Since enactment of the Drug Quality and Security Act (DQSA) in late 2013, the US Food and Drug Administration (FDA) has gone significantly beyond the letter of the law in developing regulations that would limit access to safely compounded medications and their availability for office use – particularly through the traditional (503A) channels that doctors and patients have come to rely on.
In passing the DQSA, Congress made clear statements noting the importance of ensuring that the new compounding regulations should not interfere with the practice of medicine. FDA officials are convinced that compounded medications bring only a marginal benefit to health compared with FDA-approved drugs.
The FDA’s current default position is that if there is an FDA-approved Pharmaceutical Drug for a specific condition, then a compounded substance is unnecessary - despite the needs of thousands of patients who may not be able to use the FDA pharmaceutical safely. Patients, naturopathic doctors, and other healthcare practitioners know better.
Click here to view the list of ingredients to see if the medications you compound or use might be impacted.
AANP Actions and Strategies
Over the past 4 years, AANP and many other organizations (compounding pharmacists, integrative and conventional health care practitioners and patient advocacy groups) have worked tirelessly to convince the agency that limiting access to these compounded substances would be harmful to patient health. Collectively, we have:
- Submitted numerous formal comments to the Agency
- Presented in-person stakeholder comments
- Testified before meetings of the FDA’s Pharmacy Compounding Advisory Committee
- Convinced Members of Congress to direct the FDA concerning the intent of the DQSA law through notes attached to the FDA’s budget.
None of these actions have deterred the Agency from its regulatory path. On February 15, 2019, the Federal Food and Drug Administration (FDA) issued a final rule to establish criteria for and establish a list of bulk drug substances that can be used to compound drug products in accordance with section 503a of the Federal Food, Drug, and Cosmetic Act. The Citizen’s Petition was filed on March 20, 2019 as a direct response to this final rule.
Our Plan of Action:
Phase 1: Education and Research
Phase 2: Construct a Citizens Petition and Build Coalition Support
Phase 3: File/Defend the Citizens Petition and Engage Coalition Partners (current phase)
Phase 4: Begin litigation to defend patient access to compounded ingredients
Parallel Campaign: Ask Congress to pass a bill to stop FDA's overreach, and ensure that these substances will still be available for compounding
Current Phase (Phase 3)
In addition to supporting a congressional bill, we formally filed a Citizen’s Petition with the FDA on March 20th, 2019. The petition was filed on behalf of the Integrative Medicine Coalition (see below for members), the Academy of Integrative Health & Medicine, Medisca and McGuff Compounding Pharmacy Services. It will challenge the FDA’s process, its decision making, and its manifestly ‘stacked deck’ against compounding. An expert attorney was retained to draft the petition, with input from other attorneys active in the DQSA Coalition, an organization formed by the International Academy of Compounding Pharmacists that involves some three dozen national groups. The FDA is required to respond to the petition within 180 days. A Citizen’s Petition is the first and required step in the process of establishing standing to bring legal action. Physicians’ practice of medicine is being interfered with, and patients’ health is being compromised.
Our Citizen’s Petition challenges the FDA’s process on several fronts:
- Compounded drug products are being rejected whenever there is an FDA-approved drug that treats the same condition(s) as the given compounded drug.
- The FDA’s criteria were never set out for public notice and an opportunity for public comment. This constitutes a violation of the Administrative Procedure Act.
- The FDA invariably ignores a compounded drug product’s history of safe use. Even when the evidence of patient benefit is amply documented, the decision is invariably against approval.
- The FDA’s complex and expensive nomination process places an undue burden on healthcare professionals and small pharmacies to submit voluminous clinical evidence and usage data. The amount of information required is unreasonable and burdensome, and mostly ignored.
Now that the Citizen’s Petition has been launched, $100,000 will be needed to support the filing and advocacy efforts needed to submit letters of support to the FDA into the Citizen’s Petition docket. Depending on how the action plays out, an additional $150,000 may be needed to file a lawsuit in Federal court. If this effort is to succeed, we need the naturopathic community and our allies to be on board. AANP asks state associations, individual naturopathic doctors, supporting organizations, and grateful patients to support the petition with a meaningful financial contribution.
Ways to Help
If the medications (ingredients) you use or compound will be impacted, directly submit comments on the Citizen's Petition to the FDA! Do so by clicking here.
Other ways to help:
- Donate generously to the Protect Patient Access to Compounded Medications fundraising campaign that supports this legal strategy. Consider sharing this information with your patients and colleagues who would consider supporting the effort.
- Attend the AANP 2019 DC FLI lobby day! If you use compounded medications in your practice, or if you are a patient who uses compounded medications, we need you to show up to explain why Congress has to pass legislation to stop FDA!
- Share this campaign with patient advocate organizations and integrative medicine clinics. We need letters of support written to FDA from organizations that work with patients who use these medications: cancer, Parkinson’s, allergy groups, diabetes, etc. Email us at Advocacy@naturopathic.org for a sample letter of support and to help us engage their voices.
Important Information and Documents:
Samples of Comments to the FDA Draft Rule
The Protect Patient Access to Compounded Medications initiative is a joint effort of the Integrative Medicine Consortium, which consists of:
American Academy of Environmental Medicine (AAEM)
American Association of Naturopathic Physicians (AANP)
American College for Advancement in Medicine (ACAM)
International College of Integrative Medicine (ICIM)
Along with our other petition co-signers:
Academy of Integrative Health and Medicine (AIHM)
McGuff Compounding Pharmacy Services, Inc.