Dr. Michael Cronin, AANP Board member and Chairman of the Integrative Medicine Consortium, represented both organizations at an April 30 “listening session” held by the FDA for stakeholders concerned about its rules on compounded medications.
Dr. Cronin used the opportunity to educate FDA staff about how integrative medicine differs from conventional medicine, i.e., integrative physicians aim to improve a person’s overall health rather than treating just the symptoms of illness. To that end, compounded medications have significant benefit for patients who have not found relief through conventional medicines, as well as for highly sensitive patients who have frequent adverse reactions to standard medications. Dr. Cronin explained that intravenous nutrients, chelation, intra-muscular injections, and prolotherapy all have their place in meeting patient needs. The medications used in these therapies are obtained from trusted compounded pharmacists, stored on the premises for in-office use, and provided to meet individualized patient needs.
AANP and the Consortium expressed concern over the way FDA’s new regulations are impeding office use, with a patient-specific prescription being required for each compounded substance. Concern was likewise expressed that integrative physicians should have continued access to a variety of compounded substances that are commonly used and have a strong safety record. Dr. Cronin also objected to arbitrary limits on out-of-state sales by compounding pharmacies, which are leading to higher costs.
AANP will continue to work with a variety of organizations in order to temper the FDA’s approach. If you would like a copy of these comments, click into AANP’s Advocacy Toolkit