Kleinfeld, Kaplan & Becker represents clients in a variety of enforcement actions by FDA, FTC, USDA, DEA, CPSC and other federal and state agencies. We advise clients on compliance with postmarketing requirements and responding to inspectional observations, requests for regulatory meetings, warning letters, recall requests and import detentions. We also work with clients to resolve investigations by the FDA, FTC and other agencies; respond to seizures, injunctions and other enforcement actions; and negotiate consent decrees, where appropriate.
To assist clients in maintaining compliant business practices, our firm conducts internal investigations at the request of corporate management of matters within our area of expertise. We have, for example, conducted internal investigations of matters involving compliance with prescription drug advertising rules, drug and dietary supplement good manufacturing practice (GMP) regulations, and FDA reporting requirements. Our firm also guides clients on federal and state requirements relating to interactions with healthcare professionals; interactions with hospitals, insurance companies, Medicare/Medicaid and other payors; compliance with antikickback, false claim and sunshine laws; and developing corporate compliance programs.