The Department of Health and Human Services’ (HHS) announced an interim enforcement discretion policy, under Section 503A of the Federal Food, Drug, and Cosmetic Act, concerning the compounding of six non-FDA approved peptide bulk substances. In new comments for the record, AAF President Douglas Holtz-Eakin and Director of Health Care Policy Michael Baker argue that while pharmaceutical compounding serves a distinct purpose in the U.S. health care system, the enforcement discretion policy could establish a parallel commercial market for unapproved drugs.

They recommend:

HHS should withdraw the interim policy, in line with counsel from the Food and Drug Administration’s scientific review team, and require full safety and efficacy testing before allowing these products in the pharmaceutical market. Should the department elect to retain the policy, substantial modifications are warranted to limit its duration, strengthen safety oversight, and prevent enforcement discretion from facilitating widespread commercialization of unapproved drugs.

Read the analysis.