The US opioid epidemic, drug compounding and the proliferation of stem cell clinics selling unproven treatments were highlighted as some of the focal points for US Food and Drug Administration (FDA) enforcement efforts last year and next year, officials said Wednesday at the Food and Drug Law Institute’s litigation and compliance conference in Washington, D.C.
Becky Wood, chief counsel for FDA, keynoted the conference and discussed the opioid crisis, and in particular, the challenge of tracking and enforcing the distribution of illicit fentanyl and other opioids. She said FDA has increased inspections and staff at mail facilities that receive these shipments, often from online pharmacies.
For drug compounding, Wood pointed to issues with sterile drugs, while Donald Ashley, director of CDER’s Office of Compliance, noted that one out of every four drug compounding inspections led to a recall in 2017. Ashley added that in 2017, FDA conducted 141 inspections of compounders, issued 62 warning letters and brought two injunctions against companies.
Back in January, FDA issued revised versions of two final guidance documents explaining the use of bulk drug substances in compounding and clarifying that the agency does not intend to take action against certain outsourcing facilities and compounded drugs.
Wood also highlighted FDA’s launch last month of a new framework for regulating regenerative medicine, noting the field has great promise across a range of vexing conditions (which is why the agency has offered a Regenerative Medicine Advanced Therapy designation), though there is an underlying danger of unscrupulous claims and uses by bad actors posing as legitimate companies.
Mary Malarkey, director of FDA’s Office of Compliance and Biologics Quality, added that the 36 months of enforcement discretion announced in the framework, “Doesn’t mean we won’t act, we will, particularly against those with routes of administration associated with higher risks” and that are for non-homologous uses, such as stem cells injected directly into patients’ brains, spinal cords and eyes.
In terms of drug and device manufacturing inspections, Ashley highlighted two examples from 2017: A warning letter sent to Mylan for deficiencies noted by both CDER and CDRH, and a warning letter sent to Sage Products, which used a contract manufacturer that was manufacturing a mouthwash using the same equipment in which it manufactured toxic industrial-grade car washes and waxes.
As far as other updates, Wood also mentioned that a clarification on FDA policy may be forthcoming for cases when an executive could be liable for wrongdoing done by subordinates.