Outgoing FDA Commissioner's Compounding Pharmacy Impact

The news of Margaret A. Hamburg, MD, resigning from her long-standing post as FDA Commissioner stirred memories of her success with improving access to emergency contraception, but more so her struggles with regulating drug compounding following a deadly fungal meningitis outbreak traced to a compounding pharmacy’s tainted drugs.

In the outbreak, which began in 2012, more than 680 individuals developed meningitis or other infections after receiving the New England Compounding Center’s contaminated steroids, with 64 reported deaths. Recently, the incident was highlighted again when 2 cofounders and 12 former employees of the Massachusetts compounding pharmacy were arrested in December 2014 for their alleged actions that led to the outbreak.

“The deadly outbreak of fungal meningitis associated with a compounded medication was a horrible tragedy, and I’ve asked myself many times if and how it could have been prevented,” Dr. Hamburg wrote in an FDA Voice blog post on March 22, 2013. “While our investigation of this deadly outbreak has been a top priority, our responsibility at FDA is also to help make sure this doesn’t happen again.”

To help ensure that it wouldn’t, President Obama signed the Drug Quality and Security Act into law on November 27, 2013, with provisions to encourage health care professionals to use only large-scale compounders that have voluntarily registered with the FDA as “outsourcing facilities.”

In a blog post published 5 days later, Dr. Hamburg explained that compounding pharmacies registered with the FDA would be subject to federal quality standards known as current good manufacturing practice (cGMP) and inspection on a risk-based schedule.

“If compounders register with FDA as outsourcers, hospitals and other health care providers will be able to provide their patients with drugs that were compounded in facilities that are subject to FDA oversight and federal requirements for cGMP, among others,” Dr. Hamburg wrote. “To that end, we will be encouraging health care providers and health networks to consider purchasing compounded products from facilities that are registered with FDA and subject to risk-based inspections.”

Over the past 2 years, the FDA has conducted more than 175 inspections of compounding facilities and worked with the US Department of Justice to initiate enforcement actions against those that violate federal law, according to Dr. Hamburg’s December 17, 2014, blog post.

Under Dr. Hamburg’s watch, the FDA recently established a Pharmacy Compounding Advisory Committee composed of experts in pharmacy, pharmaceutical compounding and manufacturing, medicine, and pharmaceutical regulation who will offer recommendations to companies that prepare compounded medications under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.

In addition to addressing problems with drug compounding, Dr. Hamburg has confronted the issues of antibiotic-resistant bacteria, opioid abuse, food safety, tobacco control, Ebola, and speeding the regulatory review process for new therapies. The FDA approved 51 novel drugs and biologics in 2014 alone—“the most in almost 20 years,” Dr. Hamburg noted in a February 4, 2015, blog post. Her tenure is expected to conclude in March.