The FDA has been distorting law and trampling on our right to access needed medicine. Now, it’s time for us to fight back! Major Action Alert!
Congressmen Morgan Griffith (R-VA) and Henry Cuellar (R-TX) recently introduced HR 2871, the Preserving Patient Access to Compounded Medications Act of 2017. This is an important first step toward saving many natural, customized medicines from the chopping block.
Without a doubt, this will receive significant opposition from Big Pharma and from the FDA itself making your support crucial for getting this legislation passed.
This is our moment to act. We’ve been telling you for years how the FDA has been waging an all-out war on customized, natural medicines made at specialized pharmacies. FDA actions threaten to wipe these life-saving medications off the map (see here for more background).
The only way to stop this is for lawmakers to step in. Congress has also repeatedly scolded the FDA through language in congressional spending bills for distorting lawmakers’ intent and needlessly limiting patient access to important medications. The agency’s fidelity to Big Pharma is the only explanation we can develop for this lawless behavior.
Beyond codifying congressional intent, the new bill does two important things. It amends section 503A of the Food, Drug, and Cosmetic Act to unequivocally allow “office use” of compounded drugs, which allows a doctor to keep a supply of certain medications in his or her office in order to provide immediate treatment to patients who need it.
For example, a patient in extreme pain cannot wait days, get his or her prescription filled and then return to the doctor for an injection. Even if the patient does not require urgent treatment, the delay will greatly increase costs, which seems to be a by-product of everything the FDA does.
The bill also mandates the FDA to accept USP monographs. This is a pivotal issue. In order to be made into a customized medicine, a substance in the past had to meet one of three criteria. It must either:
- appear on an FDA pre-approved list (the Bulk Drug list);
- have a USP monograph; or
- be a component of an approved drug.
Last year the FDA, with no explanation or justification, stated that it would not accept supplement USP monographs. This meant that in order to be used in customized, natural medicines, supplements had to be nominated for the FDA’s pre-approved list. Many supplements were nominated, but, no surprise, the FDA rejected them. Even a supplement, however, like curcumin, with very important medical uses. Behind the scenes, of course, Pharma is trying to turn curcumin or a synthetic analogue in a drug.
This bill doesn’t fix every misguided action of the FDA since the agency began implementing the Drug Quality and Security Act of 2013. Patient access to bioidentical hormones like progesterone and estriol is still threatened, since they’ve been nominated to the Demonstrably Difficult to Compound list. Still, this bill is a major first step forward in saving important natural medications from the FDA’s chopping block, and it needs our support.
Action Alert! Write to your representatives in Congress and urge them to support HR 2871. Please send your message immediately.
Other articles in this week’s Pulse of Natural Health: