Represented tobacco company on numerous Substantial Equivalence Reports, grandfather determinations, appeals of NSE Orders, and meetings with FDA’s Center for Tobacco Products.
Represented a pharmaceutical company in numerous regulatory matters including assistance with New Drug Application (NDA) submissions, counseling concerning clinical trial informed consent issues, licensing agreements concerning combination (drug/device) products, and FDA recall issues.
Advised providers and suppliers on pharmaceutical managed care, Medicare Part D, and Group Purchasing Organization agreements.
Successfully petitioned CMS for a “narrow exception” allowing on behalf of a large pharmaceutical company for one of their drugs to be subject to a reduced Medicaid rebate.
Provided counseling to specialty pharmaceutical company on numerous FDA regulatory, fraud/abuse compliance, and pharmaceutical pricing matters including: performing regulatory due diligence on proposed marketing arrangements and acquisitions, advising on VA and Medicaid Drug Rebate pricing issues, FDA regulated clinical trial matters, group purchasing organizational contracting issues, and country of origin labelling.
Represented a personal care products manufacturer on responding to FDA inspectional observations and conducting cosmetic and drug product recalls. Worked with the company’s internal quality professionals and external consultant to develop a plan for corrective and preventative actions in response to the FDA inspection.