The Legal Side

By Eric F. Greenberg, Attorney-at-law One New Regulator, and Thoughts About All of Them

Whenever a president nominates a new commissioner to head the U.S. Food and Drug Administration, it inspires in me some thoughts and questions about the agency, and regulation generally.

This time, one can’t help but notice that President Biden was in office almost a full year before he nominated someone to be commissioner of FDA. He offered up Dr. Robert Califf in mid-November.

My first question is, Who cares?

Well, we care because many of the big policy issues on FDA’s plate directly affect the packaging industries, including controversies over the safety of substances in packaging that migrate to food, the recent revision of the nutrition label, how to deal with GRAS substances in food including those from packaging, and what exactly to do about cannabis and CBD products.

Even so, why do we care if FDA goes along operating under an ‘acting’ commissioner, as they did ever since Biden took office, instead of a President-nominated-then-Senate-confirmed head, informally referred to as a ‘permanent’ commissioner?

After all, even without a permanent head, thanks to the thousands of lesser officials at any agency, petitions still get analyzed and applications still get processed and facilities still get inspected and enforcement actions get advanced. The pandemic has slowed FDA, as much or more than the absence of a permanent commissioner.

The conventional answer is that agencies with permanent heads can more clearly set and pursue long-term programs and goals, and inspire personnel. That all sounds vague, but the effects are real. That’s especially so right now, as FDA contends with important decisions about new vaccines and drugs for COVID-19, every one of which is controversial and seems to inspire not just public controversy but real animosity.

The current acting FDA commissioner, Dr. Janet Woodcock, is a widely respected veteran who has been at FDA for over 30 years, but was not nominated to be the permanent head reportedly because she was opposed by some Senators who said she was too buddy-buddy with the drug industry and didn’t effectively fight against opioid addiction.

The nominee, Dr. Califf, has been FDA commissioner before, serving 11 months during the Obama administration. He’s a cardiologist with a specialty in issues relating to clinical trials. Before he was confirmed back in 2016, he too was accused by some Senators of being too close to drug makers, and was also criticized for his handling of the opioid epidemic while he was FDA’s deputy commissioner for medical product and tobacco regulation. We’ll see if he can weather those objections again in the Senate.

Next question: What kind of person makes a good FDA commissioner? Before you answer, keep in mind that FDA regulates about 80% of the U.S. food supply, plus all drugs, medical devices, vaccines, cosmetics, tobacco, radiation-emitting devices, and animal food and drugs. It is frequently found squarely in the middle of public controversies about many of its decisions, controversies that are often quite emotionally charged, but are sometimes fueled by misguided nonsense on social media. Either way, FDA’s got to contend with them.

A better question might be, who would even want this job?

Commonly, FDA commissioners have come from industry or academia or public health roles. The choice often reflects a specific philosophy: you won’t want an industry veteran to run it if you think FDA isn’t tough enough on industry, or, if you think they’re already too tough, you won’t want an individual with a history as a regulator.

Decisions like this reflect a broader debate over the role of regulators generally. If you believe government regulation helps protect the public from danger and fraud, then you want effective regulation. If you tend to think government actions are always a failure and waste of money, then you’d say there shouldn’t be an agency mediating between drug or device or food packagers, and the public.

For an example of differing ideologies, remember that former President Trump used to loudly and frequently tout his opposition to ‘regulations,’ (never acknowledging that some regulations were useful even if some were wasteful). Remember his Executive Order to regulatory agencies that for every new regulation they make, two older ones need to be withdrawn? Reflecting his different ideology, President Biden swiftly withdrew that order when he took office. Besides, the 2-for-1 order doesn’t appear to have caused many regulations to be cut, in part because the last administration was ideologically opposed to making new regulations anyway.

Debating the best regulatory philosophy is part of the traditional operation of our democracy. I’m a bit concerned that some academic types, and even some members of Congress, appear to be giving up on those debates and are instead sympathetic to scrapping the democracy model altogether, with its rights to free speech and voting and impartial courts of law and the like.

If you doubt that more and more folks are in favor of such an extreme approach, think about how often, when the topic is something mundane like how much the government should spend on building roads or defense, people now refer to their political opponents as ‘enemies’ worthy of violence and destruction because they ‘hate America,’ rather than fellow citizens whose policy ideas are worthy of robust debate.

So, I wish Dr. Califf good luck in leading FDA, and encourage him to act fairly and reasonably and not to place too many new burdens on packagers. And here’s hoping that future debates over regulatory approaches are drawn within the traditional lines. PW