Are You ASKING For An FDA Warning Letter?

By Ed Miseta, Chief Editor, Clinical Leader

Quality agreements, the contracts signed between drug sponsors and contractors, continue to be an object of interest for the FDA. The agreements are intended to define and explain the roles and responsibilities of parties involved in the making and handling of drugs and drug products. By stating who is responsible for what, they not only ensure regulatory compliance, but define responsibilities in the event of an adverse outcome. With the number of FDA 483s (Notice of Inspectional Observations) and warning letters on the rise, it is more important than ever for companies to not only have a quality agreement in place, but to make sure both sides adhere to its provisions.

“It’s not mandatory for firms to have a quality agreement in place,” says attorney Alan Minsk, partner and leader of the Food and Drug Practice for law firm Arnall Golden Gregory LLP. “There are provisions in FDA’s regulations that say there should be certain things written down, but that does not mean you are legally required to have a quality agreement per se. Not having one doesn’t necessarily mean you will get an enforcement letter. In fact, it’s possible you have the significant provisions of the contract agreement noted on other documents. However, I believe if you don’t have one, it could be a potential red flag for the FDA.”