ISSUES

What is the TDTC list

The Food & Drug Administration (FDA) commissioned an ad hoc committee of the National Academies of Sciences, Engineering, and Medicine (NASEM) to conduct a study to determine whether women and men need the option for “Compounded Bioidentical Hormone Replacement Therapy” (cBHRT), or whether existing manufactured drugs made by large pharmaceutical companies can meet this demonstrated need. In July 2020, NASEM issued a controversial report of its findings. (See What is the NASEM Study?)

The NASEM Committee recommended that FDA add all compounded hormones to its “Too-Difficult-To-Compound” list, even though this recommendation greatly exceeds the scope of the study, the list itself is extremely controversial, and only individual medications may be placed on the list. The NASEM Committee did not have the expertise to evaluate the difficulty of compounding hormones, and this is the most dangerous of its biased recommendations. Placing compounded hormones on this list would essentially outlaw most if not all of the cBHRT that millions of women and men currently take. According to the American Pharmacists Association, “it was clearly not Congress' intent [in the Food and Drug Administration Modernization Act of 1997 ] to include entire groups of drugs on the list." Yet, this is exactly what the NASEM study recommended!

Hormones are not difficult to compound. They have been routinely compounded for decades and have been used by millions of patients without significant reports of widespread adverse events. With the current heightened scrutiny of compounded medications, a rash of adverse events associated with compounded hormones would make the news, and state regulators keep track of any issues that do arise.

Under federal law, FDA does have the authority to place individual drug products (not entire classes of drugs) on a too-difficult-to-compound list if “a drug product presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product.” This list currently contains complex, technical drug-delivery systems such as metered-dose inhalers that are technically difficult to compound.

The NASEM committee did not study or examine in any detail whether hormones are “too difficult to compound.” And even though it was not charged to do this and did not have the technical expertise to make this determination, this recommendation was included in its final report. The only public mention recorded arguing for adding compounded hormones to the too-difficult-to-compound list was made by a former high-ranking FDA official with an anti-compounding history, who made this suggestion at the end of the NASEM study process. Interestingly, this former FDA official has consulted for large drug company interests since leaving the agency and was selected as a reviewer of the final report. (See Who Funds the FDA? Follow the Money.)