OIG to Evaluate FDA Postmarketing Requirements

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By Jeannie Baumann

Nov. 16 — An OIG evaluation on how well the FDA manages pharmaceutical safety research for drugs after they reach the market will be out next year, a program analyst in the Health and Human Services Office of Inspector General's evaluation division said Nov. 14.

Elizabeth Havener, who works out of the OIG's Boston office, declined to indicate specifically when the report would be released publicly.

“I've learned not to say,” said Havener, who was one of the analysts on the report. She indicated that it's now under review in the OIG's office.

“It's out of my hands,” she said during a presentation at the Advancing Ethical Research conference hosted by Public Responsibility in Medicine and Research. “We're hoping soon.”

Postmarketing requirements offer an important safety tool, she said, but a 2006 OIG report found holes in the Food and Drug Administration's management of postmarket surveillance. The OIG concluded in that report that the agency was unable to determine whether, or how promptly, drugmakers are completing postmarketing studies, and that the FDA should require more and better information about such studies on annual reports .

Impact of FDAAA Evaluated

The report will evaluate the impact of new authorities provided to the FDA under the Food and Drug Administration Amendments Act (Pub. L. No. 110–85), which President George W. Bush signed into law in September 2007.

“Prior to FDAAA’s passing in 2007, FDA had a pretty limited authority to require these kinds of studies, and it mostly focused on pediatric research,” Havener said. “Now FDA can require postmarketing studies whenever there’s a signal of significant risk.”

Under the FDAAA, the FDA has the authority to require additional research to be conducted on drugs once they’re already on the market, either because of a signal of risk or in conjunction with the drug's approval.

“So we wanted to check back in,” she said, adding that follow-up reports are a common practice at the OIG, “especially if the regs change.”

To conduct the report, Havener said, the OIG analyzed FDA data on postmarketing research from fiscal years 2008 to 2014. The OIG selected FY 2008 because that's the year the FDAAA went into effect; FY 2014 had the most current data when the OIG submitted its request for information. The OIG also reviewed postmarketing status reports that drug sponsors must submit to the FDA every year and conducted interviews with FDA staff. Havener added that the interviews are an important part of the evaluation process.

“This helps us get a better understanding of the way the program works on the ground,” she said. “And it really provides us with the context to be able to interpret the numbers correctly to make sure we’re really seeing what we’re seeing from our data.”

“I can't tell you what we found, but it will be another thing to look forward to next year,” she said.

The OIG's 2016 work plan also referenced the report (OEI; 01-14- 00390).

“We will determine the extent to which FDA requires postmarketing studies and clinical trials (referred to as postmarketing requirements, or PMRs) for new drug applications. We will also assess how FDA monitors PMRs and takes enforcement action against applicants that do not comply with them,” it said.

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bna.com

To contact the editor responsible for this story: Lee Barnes at lbarnes@bna.com

The 2006 OIG report is available at http://www.oig.hhs.gov/oei/reports/oei-01-04-00390.pdf.

The OIG 2016 work plan is available at http://www.oig.hhs.gov/reports-and-publications/archives/workplan/2016/oig-work-plan-2016.pdf.

More information on the conference is available at http://www.primr.org/aer15/.


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