How S.959 Will Affect Access to BHRT

BHRT CoupleLegislation Passed by the U.S. Senate HELP Committee Could Put Your BHRT At Risk–Again.

On May 22, 2013 the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) passed a bill, S.959 that contains provisions that threaten access to compounded Bioidentical Hormone Replacement Therapy (BHRT) by both patients and providers. The entire Senate could consider the bill as early as late June 2013.
 
This bill would give the Food and Drug Administration (FDA) broad and unprecedented powers to regulate compounding pharmacy, including the power to reduce or eliminate access to certain compounded medications used for BHRT. Here is a description of the main provisions of this legislation:
 
S.959 grants FDA the authority to ban certain components of compounded BHRT if, in the opinion of the FDA, they pose “public health concerns.” In 2008, FDA took similar action against the female hormone estriol, a component contained in approximately 80 percent of all compounded estrogens. FDA’s action was in direct response to a request in a “Citizen Petition” filed by a drug company with synthetic hormones that competed with BHRT. FDA instituted import bans on estriol and sent warning letters to suppliers and pharmacies trying to prevent or limit women from obtaining BHRT with estriol. FDA was unable to enforce these actions. S.959 gives them that authority.
 
S.959 greatly expands the definition of a “copy” of a drug company product to include a “variation.” FDA is given expansive authority to determine the definition of variation, and would have the power to determine that compounded BHRT medications are copies of one-size-fits-all and synthetic hormones manufactured by drug companies. This could turn compounded BHRT into an illegal copy of a drug company product.
 
While there is an exception that allows a provider to continue to write prescriptions for the now illegal BHRT, under S.959 he or she would have to determine that BHRT produces a “clinical difference” in a patient’s treatment outcome as opposed to using the drug company product. While a doctor would be able to make this determination, the bill would allow the FDA to determine compliance.
 
In the past, FDA attempted to require practitioners to file costly and invasive Investigative New Drug applications (INDs) for certain compounded BHRT. The agency refused to recognize the considerable expense and bureaucratic procedures involved in setting up and IND. Instead, FDA dismissed legitimate concerns as “misconceptions that obtaining an IND is costly, cumbersome, and time consuming process.” A requirement for an IND for such commonly used medication is an unwarranted intrusion of federal bureaucrats into the patient/provider relationship. But it would be allowed under S.959.
 
For men, compounded testosterone therapy (both injectable versions and creams) could be determined to be copies of manufactured products. Even if a provider can justify a clinic difference in outcomes, S.959 would allow FDA to erect barriers to the prescribing of these medications.
 
FDA has demonstrated hostility towards BHRT in the past, and on its website it still has a consumer alert stating, “’BHRT’ is a marketing term not recognized by FDA.”  In the same alert, which was specifically requested by the drug company filing the Citizen Petition mentioned about, FDA denies the scientific fact that bioidentical hormones are identical to hormones made by the body.  With such contempt toward BHRT, giving FDA broad and sweeping powers over patient and provider access to these medications, as is contained in S.959, is frightening.