Report: FDA safety monitoring, public alerts lacking

The FDA's oversight of drugs doesn't end once they hit the market--or at least, it isn't supposed to. It has an early warning system in place to spot safety issues. Problem is, regulators are struggling to keep up--and falling behind on alerting the public in the process.

The agency's so-called watch list--based on its Adverse Event Reporting System (FAERS)--for the first, second and third quarters of 2015 tardily appeared on the FDA's website on Feb. 5, 2016, Medscape Medical News reports--meaning that the public found out late about potential problems with 39 drugs or drug classes.

Case in point: It took months for news that the FDA had identified stroke and thromboembolic events as a "potential signal of a serious risk" for 7 SGLT-2 diabetes drugs to reach doctors and patients, the publication notes. And while the point isn't for the FDA to allege that the meds caused the adverse events, the agency is required by law to let patients and physicians know within three months that regulators are looking into them.

As FDA spokeswoman Angela Stark previously told Medscape, the agency was working to catch up on entering safety issues into its post-approval monitoring system. The slowdown reflects "challenges with balancing the important work of timely evaluation" with the data entry process, she noted, citing "multiple competing priorities and understaffing" as reasons agency staffers hadn't completely adhered "to the time-consuming data entry procedures of tracking safety issues."

The FDA has drawn criticism for falling behind with other postmarketing requirements, too. It's facing a huge backlog on postmarketing safety studies it began mandating in 2007--and its lack of follow-up has allowed some pharma companies to delay shelling out for the costly studies. And in January, the Government Accountability Office slammed the body for approving more and more drugs under its expedited programs--but failing to properly monitor them after they hit the marketplace.

"The lack of reliable and accessible data restricts FDA's ability to conduct systematic oversight of postmarket safety," the GAO's report said.

- read more from Medscape

Special Report: The most influential people in biopharma today - Janet Woodcock - FDA

Read more on

Suggested Articles

The future may be uncertain for AZ’s Imfinzi in first-line lung cancer, but its targeted med Tagrisso now boasts a green light in that setting.

Ultragenyx is back with another FDA nod, this time for Crysvita to treat X-linked hypophosphatemia in patients one year and older.

Roche got a two pieces of good Hemlibra news early this week—and what's good for Hemlibra must be good for Roche.