FDA Issuing Fewest Warning Letters Since 2008

Image courtesy of Eric Arnold

The Trump administration has not been shy about its desire to cut regulations, so perhaps it’s not surprising that the Food and Drug Administration could be pulling back on its efforts to hold companies accountable. The FDA has sent out fewer warning letters to date this year than in any year since 2008. If warning letters and enforcement actions are down, does that mean we’re all less safe?

What warning letters are for

The FDA sends letters of warning to companies for all kinds of reasons. They might receive warnings as a follow-up to an inspection, when they’re caught selling tobacco products to minors, or when the FDA learns about problematic labeling or marketing. Fewer letters going out could mean cutbacks in inspections, or cutbacks in enforcement actions.

Compared to this point during the first year of the Obama administration, research by Bloomberg Politics shows, the FDA has sent 8% fewer warning letters. So far this year, the agency has sent 30% fewer letters than it had on average by this point of the year during all eight years of the Obama administration. Yet the agency says that there’s been no deliberate slowdown in enforcement under the Trump administration.

Companies probably aren’t suddenly behaving better

It would be great to hear that this is that because food and drug manufacturing facilities worldwide are suddenly cleaner and safer, but that seems unlikely. It’s especially unlikely because the agency’s new Commissioner, Scott Gottlieb, has been critical of the FDA’s actions toward drug manufacturers in the past. He wrote a Wall Street Journal op-ed accusing regulations of making certain generic drugs scarce by over-regulating their production.

“Instead of calling for targeted fixes of troubled plants, the agency has often taken a very costly shotgun approach that requires upgrades virtually everywhere,” he wrote.

That’s not to say that the FDA hasn’t taken some dramatic enforcement actions under the new administration. Since Gottlieb was confirmed in May, the agency has asked a drugmaker to take Opana, a prescription opioid painkiller linked to abuse and to an HIV outbreak, off the market, and the company complied. His FDA is also considering lowering nicotine levels allowed in cigarettes to reduce their addictive power.

You can keep an eye on warning letters going out for yourself, since they’re all public documents. They can be both tedious and fascinating reading.