Here’s the issue: The FDA is once again overstepping by protecting the interests of Big Pharma rather than patient care by restricting access to compounded medicines. Physicians and patients will lose access to these safe, effective and cost effective medications unless we act using the legal methods demonstrated to defeat prior FDA overreach. The activities of FDA staff have been inspired to act quickly to approve the restrictive policies and ignoring the Presidents action to freeze new agency rules. FDA is claiming a “health and safety” exemption from Trumps federal policies freeze.
Background: The Food Drug and Modernization Act (FDMA) and the Drug Quality and Security Act (DQSA) were passed after the tragedy in Massachusetts by a compounding pharmacy that distributed steroids corrupted with mold that were used in epidurals that killed patients. FDA has recently approved rigid and illogical rules to restrict the availability of compounded medications with a long history of safe and effective use (such as glutathione). The new rules require FDA approval for all compounded medicines and requires proof of safety and effectiveness. If there is an approved drug that treats the same condition or disease, as the safe and effective compounded substance then the compounded drug is not needed and not approved unless it offers a definite unique therapeutic benefit. This is a very unusual and biased requirement for a medication and is illogical. There are approved drugs for cancer, arthritis and autoimmune conditions. Why would we discard the affordable, safe and effective compounded medications?
The FDA’s history is clear: give them an inch, and FDA will interpret it as a mile. What it all means: Currently the compounded medicines that we use daily are only available under a “safe harbor“ provision that will go away once the FDA rules process is finalized. Our actions will at least delay their removal and if successful with establish a sane-scientific procedure to evaluate which compounded medications shall remain available. FDA actions will severely limit your right to prescribe compounded medications either by oral or intravenous administration. Big Pharma wins by eliminating access to many safe, effective and affordable compounded medications. As a result, doctors and patients will be forced to buy only expensive, Big Pharma medications.
How to defend: We will be submitting a citizens petition to challenge the FDA (fools) rules. The citizen’s petition is an established legal procedure that has successfully defeated FDA. The Integrative Medical Consortium, http://integrativemedicineconsortium.org, has been working and funding this effort for 2 years. IMC member include ICIM, ACAM, American Academy of Environmental medicine and American Association of Naturopathic Physicians. Our esteemed attorney is Alan Dumoff, Esq. Another group; the IACP International Association of Compounded Pharmacists (IACP) has a focus on passing a new law that restricts FDA actions on office use and interstate commerce. Our efforts with the citizen’s petition are a back up to their efforts but also directly address practitioner concerns about the specifics about the drug approval process. If “office use” provisions become more reasonable but the substances we use daily are not approved then we have won a battle but lost the war.
What it would cost to defend: We expect a 2-year process that will cost upwards of $40,000 for the next 12 months. The outcome of our 2017 efforts will determine costs for the second 12 months. We have funded to date $30,000 in legal expenses.
What you can do: Contact your legislator with the attached link: Take action now! Please consider financial support our legal efforts. Here is a link to video that describes the situation. It also is a donation website all of which goes to legal costs. “Defend Glutathione Fund” Michael Cronin, ND Chair, Integrative Medicine Consortium