We were glad to see drug safety in the spotlight on Sunday’s 60 Minutes segment on the GlaxoSmithKline quality problems at Cidra, its now-closed flagship plant in Puerto Rico. Cheryl Eckard, the former GSK quality assurance manager and whistleblower at the center of a $750M court settlement in October 2010, talked about the numerous quality and contamination problems her team found at Cidra, which was shut down in 2009 after the company failed to fix the manufacturing problems.
Whistleblowers like Eckard can act as an important safety valve in the current system, exposing potentially harmful safety problems and misconduct by companies that show unwillingness to comply or fix issues on their own.
But the story is a good reminder of the role of the FDA in all this. As the 60 Minutes segment reported, Eckard was sent in to address problems documented by an FDA warning letter, and that’s when her team found even more. Under current rules, companies must report manufacturing problems to the FDA—in a protocol known as “field alerts”—in only very narrow circumstances: when a distributed drug is mislabeled, contaminated, or does not meet required specifications. (And according to allegations in the case, GSK failed to do some of that.)
So how can we make sure that FDA knows whenever there is a quality or safety issue with our drugs that could affect the public health?
Better notification requirements are one way. The Drug Safety Enhancement Act (DSEA) introduced late last month by Rep. John Dingell, would expand notification requirements beyond field alerts in important ways, requiring manufacturers to get more information to the FDA whenever a manufacturing problem is detected.
Currently, many makers of OTC products don’t have to file under the field alert system (for any drug that doesn’t have a New Drug Application on file). But as we were reminded with the flotilla of recent J&J recalls, OTC manufacturers are susceptible to the same splintered manufacturing problems that prescription drugmakers are. The DSEA would include OTC producers.
It would also require companies to inform FDA about all issues with potential impact to the public health, including instances when: –a drug may cause illness or injury –possible theft or other loss has occurred –counterfeit is probable –the manufacturer has experienced repeated quality failures with a component supplier.
Under the Dingell bill, these reporting requirements would also extend to importers and distributors, which is key in such a fragmented supply chain. Both that bill and one introduced last year by Rep. Edolphus Towns would bolster the notification systems and give the FDA recall authority, another important tool the agency should have to make sure unsafe or substandard drugs—the kind GSK allowed to get to consumers—are off trucks and pharmacy shelves promptly.
Currently, whistleblower protections under the False Claims Act require the allegation of false claims against the U.S. government. But one can imagine numerous scenarios in which the public health is at risk though no false claim has been made against the feds. Whistleblowers who report such threats would have similar protections under the DSEA.
The Cidra case is evidence that the system partially works. According to allegations, Eckard went to the FDA after her continued petitions to GSK management to fix things went unaddressed. The FDA inspectors of Cidra found quality problems, then Eckard found more. But a better notification system that requires more players to report to regulators all potential problems that could affect the public health puts the emphasis in the right place—in-house quality control and accountability—rather than waiting for outside inspectors to discover just how much has gone wrong.
–Kate Petersen, PostScript blogger