Howard Sklamberg Discusses FDA Oversight of Compounded Peptides in Women's Health

Howard Sklamberg, Arnold & Porter Life Sciences & Healthcare Regulatory partner and former Deputy Commissioner for Global Regulatory Operations and Policy at the U.S. Food and Drug Administration (FDA), was quoted in the Women's Health article, “You Might Be Able to Purchase Peptides Soon—but That Doesn’t Mean They’re FDA-Approved,” which explores the FDA advisory committee's recommendation to allow certain peptides to be compounded under Section 503A and the regulatory and public health implications of that decision.

Howard explained that the advisory committee's recommendation marked a significant departure from the FDA's traditional scientific review process, noting that "the most abnormal thing here is the advisory committee overruling FDA scientists in a wholesale fashion." He also emphasized that inclusion on the 503A bulk drug substances list should not be confused with FDA approval, highlighting that FDA-approved drugs undergo rigorous premarket review and are manufactured under current good manufacturing practices (CGMP), which provide substantially greater safeguards than those applicable to most compounded drugs. As Howard noted, "That is a much more protective set of regulations for manufacturing than applied to typical compounded drugs."

Looking ahead, Howard cautioned that if the FDA ultimately follows the committee's recommendation, the decision could "open up a can of worms" by encouraging additional manufacturers to pursue the compounding pathway rather than the traditional FDA approval process. He further warned that if compounded peptide products proliferate faster than the agency can oversee them, "you are going to have people who get hurt."

Read the full article (subscription required).