The United States Commissioner of Food and drugs is the head of the Food and Drug Administration (FDA), an agency of the United States Department of Health and Human Services. The commissioner is appointed by the president of the United States and must be confirmed by the Senate. The commissioner reports to the secretary of health and human services.

Due to frequent controversies involving the FDA, appointments are not always prompt and the agency is often headed by an acting commissioner. For example, Andrew von Eschenbach’s appointment was held up by senators who objected to the FDA’s refusal to allow emergency contraception to be sold over the counter. The commissioner has frequently been a physician, but this is not a requirement for the post. Commissioners rarely come from a food-related background.

The Food and Drug Administration (FDA), the United States’ regulatory agency for food, medical, and an array of other products, is a critical part of U.S. public health infrastructure. Its role has expanded considerably with the proliferation of cross-border trade: today, significant portions of FDA-regulated products, including food and medical supplies, come from abroad.

Criticisms of the agency center on the extent of its regulatory powers and the risk that FDA officials could be swayed by the powerful pharmaceutical lobby. The agency has in particular taken heat over its part in approving the drugs at the center of the national opioid epidemic. Its work has also come into the spotlight amid the COVID-19 pandemic, as the FDA is tasked with reviewing all potential vaccines and treatments for the new coronavirus disease.

The FDA is the U.S. federal regulatory agency for an extensive range of food and health-related products, including drugs, medical devices, tobacco products, cosmetics, food for pets and livestock, and dietary supplements. Its primary role is to ensure that these products meet certain quality standards before they are introduced to the U.S. market. Altogether, FDA-regulated products make up about 20% of consumer purchases in the United States.

The agency is headquartered in White Oak, Maryland, and has several hundred field offices and more than a dozen laboratories across the U.S. states and territories. In 2020, it had a staff of more than eighteen thousand people. The FDA has more than a dozen centers and offices: these include the Center for Biologics Evaluation and Research, the Center for Tobacco Products, and the Office of Women’s Health. Its budget in fiscal year 2021 totaled around $6 billion, with just over half provided by the federal government and the remainder from industry user fees. Since 1992, the agency has increasingly depended on collecting user fees from the manufacturers it regulates, raising concerns about its independence.

What are the main issues of the FDA?

User fees

The FDA collects fees from companies that produce certain products, such as drugs and medical devices, and from some other entities, such as certain accreditation and certification bodies. These fees are called “user fees.” Federal law authorizes the FDA to collect user fees to supplement the annual funding that Congress provides for the agency. User fees help the FDA fulfill its mission of protecting public health and also facilitate the timely availability of innovative FDA-regulated products without compromising the agency’s commitment to scientific integrity, public health, regulatory standards, patient safety, and transparency.

For most major user fee programs, the FDA and industry negotiate agreements on user fees every five years. As a part of this process, companies within the regulated industry (“industry”) agree to the collection of fees in exchange for commitments from the FDA to meet certain performance goals, for example, to make decisions on drug applications within a predictable timeline. To implement the agreements for the medical product user fees, Congress passed reauthorization legislation that enabled the FDA to continue to collect user fees. Importantly, the outcomes of decisions the FDA makes (such as whether to approve a product) do not depend on the agency’s ability to collect user fees. The FDA’s decisions are made based on science and are consistent with the legal/regulatory standards that govern the agency.

While the number and speed of drug approvals have been increasing over time, so have the number of drugs that end up having serious safety issues coming to light after FDA approval. In one assessment, investigators looked at the number of newly approved medications that were subsequently removed from the market or had to include a new black box warning over 16 years from the year of approval. These black box warnings are the highest level of safety alert that the FDA can employ, warning users that a very serious adverse event could occur.

Before the User Fee Act was approved, 21% of medications were removed or had new black box warnings as compared to 27% afterward.

Some potential reasons that more adverse effects are coming to light after drug approval include senior FDA officials overturning scientist recommendations, a lower burden of proof for medication approval, and more clinical data in new drug applications coming from foreign clinical trial sites that require additional time to assess in an environment where regulators are rushing to meet tight deadlines.

Slow and complicated processes

The FDA has had five commissioners (three of whom were acting commissioners) in four years. In addition, the FDA has many internal agencies, 16 of which are aimed at the administration’s mission. There’s too much competition and confusion in the FDA for it to fully focus on the regulatory affairs with which it is charged. It is lethargic at the best of times. And the FDA is historically unwilling to put a deadline on anything. Even when it does, it generally blows months or years past it. For example, it took nearly eight years to get changes to nutrition labels and calorie counts on fast food menu boards.

US consumers can remain at risk of illness or death for weeks after the US Food and Drug Administration (FDA) is aware that potentially hazardous food is in the supply chain because the agency lacks policies and procedures to ensure prompt product recalls.

Each year, millions of Americans are sickened, and thousands die from foodborne illnesses. And yet, the leadership of the Food and Drug Administration continues to be preoccupied with drug oversight and overlook food safety. Last fall the credibility of the FDA again was on the butcher block. This time it was the FDA’s failure to adequately inspect an infant formula manufacturer which led to likely ill children, a recall, a plant closure, and shelves bare of infant formula.

Once a manufacturer issues a recall, it can take an average of two months just for the Food and Drug Administration (FDA) to publish the recall notice on its website. It can take even longer for products to come off the shelves. In the meantime, these products might end up still being used—with deadly consequences.

Inspections are not carried out regularly

Even under the best of conditions, the FDA never inspects all foreign pharmaceutical plants annually. But, it does make an effort to visit at least one-third of these manufacturers. To be fair, the FDA doesn’t do a lot better in the US.

India is a major supplier of generic drugs to the US. Because of lax standards or outright fraud, the FDA has tried harder to visit drug companies in that country. The FDA visited 45% of the pharmaceutical plants there in 2019. In 2022 the investigative reporters state that only 3% of the drug-making facilities were inspected.

There have been drug manufacturing problems in the US as well. However, the FDA generally does more inspections in its home territory. When it does so, the visits are unannounced, just like the public health checks at local restaurants. In other countries, however, arrangements for visits are often made well in advance. The companies have an opportunity to clean up their acts and many do.

The percentage of overseas manufacturers that hadn’t been inspected within five years, or which have never once been inspected, has grown from 30% in 2020 to more than 80% in 2022. We know from investigating the FDA’s approval process ourselves that the honor system does not work. There have been problems with records in the past: deceit, falsification of documents, and even outright fraud. Since the start of 2013, pharmaceutical companies based in the U.S. or abroad have recalled about 8,000 medicines, comprising billions of tablets, bottles, and vials that have entered the U.S. drug supply and made their way to patients’ medicine cabinets, hospital supply closets, and IV drips.

Working for the competition

More than a quarter of the Food and Drug Administration employees who approved cancer and hematology drugs from 2001 through 2010 left the agency and now work or consult for pharmaceutical companies. The revolving door is a fair topic to study, but having former FDA officials on the pharmaceutical industry payroll can have a public health benefit. Former FDA employees with deep knowledge of the approval process help make it go smoother by ensuring all the relevant research is complete and the latest pathways to approval are understood.

The Food and Drug Administration (FDA) says its rules, along with federal laws, stop employees from improperly cashing in on their government service. But how adequate are those revolving door controls? It has been found that much like outside advisers, regular employees at the agency, headquartered in Silver Spring, Maryland, often reap later rewards—jobs or consulting work—from the makers of the drugs they previously regulated.

FDA staffers play a pivotal role in drug approvals, presenting evidence to the agency’s advisory panels and influencing or making approval decisions. They are free to move to jobs in pharma, and many do; in a 2016 study in The BMJ, researchers examined the job histories of 55 FDA staff who had conducted drug reviews over 9 years in the hematology-oncology field. They found that 15 of the 26 employees who left the agency later worked or consulted for the biopharmaceutical industry.

FDA’s safeguards are supposed to keep the prospect of industry employment from affecting employees’ decisions while at the agency, and to discourage them from exploiting relationships with former colleagues after they depart. For example, former high-level employees can’t appear before the agency on the precise issues they regulated—sometimes permanently, in other cases for a year or two.

Pharma-giant Pfizer announced that the former US Food and Drug Administration commissioner Scott Gottlieb would be joining its board of directors. The move fell in line with a troubling pattern: After their tenure at the FDA, commissioners tend to go on to advise private companies in the pharmaceutical industry. 9 out of the last 10 FDA commissioners—representing nearly four decades of agency leadership—have gone on to work for pharmaceutical companies.