he Senate will soon begin the process of considering President Trump’s nomination of Dr. Scott Gottlieb, who has close professional and financial ties with the pharmaceutical and biotechnology industries, for commissioner of the Food and Drug Administration. A trial that began in a federal courtroom in Boston in January is a timely reminder of how the laissez-faire regulatory posture that Gottlieb is expected to promote can harm the public’s health.
The Boston trial involves the first of more than a dozen employees of New England Compounding Center (NECC) who distributed steroids contaminated with fungi. These caused infections that led to 64 deaths and more than 700 cases of illness or disability in 20 states in 2012 and 2013. The NECC employees now face charges that include fraud, murder, and violating federal laws. They exploited weaknesses in FDA oversight. The company essentially became a manufacturer of prescription medications without following the FDA’s requirements for manufacturers.
As the tragic consequences of the NECC episode fade from our collective memory, the Trump administration’s overall deregulatory orientation, deregulatory provisions in newly enacted and proposed laws, and corporate-friendly judicial doctrine constitute a prescription for future public health crises. In this context, Gottlieb’s documented advocacy for deregulation is particularly troubling. In addition, his close ties to industry may pose untenable conflicts of interest requiring him to recuse himself from many important FDA decisions.
Just six weeks before Trump took the oath of office, President Obama and Congress enacted the 21st Century Cures Act. This law promises to increase federal funding for research and for pressing public health concerns like the opioid addiction epidemic, but at the same time it reduces the evidence required for FDA approval of new drugs and devices.
Meanwhile, Trump’s executive order requiring that any new agency regulation be accompanied by eliminating two regulations is a simple-minded approach to addressing perceived problems of overregulation. Which regulatory protection — lead levels in drinking water, bacteria levels on lettuce — should we give up for a new regulation to prevent future tragedies like the NECC crisis?
Viewpoints of other candidates reportedly considered for the FDA position make Gottlieb look moderate by comparison. Jim O’Neill, whose name was circulated as a possible candidate, advocates for FDA approval of drugs proved safe but would let claims of effectiveness be demonstrated by people using the products at their own risk. Another reported candidate, Balaji S. Srinivasan, once tweeted that the public “can do vastly better than the FDA with a Yelp for drugs.” Such statements show a disregard for science and the risks involved in medical treatment.
The success of the drug and device industries in persuading the courts that the First Amendment protects “commercial speech” has limited the FDA’s regulation of prescription drug advertising, which may help manufacturers promote off-label uses, a practice that would amplify the harmful effect of reducing the FDA’s key role in approving products. Gottlieb’s writings indicate support for removing some of these restrictions.
Most consumers lack the information or expertise to assess the risks and benefits of drugs and medical devices. Clever marketing could entice some patients to forego using products known to be effective in favor of ones that are less effective and possibly more expensive. Evaluating drugs is not the same as deciding whether one prefers Prego or Ragu.
Proposed federal and state laws that disregard research about the value of multilevel testing before FDA approval would give some patients access to any drug or device that has completed the first phase of clinical investigation and would relieve manufacturers of liability for harm caused by their use.
Insurers rely on FDA determinations in deciding what treatments to cover. The pharmaceutical and medical device industries rely on FDA approvals to level the playing field and prevent charlatans from confusing the public with inaccurate claims about substandard products. Physicians and the public rely on the regulatory process to ensure that products will perform as described and that the risks in using them are not unreasonable. Squandering confidence in a system so vital to public health in an ideologically driven and profit-motivated pursuit of reducing regulations defies logic.
The 21st Century Cures Act has already done harm. We should not compound the error.
The Senate should refuse to confirm any candidate to be FDA commissioner who is not committed to maintaining a rigorous scientific process of regulatory approvals for drugs and devices, and to limiting the marketing of those products to FDA-approved uses. In addition, the Senate should work to protect public health by not confirming judicial nominees who would elevate corporate speech over appropriate regulation.
Congress and state legislatures should reject any further weakening of the laws that hold the drug and device industries accountable for demonstrating that their products are safe and effective before they can be sold to the public.
Deregulatory fervor and efforts to weaken the FDA’s authority ignore the lessons learned from the NECC crisis that needlessly harmed so many only five years ago.
Renée M. Landers is professor of law and faculty director of the health and biomedical law concentration at Suffolk University Law School. She was deputy general counsel of the Department of Health and Human Services from 1996 to 1997.