You Can’t Change That: FDA Reiterates Risk of Delegating Responsibility in Quality Agreements

In the span of three weeks, the Food and Drug Administration issued Warning Letters to two dietary supplement companies, in part, for relying, to their detriment, on quality agreements. We discussed another similar Warning Letter in a recent Bulletin. Regardless of the type of FDA-regulated product, the agency made clear that, despite an agreement, a company that sells a product cannot delegate its regulatory compliance responsibilities – to quote Raydio’s 1979 single, “You Can’t Change That.”

In one Warning Letter, FDA wrote:

 

 

Although a firm may contract out certain dietary supplement manufacturing, packaging, and/or labeling operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP [Current Good Manufacturing Practice] requirements … Thus, a firm that contracts out some or all of its operations must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record….

In another Warning Letter, dated a few weeks later, the agency used similar and, at times, identical language.

AGG Observations 

• • FDA is clear. The agency allows quality agreements and, in fact, these agreements may be useful. However, they do not allow a company selling a product to abdicate its regulatory obligations.

• • In both Warning Letters, FDA referred to two United States Supreme Court cases, U.S. v. Dotterweich (1983) and U.S. v. Park (1975). The Dotterweich decision noted that a violation can occur under the Federal Food, Drug, and Cosmetic Act by anyone who has a “responsible share” in the furtherance of the transaction which the statute outlaws. The Park case held that criminal liability under the FDC Act does not rely on awareness of wrongdoing.

• • Companies should prepare quality agreements, but they must also have quality systems in place to ensure manufactured and distributed products are FDA-compliant.

• We draft and negotiate quality agreements. The agency issued a quality agreement guidance for drug companies. So, they are beneficial. However, the agreement is not the final step. It is a means to an end to maximize compliance; it is not the end itself. And, you can’t change that.

AGG will hold a complementary webinar on quality agreements in the near future. More details to come.