FDA Warning Letters Drop on Potential ‘Trump Effect’
FDA Warning Letters issued to medical product makers are significantly down in 2017, and several agency watchers are worried that president Donald Trump’s anti-regulation stance could be behind the drop. Letters posted on FDA’s Web site show a 30% decline from the eight-year average of the Obama administration, according to a Bloomberg news report. Center for Science in the Public Interest president Michael Jacobson told the news outlet that the drop in letters is “an ominous sign” that Trump’s anti-regulation rhetoric has become official policy. “More Americans will get sick—or not get well—if laws ensuring the safety of our food and drugs are not enforced,” he said.
From January to July, the agency sent 265 Warning Letters to companies, which is the lowest tally for the first seven months of any year since 2008, according to a Bloomberg review of letters posted. Public Citizen health director Michael Carome said his group is worried that Trump’s pledge to roll back red tape has reached FDA. “I think there’s little reason to believe that, overall, the industry is doing dramatically better,” he told the news outlet. “That’s unlikely to be the explanation for the drop in these numbers.”
Asked to comment, FDA told Bloomberg that there has been no administration directive to curb enforcement and that commissioner Scott Gottlieb doesn’t plan to relax the agency’s regulatory approach. “Any honest analysis of the agency’s overall enforcement statistics will reflect results that are comparable to annual statistics from previous years,” a spokeswoman said. “Enforcement statistics reflect actions initiated many months and sometimes more than a year prior to the reporting of the final action.”
Former FDA principal deputy commissioner during the Obama administration Joshua Sharfstein said it is possible that the dip in letters may be tied to the administration’s slow pace in filling federal posts. Pending matters from a previous administration are also sometimes delayed, he told Bloomberg. “There were definitely some enforcement actions that were held up for me to review” in 2009, said Sharfstein, now an associate dean at Johns Hopkins Bloomberg School of Public Health.
The biggest drop in letters is seen in those issued by CDRH to medical device companies, according to Bloomberg. Since 11/2016, the Center posted one warning letter on St. Jude heart implants that had previously been recalled for battery issues. The FDA spokeswoman said that the Center has issued additional Warning Letters — 11 in total — but didn’t specify when they were sent or why they weren’t posted publicly. She said the center is working to “improve the issuance and posting process.”