Who needs compounded medications, and why?
Compounded medications are necessary for patients with conditions that make them resistant to mass-produced medicine. They can be lifesaving for:
1. Patients with allergies to common fillers and preservatives used to store and shelf mass-produced, commercially available drugs (lactose, gluten, or artificial dyes)
2. Children and adults with digestive issues who are not able to take medication orally
3. People who need customized dosage or strengths not available in mass-produced, commercially available drugs
Why is the FDA trying to remove them?
The 2013 Drug Quality & Security Act (DQSA) was passed in response to a meningitis outbreak from contaminated sterile drugs compounded that tragically resulted in dozens of deaths. The law gives the FDA new authority to regulate some compounding facilities to address these safety concerns.
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.
Unfortunately, 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.
*The actions of the FDA are the exact opposite of what Congress intended.*
How are patients directly impacted by the new FDA regulations?
Removing Drugs From Ability to Compound
The FDA requested that substances that are currently compounded be nominated for a review process to determine indications for use, history of use, safety, etc. Over 300 ingredients were nominated. The FDA divided these into three categories:
-Category I - 55 substances that the FDA agreed to review in the Pharmacy Compounding Advisory Committee
-Category II - 4 substances that were deemed too dangerous to compound and immediately banned.
-Category III - Over 260 substances that the FDA determined there was not enough evidence to support and will not even review. This list will be banned from compounding use without any review, and includes many herbs and natural substances.
95% of substances nominated have been denied during the FDA’s review process, either through a public hearing or by being listed in Categories II or III.
If FDA is allowed to continue this overreach, patients would immediately lose access to lawful prescriptions that they rely on every day as soon as the FDA finalizes its review process.
“I have been chronically ill for 20+ years and seen dozens of doctors... Additionally I am allergic to almost everything and need compounded medicines. Dr. Holtorf has literally saved my life with his prescribed [compounded] treatments and care. Without the IV treatments and compounded medicine I would have had to quit my career and been mostly bed ridden without these treatments. I literally have no treatment for my disease without these compounded medicines. Patients should have choices especially when their life is at risk due to allergies. Please don’t put my future at risk. I am finally healthy and feel amazing for the first time in over 20 years.” - Heather O.
“As one of many people with allergies to various substances, it would be impossible for me to use almost any kind of conventional medicine, either prescribed or over the counter, simply because of the fillers, binders, and sweeteners used. I've used the compounded, injectable form of Methycobalamin (Vitamin B12) for a number of years – it seems to be the only way my very low B12 levels will be elevated to a normal range. I sincerely hope that we continue to have access to compounding pharmacies.” - Catherine W.
What are we doing about it?
Our organizations have testified before the FDA’s Pharmacy Compounding Advisory Committee, we’ve advocated before Congress and had Congressional members instruct FDA to stop the over-reach. Yet FDA still marches on.
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
Phase 4: Begin litigation to defend patient access to compounded ingredients
Parallel Campaign: Ask Congress to pass a bill to stop FDA's overreach to allow these substances for compounding
Our initiative is solely intended to support the lawful practice of pharmacy compounding, which includes compliance with all state laws and best practice guidances regarding the compounding of sterile and non-sterile products as outline in the United State Pharmacopeia and elsewhere.
PDF: Needed Medications are Going to Disappear: A Call for Intervention
Your donation will support legal actions we are taking to protect patient access to compounded medications. Specifically, donations will be used in one of three areas:
1. Legal counsel and expert witness to prepare nominations and testimony to defend medications called for review by the FDA.
2. Preparation and filing of a Citizens Petition to challenge FDA on the process/criteria used to remove effective and safe substances from patient use
3. Staff coordination of outreach efforts to ensure the public is aware of FDA's efforts to remove safe and effective alternatives to pharmaceutical drugs from the market.
Protect Patient Access to Compounded Medications is a joint project of the Integrative Medicine Consortium, whose members include:
American Academy of Environmental Medicine (AAEM) - www.aaemonline.org
American Association of Naturopathic Physicians (AANP) - www.naturopathic.org
American College for Advancement in Medicine (ACAM) - www.acam.org
International College of Integrative Medicine (ICIM) - www.icimed.com
Other petition co-signers:
Academy of Integrative Health and Medicine (AIHM) - www.aihm.org
Medisca - www.medisca.com
McGuff Compounding Pharmacy Services, Inc. - www.mcguffpharmacy.com
All funds are held in a restricted account dedicated to the campaign to Protect Patient Access to Compounded Medications and managed by the Washington, DC-based American Association of Naturopathic Physicians, which represents licensed and licensable naturopathic physicians.
A sincere thank you for helping to raise awareness about the threats to these important medications! For additional information, please contact the Fund's administrator, AANP Executive Director Laura Farr at [email redacted].
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