Rollbacks, Science and FDA

President Trump’s false
or misleading statements
keep coming
(www.politifact.com/truth-o-meter/).

Welcome back. President Trump says the U.S. has the cleanest air in the world; that it’s even gotten better since he’s been president. Regrettably, that claim must be added to the list of what, by now, must have reached 11,000 false or misleading statements by the president (see earlier post, So Many Lies).

After years of improvement in response to environmental regulations, air quality has gotten worse. There were more bad air days during the president’s first two years than in any of the four years before--15% more days with unhealthy air.

The decline in air quality shouldn’t be blamed on Trump, not yet anyway. But his attempts to rollback everything associated with Obama and promote fossil fuels don’t bode well for our future air quality.

Regulatory Reform
Building upon research from Harvard and Columbia law schools, the New York Times recently tallied 49 environmental rules that have been rolled back and 34 others for which rollbacks are in process.

New York Times tally of environmental rollbacks under the Trump administration through June 2019 (from www.statista.com/chart/18268/environmental-regulations-trump-administration/).

Regarding air quality, 10 rollbacks are complete, such as the 2015 rule that prohibited the use of hydrofluorocarbons in air-conditioners and refrigerators. (Hydrofluorocarbons are extremely potent greenhouse gases.) Twelve other air quality-related rollbacks are in progress.

This is not to imply that regulatory reform is unwarranted. As the Union of Concerned Scientists stated: While thoughtful updates to the regulatory system are much needed, most proposals touted as “regulatory reform” are actually intended to hamstring the ability of the federal government to issue science-based public health, safety, consumer, and environmental protections.

One noteworthy example is Trump’s Executive Order 13777, requiring agencies to establish task forces to recommend regulations for repeal, replacement or modification. Unfortunately, those task forces are often filled by political appointees, which in this administration have been burdened by potential conflicts of interest.

Science Takes a Hit
Instead of “Where’s the Beef?” from Wendy’s 1984 commercial, with the Trump administration, it’s where’s the science? (See earlier post, Marching for Science.) The Union of Concerned Scientists and others have documented the administration’s pervasive pattern of sidestepping science in critical decision making. Climate change stands out, of course, though it doesn’t stand alone.

One new area of concern was recently exposed by an investigative report in Science: The U.S. Food and Drug Administration’s compliance and enforcement actions have tumbled under Trump.

The FDA regulates clinical trials, food safety, medications, medical devices and more to protect public health. A key tool the FDA wields to flag violations and prevent dangerous drugs, foods and products from reaching consumers is a warning letter. 

The number of warning letters issued during Trump’s presidency dropped by about a third compared to Obama’s presidency. Warnings from certain FDA units and district offices have dropped even more. While the cause is unknown, the FDA suggests that other types of compliance and enforcement actions are ongoing. Agency watchers, including former FDA insiders, find the trend alarming.

The number of Food and Drug Administration warning letters and injunctions (through 22 May 2019) and Official Action Indicated (OAI) reports (through 22 Apr 2019) fell steeply from equivalent periods before President Trump’s inauguration (graphic by N. Desai from www.sciencemag.org/news/2019/07/exclusive-fda-enforcement-actions-plummet-under-trump).

Wrap Up
Out of respect for the office, I would love to give the president credit for doing something right. Since he and his administration are easy targets for criticism or concern in so many areas, it’s probably kindest if I don’t stray beyond environmental and the lack of science input and don’t go deeper into environmental. Thanks for stopping by.

P.S.
TIME magazine article on changing air quality: time.com/5609569/us-air-quality-decline/
New York Times report on environmental rollbacks: www.nytimes.com/interactive/2019/climate/trump-environment-rollbacks.html
Union of Concerned Scientists on Trump’s first years:
www.ucsusa.org/sites/default/files/attach/2018/08/science-under-trump-report.pdf 
www.ucsusa.org/sites/default/files/attach/2019/01/ucs-trump-2yrs-report.pdf 
www.ucsusa.org/sites/default/files/attach/2019/01/regulatory-reform-trump-2year-fact-sheet.pdf
FDA enforcement actions: www.sciencemag.org/news/2019/07/exclusive-fda-enforcement-actions-plummet-under-trump
Article on FDA enforcement on EurekAlert! website: www.eurekalert.org/pub_releases/2019-07/aaft-iro070119.php