Agents of regulatory guidance, drug problem reports, and whistleblowers.
Mary E Kremzner, PharmD, MPH, BCGP
Sonia Kim, PharmD, MS
When you think of drug information (DI) specialists, you may envision pharmacists providing empiric therapy recommendations, writing hospital newsletters, or performing literature searches. Unlike the work of traditional DI specialists, the role of an FDA DI pharmacist is much broader. In addition to the traditional DI role of answering inquiries about drug products, pharmacists at the FDA also provide regulatory guidance for drug development, serve as a conduit for reporting drug problems, and are often the first agency contact for whistleblowers.
The DI specialists in the Center for Drug Evaluation and Research’s (CDER’s) Division of Drug Information (DDI) can be the first to learn of an emerging public health risk or patient safety issue. Nothing illustrates this better than the fungal meningitis outbreak in 2012. What began as one call-a patient reporting serious complications after use of contaminated injection produced by the New England Compounding Center-signaled the beginning of the outbreak.
In July 2018, DDI specialists began fielding an unusually high number of questions about a recall occurring in Europe. The European Medicines Agency had recalled some valsartan medicines due to an impurity in the bulk active ingredient, which came from a Chinese company that supplied several manufacturers. A division pharmacist consulted with CDER’s Office of Compliance and the FDA issued a statement about three voluntary recalls from U.S. manufacturers that had used the affected ingredient. Within the first month of the investigation, 4,000 inquiries informed the FDA’s expanding investigation and communications to the public.
In another incident, a concerned pharmacist alerted FDA to a new sleep aid named Elavil OTC Sleep that was being marketed as an OTC dietary supplement labeled as containing melatonin, valerian root, and vitamins. The DDI pharmacist recognized this product was being marketed in a way that would confuse consumers to think it contained Elavil, a well-known prescription antidepressant. While Elavil is no longer marketed as a brand-name drug, generic amitriptyline products are still often referred to as Elavil. CDER collaborated with the FDA’s Center for Food Safety and Applied Nutrition, which regulates dietary supplements, to address concerns with the company marketing Elavil OTC Sleep. A warning letter was issued to the company within weeks, and it was cited for misbranding and for making multiple drug claims. The product’s website has been taken down and many pharmacy professional associations, including the Institute for Safe Medicine Practice, issued warnings about it.
DDI also receives whistleblower complaints about good manufacturing practice violations. DDI has escalated several whistleblower complaints ranging from drug registration and listing violations to major quality issues in manufacturing sites. Many of these cases have resulted in warning letters and nationwide recalls.
If something looks peculiar with a product you receive, drug you dispense, or the place you work, tell us. Contact FDA’s Division of Drug information at firstname.lastname@example.org or 855-543-3784. Our staff will work with you to get the information to our experts. Your report may be the index case for an investigation that protects the public and patient safety.