Duke University's McClellan cites FDA improvements

The FDA has made significant strides in drug safety reform over the past decade, says a leading authority from Duke University.

In 2007, Dr. Mark McClellan published a paper in the New England Journal of Medicine posing the question “Drug Safety Reform at the FDA — Pendulum Swing or Systematic Improvement?” In the article, McClellan discussed the essential tension posed by the process of approving prescription drugs: the need to protect patients from adverse side effects vs. the need to get effective drugs to the people who need them as quickly as possible. 

McClellan, director of the Duke-Margolis Center for Health Policy at Duke University, referenced a 2006 review of FDA procedures by the Institute of Medicine (IOM) that called for improvements in several aspects of the process, including increasing funding for and the authority of the FDA as well as improving its post-surveillance process, which involves tracking patients who are actually using the drug. 

More than a decade later, McClellan told FDA Health News that progress is being made. 

Dr. Mark McClellan  

“I think we’re significantly farther along to having support and infrastructure to enable drug-safety surveillance and better protection of the American public,” he said.

Among them, he said in a telephone interview, are three pieces of legislation that have increased the FDA Drug Center’s funding and access to resources, most of it funded by additional fees levied on drug manufacturers. The FDA has also increased its ability to impose requirements on those who make the drugs, and even the physicians who prescribe them, in regard to drugs that can be useful to some patients but pose serious risks to others. For example, a doctor who wants to prescribe Accutane, which treats severe cystic acne but is also known to cause birth defects, must first take steps to ensure the patient is not pregnant or likely to become pregnant.

Some consider such regulations burdensome, McClellan said, but the alternatives — approving a drug with known adverse affects, or keeping one off the market when it could help some people — are in his estimation worse.

The most important stride since he wrote that article, he said, is the ability, thanks to modern digital technology, to track patients who are taking a medication and become aware of their side effects — or lack of them — much earlier than before. In the past, it could take years or even decades for the agency to become aware of the health effects of medications, and then only if someone took the initiative to report them.

Now, he said, hospitals, health care providers and insurance companies all have records that the FDA can scan, thus finding out quickly if people are experiencing adverse effects from prescription medications or, conversely, if a drug suspected of causing problems in fact does not.

He used the example of Vioxx, an arthritis medication that was taken off the market in 2004, after five years of use, when it was discovered to increase the risk of heart attack and stroke.

“Situations like Vioxx back in 2004 really shouldn’t be happening again for prescription drugs,” McClellan said. “We’ve taken many steps in the right direction since 2007.”