Response to FDA Statement on Improving Adverse Event Reporting of Compounded Drugs
Response to FDA Statement on
Improving Adverse Event Reporting of Compounded Drugs
BioTE Medical (“BioTE”) is aware of FDA’s September 2019 “Statement on improving adverse event reporting of compounded drugs to protect patients” (“FDA’s Statement”). In that Statement, FDA emphasized the vital role that industry-submitted adverse event reports play in helping the Agency monitor safety issues. BioTE shares FDA’s interest in protecting the public, and to that end we have always worked to ensure compliance with appropriate legal and regulatory requirements. Nevertheless, BioTE wishes to note several factual inaccuracies and errors in FDA’s Statement.
First, contrary to the suggestion made in FDA’s Statement, BioTE is not a 503B outsourcing facility. BioTE is a medical marketing and training company that works with medical practitioners throughout the United States and educates them about compounded hormone replacement therapy. As part of its business model, BioTE offers practitioners a complete package of partners and services, which includes the ability to order and receive compounded hormone pellets directly from a licensed 503B outsourcing facility. BioTE does not produce, package, or ship compounded drugs. BioTE does not own or operate any 503B outsourcing facilities.
This distinction is significant because FDA’s Statement misrepresents BioTE’s alleged obligations to report adverse events to FDA. Contrary to FDA’s Statement, BioTE neither makes nor distributes compounded hormone replacement medication and, thus, unlike 503B outsourcing facilities, has no legal obligation to track and report adverse event reports to FDA. As a medical marketing company, BioTE collected data from its trained practitioners over a period of six years on secondary outcomes associated with compounded hormone pellet replacement therapy in order to assess overall patient improvement following treatment. BioTE’s goal in tracking this information was to update our training, where necessary, and provide better education to its practitioners. BioTE’s information tracking mechanism was never intended to serve as an adverse event reporting mechanism or to supplant the well-defined adverse event reporting requirements applicable to 503B outsourcing facilities.
FDA’s Statement grossly mischaracterizes the nature of the data BioTE collected and, therefore, wrongly suggests that compounded hormone replacement therapy is unsafe. The “adverse events” referenced in FDA’s Statement reflected possible secondary reactions from treatment with compounded hormone replacement therapy (i.e. acne, rashes, etc.) and not serious and/or unexpected adverse events. FDA does not require that healthcare entities report these secondary reactions. Thus, even if BioTE were obligated to report adverse events to FDA, the information it collected on secondary reactions is not reportable. Simply because BioTE was tracking secondary complications does not mean that any of the information collected by BioTE should have been reported to FDA, nor does it suggest, in any way, that compounded hormone replacement therapy is dangerous, risky or somehow inappropriate for treatment.
BioTE takes patient safety and health very seriously. BioTE is dedicated to helping patients live better and longer by changing the way health care is practiced on a global level. BioTE recognizes the value in ensuring that patient complaints are accurately recorded and thoroughly investigated. Since FDA published its Statement, BioTE has taken steps to further educate practitioners on the appropriate steps to take to report adverse events, should any arise. Practitioners are trained to submit any negative outcome directly to the appropriate 503B outsourcing facility so that the outsourcing facility can fulfill its regulatory obligation to investigate and submit any required adverse event reports to FDA.
BioTE desires to be an active part of the solution and to alleviate any lingering concerns FDA may have about compounded hormone replacement medication. BioTE can assure practitioners, the public, and FDA that it acts appropriately and in compliance with any legal and regulatory requirements applicable to its business.
 BioTE is unable to determine where FDA obtained the number of allegedly adverse events referenced in its Statement. BioTE’s records do not reflect 4,202 separate events.