FDA’s consumer protection warnings falling under Trump | 2017-09-28 | Indianapolis Business Journal

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 it may be pulling back 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 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.”

Besides warning letters, the FDA has a variety of other tools to get companies to comply with food, drug, and safety laws.

For the most serious violations, it can order recalls, seize products, and seek court-ordered injunctions. The agency obtained 17 injunctions in the 2016 fiscal year, which ended Sept. 30. It also has a criminal investigation office that can help initiate prosecutions. The FDA declined to provide additional data on its enforcement activities in 2017, including the total number of inspections, citing ongoing investigations. Agency representatives also contend it’s too early to fairly assess FDA enforcement under Trump by looking at the data it makes public.

Nevertheless, warning letters remain one indicator of the agency’s enforcement intensity. Any slowdown would be consistent with reports of diminished activity by other federal agencies since Trump, who campaigned on the promise of cutting regulations, took office. The Environmental Protection Agency has brought fewer actions and collected smaller fines compared with previous administrations during the same period, according to an Aug. 10 report by the Environmental Integrity Project, a non-partisan watchdog group.

Warning letters represent “one of their more forceful instruments to use in trying to assure high-quality manufacturing processes,” said Eric Sacks, director of health-care product alerts at the ECRI Institute, which monitors the safety of medical products. He said the number could decline for many reasons and didn’t necessarily reflect a drawback in enforcement. Voluntary product recalls initiated by companies have not declined, Sacks said.•

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