SAVE COMPOUNDED MEDICATIONS, SAVE LIVES, HELP PATIENTS

For: Patients Who Benefit from Compounded Medications
Washington, DC
Organizer: Laura Farr
$43,610
of $80,000 goal
54% Complete
Raised by 195 donors

The Story

WHY WE NEED YOUR HELP RIGHT NOW

Compounded medications are at risk of being banned by the FDA and its Pharmacy Compounding Advisory Committee. The Agendy is taking long-used safe ingredients off the market, and restricting the ability of doctors to have the drugs that will remain an an approved list available in their office (so-called “office-use.”)

KEEP CRITICAL MEDICATIONS AVAILABLE AND AFFORDABLE: SAVE COMPOUNDED MEDICATIONS!

LAUNCHING PHASE II

Our Citizen’s Petition is getting closer to filing! Phase II of this effort is recruiting coalition partners and organizational allies to sign onto the petition with us to demonstrate the wide ranging negative impact that the FDA’s restrictions on compounded medications is having on practitioners and patients.

Please watch the video to understand more.

SUMMARY

Compounded medications are used to treat a wide range of conditions, from chronic pain, gastrointestinal disorders, Meniere’s Disease, and psoriasis to Lyme disease, Celiac disease and Parkinson’s.  These medications can also save lives – such as the use of DMPS in curing patients of lead and mercury poisoning, when no FDA-approved chelation drug has demonstrated similar success.

If you or a loved one suffers from one of the conditions listed above or if you are a physician or pharmacist who relies on compounded medications to treat patients, please consider supporting our cause!

What is FDA doing?

  • It wants to ban for compounding products like 5-HTP, MSM, N-acetyl-D-glucosamine (NAG), curcumin, glycyrrhizin, Boswellia, 7-Keto-DHEA, aloe Vera, astragalus and resveratrol, among others.
  • It has rejected 390 nominations of substances, which may no longer be compounded.
Others on the block for likely rejection include:
  • Glutathione
  • Phosphatidylserine
  • Methylcobalamin
  • Germanium
  • ACeylon-l-carnitine

FDA’s presumption is that if there is an approved drug that might treat a condition, then the compounded competitor should likely be taken off the market, even where it has a long history of safe use, and even where the approved drug has a black box warning!

As well as restricting access to compounded medications, there is a real risk that this will have a chilling effect on the  availability of dietary supplements in upcoming years. The FDA has long sought to restrict access to dietary supplements. If left unchecked, the FDA misn’t take advantage of these rulings to argue to Congress that it has reviewed many of these ingredients for compounding and found that they could not be safely used even under a physician’s supervision, therefore should not be available as over-the-counter supplements either. 

The time to act is now! 

What has AANP done about it?


The AANP is part of the Integrative Medicine Coalition (which consists of the AANP, American Academy of Environmental Medicine (AAEM), American College for Advancement in Medicine (ACAM), International College of Integrative Medicine (ICIM), and a coalition sponsored by the International Academy of Compounding Pharmacies (IACP) which together represent over 30 medical organizations working with Congress and the FDA to rein in this blatant attack to alternatives to pharmaceutical products. 

Together, we have:

  • Testified 3 times before the FDA’s Pharmacy Compounding Advisory Committee (thank you to Paul Anderson, NMD, Ron McGuff of McGuff Compounding Pharmacy, and other coalition partners!)
  • Submitted 70 ingredients for FDA to continue allowing to be compounded (only 14 have been approved, of which 6 were for topical use only)
  • Successfully defended DMPS, which will continue to be allowed to compound
  • Supported Congressional bills (HR 2871) and actions to rein in the FDA’s intrusion into the ability to practice medicine
  • Submitted detailed comments on FDA proposed rules and compliance policy guidances addressing the clinical, policy and legal difficulties with their actions.
  • Retained an attorney to draft a Citizen’s Petitionand produce formal comments challenging FDA’s biased and flawed process for reviewing ingredients. 

The Citizen’s Petition is the first necessary step in potential legal action and preserves the right to sue if the FDA does not change their precess.

Phase II
The Citizen’s Petition will have much more impact with a large number of organizations representing a diverse array of coalition partners from the medical and patient communities. The petition has been drafted and is ready for circulation. We need your support to move into the next phase of challenging the FDA, which is to solicit participation in the petition from groups.

When these compounds are not available, the cost for alternative drugs can be A LOT more expensive for health care providers and patients, not to mention patients would not have access to natural, preservative free options.

DONATE NOW 

Suggested Donation Levels towards administrative petition and legal fees (Individuals):

  • $100 
  • $500
  • $1,000
  • Other donation amounts are also welcome and appreciated

FOR ORGANIZATION/COMPANY DONATIONS:

If you are a compounding pharmacy or are an association/organization of integrative health care professionals, please send your donation inquiry to Laura Farr at [email protected].


MORE INFORMATION

Compounds are administered not only by integrative physicians but by ophthalmologists, allergists, dentists, dermatologists, OB-GYNs, urologists, podiatrists, even veterinarians.  Compounded medications have a significant role to play in vitamin and mineral replacement therapy, in hormone replacement therapy, and in boosting patients’ immune system function.  Hospitals use compounded drugs to a considerable extent, especially for intravenous therapy.  And compounded medications are known to save lives – such as in curing patients of lead and mercury poisoning when no FDA-approved chelation drug has demonstrated similar success.

In a recent survey by AANP, 36% of the naturopathic doctors (NDs) responding say they treat their patients with safely compounded medications.  Menopause is the condition most frequently treated, followed by hypothyroidism and hormone imbalance.  Compounded medications are also used by NDs to treat chronic pain and fibromyalgia, low testosterone, chronic fatigue and adrenal deficiency, as well as various autoimmune diseases.

Alan Dumoff, JD, has been retained as the lead attorney expert in these matters.

Fundraiser Updates

Posted on February 19, 2018

Posted on February 19, 2018

Dear Doctors and Patients Concerned about the FDA's attempt to restrict access to compounded drugs commonly used in integrative and naturopathic medicine. Your donations have been helping us challenge FDA's actions, but now we need your help too! Please respond by February 21.

The FDA's Pharmacy Compounding Advisory Committee (PCAC) is asking for additional information to defend why these four ingredients should be reviewed and included in the 503A bulk drug substances list. 

  • Methycobalamine
  • Quercitin
  • Reduced L-Glutathione
  • Alpha Lipoic Acid
  • Choline Chloride

We have a deadline of February 23rd to provide, “…any additional information that FDA should consider in its evaluation that may help to clarify the role of these nominated bulk substances in compound drug products in current clinical practice…”  

We are again requesting your assistance to ensure compounded preparations using these substances remain available for your patients.  Share with us any of the following:

  • Personal anecdotal experiences you may have using these substances in your practice. Please include as much as you can about common dosing, frequency, indications, and outcomes.
  • Your patients’ experiences with the use of these specific substances—let your patients know their access to this important compounded drug is in jeopardy!
  • Scientific literature supporting uses of these substance.
  • Statements or guidelines from professional medical societies regarding uses.

Be aware that your response or your patient’s may be referenced in our statements to FDA’s PCAC.

The FDA’s PCAC must be persuaded of the medical therapeutic value of these substances. Please respond TODAY with your own experiences by emailing [email protected] with a cc to [email protected] under the subject heading "PCAC Review Information."

Thank you! Every piece of information, and every donation helps us continue this fight!

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