Compounding pharmacies should be aware of recent developments in the law surrounding bioidentical hormone therapy (cBHT). In the field of pharmacy, compounding (performed in compounding pharmacies) is preparation of a custom formulation of a medication to fit the unique need of a patient which cannot be met with commercially available products. Compounded drugs are not FDA-approved. The Food and Drug Administration (FDA) has been looking at cBHT (e.g. estriol, estradiol, progesterone) for a while and has commissioned several studies to look into the safety and efficacy of these ingredients. Most recently, FDA convened a National Academies of Science, Engineering, and Medicine (NASEM) committee to study the clinical utility of treating patients with cBHT. The FDA will utilize the committee’s findings to make a final decision on the fate of cBHT. In July 2020, the NASEM study released unfavorable results reporting the widespread use of cBHT as a public health concern and recommending that prescribers restrict the use of cBHT to two circumstances: when a patient is allergic to an ingredient in an FDA-approved hormone product, and when a patient requires a specific dosage form unavailable for an FDA-approved product. As a consequence of the public health concern, FDA will likely move quickly to ban these medications.
Over 2.5 million women in the U.S. rely on bioidentical hormones for menopause, fertility challenges, or other hormonal imbalances. Public access restrictions will have far reaching consequences for patients. Despite being compounded safely for decades, FDA has nominated and its Pharmacy Compounding Advisory Committee (PCAC) is currently reviewing cBHTs, for the FDA’s Demonstrably Difficult to Compound List items that appear on the list, when it is final, will no longer be able to be utilized by compounding pharmacies in the mixing of cBHT. FDA will have to issue a “proposed rulemaking” to actually add these hormones to the Difficult to Compound List. It is also possible that FDA will issue a draft guidance that restricts use of cBHT as outlined in the NASEM’s report recommendations. Frier Levitt has experience submitting “comments” to the FDA in connection with the “Difficult to Compound” list, on behalf of compounding pharmacies and trade groups.
One of the committee’s recommendations is that “the federal government and State Boards of Pharmacy should expand and improve oversight of 503A “traditional” pharmacies to ensure quality standards for every cBHT dispensed”. Is this crux of the matter? Has FDA overreached in implementing the provisions of the Drug Quality and Security Act, all but halting common compounding practices that have been safely performed for years and on which patients with legitimate needs for compounded medications rely? Has the FDA done so by circumventing the federal Administrative Procedure Act (“APA”), issuing “guidance documents” to implement policies rather than following the statutory rule-making process that requires stakeholder input regarding proposed regulations? The APA is an important tool in the valid rule making process, as well in a democratic form of government that celebrates separation of powers.
There is a public docket allowing public comments concerning the products nominated for the list. Interested parties need to prepare and submit comments to FDA on the docket in anticipation of FDA acting to ban cBHT. The comments should urge FDA to remove the nomination of these compounds from the list. Further, comments should opine that the ingredients are not difficult to compound but are being considered for the list for other reasons (e.g. the systematic chiseling away of ingredients allowed to be compounded). A non-biased review of the vast clinical literature (Safety & Efficacy) is needed to rebut the findings of the FDA commissioned report. There have been no trials comparing the safety of synthetic hormones versus bioidentical hormone formulations.
How Frier Levitt Can Help
FDA has tried unsuccessfully in 2008 and 2018 to ban cBHT, commissioning this most recent study. For legal and regulatory advice to address this latest effort, please contact us
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