Dan Kravoc, Esquire
Arnold & Porter LLP
Washington, DC
In reading this excellent interview with Gerald Masoudi, I was struck by his views on a fundamental and long-debated question about the FDA Chief Counsel’s Office: do FDA lawyers make policy? While I wholeheartedly agree with him that not every FDA decision can or should flow through the Chief Counsel’s Office, his characterization of the very limited role of the Chief Counsel in policymaking runs contrary to the reality of food and drug law.
Although the Federal Food, Drug, and Cosmetic Act has grown more specific and prescriptive as amended over the years, it still leaves plenty of room for legitimate interpretation and maneuver. Many legal interpretations within the agency in fact contribute greatly to policy, and lawyer-driven policy is in certain cases more transformative than many FDA scientific or medical decisions.
Even if well-grounded in statutory language and historical precedent, such legal policymaking can often be controversial. For example, FDA statements on the extent to which drug labeling decisions pre-empt product liability suits—at heart a constitutional issue—have launched a complex debate involving patient rights, effective risk communication, and innovation. The list of such law-infused issues of policy could go on and on, ranging from the proper regulation and labeling of genetically modified foods to the dissemination of off-label reprints. Even policy driven by legal interpretations that stretch the Act too far—such as FDA’s ill-fated attempt to shoehorn cigarettes into the Act by the force of very clever legal arguments—test the boundaries of the law and may lay the groundwork for later congressional action.
Given the deference afforded the Agency, a cautious approach to legal policymaking is certainly warranted. However, I suspect that those who will now take the legal helm at FDA are well aware of the potential role of the Act in creating new policies, and Mr. Masoudi’s modest conception of the role of the Chief Counsel will soon be tested.