Protect Patient Access to Compounded Medications!

$61,721 of $100,000 goal

Raised by 147 people in 12 months
Created August 23, 2018
Organizations in the field of integrative and natural medicine have launched a coordinated campaign to protect patient access to compounded medications. Despite a long history of safe use and patient need, the FDA has blocked patient access to ingredients used in compounded medications and is in the process of reviewing and potentially blocking access to more than 300 compounded ingredients needed by hundreds of thousands of patients.

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.


Patient Testimonials: 

“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 Executive@naturopathic.org.
+ Read More
Breaking News! AANP Files Citizen's Petition to Challenge FDA Attack on Compounded Medications!

We are now in Phase 3 of 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

If you are a patient or ally of compounded medications, there are two things you can do to help:

1. Donate generously to our efforts. We simply cannot let FDA take away YOUR access to the safe and natural medications that YOU depend on! Please share this campaign with your family, friends, and colleagues who would consider supporting the effort.
2. Share this campaign on your Facebook, Twitter, and all other social media platforms that you use. If you want to share a testimonial, please email us at Advocacy@naturopathic.org.

If you are a physician, there are three things you can do to help:

1. Donate generously to this campaign. Please share this information with your patients and colleagues who would consider supporting the effort.
2. Attend the AANP 2019 DC FLI lobby day! If you use compounded medications in your practice, we need you to show up to explain why Congress has to pass legislation to stop FDA!
3. Share this 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 to help us connect and engage their voices.
+ Read More
FDA 503(A) Compounding of Bulk Substances Hearing Updates: https://www.consultdranderson.com/fda-503a-compounding-of-bulk-substances-hearing-updates/

In the PDF on the link provided, Dr. Anderson provides the latest status of the FDA actions around compounding of substances. Additionally a FAQ and a specific annotated Q&A are included on pages 6 – 8 of the document. Please review and share!
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$61,721 of $100,000 goal

Raised by 147 people in 12 months
Created August 23, 2018
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