

The idea for the FDA study emerged from the impending reauthorization of the Prescription Drug User Fee Act (PDUFA), which was first enacted in 1992 to allow the FDA to collect fees from drug companies to fund the process of new drug approval. In addition, there had been “a lot of noise about the FDA being slow” in the media, Downing said.

But this need for speed must be balanced by quality assurance, Downing added. As a result, it wasn’t clear what the appropriate speed might be, so the team decided to compare the FDA with peer agencies in Europe and Canada.

The team found that the FDA reviewed applications for new molecular entities or biologic drugs more rapidly on average than the European Medicines Agency and Health Canada from 2001 to 2010. Downing’s team found that the FDA completed its initial reviews 50 to 60 days ahead of the other two agencies, with its median time for completion being 303 days. And for 72 drugs that were approved by all three agencies, the FDA’s first review time was about 100 days faster. For those drugs approved in at least two regions, two-thirds were first approved in the United States.

The report concludes that given the FDA’s lead over its peer institutions, criticisms about the inefficiency of the agency’s review process for novel drugs may be unfounded.

The study is important because “it injected some objective information into what had become a relatively subjective debate,” Downing said. PDUFA V, the fourth reauthorization of the 1992 act, was signed into law by President Barack Obama on July 9.

Downing said the team’s next step is to examine the quality of the FDA’s drug reviews. “I think it’s the responsibility of every physician to understand the safety and efficacy profile of every single drug that they use,” he said.