Mike. Belcher, RPh, continues his discussion of Big Pharma's attack on compounding pharmacy, which I consider to also be an attack on our health and our freedom.
When news of Wyeth’s Citizens Complaint was made public, political action organizations began popping up like wild fire. Consumers, physicians and pharmacists deluged the FDA with over 70,000 comments against Wyeth’s actions. Resolutions were introduced in Congress admonishing the FDA for its role in restricting the use of bio-identical hormones. In spite of the negative publicity, in January 2008, the FDA ruled that estriol (one of the primary estrogens used in BHRT) was “a serious threat to the public health”; and because the FDA had never approved a product containing estriol, the agency designated estriol as a new investigational drug. This action required that physicians who wish to prescribe estriol obtain an investigational new drug application before a pharmacy could compound with the drug. The implementation of this cumbersome and expensive process has in effect banned the use of estriol as an unapproved drug. The FDA made this ruling despite decades of use of estriol without a single reported adverse event. An official monograph in the United States Pharmacopeia recognizes estriol, which is a recognized publication by the US Congress and by the profession of pharmacy. Estriol is an approved product in Europe and in fact, Wyeth, at the time the petition was filed, was marketing a product called Cyclo-Menerette in Europe that contained estriol. Estriol is one of the naturally occurring hormones in females and is at it highest levels in the body during pregnancy. Logically how can something that is produced by a properly functioning healthy human body be “a serious threat to the public health?”
Consequences of this action: It sets precedents for the future regulation of compounding by Big Pharma in collaboration with the FDA. One can speculate that anytime Big Pharma feels that the market share of one of their products is threatened by a compounded product, Big Pharma can petition the FDA to regulate the product as it did with estriol. Historically, the FDA has fought for years unsuccessfully to gain the right to regulate compounding pharmacy through legislation and through the court system. Pharmacy has maintained that the practice of compounding pharmacy is regulated through the individual state boards of pharmacy and both the courts and Congress have supported this view with pharmacy. The FDA welcomes a new ally in their fight to control compounding pharmacy. Also, the FDA gets a major portion of their operating budget from the fees paid by Big Pharma to get new drugs approved for market. Thus, the FDA may feel pressure to comply with the demands of Big Pharma if they seek to have compounding pharmacy regulated. If Big Pharma and the FDA continue on this path, physicians and patients will have fewer treatment options available to them. Essentially the new rule could be if Big Pharma does not make it, it will not be available. When the FDA moves a drug to an unapproved status or investigational new drug, many insurance companies will no longer pay for the product; and, as a result, the consumer will pay more for the product if they are able to receive the product at all. Also, any physician who continues to prescribe an unapproved product without going through the paper work process of the FDA will be subject to sanctions by the FDA as will any pharmacist that compounds the prescription for the patient and physician. As physicians have fewer treatment options available to their patients due to the more invasive and restrictive regulations of the government and health care industry, the biggest loser ultimately is the patient.
In my next post Mike and I will offer some suggestions about how you can respond using to this challenge in a way that will support your health and your freedom.