PhRMA - Pharmaceutical Research and Manufacturers of America
10/28/2026 | Press release | Distributed by Public on 10/28/2026 15:40
PhRMA Statement on HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances
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Press Release
PhRMA Statement on HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances
October 28, 2026
WASHINGTON, D.C. (October 28, 2026) - Pharmaceutical Research and Manufacturers of America (PhRMA) Executive Vice President, General Counsel and Corporate Secretary, Jim Stansel issued the following statement regarding the 'enforcement discretion policy' regarding 503A compounding using certain peptide bulk drug substances:
"It is deeply concerning that HHS is telling the FDA they should ignore the law and allow illegal compounding of unapproved peptides. Permitting access to peptides that have not been demonstrated to be safe or effective in clinical trials jeopardizes patient safety.
"The FDA's rigorous, science-based review process exists to protect patients and ensure medicines are safe and effective before they reach the market. The HHS 'enforcement discretion policy' undermines the FDA's gold standard review and approval process, directly contradicts the statutory requirement for notice-and-comment rulemaking and sows confusion amongst the American public. Notably, the FDA's own career scientific staff recommended against permitting compounding of these peptides, citing safety concerns and lack of human data.
"The FDA review and approval process is the appropriate pathway for bringing new medicines to market, not an HHS 'enforcement discretion policy' that exposes patients to untested and potentially dangerous products. Policymakers should uphold the safeguards that help protect patients from unapproved products that pose risks to their health."
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The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country's leading innovative biopharmaceutical research companies, which are focused on developing innovative medicines that transform lives and create a healthier world. Together, we are fighting for solutions to ensure patients can access and afford medicines that prevent, treat and cure disease. PhRMA member companies have invested more than $900 billion in the search for new treatments and cures over the last decade, supporting nearly five million jobs in the United States.
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