The FDA's recommendation to expand access to several compounded peptides could offer promising new treatment options, but physicians should wait for stronger scientific evidence before routinely recommending them to patients, Dr. Frank Contacessa told Newsmax on Sunday.

Contacessa, an internist at Custom Care Medical, said on Newsmax's "Wake Up America Weekend" that peptide-based therapies are not new, noting that popular diabetes and weight-loss medications such as Ozempic and Mounjaro are themselves peptide drugs.

"The peptide story is not new. These particular ones are," he said. "I agree with what the FDA is doing here, which is expanding access and being able to allow people to get these drugs compounded and control things a little bit more."

The compounds have generated significant interest for their potential use in anti-aging, recovery, sleep, and energy enhancement.

That follows a vote by the Food and Drug Administration's Pharmacy Compounding Advisory Committee recommending the addition of six peptides to the list of substances that may be compounded by licensed pharmacies while rejecting a seventh, contrary to FDA staff recommendations.

Contacessa said physicians should proceed carefully because evidence supporting many of the newly considered peptides remains limited.

"I think there's a lot of potential here. I'm not ready to use this in clinical practice on my own patients yet just because there's not enough data. But I think there's a couple here on the horizon that have a lot of potential, particularly in the anti-aging recovery," he said.

He added that some peptides designed to promote healing could also carry theoretical risks.

"There's a couple of concerns too. So now if you're going to have something that promotes recovery, you might also promote something like cancer cells," Contacessa said. "There are some concerns there. Maybe not, but I think there's enough reason to be hesitant. We can't allow the excitement to outpace the science."

Lee Rosebush, chair of the American Academy of Peptide Medicine and author of "The Peptide Revolution," took a different view, arguing that patients and physicians, rather than regulators, should decide whether peptide therapies are appropriate.

"To me, it's a pretty simple question. Should patients have safe access to these? And unfortunately, what we've had at this point is regulators step in between the most sacred relationship there is between a health care provider and their patient," Rosebush said.

"It's not the FDA's job to make that decision. It's what's in the patient's best interest and what's the provider's best interest. And so to me, it's a pretty clear and simple answer.

"Patients, if they believe this is the right thing for them, they should have access to it. If providers believe this is the best thing for their patients, they should have access to it. And just because another patient or another provider doesn't like it, there's a very simple answer. Don't use it."

Rosebush, who testified before the advisory committee, also criticized the FDA for what he said was its failure to review evidence submitted by his organization before the hearing.

He said the American Academy of Peptide Medicine submitted safety information covering more than 16 million doses of BPC, one of the peptides under consideration, along with a U.S.-based randomized, placebo-controlled clinical trial.

"Unfortunately, during the hearings, we actually heard the FDA have to admit they didn't review it," Rosebush said.

He said the academy also established a Peptide Council to help accredit pharmacies and develop standards for manufacturing compounded peptide products safely.

"The material that we provided over to the agency provided human trials domestically, done domestically, made under domestic standards. Those are all what everybody's been asking for," he said.

"If the FDA needed more time, they should have just sort of set a different deadline," Rosebush added. "They didn't do it because we met the agency's deadline. And unfortunately, we had to get them to admit in the hearings that it wasn't done."

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