FDA’s Gottlieb Weighs in on the Drug Quality and Security Act (DQSA)

The agency is taking a robust enforcement perspective.

FDA Director Scott Gottlieb issued a statement outlining the agency’s enforcement efforts since the enactment of the 2013 Drug Quality and Security Act (DQSA), following the recent adjourning of a case in which contaminated steriods were released to the public. 

According to Gottlieb, the FDA has devoted “significant resources” to oversee the compounding drug industry and implement the provisions of the law. “As of June 1, 2017,” said Gottlieb, “the FDA has conducted more than 400 inspections, including 109 inspections of outsourcing facilities; issued more than 150 warning letters advising compounders of significant violations of federal law; issued more than 50 letters referring inspectional findings to state regulatory agencies; overseen over 125 recalls involving compounded drugs; and worked with the Department of Justice on a number of civil and criminal enforcement actions.”

Gottlieb noted that the agency has taken a risk-based approach to their efforts in order to ”make sure that we are maximizing the public health purpose of these new provisions relative to the resources we use to achieve them, and any obligations that these new requirements place on market participants.” Gottlieb further explained that “these foundational regulations” and guidance provide both predictability and transparency crucial for compliance.

As part of the implementation, Gottlieb said that under DQSA the agency has issued 21 draft guidances, ten final guidances, three proposed rules, a final rule and a draft memorandum of understanding. As a forward-looking statement, Gottlieb summarized the FDA’s work thus far, noting, “These efforts are part of our commitment to doing all we can to protect the public from poorly compounded drugs. We will continue to actively oversee drug compounders and, when appropriate, initiate regulatory action as it fulfills the FDA public health mission on behalf of patients.”


Guy Tiene

Guy supports the success of life science organizations by identifying synergies across research, content, marketing and communications resources to drive value for clients. With over 30 years of education and marketing experience and 18 years in the life sciences alone, Guy leads our editorial standards for client content, Pharma’s Almanac and Nice Insight research-based industry content as well as external communications for clients. Having served as head of global marketing and communications for a CMO, he also brings critical insight and guidance to all communications. Guy holds a Masters degree from Columbia University.