Christin Helms Carey is counsel in the health care and life sciences practice. Her practice is focused on food and drug law.Ms. Carey represents clients on a broad range of matters concerning government regulation of, and public policy initiatives affecting, the pharmaceutical, biotechnology, medical device, food and dietary supplement industries, with a focus on regulatory strategies and compliance with laws implemented by the U.S. Food and Drug Administration (FDA). Her work includes advising medical device and technology companies on U.S. and international laws and regulations related to the development and commercialization of medical devices and other health technologies, including human subject protection, privacy, product liability, fraud and abuse, research on biospecimens, and FDA labeling and promotional matters. She counsels pharmaceutical companies on product approval strategies, regulatory exclusivity, compliance and enforcement actions, and product liability preemption issues. She also counsels makers of food products, dietary supplements, and over-the-counter and homeopathic drugs on promotion and compliance issues.
Ms. Carey recently returned from a secondment with a California-based company specializing in medical technology, where she served as product counsel. In that capacity, she provided solution-oriented legal advice to product development, regulatory and clinical teams on FDA regulatory submissions, good clinical practices, and privacy and data use, from the initial stages of product development to launch and beyond.
Ms. Carey received her law degree from American University Washington College of Law. She is a member of the Order of the Coif and was a senior staff member of The Administrative Law Review.Ms. Carey is a member of the American Bar Association, the Food and Drug Law Institute, and the Virginia Bar Association.
- assisted a pharmaceutical company in developing public policy, legal and regulatory strategies in response to recent court decisions involving product liability and federal preemption
- counseled tobacco product manufacturers on compliance with federal law and FDA regulations under the Family Smoking Prevention and Tobacco Control Act
- assisted a pharmaceutical company combating illegal importation of bulk drug substances for pharmaceutical compounding
- advised clients on the law governing prescription to over-the-counter switches and strategic considerations concerning those switches
- advised clients on compliance with laws governing drug and device promotion and marketing practices, including rules enforced by the FDA, the Federal Trade Commission (FTC) and the U.S. Securities and Exchange Commission
- provided regulatory counsel regarding bioequivalence standards, Abbreviated New Drug Application and 505(b)(2) New Drug Application strategies
- advised clients on laws governing pediatric studies and market exclusivity opportunities
- counseled clients on Orange Book patent listing strategies and limitations and the intellectual property considerations affecting the scope and timing of generic market entry.
- completed a comprehensive Safe Harbor review and certification for several products on behalf of a medical technology client
- embedded with scientific, engineering and regulatory teams to develop product submission and life cycle strategies for a chronic disease management technology platform and companion devices
- drafted comprehensive compliance policies for a generic pharmaceutical manufacturer
- advised a pharmaceutical company on FDA Office of Prescription Drug Promotion enforcement actions
- advises clients on orphan drug development and exclusivity issues
- counseled a cellular communications manufacturer on the FDA regulation of mobile medical applications
- researched and analyzed clinical trial regulatory requirements and advised a pharmaceutical company regarding publication of clinical trial data
- counsels drug manufacturers on Hatch-Waxman patent and exclusivity matters
- counseled chain restaurant clients on menu nutrition labeling requirements
- counseled clients on food safety compliance and recalls
- advised a client on FDA regulation of cosmetic ingredients
- advised a defense contractor on FDA regulation of laser-emitting devices
- J.D., American University, Washington College of Law, summa cum laude, 2011
- B.A., Vanderbilt University, magna cum laude, 2008
- District of Columbia
Rate : $$$