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. held a press conference to announce the “phase out” plan synthetic food dyes.

Food and Drug Administration Commissioner Marty Makary He opened the event by saying his agency was “removing all petroleum-based food dyes” from U.S. foods. However, details did not become clear until the last minutes, when Kennedy announced that the government had reached a voluntary agreement with food producers. Stop using chemicals. A “national standard and timeline” for completing the process will be determined soon, according to a report. FDA’s statement.

More than a year later, the FDA has yet to provide any of the detailed, scientific regulatory documentation needed to establish a safety concern with a half-dozen commonly used dyes. Instead, the FDA maintains an online list of manufacturers that have made commitments. phase out chemicals.

The administration’s stance on food dyes reflects its approach to a number of health priorities. Instead of using the time-consuming process of federal rulemaking that can span multiple administrations, officials working under Republican administrations President Donald Trump I found a quicker approach: Announce sweeping changes first and deal with edits later.

“It speaks volumes that the administration has yet to produce a document explaining 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 reports. long lasting result The “total scientific evidence” does not show a link between synthetic dyes and health problems.

“If the FDA changed its position, the FDA should document why and follow up on the ban,” Mayne said.

A spokesman for Kennedy said the administration was using “multiple approaches” to make further progress on food dyes “more quickly than in the past.”

“FDA engaged industry early in this effort to promote 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 assessing 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 required to refrain from making major policy announcements in newsletters, speeches or other informal settings.

However, first came a series of changes made by Makary and his assistants. medical journal columnstelevision interviews or online posts, including new restrictions Covid-19 vaccines and other therapies.

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

As surprising as the agency’s move away from rulemaking is that the powerful companies the FDA regulates offer little resistance.

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

But drugmakers and other multibillion-dollar companies are staying 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 see that.”

One of the biggest changes was last May when Makary and then-FDA vaccine chief Dr. The time has come when Vinay Prasad did it. published a medical journal article announced that the FDA will no longer routinely approve COVID-19 vaccines for healthy adults under 65 and children with no underlying health conditions. To gain approval from this group, vaccine makers will need to conduct large studies that many experts say may not be possible in today’s post-pandemic environment.

As with other vaccine decisions, Makary and Prasad bypassed the agency’s outside experts, who are traditionally consulted on major decisions about vaccines. Makary says FDA advisory panels they are often biased and take a lot of time and money to get together.

Dr., who previously directed the FDA’s vaccine panel. “We had this whole experience with the safety of how these vaccines work, and then these two cowboys came in and said: ‘We’re going to enforce this policy,’” Kathryn Edwards said.

Edwards and other experts say vaccine makers’ failure to back down may reflect the enormous power the FDA has over them.

“Ultimately, you need the FDA to license your product,” said Edwards, a retired vaccinologist at Vanderbilt University. “If you try to go against the FDA—especially in this environment—the likelihood of your product receiving a positive review will be extremely low.”

Earlier this year, the FDA briefly declined to consider this issue. a new mRNA flu vaccine From Moderna. agency he reversed his decision after pushback from the company and the White House.

There may be other reasons why plaintiff companies normally do not challenge the agency.

Some FDA initiatives, including a rewards program, have the potential to benefit companies. ultra fast reviews to drugs preferred by Trump administration.

Even seemingly burdensome changes may have little staying power because the agency does not go through the process of incorporating them into federal rules or guidelines. This includes stringent new standards that must be approved CAR-T therapies It has previously been approved for several types of cancer based on early results.

“Anything this administration has done that has not been enacted can easily be undone by a future administration,” Troy said.

Still, with more than two years left in Trump’s administration, there are signs that at least some companies may be willing to raise objections.

Last year, the FDA began issuing rejection letters for drugs it refused to approve. This information was previously thought to be confidential and the property of drug manufacturers.

Last month, an unnamed drugmaker filed a formal petition challenging the practice, saying the FDA offered “only a two-sentence explanation of its purported legal authority” to issue the letters.

The petition is not a lawsuit, but it uses the same language as many legal challenges to the agency, calling the FDA’s action “arbitrary and capricious.”

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