FDA Warnings Meant to Protect Consumers Fall Under Trump – Bloomberg
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.”
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 (PDF), 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. Penalties levied by financial regulators against Wall Street firms are down significantly as well, the Wall Street Journal reported Aug. 6. The slowdown isn’t across the board, however: During the first six months of the new administration, the Occupational Safety and Health Administration conducted workplace inspections at a pace similar to the first six months of 2016, Bloomberg reported Aug. 3. (However, OSHA’s reporting of workplace fatalities is falling, the Wall Street Journal said Aug. 27.)
The FDA conducts thousands of inspections each year in the U.S. and globally, sending companies detailed observations of possible violations. If manufacturers don’t address serious problems, a warning letter may follow, sometimes months or more than a year after inspectors first find something wrong. The letters are a potent tool to alert both companies and the public to trouble at manufacturing plants or other sites. The agency’s policy (PDF) is to post all warning letters publicly, with most published within a few weeks of having been sent to the target company.
For example, an August 2015 letter to snack-making giant Frito-Lay Inc. cited “insanitary conditions” at a plant in Pulaski, Tennesee, that could lead food products to “become contaminated with filth or rendered injurious to health.” The FDA pointed out leaks in the roof and peeling paint directly above exposed food production lines, cookie dough and cheese filling leaking from machinery and large areas of the plant “soiled with apparent food debris and dust.” In an inspection the following July, the that Frito-Lay had fixed the problems. (Frito-Lay didn’t respond to a request for comment.)
An October 2016 letter to a Chinese dental implant-maker stated that tanks of water at its plant had “unidentified green/brown particulate accumulation.” The water was used to steam-clean implants throughout the manufacturing process. As a result, the FDA said it would stop the products from entering the U.S. until the concerns were addressed.
One FDA official whom the agency allowed Bloomberg to interview on the condition he wouldn’t be identified said there’s natural variation in the pace of enforcement activities, and that the FDA prefers to evaluate its performance with a full year of data.
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.
Another potential contributor to a dip in regulatory activity may be tied to the administration’s slow pace in filling federal posts, a former FDA official said. Pending matters from a previous administration are also sometimes delayed, said Joshua Sharfstein, the first FDA political appointee under Obama. “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 change in warning-letter activity this year hasn’t been uniform across the FDA. The regulator operates through a network of district offices and several national centers focused on specific industries such as drugs, medical devices, food, and tobacco. Activity varies across these units, according to FDA data.
The sharpest drop has been at the group that regulates medical devices, which has all but stopped publishing warning letters. Since mid-November 2016, the Center for Devices and Radiological Health posted a single warning letter, regarding St. Jude heart implants that had previously been recalled for battery problems. (A spokesman for St. Jude parent company Abbott Laboratories said in an email that the company is making progress toward resolving the FDA’s concerns.)
In 2016, the device center had sent 18 warning letters by the end of July. On average, from 2009 to 2016, the device center sent 48 letters to manufacturers during the first seven months of a year. Meyer, the FDA spokeswoman, said in an email that the device 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.”
A slowdown in enforcement would be worrisome, said Michael Carome, director of Public Citizen’s Health Research Group, a watchdog organization. He reviewed the data analyzed by Bloomberg.
The dramatic dropoff in warning letters to medical device makers appears particularly problematic, Carome said. “This is a huge market,” with hundreds of thousands of products, he explained. FDA oversight “is critically important to make sure that there aren’t defects” and that malfunctions are properly reported.
The FDA’s food regulator, the Center for Food Safety and Applied Nutrition, ensures the safety of America’s food supply, polices dietary supplements, and oversees cosmetics. That office is in the process of implementing new rules related to the Food Safety Modernization Act, which was signed into law in 2011. Its warning letter rate dropped significantly this year compared with 2016.
The FDA official said the new rules focus on preventing contaminated food from entering the market, rather than reacting after the fact. The agency wants to help companies understand the new regulations before enforcing them, he said. The agency has issued blanket restrictions on certain food imports from regions with a record of problems, he noted, including cilantro from Mexico and shrimp from Malaysia—actions he noted wouldn’t show up in the food safety center’s warning letter tallies.
The food center has sent nine letters from January to July of this year, compared with 36 sent during the same period last year. The FDA official said the effort to put the new rules into place may have affected agency activity.
The FDA is a sprawling agency. Beyond its White Oak, Maryland, headquarters, it operates 19 district offices across the U.S. and Puerto Rico. These outposts are empowered to issue warning letters regarding food, drugs, devices, and other products regulated by the agency. So far, they have issued more than half of all agency warning letters in 2017. But their numbers have dropped as well.
In the first seven months of this year, district offices were responsible for 168 letters, compared with 228 over the same period in 2016. That’s a 30 percent decline—the same percentage drop for the agency overall—from the average January to July pace in all eight years of the Obama administration.
Michael Jacobson, co-founder and president of the health-advocacy group Center for Science in the Public Interest, called the drop in FDA warning letters “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 in an email.
The pace of warning letters this year seems to match the pace set during the administration of George W. Bush. On average, the agency overall issued 251 warning letters in the January to July period of each year between 2005 and 2009, close to the 265 issued overall this year. (Warning letters prior to 2005 are not archived on the FDA’s website.)
After Bush left office, the scope of FDA authority expanded to include tobacco. Enforcement activity by the FDA’s Center for Tobacco Products, created as a result of additional powers conferred by Congress, has picked up in 2017. The 49 warning letters it has sent through July exceeds the 42 it sent in the same period in 2016. (Bloomberg’s analysis excludes warning letters sent to tobacco retailers, which the FDA issues by the hundreds to stores that sell tobacco to minors. The agency reports those letters separately.)
Likewise, the Center for Drug Evaluation and Research, which regulates pharmaceuticals and such over-the-counter products as toothpaste, issued slightly more warning letters this year than over the same period in 2016.
Beyond warning letters, there are other ways in which to view FDA performance. One data set the agency publishes tracks the number of citations issued by inspectors. Citations are observations recorded to alert companies about possible problems in manufacturing, food safety, or other areas. They don’t necessarily constitute violations and usually come before warning letters.
Citations reported in the first quarter of 2017, the latest period available, appear to be down significantly compared with recent years—but there are important caveats. Citations made during inspections that could lead to further enforcement actions are withheld from published data until cases are resolved, the agency says. Data for recent months, therefore, may undercount the number of citations actually issued in that period. The agency declined requests for additional data to gauge the number of inspections performed and citations issued in 2017.
In written testimony (PDF) for his confirmation hearing, Gottlieb pledged to run the FDA “as an impartial and passionate advocate for public health” guided by science. He said the “FDA’s enforcement tools are a bedrock of its mission.”
These initial numbers, however, have watchdogs such as Public Citizen’s Carome worried that Trump’s pledge to roll back red tape has reached the FDA—potentially endangering Americans who rely on the 17,000-employee agency to protect them.
“I think there’s little reason to believe that, overall, the industry is doing dramatically better,” he said, reflecting on the decline in warning letters. “That’s unlikely to be the explanation for the drop in these numbers.”