Mike Jawer | AANP Director of Government & Laura Farr | OANP Executive Director
The AANP continues to push back against the Food and Drug Administration's efforts to restrict access to compounded medications that have been safely used for decades. Tell Congress to preserve office use of compounded medication, and read on for more info.
In an FDA-sponsored stakeholder listening session on June 3, the AANP presented comments. In its statement, AANP argued that compounded drugs, "Are an important part of the treatment toolkit of naturopathic doctors - and the FDA's implementation of the Drug Quality and Security Act is going well beyond the letter and intent of the law. The effect on patient care will be significant, and our members' practice of medicine will be hampered. Congress never intended for bulk drug products that have a clear history of safe use to be rejected simply because mass-manufactured drugs are conceivably available to treat the same conditions."
At a June 23rd hearing, Dr. Paul Anderson testified in defense of three medications used in cancer, immunology and toxicology – all of which FDA wants to make “illegal to compound.” FDA staff have recommended to the approving committee to deny access to all of these compounded materials. In the end, the committee voted 7-4 to recommend allowing use of DMPS. FDA can still overrule the recommendations of the committee, but it marked a small victory in a sea of overwhelming denials for physician use of other compounded medications without a patient-specific prescription.
Please send your enormous gratitude to Dr. Anderson and the AANP for representing all NDs in this battle with FDA to preserve in-office physician-use of compounded materials.