Food, Drug and Medical Device Regulatory
Areas of Focus
Admissions & Certifications
COLEEN KLASMEIER heads Sidley’s Food, Drug and Medical Device Regulatory Practice. She represents FDA-related entities, primarily manufacturers, with respect to the full range of regulatory issues confronting FDA-regulated companies. Her practice also includes strategic advice and compliance counseling, enforcement, litigation and transactional matters, as well as representation of individuals in criminal FDCA and analogous proceedings. She also counsels manufacturers with respect to legislative matters, and has represented clients in connection with congressional inquiries and GAO investigations. Before joining the firm in January 2005, Ms. Klasmeier served as Staff Attorney/Special Assistant to the Chief Counsel of FDA.
In a recent opinion, the Office of Legal Counsel (OLC) in the US Department of Justice concluded that an article intended to effectuate capital punishment by a state or the federal government is not subject to regulation by the Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetic Act. The OLC's opinion appears to have been issued as a result of litigation involving the FDA's obligation to block the entry of misbranded and unapproved drugs used under state lethal injection protocols.
The Food and Drug Administration (FDA) recently released three untitled letters from the Office of In Vitro Diagnostics and Radiological Health to clinical laboratories offering direct-to-consumer genetic tests, and a report of case studies purporting to provide public health evidence for FDA oversight of all laboratory-developed tests. These developments signal that the FDA remains focused on direct-to-consumer tests and willing to assert authority over them.
In a widely anticipated recent ruling in the ongoing Amarin litigation against the US Food and Drug Administration (FDA), the judge granted Amarin's general and specific requests for relief. This ruling is of major significance for FDA-regulated manufacturers as it addresses and rejects the FDA's frequently articulated rationale that it must be allowed to regulate truthful, non-misleading off-label speech.
The Food and Drug Administration has issued draft guidance announcing that it does not intend to enforce compliance with the regulatory controls that apply to software medical device data systems, medical image storage devices or medical image communications devices, due to the low risk they pose to patients and the importance they play in advancing digital health.
The Food and Drug Administration recently announced the availability of draft guidance, Medical Device Reporting for Manufacturers, which, when final, will supersede the 1997 version. The draft addresses specific questions about the reporting and record-keeping requirements for device-related adverse events.
In a widely anticipated ruling the US Court of Appeals for the Second Circuit recently reversed the conviction of pharmaceutical sales representative Alfred Caronia for misbranding under the Federal Food, Drug and Cosmetic Act, based on alleged off-label promotion. The court agreed with Caronia that the government's prosecution had been based solely on speech promoting off-label uses.