Gottlieb and others say it reflects a smarter, more surgical approach. “It’s not the number of inspections we do, it’s whether we’re targeting effectively,” he said.
Industry proponents and the FDA say it decides which facilities to inspect using a risk score calculated by the agency. They also say that the FDA can’t inspect its way to better quality drugs, particularly with the limited resources it’s given, and that it’s up to drugmakers to police themselves.
But others, including Margaret Hamburg, the FDA commissioner under President Barack Obama from 2009 to 2015, see cause for concern, given the sprawling complexity of the system delivering more and more of the drugs that Americans consume. “Maintaining, if not increasing, inspections would seem crucial, given the global sourcing, supply chain, increase in approvals and quality issues,” Hamburg said after Bloomberg shared the inspection numbers with her.
Lawmakers shown the figures expressed similar worries—that the recent figures could reflect the agency putting approvals above enforcement. This was particularly true in the case of China, where FDA inspections fell almost 11 percent even as U.S. regulators oversaw a massive recall of a Chinese-made heart drug contaminated with a possible cancer-causing chemical.
“Any actions by the FDA to prioritize expediting drug approvals over ensuring manufacturing quality and compliance would be concerning, as it has the potential to risk patient safety,” said Representative Frank Pallone, the New Jersey Democrat who is the new chairman of the House Energy & Commerce Committee, with jurisdiction over the FDA. “I look forward to hearing more from the agency about how they are balancing both missions.”
To patients in the U.S., the origin of their drugs shouldn’t make a difference. Whether treatments are made in West Virginia or Mumbai, they’re supposed to meet FDA standards for safety and efficacy. But as the industry has become increasingly global and desire for lower drug prices continues to grow, signs are indicating that U.S.-made drugs aren’t immune from the same forces that have led to corner-cutting overseas.
The FDA’s current approach was mandated by a 2012 law. To determine when to visit a facility, the agency takes into account when the facility was last inspected, what that most recent look found and what the plant manufactures, among other factors. The agency sends inspectors to facilities with the highest risk scores first.
“There’s things that go wrong that are hard to predict,” Gottlieb said. “But there’s certain actors that are more likely to make mistakes that present public-health challenges. And there are certain actors that are more likely to do something deliberate—and those are the ones that you need to be focused on.”
Congress focused on drugmaker inspections after a 2008 crisis in which a contaminated blood thinner called heparin made in China was linked to more than 200 deaths in the U.S. Lawmakers used the 2012 law to boost the FDA’s ability to inspect foreign drugmakers.
Today, 90 percent of the medications that Americans take are generics. They’re cheap because they rely on research done by brand-name pharmaceutical companies. When a brand-name drug’s patent protection runs out—generally after about 20 years—a generic firm can copy the product. The maker only has to prove it works the same as the original, saving hundreds of millions of dollars on research and development.