FDA to ‘institutionalize’ compounding regulation to ‘protect consumers’
Regulatory focus on drugs manufactured at compounding pharmacies has ramped up in recent years, as a result of the 2012 fungal meningitis outbreak and the political response to the quality failings that caused it. However, the drug compounding program lacked a defined place within the US Food and Drug Administration (FDA).
This is now set to change. Writing in an email to FDA staff, Janet Woodcock, director of the Center for Drug Evaluation and Research, detailed plans to “institutionalize” the drug compounding regulatory program by centering it in the Office of Compliance.
The choice of office reflects the FDA’s goals for the compounding program. The Office of Compliance is responsible for enforcing quality regulations to stop substandard products from harming patients. The list of tasks handled by the office includes “to protect consumers from unsafe compounded drugs.”
This objective lay behind the priorities the FDA set for its drug compounding program earlier this year.
“A key component of our 2019 work will be continuing to perform our risk-based inspection and pursue other enforcement efforts to identify compounders who produce drugs under substandard conditions or use inappropriate practices that could lead to serious harm,” then-FDA commissioner Scott Gottlieb wrote.
Now, this focus will be squarely in the remit of the Office of Compliance. However, some of the program’s other activities overlap with those of different FDA departments. For example, Gottlieb also listed regulation of bulk substances used in compounding and the finalization of guidance as key priorities for the program.
Woodcock said departments other than the Office of Compliance will continue to perform activities outside of the remit of the new home of the compounding program. This means the Office of New Drugs will retain responsibility for the review of drug substances and the Office of Pharmaceutical Quality will still develop current good manufacturing practices (cGMP) policies.
The FDA has tasked Gail Bormel with leading collaborative efforts with other departments. Bormel, who will report directly to compliance director Donald Ashley, is leading a new compounding team within the Office of Compliance.
The establishment of compounding within the Office of Compliance builds on changes to the oversight of the industry that have happened over the past seven years. In 2013, Congress responded to the fungal meningitis outbreak by giving the FDA additional powers over compounders through the Drug Quality and Security Act.
Since then, the FDA has increased its focus on drug compounding, aided by Congress’ willingness to make money available to support the activities. Last year, the FDA inspected 128 compounders, issued 24 warning letters and oversaw 54 recalls.
The figures are a testament to both rising standards and ongoing problems in the compounding sector. At 19%, the proportion of inspections that led to warning letters is well down on previous years, such as the 40% rate seen in 2017.
However, the rate remains well above that seen in the traditional drug manufacturing sector. Last year, 5% of drug inspections conducted by the FDA led to warning letters.