FDAs new playbook: Lots of media announcements but not much rulemaking

WASHINGTON (AP) — In one of his first major announcements as health secretary, Robert F. Kennedy Jr. called a news conference to unveil a plan to “phase out” synthetic food dyes.

Food and Drug Administration Commissioner Marty Makary opened the event by saying his agency was “removing all petroleum-based food dyes" from U.S. foods. But the specifics did not become clear until the final minutes, when Kennedy revealed that the government had “an understanding” with foodmakers to voluntarily stop using the chemicals. A “national standard and timeline” for completing the process would soon follow, according to an FDA statement.

More than a year later, the FDA has not introduced any of the detailed, scientific regulatory documents needed to establish a safety issue with the half-dozen widely used dyes. Instead, the FDA maintains an online list of manufacturers that have pledged to phase out the chemicals.

The administration’s handling of food dyes reflects its approach to a number of health priorities. Instead of using the time-consuming process of federal rulemaking, which can stretch across multiple administrations, officials working under Republican President Donald Trump have found a quicker approach: Announce sweeping changes first and deal with the regulations later.

“It speaks volumes that the administration has yet to produce a document articulating the scientific basis for the voluntary request,” said Susan Mayne, a Yale University public health expert and former director of the FDA’s food program. Meanwhile, the FDA's website continues to carry the government's longtime conclusion that “the totality of scientific evidence” does not show a link between synthetic dyes and health problems.

“If FDA has changed its position, then FDA should document why and pursue a ban,” Mayne said.

A spokesperson for Kennedy said the administration has used “multiple approaches” to quickly make more progress on food dyes “than at any point in the past.”

“FDA engaged industry early in this effort to encourage timely changes while continuing its scientific and regulatory work,” said Emily Hilliard of the U.S. Department of Health and Human Services. “The agency maintains its role in evaluating safety and will continue to use its regulatory authorities, guidance, and review processes as appropriate.”

The lack of initiative in drafting new regulations is particularly striking at the FDA. Under federal law, the agency is supposed to refrain from making major policy announcements in news releases, speeches or other informal settings.

But a string of changes from Makary and his deputies have appeared first in medical journal op-eds, television interviews or online posts, including new restrictions on COVID-19 vaccines and other therapies.

Traditionally, those changes would be published first in the Federal Register, giving consumers, experts, and companies a chance to comment and suggest revisions to FDA proposals.

Almost as surprising as the agency’s shift away from rulemaking is the fact that the powerful companies FDA regulates have put up little resistance.

The FDA has faced hundreds of lawsuits over the decades — from drugmakers, pharmacies, tobacco companies and others — that accused the agency of failing to follow the legally required steps for new regulations and guidelines.

But drugmakers and other multibillion-dollar companies are sitting on the sidelines, at least for now.

“Does the government have the ability to basically bully companies?” asked Dan Troy, the FDA’s former chief counsel. “Yes, and I think we’re seeing that.”

One of the biggest changes came last May, when Makary and then-FDA vaccine chief Dr. Vinay Prasad published a medical journal article announcing that the FDA would no longer routinely approve COVID-19 shots for healthy adults under age 65 and children without underlying health problems. To win approval for that group, vaccine manufacturers would need to conduct large studies that many experts say may not be feasible in today's post-pandemic environment.

As with other vaccine decisions, Makary and Prasad bypassed the agency’s outside experts, who had traditionally been consulted on major decisions involving the shots. Makary says FDA advisory panels are often biased and take too much time and money to convene.

“We had all of this experience looking at the safety of how these vaccines work, and then these two cowboys come and say: ‘We’re going to make this policy’,” said Dr. Kathryn Edwards, who previously led the FDA’s vaccine panel.

Edwards and other experts say the lack of pushback from vaccine manufacturers may reflect the tremendous power the FDA holds over them.

“Ultimately, you need the FDA to license your product,” said Edwards, a retired vaccine scientist at Vanderbilt University. “If you’re going to try and buck the FDA -- especially in this environment — the likelihood of your product getting a positive review is going to be pretty low.”

Earlier this year, the FDA briefly refused to consider a new mRNA flu shot from Moderna. The agency reversed its decision after pushback from the company and the White House.

There may be other reasons why normally litigious companies are not challenging the agency.

Some FDA initiatives have the potential to benefit companies, including a program that awards ultrafast reviews to drugs favored by the Trump administration.

Even seemingly burdensome changes may have little staying power because the agency is not going through the process to enshrine them in federal rules or guidelines. That includes stringent new standards to win approval for CAR-T therapies that were previously approved for various forms of cancer, based on early results.

“Anything that this administration does that they don’t embody in law can easily be undone by a future administration,” Troy said.

Still, with more than two years remaining under Trump, there are signs at least some companies may be willing to raise objections.

The FDA last year began releasing rejection letters for drugs it declined to approve. Previously, that information was considered confidential and the property of drugmakers.

Last month, an unnamed drugmaker filed a formal petition challenging the practice, noting the FDA had provided “only a two-sentence explanation addressing its purported legal authority” to release the letters.

The petition does not carry the force of a lawsuit, but it invokes the same language as numerous legal challenges to the agency, calling the FDA’s action “arbitrary and capricious.”

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