Access to Estriol
In January 2008, the FDA issued several warning letters to compounding pharmacists prohibiting the compounding of medications with estriol—a bio-identical estrogen that is produced naturally by a woman’s body—unless the pharmacist has a valid investigational new drug application on file with the FDA. This action was simultaneous to the FDA’s response to a Citizen Petition filed by Wyeth Pharmaceuticals, the maker of the synthetic hormone replacement drugs Premarin and Prempro. Wyeth’s petition requested investigations into and enforcement actions against pharmacies engaged in compounding bio-identical hormone replacement therapy, also requested additional consumer-related materials, and FDA to issue an Alert Paper.
In direct response to the petition, FDA developed a public awareness campaign about bio-identical hormone replacement therapy and issued a new policy banning pharmacies from compounding hormone medications—short of going through a time-intensive new drug approval process. Fortunately, such policy has not been strictly enforced and consumers have access to compounded bio-identical products.
FDA permits drug compounding with active ingredients (such as estriol) that are not components of FDA-approved drugs if the substance is shown to be safe and effective for the use which it is being prescribed. FDA issued the ban on estriol without knowing the safety or the effectiveness of the substance. Now a physician must file an investigational new drug application if he/she wants to prescribe estriol.
In announcing the ‘new policy’ on estriol, FDA admitted that it had not received a single adverse event report from the use of this hormone or any evidence of harm from the product. FDA was simply reacting to pressure from a major drug company attempting to insulate patentable products from a readily available bio-identical therapy at the expense of women’s health. Estriol is a very weak and beneficial hormone, and has been used safely in the U.S. for decades. It is approved in Europe, Japan and other developed nations and is a standard of care in most of the world. In fact, Wyeth sells estriol in Europe.
The reason for Wyeth’s request on estriol is clear: over 80 percent of all compounded bioidentical estrogens contain estriol and thousands of women prefer a bioidentical hormone during menopause versus a synthetic product. Wyeth manufacturers synthetic hormone replacement drugs and by successfully influencing the FDA to ban estriol, Wyeth has free rein to capture the market. Synthetic patentable products are extremely profitable and the increase in demand for the bio-identical product was a threat that Wyeth needed to address.
ANH-USA responded to FDA’s policy by running full-page ads in the New York Times and the Wall Street Journal opposing this effort. ANH-USA joined with other groups and together sent over 100,000 communications to Congress opposing this effort. ANH-USA also funded legal action to protect physicians who prescribed estriol and were wrongly targeted by the FDA. With a record number of consumer complaints filed in response to Wyeth’s request for the ban, Congress heard the concern and even requested FDA to reverse its ruling. Senate Concurrent Resolution 88 and House Concurrent Resolution 342, “Expressing the sense of Congress that the Food and Drug Administration’s (FDA) new policy restricting women’s access to medications containing estriol does not serve the public interest.”
Currently there is a stand off on the issue, and while some women have had difficulty-accessing estriol, and while insurance providers have cited FDA’s action to deny reimbursement for this medication, estriol is still generally available. Moreover, recent federal court decisions have restricted the ability of FDA to enforce its action.
ANH-USA continues to work to make sure that estriol is available for the growing number of women who are use bioidentical hormones rather than the synthetic products, which are more foreign to the body than that of a natural occurring substance. Congress is likely to consider legislation in the near future dealing with the federal regulation of compounded medications, and we will work to remove FDA’s authority to unjustly restrict the use of estriol.