Making the Grade: Reviving the New Drug "Report Card"
This article was originally published in RPM Report
Executive Summary
The Food & Drug Administration is proposing the development of a pilot program to assess and communicate post-marketing experience for newly approved drugs and biologics. The pilot, which is part of FDA's response to the Institute of Medicine report on drug safety, is a revival of the "report card" idea from the late 1990s.
It’s high school all over again for new drug approvals.
The Food & Drug Administration is proposing the development of a pilot program to assess and communicate post-marketing experience for newly approved drugs and biologics. The pilot, which is part of FDA’s response to the Institute of Medicine report on drug safety, is a revival of the "report card" idea from the late 1990s.
The program will "systematically produce safety profiles of newly approved drugs on a regularily scheduled basis...after a drug has been on the market for about 18 months," Center for Drug Evaluation & Research Director Steven Galson, MD, said during a January 30 press conference.
"From these assessments, medical professionals and the public will learn what we have gleaned from adverse event reports, useage patterns and new studies that have been conducted since the drug’s approval," Galson said. "We’ll also report on whether changes should be made to the label, to our initial assessment of the benefit-risk balance, or whether additional steps will need to be taken to maximize benefits and mimimize risks."
FDA has been thinking about reviving the idea for some time. Paul Seligman, MD, associate director for safety policy & communication announced the agency’s intention to revive the "report card" idea during The RPM Report’s FDA/CMS Summit in December. "We have already begun in [CDER] to look at how we would develop a ‘report card,’ and what drugs we would look at," he said. "We think it’s a superb idea that we would have a formal evaluative process that continues after approval."
But not all drugs would be reviewed—at least not in the beginning. "We believe the periodicity should be based on providing priorities: whether is a new molecular entity; first-in-class product; whether we expect there to be a large patient population exposed or rapid uptake," Seligman said. FDA expects to choose an early 2007 drug approval as the first drug under the pilot. That’s a distinction one drug company will likely be loathe to recieve.
The program isn’t a new concept for FDA: a "report card" system has been kicking around the agency for years, but limited resources have made it difficult to implement. The IoM report "reignited this activity," Seligman said.
The pilot program is FDA’s response to the IoM report recommendation that the agency conduct a five-year re-review of new products. (See "Designer Labeling: Drug Safety Reform Proposals Include New Powers for FDA," The RPM Report, November 2006 (Also see "Designer Labeling: Drug Safety Reform Proposals Include New Powers for FDA" - Pink Sheet, 1 Nov, 2006.).)
Seligman suggested the "report card" system would take that idea a step further. "For products that are of high priority, waiting five years is probably too long," he told the FDA/CMS Summit. "We really need to be more active in evaluating these data much sooner than five years subsequent to marketing."
Currently, CDER’s evaluative process for post-marketing safety consists of monitoring data from the passive Adverse Event Reporting System (AERS), and keeping tabs on clinical and epidemiological studies—both pre-approval trials and Phase IV commitments. "But there’s no formal process where we sit down on a regular basis and pool together...all this information," Seligman acknowledged.