The number of agency warning letters is at its lowest level since 2008.
Many aspects of your daily life, the sorts of activities and purchases you take for granted, are regulated by a single federal agency.
From the toothpaste you use to the lipstick you apply, the medicines you take to the food you eat, the Food and Drug Administration is supposed to stand between consumers and faulty products that could do them harm. It oversees $2.4 trillion of the U.S. economy—some 20 cents of every dollar Americans spend.
But in the first months of Donald Trump’s presidency, the FDA has shown signs of retreating from its mission.
From January to July, the agency sent 265 warning letters to companies, notifying them of what it alleged to be serious violations of federal rules. That’s the lowest tally for the first seven months of any year since 2008, according to a review of letters posted on the FDA’s website. Compared with the first seven months of the Obama administration, that’s an 8 percent decline. On average, it’s a 30 percent drop from the number of letters sent during the same period of all eight years Barack Obama was president.
In March, Trump nominated 45-year-old Scott Gottlieb to run the FDA. Confirmed by the Senate in May, he’s embraced some muscular regulation over the past few months: The agency recently asked drugmaker Endo International Plc to take an opioid painkiller off the market and proposed ratcheting down the amount of nicotine in cigarettes to non-addictive levels.
But Gottlieb, who also worked for the agency under President George W. Bush, has been critical of FDA practices in the past. In late 2011, when he was a resident fellow at the conservative American Enterprise Institute, he wrote an op-ed for the Wall Street Journal suggesting that the regulator’s enforcement approach contributed to generic drug shortages by driving up costs for pharmaceutical companies. While concerns with product safety are valid, he wrote, “the FDA and the manufacturers often don’t understand the drug-production processes well enough to detect the root cause of problems. 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 echoed those remarks in Congressional testimony (PDF) later that month.
The FDA, in response to questions about the drop in warning letters under Trump, says there’s been no order to slow down enforcement and that Gottlieb doesn’t plan to soften the regulator’s approach.
“Commissioner Gottlieb and the FDA support and will vigorously enforce the agency’s current laws and regulations,” FDA spokeswoman Lyndsay Meyer said in an email. “Any honest analysis of the agency’s overall enforcement statistics will reflect results that are comparable to annual statistics from previous years. Enforcement statistics reflect actions initiated many months and sometimes more than a year prior to the reporting of the final action.”