FDA advances peptide push to White House

The Food and Drug Administration (FDA) this week submitted a peptide “interim access policy” to the White House for review, according to a government filing, which would reportedly allow compounding pharmacies to temporarily produce and sell previously restricted peptides.

Such a move would let these peptides on the market while FDA develops permanent rules, according to the Associated Press, despite a lack of evidence supporting their purported benefits .

The FDA’s filing with the Office of Management and Budget did not give details on the policy, but it follows an agency advisory panel meeting this summer that voted to allow production of peptides to treat conditions like insomnia, obesity and wound healing.

Health Secretary Robert F. Kennedy Jr. describes himself as “a big fan of peptides” and has promised action to expand access to them. Kennedy said compounding pharmacies must be allowed to sell peptides because Americans are using unsafe, “gray market” versions of these drugs made in China and other countries.

Pharmaceutical companies have brought several peptide drugs to market, including insulin. But the peptides the Health and Human Services Department (HHS) are interested in have not been tested or vetted by the FDA.

The FDA’s Pharmacy Compounding Advisory Committee (PCAC) voted in July in favor of adding six peptides to the list of substances compounding pharmacies can make.

Those substances were among 14 that had previously been banned because of potential serious safety risks.

The votes were split nearly evenly among the committee, and the decision to vote in favor of adding the peptides to the list went against FDA scientists’ evaluations.

In briefing materials, agency researchers concluded that “based on the available data, there is a lack of evidence to make a conclusion on the effectiveness of BPC-157 for treating [ulcerative colitis]” and that current information “weighs against” adding it to the 503A compounding list.

Staffers came to the same conclusions for all six peptides the committee approved, finding there wasn’t enough evidence to support adding any of them to the permitted compoundable substances.

Welcome to The Hill’s Healthcare newsletter , we’re Nathaniel Weixel and Joseph Choi — every week we follow the latest moves on how Washington impacts your health.

Did someone forward you this newsletter? Subscribe here.

How policy will be impacting the healthcare sector this week and beyond:

A political action committee associated with Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.’s “Make America Healthy Again” (MAHA) movement announced Thursday it is investing more than $1 million in the Iowa governor’s race — the group’s largest contribution to date. MAHA Action PAC, a federal super PAC run by Kennedy ally and book publisher Tony Lyons, said it is donating $1.5 million to Republican Zach Lahn’s …

(NewsNation) — The U.S. Food and Drug Administration (FDA) has finalized a rule allowing manufacturers to use salt substitutes in dozens of standardized foods — including bread, sour cream, canned peas, cheese, mayonnaise and canned tuna, while still selling those products under their traditional names. The rule takes effect Dec. 14. The change applies to 139 food standards and is intended to help reduce sodium in the U.S. …

Senate Democrats demanded answers Thursday from Environmental Protection Agency (EPA) Administrator Lee Zeldin about an agency study to detect the abortion pill mifepristone in drinking water. Led by Sen. Patty Murray (D-Wash.), the entire Senate Democratic Conference signed a letter to Zeldin calling on him to remove mifepristone, misoprostol and their metabolites from the list of emerging contaminants targeted for surveillance. …

Branch out with a different read from The Hill:

Congo’s Ebola outbreak reaches 5,000 cases as it outpaces response efforts at unprecedented speed

BUNIA, Congo (AP) — The Ebola outbreak in Congo has reached 5,000 cases, government data showed Wednesday, as responders warn it is spreading at an unprecedented speed outpacing efforts to slow it in one of the country’s remotest regions. Data from Congo’s Ministry of Health showed the outbreak had so far recorded 5,021 cases, including …

Local and state headlines on healthcare:

Nebraska DHHS plans to cut budget by reducing services, enacting federal Medicaid changes ( Nebraska Public Media )

What Texas reveals about the obstacles to getting hospital financial aid ( KFF Health News )

Oregon retreats from enforcing landmark trans health care coverage mandate ( Oregon Capital Chronicle )

Health news we’ve flagged from other outlets:

On Wall Street, there’s trouble stirring for biotech ( Stat )

What it means for RFK Jr.’s vaccine panel to be MIA during a measles outbreak ( The Washington Sun )

Why so many people still are not screened for lung cancer ( The New York Times )

Opinions related to health submitted to The Hill: