Call goes out for feedback on US health deregulation

 President Donald Trump's push to deregulate the US federal governance system has stepped up a gear, and the administration wants the public to join in the effort to simplify health regulations.

"If you know a regulation that's making our health system worse, tell us," says a notice from the federal government, which has set up a page for comments to be submitted at its regulations.gov website for 60 days.

The drive revolves around a "10-for-one" policy laid out in a Trump executive order at the end of January, which demanded that for every new regulation proposed, at least 10 would be rescinded, with the net cost of all new rulemaking "less than zero."

It's not clear what the rationale or justification is for that ratio, although Trump has claimed he achieved a five-for-one cull in his first term in office. The new drive comes with an expanded scope that covers not only formal regulations but also "guidance documents, memoranda, policy statements, and similar directives."

The argument is that American companies and citizens are beset by unwarranted regulations that stifle competition and innovation, hamper economic growth, and drive up prices for consumers.

"This initiative is about restoring common sense to health care regulation," said FDA Commissioner Marty Makary in a statement.

"By cutting outdated red tape, we can lower costs, increase access to innovation, and let clinicians spend more time with patients – not paperwork," he added. "We welcome public input to help identify reforms that truly make a difference."

Health and Human Services (HHS) Secretary Robert F Kennedy Jr claimed in a video to introduce the request for information (RFI) that larger companies with greater resources may have been "responsible for writing a lot of these regulations in the first place" as their complexity helps them to "maintain market monopolies and to keep lower-cost and more agile, innovative players off the field."

The RFI asks commentators to identify the rules that need to be rescinded, how it operates, the reasons why it is not fit-for-purpose – for example because its costs outweigh its benefits, it no longer reflects the current state of technology, or is "bad policy, unreasoned, or unsound."

Ban on fluoride prescription drug products

Meanwhile, the FDA has said it will impose a ban on ingestible fluoride prescription drug products for children, saying they have never been approved for marketing and may have deleterious effects on the gut microbiome.

The restriction will not apply to toothpaste or mouthwashes that contain fluoride, according to the regulator, which said studies have suggested a link between fluoride and "thyroid disorders, weight gain, and possibly decreased IQ."

Several US states have stopped fluoridation of drinking water, and the FDA pointed out that fluoride is not added to drinking water in most of Europe or other countries of the world.

In April, Kennedy – who has claimed for some time that fluoride is linked to a variety of health conditions – said he had asked the Centers for Disease Control and Prevention (CDC) to stop recommending fluoridation of water and was assembling a taskforce to look into the risks.

"For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child's health," commented Makary.

"I am instructing our Center for Drug Evaluation and Research to evaluate the evidence regarding the risks of systemic fluoride exposure from FDA-regulated paediatric ingestible fluoride prescription drug products to better inform parents and the medical community on this emerging area," he added.

"When it comes to children, we should err on the side of safety."

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