HHS and the FDA submitted an "interim access policy for compounding using certain peptides" to the White House Office of Management and Budget for review, according to a government filing reported by Reuters and the Associated Press on October 15, 2026. The filing gives no details, but AP, citing two people familiar with the plan, reported that it would let specialty compounding pharmacies temporarily make some popular peptides, including BPC-157, through enforcement discretion, meaning the FDA would choose not to act against them. Formally adding the peptides to the FDA's compounding list would still require rulemaking, and FDA staff scientists said in July that none had been studied enough to establish safety and effectiveness.
Senator Maggie Hassan (D-NH), ranking Democrat on the relevant committee, sent a formal written letter to HHS Secretary Robert F. Kennedy Jr. on June 25, 2026, demanding answers about whether President Trump (who turned 80 on June 14) is the 79-year-old patient who received compassionate-use access to Eli Lilly's investigational retatrutide. Hassan wrote: 'Reporting suggests that you have used this pathway to provide a highly anticipated medication for obesity to a single VIP individual for free, without providing that opportunity to other Americans.' Hassan also questioned Kennedy at a Senate committee hearing earlier the same day about 'vanity projects' at HHS. The June 25 letter is the first formal congressional action on the compassionate-use case originally reported by STAT News on June 23. Eli Lilly issued its first public statement to STAT News on June 25: 'We make these decisions following all applicable regulations.' The company has not disclosed how it evaluates retatrutide expanded-access requests or whether other applications are pending. Outside experts continue to question whether refractory obesity plus obstructive sleep apnea plus pulmonary hypertension meets the FDA's 'serious or immediately life-threatening' threshold typically reserved for terminal illness. The Senate letter creates an oversight track parallel to the political controversy already running through cable news and X.