UNCOMMON SENSE

FDA Goon Delivers Wild Take on Prescription Drug Safety

Marty Makary has been on a quest to slash drug review times.

FDA commissioner Marty Makary said it would be “magical” for consumers to see prescription drugs on pharmacy shelves instead of behind the counter.

Makary, who has been helping Donald Trump shorten the drug review process, stated that medications should be available over the counter instead of prescribed. He said that the U.S. should allow “common sense medications that are safe” to be available without the need for a doctor’s visit.

“If you think about it, if a medication is safe, doesn’t require laboratory test monitoring, and can’t be used in some nefarious way, why do we require a prescription?” Makary said during an appearance on Fox & Friends Weekend. “Most of the world does not do that.”

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The FDA commissioner’s comments come days after Trump announced his thin “Great Healthcare Plan,” which he said would lower prescription drug prices and insurance premiums.

While Makary and Fox News host Griff Jenkins were discussing Tamiflu, it’s unclear which other medications the FDA boss had in mind.

In many countries across the world, prescriptions are used to prevent drug misuse and promote safety. Tamiflu, which is an antiviral, works best if an individual is at risk of complications or is very sick with the flu, per the CDC. It’s not necessary for those with mild illness, which is why it’s important to get a doctor’s professional opinion.

Makary insisted that removing prescription requirements on drugs would lower the price of medication.

“There’s something magical about price transparency when a drug is on the shelf of a store or a pharmacy,” he said. “You see the price, you have competition, and those who shop by price keep prices in check. That lowers drug prices and it cuts out the middlemen.”

The middlemen in this case include doctors who advise their patients on the best course of treatment for their symptoms. Makary did not mention any potential safety issues that might arise in this plan, although everyday people are not typically well-versed in medication doses, duration, and side effects on their own.

Makary has been pushing for an expedited drug review process, despite the U.S. already having the fastest review times in the world at six to 10 months. A new national priority voucher program has drastically decreased the time to one to two months for drugs that support “U.S. national interests.”

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However, experts and FDA staffers told the Associated Press that the commissioner’s plans flouts legal, ethical, and scientific standards that ensure drug safety. With over 20% of the FDA’s manpower getting slashed last year, the agency also lacks the bandwidth to execute this new truncated process.

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Currently, the FDA differentiates prescription and over-the-counter (OTC) drugs by assessing them through its OTC Drug monographs. These are standardized booklets listing doses, acceptable ingredients, formulations, and labels. If a drug conforms to these standards, it doesn’t need further FDA clearance to be marketed. However, if it strays, it requires new drug approval, which is how prescription drugs are regulated.

Makrary has received backlash for his bizarre health stances before. The FDA head previously said that diabetics should be treated with cooking classes instead of insulin.

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