APA Litigation & Regulatory Strategy in the Pre-Litigation Phase
Lawyers in our Food, Drug and Medical Device (FDMD) Regulatory Practice have significant experience litigating issues related to the Administrative Procedure Act (APA) – both against FDA, and as former government lawyers from within the government.
Manufacturers of FDA-regulated products face an ever-present threat of government enforcement, particularly given the pronounced uptick in regulatory efforts that has been a conscious focus in recent years. As agencies like FDA advance increasingly creative and aggressive interpretations of the law, manufacturers regulated by the agency cannot ignore a litigation strategy. Such lawsuits can seek to constrain FDA to act in a fashion consistent with its statutory mandate, and even if litigation does not proceed, the possibility of litigation may serve to constrain federal prosecutors to act within the law. For many clients, suing the federal government may not be a first resort, but it has become essential to prepare for such litigation as part of a comprehensive strategy for dealing with FDA.
Lawyers in our FDMD Regulatory practice work together with litigators to deliver seamless legal counsel to clients considering litigation among other means of resolving disputes with litigators. We assist life sciences clients considering litigation against FDA by:
- Identifying disagreements with FDA that are not susceptible to resolution through direct agency engagement;
- Developing legal arguments, building on our deep knowledge of substantive food and drug law, and taking account of special concerns that arise in agency litigation such as judicial deference to agencies, and issues of jurisdiction and justiciability;
- Handicapping legal arguments according to their likelihood of success in court and their value in settlement negotiations with the government, taking into account the institutional imperatives of regulatory bodies and other extrinsic considerations;
- Spotting opportunities to advance public health arguments that present lifecycle management and other business concerns in their broader context and therefore enhance settlement appeal and reduce negative media exposure;
- Supporting internal company communications aimed at addressing concerns about “suing the regulator,” and developing consensus among key stakeholders about whether a litigation strategy can accomplish key business objectives without posing unacceptable risks to institutional relationships;
- Analyzing the best venue for litigation, accounting for the relative experience of different courts in reviewing agency actions and related constitutional issues, and the possibility of home-field advantage for the agency or the client;
- Managing pre-litigation meetings with the government, including preparing for and representing clients in “last clear chance” meetings with the FDA Office of the Chief Counsel.