The patients of Naturopathic Physicians derive tremendous benefit from safely compounded medications that are made available or administered to them in the physician’s office (known as “office use”). Nutritional, herbal, homeopathic and Bio-Identical Hormone Replacement medications are compounded to meet unique patient needs. These medications are not available from large pharmaceutical manufacturers that do not make small batches of these specialized products. These medications, as well as nutritional injectables and IV solutions, have been used in doctors offices safely for decades.
The FDA is seeking to limit the availability of these safely compounded drugs, including Bio-Identical Hormones, which goes far beyond the legislative intent of the Drug Quality and Security Act of 2013. On the one hand, the FDA interprets the law as banning office use under Section 503A of the Food, Drug, and Cosmetic Act – despite the long-standing practice of many states to permit office use. At the same time, the FDA has issued a proposed Memorandum of Understanding (MOU) relating to Section 503A that would unreasonably limit the interstate distribution of safely compounded drugs. If these FDA actions go unchecked, patients will lose access to products that they need and are used to receiving.
This is why I am asking you along with the American Association of Naturopathic Physicians (AANP) to urge your Senators to cosponsor S. 1406, the Saving Access to Compounded Medications for Special Needs Patients Act. The bill is sponsored by Senator David Vitter of Louisiana (one of the many states that would be severely affected by the FDA’s actions). S. 1406 clarifies that Congress did not intend state regulation of office use under Section 503A to be overridden. The bill would also revise the FDA’s proposed MEO so that the interstate distribution of safely compounded medications is not arbitrarily limited.
Vitter Bill – S. 1406 will ensure that the manifest needs of patients, and the pragmatic needs of doctors, will be safeguarded from FDA overreach. We appreciate your emailing your United States Senators today!
Take Action Now: Save Access to Compounded Medications – Support S. 1406
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