FDA Trying to Ban Compounding Pharmacies

Dr. Brownstein's Blog

To My Blog Subscribers,

I need to bring to your attention what has been going on in Washington as it relates to your ability to have access to compounded medications. I have been prescribing compounded substances including bioidentical, natural hormones for nearly 20 years. I can assure you that if the FDA removes compounded substances from the marketplace, we all will suffer.

The FDA has been looking for an opening in order to eliminate compounding pharmacies. Unfortunately, they found their opening when a rogue compounding pharmacy’s products killed and injured hundreds of patients. This pharmacy and the people who did this should be held accountable. However, that doesn’t mean we should get rid of compounding. The FDA should concentrate on regulating prescription drugs–which kill hundreds of thousands of patients per year. The FDA has not done too well regulating prescription drugs.

What makes you think they will do better with compounding pharmacies? Big Pharma is behind this push as they want compounding pharmacies to be a thing of the past. If we don’t make our voices heard, compounding pharmacies will be a thing of the past. I am encouraging each of you to read this post and send your comments to your Senators and Congressmen and women. Access to your bioidentical hormones is at risk again! Take action immediately at www.MyMedsMatter.com to oppose the provisions contained in S.959 that give the FDA the authority to restrict or even eliminate the bioidentical hormone replacement therapy (BHRT) that women depend on. Five years ago, FDA tried to ban the most commonly compounded BHRT treatments. The agency failed because it did not have the authority to do so. This bill gives the FDA the authority to do that and much more. It’s that simple.

Here’s what is happening. On May 22, 2013, a powerful Senate Committee approved legislation, S.959, which would give FDA unprecedented control over compounding pharmacies and the medications that patients depend on. This legislation is in response to the tragedy caused by the New England Compounding Center in which a rogue pharmacy acted like a manufacturer and violated numerous laws that ultimately killed many people and made even more gravely ill. We all agree that patient safety is of utmost importance. Like us, I’m sure you would support legislative efforts to improve quality and assure safety. But this legislation has turned into a bill that can deny men and women access to the medications they rely on.

Here’s the short version on how S.959 can affect you and the BHRT you take: FDA would be able to ban certain components of compounded BHRT if, in the opinion of the FDA, they pose “public health concerns.” That’s exactly what a drug company asked FDA to do with BHRT containing estriol back in 2005. Estriol is one of the most common components of BHRT, so this action would have disrupted the lives of countless women. The FDA ignored the voices and comments of more than 77,000 patients and physicians and three years later in 2008 they sided with the drug company, even though the FDA could not document a single adverse event with estriol. Fortunately, the FDA did not have the authority to enforce its decision in 2008. S.959 would give the FDA that authority. •FDA would be given the authority to declare your BHRT to be “copies” of drug-company products that cannot be compounded, even though the products you use are not commercially available.

A doctor could use an “exception” in the bill to continue a woman’s prescription, but he or she could be required to document a clinical difference in using compounded BHRT as opposed to drug-company products. Many women have trouble finding the personalized, natural treatment they need to control their menopause symptoms. This could make it even harder. FDA has been openly hostile to BHRT. According to its literature, “’BHRT’ is a marketing term not recognized by the FDA.” With a hostile attitude that refuses to even recognize the important medication that countless women take as legitimate, what do you think FDA will do when they get full authority to determine whether women can have access to BHRT? And the drug companies would love to eliminate the competition for their synthetic hormones. Please take action today at www.MyMedsMatter.com. Email your Senators and Congressmen and demand that they remove these dangerous provisions from this bill. We are all for increased safety, but the NECC tragedy should not be used to deny you the medications you need. Tell Congress what you think!
 -DrB

Dr. David Brownstein is a Board-Certified family physician and is one of the foremost practitioners of holistic medicine. He is the Medical Director of the Center for Holistic Medicine in West Bloomfield, MI
Related:  Senate bill aimed at tighter regulation of compounding pharmacies