The contested decision by the Food and Drug Administration earlier this week to approve a drug to treat Alzheimer’s has renewed concerns about the Biden administration’s prolonged delay in choosing a permanent commissioner to lead the agency.
It has also once again exposed the sharp divide between supporters and detractors of the F.D.A.’s interim commissioner, Dr. Janet Woodcock, the longtime chief of the agency’s drug division who has seemed to be on an extended tryout for the top post.
To Alzheimer’s patient advocacy groups, which had called for Dr. Woodcock’s nomination back in February when the application for the drug, aducanumab by Biogen, was pending, its approval was a sign that they backed the right candidate.
But Dr. Woodcock’s decision to allow the accelerated approval of aducanumab over the overwhelming opposition of the agency’s own independent advisory panel has provided further ammunition to her critics, including a group of leading Senate Democrats who consider her too close to the pharmaceutical industry.
“Senator Hassan continues to believe that President Biden needs to put forward an F.D.A. commissioner who will act independently from the industry that he or she regulates,” Laura Epstein, a spokeswoman for Maggie Hassan, Democrat of New Hampshire, said on Wednesday.
William B. Schultz, who served as a deputy F.D.A. commissioner and general counsel for the Department of Health and Human Services, called the Alzheimer’s drug approval “a watershed event.”
The F.D.A. advisory committee and other experts said the evidence from the clinical trial raised significant doubts about whether the drug works. Three of the panel’s members have resigned since the drug’s approval on Monday.
“We are facing a potential change in the standard for approving drugs that is the most significant change since Congress adopted the efficacy standard in 1962,” he said.
Few public health experts consider it a good idea to allow a temporary leader to guide the agency that oversees the safety of products that make up one-quarter of the nation’s consumer spending.
“I find it a little perplexing,” said Anna K. Abram, a former F.D.A. deputy commissioner who is now a senior adviser with Akin Gump, a law firm. “You get a grace period, but now it’s starting to get into a window of ‘what is the plan for the F.D.A.,’ because it’s such a vitally important agency. Priorities may change depending on who is at the helm.”
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The pandemic had forced the F.D.A. into crisis mode, and much work that wasn’t Covid-related was put on hold. Inspections of many food and drug facilities were halted; the review of new gene and other therapies was delayed; and the deadline for manufacturers to switch to a new identification system to track medical devices was pushed back two years.
At the same time, the crisis prompted regulators to grant emergency authorizations to more than 500 Covid-related medical products before determining how well they actually worked. And in some cases — including dozens of Covid tests, and Battelle’s system for decontaminating N95 masks — they did not work well or were defective.
When Donald J. Trump was president, his frequent harangues against the F.D.A., accusing it of delaying approval of Covid vaccines and treatments to prevent his re-election, took a serious toll on staff morale, as did moves by the Department of Health and Human Services to weaken the F.D.A.’s authority.
Now, as steeply declining caseloads and rising vaccination rates ease pandemic pressures, the agency is resuming some of its normal functions, regulating vaccines, drugs and medical devices; regenerative medicine and other new treatments; veterinary medicines; cosmetics and much else on the grocery shelves.
But without a permanent commissioner, the agency lacks the leadership to set long-term goals and a new agenda in the first year of Mr.’s Biden administration, which has overturned many Trump policies in other government areas.
The Biden administration has vetted other candidates besides Dr. Woodcock, but no one has been publicly announced as the nominee in the sixth month of the president’s term. A spokesman for the White House would not comment on the delay, or on the candidates in contention. But some people who are still said to be in the running include: Dr. Joshua Sharfstein, a former high-ranking F.D.A. official and a vice dean for public health at Johns Hopkins University and Dr. Florence Houn, a former F.D.A. official and past vice president at Celgene who now works as a consultant.
One recent addition to the roster is Dr. Michelle McMurry-Heath, a medical doctor and molecular immunologist who served as an associate science director of the F.D.A. during the Obama administration. But Dr. McMurry-Heath’s candidacy would be complicated by her current job as head of the Biotechnology Industry Association, which lobbies on behalf of biotech businesses.
In interviews, current and former F.D.A. employees and industry executives cited several pressing priorities as the country emerges from the coronavirus pandemic that gripped the nation.
First Up: Covid
The agency will soon decide whether to grant permanent approval to the three Covid vaccines already in wide distribution under emergency use authorizations, Pfizer-BioNTech, Moderna and Johnson & Johnson. AstraZeneca and Novavax are expected to submit applications for emergency use authorizations for their vaccines soon. They are finishing collecting data from their U.S. Phase 3 trials. AstraZeneca is already authorized in other countries, although some have restricted its use due to side effects. Novavax is not yet approved elsewhere. Sanofi is also in Phase 3 of clinical trials and expects to apply in the fall.
Therapeutics
The federal government poured more than $19 billion into vaccines, but less than half of that into therapeutics. The Biden administration has called for a renewed focus on development of treatments for Covid and its complications. Several therapies — remdesivir, monoclonal antibodies and the steroid dexamethasone — have improved the outcome for some Covid patients, but they do not work for everyone.
Safety data
The F.D.A. has promised a new system, known as BEST, for tracking adverse reactions to the Covid vaccines, but it is still not up and running as promised. Meanwhile, the F.D.A. and the Centers for Disease Control and Prevention are relying heavily on older tracking systems that they acknowledge are deeply flawed, chiefly because they rely on patients or health providers to report what they believe to be bad reactions to the vaccine without providing proof. The agency is under increasing pressure to fix the system.
Testing
For years, clinics, academic institutions and commercial labs have pressed the F.D.A. to let them develop their own in-house tests for various diseases without agency oversight. For just as long, the F.D.A. has resisted. But in August, the Trump administration ordered the agency to allow these lab-developed tests to be used to detect numerous illnesses including Covid-19, without first confirming that they work.
There is congressional support for allowing lab-developing testing companies and clinics to operate without F.D.A. oversight.
Cell and Gene Therapies
In November 2017, business was booming for manufacturers and clinics selling unproven products such as cellular-derived therapies and stem-cell-based products. The F.D.A. lacked the staff to oversee the industry, but received reports of patients who ended up with serious side effects from unapproved treatments, generally from the stem cell clinics, and issued warnings.
The agency vowed to crack down on companies and clinics touting dangerous stem cell therapies, and at the same time gave the regenerative medicine industry three years to seek approval of certain human cell, cellular, tissue and tissue-based products that did not pose significant safety concerns.
The F.D.A. later extended the deadline through May of this year. In the interim, the agency issued 400 letters to manufacturers and health care clinics suspected of violating the law.
Now, scores of companies must decide whether to apply for approval for their cell and gene therapies, leave the market, or hope the F.D.A. will not pursue them. Critics say the F.D.A. lacks the staff to review them in a timely manner.
In an email, Dr. Peter Marks, director of the F.D.A.’s Center for Biologics Evaluation and Research, said that only a small number of companies that are marketing unproven cellular products, including cell-derived stem cell treatments, have applied for approval. But in a speech to the Food and Drug Law Institute this month, Dr. Marks acknowledged that a backlog of companies was waiting for their pre-submission meetings with the agency.
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Tobacco and E-cigarettes
In late April, the Biden administration said it would seek to ban menthol flavors in combustible cigarettes, and all non-tobacco flavors in mass-produced little cigars, which have become increasingly popular with teenagers. The announcement kicked off the expected protest from the tobacco industry, which plans to fight the F.D.A. in court. Even if the agency wins the legal battle, it would still take several years before a final ban took effect. A ban on flavored cigars would likely be adopted more quickly.
The F.D.A. also has e-cigarettes on its agenda; most brands are allowed on the market pending agency review. The F.D.A. has until early September to decide whether Juul’s public health benefits outweigh its risks, but it is not likely to meet the deadline.
The agency is also reviewing other e-cigarette brands in order of market share, with the largest sellers going first, and is trying to stop the use of Puff Bar and other disposable flavored vaping products that have replaced Juul as the brands most favored by teenagers.
Backlog on Inspections and Approvals
The F.D.A. has long struggled to meet its requirements for inspecting drug manufacturers, both in the United States and abroad. Covid travel restrictions worsened the backlog of uninspected plants, causing the agency to delay some drug approvals. According to the Government Accountability Office, the congressional watchdog, the F.D.A. was too slow to adopt remote inspection technology or other alternatives to in-person visits. The new commissioner will have to push to catch up — and may need to shake lose additional funding from Congress to do so.
Food Safety and Nutrition
In response to a congressional report that raised concerns about environmental contaminants in food, the F.D.A. recently launched a program to reduce metals such as arsenic, mercury, lead and cadmium in food for babies and young children.
Dr. Susan Mayne, director of the agency’s Center for Food Safety and Applied Nutrition, said the F.D.A. would eventually set caps on the amount of these contaminants allowed in these foods, and also wanted to conduct more inspections to ensure that manufacturers were complying with current guidelines.
“As we are reducing exposure to these toxins, we want to avoid eliminating food from the marketplace that has nutritional benefit,” Dr. Mayne said in an interview.
The F.D.A. must also improve its tracking of the food supply, to be able to more quickly determine the cause of food-borne illness and stop it.
Other food issues include developing a definition for the word “healthy” used on food labels and choosing an icon to indicate it.
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Cannabis
The 2018 Farm Bill loosened federal restrictions on hemp, defined as cannabis and cannabis derivatives with very low concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC).
The change quickly spawned a new industry. There are thousands of products on the market now with cannabidiol, known as CBD, a component of hemp that does not produce the high associated with marijuana. Consumers can now find CBD in soda, dietary supplements and even dog food. But none of them are legal, because the F.D.A. has not yet created a path to market for CBD products.
To date the F.D.A. has approved only one CBD product, a prescription drug product to treat seizures associated with certain illnesses. It has sent more than 300 warning letters to businesses selling food and other products that claim health benefits, or which have seemed overtly dangerous.
But the agency has resisted industry pleas, arguing that it does not have enough safety and efficacy data to promote CBD use.
Carl Zimmer contributed reporting.
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