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.
- Responding to and resolving, Warning Letters and Noticies of Violation, Untitled Letters, Form 483s Observations
- Working with District and National FDA Offices on resolving Import Alerts and Import Holds
- Negotiating Certificate to Foreign Government (“CFG”) holds with FDA
- Evaluating and facilitating Recalls and Field Corrections (Part 806), drafting recall communications, assisting with Health Hazard Assessments
- Negotiating with the FDA to reach amenable Consent Decree terms
- Performing FDA-ordered Compliance Reviews and making requisite FDA submissions
- Responding to FDA requests for additional information
- Helping prepare for FDA inspections
- Onsite guidance and monitoring during FDA inspections
- Designing and implementing policies and procedures
- Assisting with Medical Device Reports (“MDRs”)
- Registration and listing support
- Assisting companies subject to Corporate Integrity Agreements (CIA)
- Resolving FDA seizures executed by the U.S. Marshals Service and U.S. Customs and Border Protection