Pentagon Hits FDA on Generic Testing
The Defense Department has been paying for independent laboratory testing of some FDA-approved generic drugs because it doesn’t trust FDA’s approvals based on inspections without testing samples. A lengthy Bloomberg News report says that while generic drugs have saved taxpayers and consumers hundreds of billions of dollars a year, drug manufacturing quality recalls doubled from 2018 to 2022.
“With almost 80% of FDA-registered generic production facilities located overseas,” Bloomberg says, “years can pass between inspections. Profit margins on generics are so thin that there are often only one or two suppliers of vital medications. As a result, quality issues are fueling shocking shortfalls in supply…. Shortages in the U.S. reached near-record highs his year, and left cancer patients, among others, waiting for lifesaving treatments. Generics are supposed to be affordable and safe. Instead, they’re cheap but sometimes dangerous.”
The article discusses FDA’s recent eye drop recall and the cancer drug shortages associated with problems at India’s Intas Pharmaceuticals.
“Concerns about the nation’s drug supply have reached the point that hospitals, the Defense Department, and Congress are raising questions about FDA’s ability to monitor it,” Bloomberg says. “The Pentagon in August chose an independent lab with which FDA has publicly feuded, Valisure LLC, to test some of the generics available to millions of military personnel and their families, two years after Kaiser Permanente, a health system serving 12.7 million in the U.S., started a similar program with the lab. The efforts have run into a major roadblock — FDA itself…. FDA resists the idea of grading drugs by quality and rarely conducts tests of its own. Agency officials sought to block the Pentagon’s nascent study, cast doubt on Valisure’s methods and, according to multiple government officials, soured a Biden administration effort this year to introduce third-party testing more widely.”
The article quotes FDA spokesman Jeremy Kahn asserting that the agency “is continuously working to ensure that all drugs meet the highest quality standards with the health and well-being of Americans top of mind.”
Bloomberg describes FDA commissioner Robert Califf’s recent trip to India and says his subsequent blog post “walked a line between pep talk and tough talk for India’s embattled generic drug industry.” It says FDA did not make Califf available to comment on the story.
The article says the person who has most shaped the modern FDA is principal deputy commissioner Janet Woodcock, who has announced her retirement. “As the regulator has lurched from controversy to controversy in recent years, it is Woodcock’s mindset that has been preeminent,” it says. She told the news service, “You cannot test products into compliance. The best quality is assured when manufacturers are dedicated to high quality.”
According to Bloomberg, FDA doesn’t regularly test either ingredients or the finished products. During inspections, it says, the agency primarily checks to see how well companies follow manufacturing procedures rather than conduct its own sampling. When FDA does find problems, the article says, it typically relies on the company to voluntarily take action to address the root cause.
The article quotes long-time People’s Pharmacy activist Joe Graedon that “FDA has a story and the story is ‘We’re FDA, we know what we’re doing. Trust us.’ Anything that interferes with that story or criticizes that story is generally not welcome.”
Bloomberg notes that in Europe, independent testing has long been standard, with a network of some 70 labs that sample medications both before they’re released and after they’re in use. It says Woodcock indicated that European regulators also rely on inspections and work closely with FDA. She said tests might motivate “certain manufacturers to make sure their products at least pass. But people who know a lot about this will tell you that testing per se is not a magic bullet.”
The article closes with a quote from Califf who was asked at a generic drug industry conference not long after he returned from India about the idea of health systems doing independent tests. “I might say there are better ways to spend your money,” he responded.