JAMA Forum: A Tale of 2 Agencies 

Images (clockwise from upper left): Ildo Frazao; MechanismDigital; Gromit702; onepamop (all Thinkstock)

Consider 2 US health agencies: One regulates drugs and biologics, medical devices, tobacco and cosmetics, and most of the food we eat. The other regulates the use of chemicals in the environment, the water we drink, and the air we breathe. The US Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) are 2 vital agencies for the health of the public. Their trajectories in the Trump Administration, however, could not be more different.

Under FDA Commissioner Scott Gottlieb, MD, the FDA has pursued ambitious plans to reduce the addictiveness of cigarettes, promote evidence-based treatment for opioid use disorders, improve nutrition through greater availability of healthful foods, and expand access to low-cost generic drugs. Many of these and other promising efforts are the handiwork of career FDA employees and began under prior administrations. Indeed, Dr Gottlieb speaks frequently about the expertise of FDA scientists. The FDA’s efforts and Gottlieb’s work have earned bipartisan praise, ranging from Democratic Senator Elizabeth Warren (“Dr Gottlieb is willing to tackle tough problems”) to President Trump (“Scott Gottlieb, as you know, is a star.”).

It’s quite a different story at EPA. Under Administrator Scott Pruitt, the agency has overturned more than 2 dozen major rules, including a freeze on leases for coal development and a ban on a potentially dangerous pesticide. The EPA has begun the process of undoing one of the most important federal regulations for reducing greenhouse gas emissions and proposed rolling back fuel economy standards. Pruitt has aggressively remade the agency’s advisory panels, including blocking scientists receiving EPA funds from participating. These efforts largely did not originate with EPA career staff; multiple reports have indicated a high degree of tension between Administrator Pruitt and longtime agency scientists. News reports have indicated that hundreds of scientists are leaving the agency, with one describing her regional office as “a morgue.”

The radically different experiences of 2 powerful agencies in a new administration begs the question: Why? A convincing answer must go beyond a comparison of 2 people named Scott—both of whom, after all, must reflect at least in part the expectations set for them.

Campaign Politics
One obvious explanation is the politics of the 2016 campaign. Candidate Trump ran against EPA’s oversight of clean air and made false and misleading statements on climate change. In this context, it was hardly shocking that President Trump nominated for the top job at EPA a state Attorney General known for suing the EPA and denying scientific consensus on carbon dioxide.

By contrast, the FDA rarely came up during the race for the White House. At one point, the Trump campaign released a statement criticizing the “food police” at FDA for putting in place too many new rules to achieve food safety. But after the remark drew criticism, the campaign quickly backed down. This relative silence gave room for a wider consideration of potential agency leaders.

A second and more fundamental reason is the nature of the regulated industry. Many businesses whose activities are under the jurisdiction of the EPA loathe the agency. They see EPA rules as hampering industrial performance, residential development, and, ultimately, economic growth. That’s why some politicians would just as soon have the agency disappear altogether.

By contrast, much of the industry regulated by the FDA not only respects its scientific expertise but understands the essential need for regulation. Without a respected arbiter of what works and is safe, the market would collapse into a sea of unjustified claims. Early in 2017, when the administration was considering someone for the top FDA job who questioned the need for the agency to review evidence of effectiveness of a drug or device prior to approval, some pharmaceutical executives described the candidate as “a worst-case scenario that could send the drug industry into chaos.”

To be sure, there is a long way to go for some of the changes Gottlieb has proposed to take effect, with major opportunities for ideology, excess industry influence, and political agendas to undermine the agency’s work. The ongoing push for a “right to try” law that would reduce the FDA’s role in drug review is a case in point. But these challenges do not detract from the basic fact that the agency has remained squarely on track.

Transparency
A telling contrast between the 2 agencies can be found on the issue of transparency. Commissioner Gottlieb has spoken in favor of greater transparency of data and agency analysis, an agenda with the support ranging from consumer advocates to investors. The FDA has launched a pilot of sharing clinical study reports (with protections for confidentiality) and is examining the potential to release some sections of nonapproval letters. The broader sharing of the FDA’s scientific assessments is widely recognized as having value for the more rapid development of safe and effective medical products.

Administrator Pruitt, on the other hand, is reportedly considering invoking “transparency” to restrict the evidence available to inform agency rule-setting to datasets that can be released in full. This would prioritize the ability of regulated industry to question the legitimacy of agency actions above concerns about confidentiality and the value of the evidence. This is transparency as a direct attack on the agency itself.

Only about 22 miles separates the headquarters of FDA in White Oak, Maryland, from those of EPA in Washington, DC. Yet the agencies are headed in profoundly different directions. The FDA’s pathway may seem like a relief for those of us in the healing professions. But for everyone who still needs to drink water, breathe air, and survive on a warming planet, it is not good news at all.

***

About the author: Joshua M. Sharfstein, MD, is Vice Dean for Public Health Practice and Community Engagement at the Johns Hopkins Bloomberg School of Public Health. He previously served as Secretary of the Maryland Department of Health and Mental Hygiene, as the Principal Deputy Commissioner of the US Food and Drug Administration, and as Commissioner of Health for Baltimore. He is also a consultant to Audacious Inquiry and to Sachs Policy Group. A pediatrician, he lives with his family in Baltimore. (Image: Chris Hartlove)

About The JAMA Forum: JAMA has assembled a team of leading scholars, including health economists, health policy experts, and legal scholars, to provide expert commentary and insight into news that involves the intersection of health policy and politics, economics, and the law. Each JAMA Forum entry expresses the opinions of the author but does not necessarily reflect the views or opinions of JAMA, the editorial staff, or the American Medical Association. More information is available here and here.

 



Categories: Health Policy, Public Health, The JAMA Forum

Tags: , , , ,