GOVERNMENT ENFORCEMENT ACTIONS
Gardner Law represents clients dealing with FDA and DOJ enforcement actions.
The regulatory environment faced by pharmaceutical and medical technology companies is more turbulent than ever. For example, 100 years of FDA policy banning the promotion of off-label uses of products was recently rejected by several courts. Several companies decided to challenge the government rather than deal with consequences like criminal convictions, paying escalating settlements, entering Corporate Integrity Agreements, or limiting promotional claims. Meanwhile, the FDA continues to prohibit off-label promotion. This lack of clarity creates confusion for industry and regulators. Regardless, government enforcement actions remain a key initiative for leadership at the FDA, DOJ, and OIG, in addition to cases brought by relators in qui tam False Claims Act cases, and state attorneys general.
Gardner Law can work with the FDA and the DOJ on your behalf to resolve concerns and avoid escalation of further enforcement activities. The firm can work with FDA headquarters and local District Offices to resolve enforcement actions by understanding FDA concerns and assisting in the development of corrective and preventative action plans to address them. Domestic and international companies can rely on Gardner Law for the help needed to address enforcement actions that can threaten the livelihood of a company. Experience matters when working with the government.