Improvement needed of prescription drug postmarketing studies

"Because rare but potentially serious adverse events of prescription drugs are often discovered only after market approval, observational postmarketing studies constitute an important part of the U.S. drug safety system," write Kevin Fain, J.D., M.P.H., of the Johns Hopkins Bloomberg School of Public Health, Baltimore, and colleagues in JAMA today. "In 2007, Congress passed the Food and Drug Administration Amendments Act (FDAAA), which authorized the FDA to require postmarketing studies for a prescription drug's approval and mandate adherence to study deadlines. We examined how fulfillment of these postmarketing studies has changed over time."

As reported in a Research Letter, the authors extracted data on the status of all postmarketing studies for both biological license and new drug applications from the FDA annual reports published in the Federal Register and reviewed the status of all studies reported by the FDA from 2007 to 2011.

"Because of heightened public scrutiny of the status of postmarketing studies, we expected uninitiated studies to decrease and fulfilled studies to increase since 2007. Indeed, our analysis found the number of studies not yet started declined during this 5-year period, and the number of studies fulfilling obligations nearly doubled. These trends help address concerns expressed by the Institute of Medicine that many postmarketing studies before the FDAAA were not implemented or fulfilled. Despite these improvements, though, more than 40 percent of studies had not yet been started in 2011. In addition, the number of studies with delays doubled to approximately 1 in 8 as of 2011, and the proportion of all studies that have been fulfilled remains low," the authors write.

"… despite some gains in studies initiated and fulfilled, our analysis reinforces continued concerns about the status of prescription drug postmarketing studies in the United States."

More information: JAMA. 2013;310[2]:202-203

add to favorites email to friend print save as pdf

Related Stories

Merck: FDA wants more studies of insomnia drug

Jul 01, 2013

Drugmaker Merck & Co. says federal regulators have ruled that they won't approve high doses of its experimental insomnia medication because of concerns about their safety.

FDA: Draft guidance issued on abuse-deterrent opioids

Jan 10, 2013

(HealthDay)—The U.S. Food and Drug Administration has issued a draft guidance document to assist the pharmaceutical industry in developing new formulations of opioid drugs with abuse-deterrent properties.

New paper from internists calls for increased role for FDA

Sep 24, 2009

A new policy paper that calls for broader authority and increased funding for the Food and Drug Administration (FDA) was released today by the American College of Physicians (ACP). Improving FDA Regulation of Prescription ...

Recommended for you

WHO: Millions of Ebola vaccine doses ready in 2015

16 hours ago

The World Health Organization says millions of doses of two experimental Ebola vaccines could be ready for use in 2015 and five more experimental vaccines will start being tested in March.

Added benefit of vedolizumab is not proven

Oct 23, 2014

Vedolizumab (trade name Entyvio) has been approved since May 2014 for patients with moderately to severely active Crohn disease or ulcerative colitis. In an early benefit assessment pursuant to the Act on the Reform of the ...

Seaweed menace may yield new medicines

Oct 22, 2014

An invasive seaweed clogging up British coasts could be a blessing in disguise. University of Greenwich scientists have won a cash award to turn it into valuable compounds which can lead to new, life-saving drugs.

User comments