Key FDA drug data goes missing amid DOGE cuts
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Food and Drug Administration databases that physicians and public health experts rely on for key drug safety and manufacturing information have been neglected due to DOGE-directed layoffs, leaving health professionals flying blind on basic questions about certain drugs they're prescribing, current and former FDA officials tell Axios.
Why it matters: Information gaps that have become a hallmark of the workforce reductions and the sweeping reorganization of federal health agencies under Health Secretary Robert F. Kennedy Jr. are putting patient safety at risk, according to agency employees.
- "It's really a nightmare," said a current FDA official who requested anonymity because they were not authorized to speak to the press. "Things that used to function are no longer functioning."
The big picture: The FDA not only reviews drugs for safety and efficacy but acts as a nerve center churning out information in real time when there are adverse events, quality problems or drug shortages.
- But in several recent instances, current and former officials said, databases didn't get updated promptly or were missing key information because there were no employees to maintain them.
- Such omissions have been unprecedented in recent times and create clear safety and quality issues, experts say.
- The FDA has previously referred all questions to Health and Human Services, which didn't response to requests for comment.
Zoom in: The FDA's drug database, which is updated when new drugs are approved, get labeling changes or are pulled from the market, has a growing amount of missing information, an FDA official who was laid off told Axios.
- Most entries into this database since the sweeping April 1 job cuts are missing labeling information, which tells doctors what the drug is approved for, what it shouldn't be used for, dosing instructions and side effects.
Another repository with delayed updates due to staff cuts is the National Drug Code Directory which provides a specific code and manufacturing information for each drug, in addition to information about active ingredients and compounded drugs.
- The Drug Registration and Listing Database, which tracks what drugs are being made, marketed, and sold in the U.S. also wasn't updated for a time until a few laid-off employees were convinced to return part time to help, the current FDA official told Axios.
- Their jobs are still set to be eliminated on June 2, the current FDA official told Axios. "Once June happens ... we have no idea what the plans are for updating these things," the official said.
Between the lines: It's not just a lack of staff that is slowing the release of safety information, but a new Trump administration requirement that communications run through a central repository at HHS, several officials told Axios.
- For example, "immediate public notifications" — or consumer alerts that might flag to patients or a sales platforms like Amazon that a supplement is tainted with a drug — typically take hours to post.
- An alert posted Wednesday about a supplement marketed for joint pain that was found to be potentially harmful due to unlisted drug ingredients took two weeks to get approved before it could be posted online, an FDA official said.
Experts say the databases are heavily used — and that the idea they might have outdated information is alarming.
- For example, "the sheer breadth of what [National Drug Codes] are tied to — from a patient, clinician, payer, a supply chain perspective — is enormous," said Reshma Ramachandran, a family physician and a health services researcher at Yale School of Medicine.
- Researchers regularly scrape FDA drug registry data to identify where products are made or identify supply chain issues — information that can otherwise be very difficult to find, said George Ball, a drug quality expert at Indiana University.
- "We have several projects underway that are continuing to exploit that data in a way to make drug manufacturing and drug quality more transparent for consumers," Ball said. "Kennedy's goal of radical transparency flies in the face of not keeping those updated."
What to watch: The staffing upheaval hasn't prevented drug recalls from being posted in a timely way. But if a company were to refuse a voluntary drug recall of a defective product, it would require a multidisciplinary team at FDA to write, vet and post a warning.
- "It's not a question of if that's going to happen. It's a matter of when that's going to happen. And then what do we do from there? Because, to piece it all together without the staff in place, is just an enormous lift," the current FDA official said.
The other side: HHS has previously said it is trying to streamline operations and cut waste and modernize the agency while preserving its core functions.
