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by Amy Shank, PCCA Director of Government Affairs, and Claire Casey, PCCA Government and Public Affairs Specialist
Decision-makers who have met with compounding pharmacists in their districts and those who have toured a compounding pharmacy are more likely to understand the role of compounding in health care. To some, the compounding profession remains misunderstood. Compounders who tell their story — about their patients’ unique medical needs and their role and impact in the community — bridge this education gap.
The annual ACT Legislative Conference in Washington, D.C., is a key avenue for compounders to connect with their lawmaker and tell their story. Scheduled on May 14-15, 2024, registration remains open for PCCA member compounding pharmacists. Compounders will highlight two front-of-mind concerns.
Access to Compounded Hormones: Patients have relied on compounded hormones for decades when a manufactured product did not meet their medical need. This access is threatened due to recommendations by the National Academies of Sciences, Engineering and Medicine (NASEM)1 that state commonly compounded hormones be considered for the FDA’s “difficult-to-compound” products list. If this proposal were fully implemented, patients from all backgrounds would face barriers in accessing therapies that include hormones such as progesterone, testosterone, estradiol and many more. Moreover, it would hinder prescribers and pharmacists from offering suitable treatment options to their patients when commercially available products don’t meet the patients’ needs.
A publication in Menopause2 shows that there is more evidence available than what was identified and considered by the NASEM committee, and the evidence review process was not thorough — which casts doubt on these recommendations. Prescribers need all available treatment options for their patients.
Ensuring the Ability to Provide Informed Feedback to the FDA: Following enactment of the Drug Quality and Security Act (DQSA), the FDA has been utilizing guidance documents to enact regulatory framework. From prescription requirements for all human compounds to guidance on insanitary conditions at pharmacies, as well as guidance on medications compounded for animal patients — the FDA has used this guidance process to communicate regulatory directives, including guidelines used during the inspection process. Recently, the agency proposed to issue certain guidance documents “‘for immediate implementation’ without prior public participation.” This effectively eliminates the comment processes from guidance development — and may lead the FDA to implement policies that negatively impact patient safety, access to medical products and overall public health.
Pharmacists and pharmacy organizations want an avenue for meaningful dialogue and engagement with the agency, and maintaining an opportunity for a public comment period is critical to this effort. FDA should preserve and enhance its notice and comment process for guidance documents so they are appropriately informed by stakeholder insights and ultimately serve the best interests of public health. PCCA and compounders would like to be a continuing resource for all decision-makers. Our hope is for patient-centric policies that allow continued access to necessary and sometimes lifesaving compounded medications.