FDA weighs easier access to some unproven peptide drugs

The proposal would give the agency room to relax enforcement even though its own scientists say the drugs are not well enough studied.

The FDA is moving toward a policy that would make certain unproven peptide drugs easier to obtain, even though its own scientists say the products have not been studied enough to show they are safe or effective and could cause harm. The proposal, called an “Interim Access Policy,” has been sent to the White House for review, according to an OMB filing notice. People familiar with the plan say it would give the agency room to avoid enforcing existing peptide restrictions, which could reassure specialty pharmacies that want to manufacture them. The story matters because it signals a possible federal softening of oversight on drugs that are popular within Robert F. Kennedy Jr.’s Make America Healthy Again circle.