Matters
- Advised numerous academic medical centers, health systems, hospitals, physician groups and research organizations on research policies and procedures.
- Advising clients on human subject research protection issues, including whether research is “human subject research,” whether research is exempt, and whether research may be reviewed on an expedited basis versus full Board review.
- Reviewing informed consent documents for compliance and for consistency with clinical trial agreements.
- Creating conflict of interest in research policies, and advising clients on managing identified conflicts.
- Advised on off label use of drugs and devices, obligations to obtain IND or IDE.
- Negotiating clinical trial agreements on behalf of institutions and research networks, assisting IRBs with compliance, HIPAA, GDPR and general privacy in clinical trials, clinical trial billing and billing for new treatment modalities.
- Creating a system for an efficient and cost-effective method of reviewing clinical trial agreements.
- Advising clients on HIPAA compliance in research, including whether informed consent documents meet HIPAA authorization requirements.
- Assisted numerous research organizations and institutions with obligations with respect to health data and tissue samples, including access for research purposes.
- Advised acute care hospital affiliated with academic medical center and large research institution on data ownership, access issues.
- Advised technology companies on use of data for research purposes and regulatory compliance issues that arise from such use.
- Advised companies on intellectual property issues related to research concepts and products.
- Representing clients in FDA audits and investigations related to clinical trials. Evaluating reporting obligations to government agencies, sponsors and IRBs on adverse events.
- Government investigations involving the academic medical center, affiliated sites and the faculty practice plan, including clinical research fraud, academic misconduct, modifier 25, narcotic diversion and inappropriate repackaging and distribution of drugs.
- Represented academic medical centers with a sealed qui tam alleging false billing in connection with clinical research studies.
- Successfully appealed the FDA’s decision to revoke our client’s mammography services certification pursuant to the terms of the Mammography Quality Standards Act (MQSA). For the first time, the FDA granted an appellant’s request to overturn the agency’s own decision to require patient and provider notices. We worked closely with the FDA to expedite the client’s recertification, enabling it to resume its mammography services in less than one week.
- Counsel clients on appropriate regulatory pathways to market for a full range of medical devices, including Class III, Class II, general wellness products, mobile medical apps, and software as medical devices, as well as counsel regarding 21st Century Cures Act.
- Represented a medical device company on a drug shortage issue – its drug-delivery device is dependent upon two drugs currently on the FDA’s drug shortage list. We advised our client on its options to encourage the FDA to exercise its regulatory authority to permit drugs into the U.S. market to alleviate the shortage, and anticipate representing the client before the agency on this matter.
- Advised a trade association to respond to recent FDA activity by CDRH which appears to run counter to a regulatory exemption from registration requirements for this particular industry.
