The Drug Quality and Security Act – is the FDA walking the walk?

In late June this year, the US Food and Drug Administration’s Commissioner Scott Gottlieb, issued a statement on the Drug Quality and Security Act (DQSA).1 The FDA’s commitment to upholding and following through on moves to protect the public from poorly compounded drugs shows that the Administration means business.

In his statement, Dr Gottlieb mentions that the FDA has issued “21 draft guidances, ten final guidances, three proposed rules, a final rule, and a draft memorandum of understanding.” This is in addition to sending out over 150 warning letters.

Dr Gottlieb underscored the fact that the FDA was taking a “risk-based approach” to ensure that the issue of public health was maximized regarding the provisions, “relative to the resources we use to achieve them.” He felt it was the FDA’s task to inform market participants of their obligations under the new requirements in order to ensure compliance. Dr Gottlieb made it clear that the FDA would supervise drug compounders and enforce regulations to uphold the FDA’s stated mission to protect public health.