The FDA has entered a new agreement with the National Academies of Science, Engineering & Medicine (NASEM), and expanded agreements with the University of Maryland and Johns Hopkins University Centers for Regulatory Science and Innovation (CERSIs) in an effort to inform the public and the agency’s policies regarding compounded drugs.
The first study that NASEM will conduct under the agreement will examine the clinical utility of treating patients with compounded bioidentical hormone replacement therapy (BHRT) products. At times, compounded BHRT products, such as progesterone and testosterone, are selected instead of FDA-approved drugs as hormone replacement therapy, and some have claimed that these BHRT products are superior to FDA-approved drugs because they are safer and are naturally derived.
However, as unapproved treatments, they have not undergone FDA assessments that test for quality, safety, effectiveness, and bioavailability. The FDA and NASEM agreement aims to rectify the missing information and provide a report evaluating the available scientific evidence relating to the safety and effectiveness of these products.
NASEM’s second study will examine available evidence of the safety and effectiveness of multi-ingredient compounded topical pain creams, particularly those that contain multiple active pharmaceutical ingredients (APIs). Often, one or more the APIs in these creams are found in FDA-approved topical creams, with lidocaine being a common example; just as often, though, the remaining ingredients may be active ingredients in drugs approved by FDA for non-topical administration and for non-pain-related indications.
The FDA is aware of a number of adverse events, ranging from skin reactions to death, in patients who have applied compounded topical pain creams. Based on the research conducted under their agreement with the FDA, NASEM will provide recommendations regarding the treatment of patients with compounded topical pain creams.
The agency also expanded two previously announced research collaborations with UMD and JHU CERSIs to gather and analyze important information for developing the list of bulk drug substances, or APIs, that may be used in compounding by outsourcing facilities.
In a press release, the FDA stated that the agency believes the results of these research projects will provide important information that will inform the agency’s policies and increase public understanding regarding these compounded products.
(Source: The U.S. Food and Drug Administration)