FDA, Products Promotion, and Defense

Overview

BakerHostetler’s FDA, Products Promotion and Defense team is set apart by its ability to resolve legal issues through in-depth knowledge of health science information and our real-world experience with a broad range of clients. Our team members hold advanced degrees in health science disciplines and have longstanding experience in advising on and advocacy of health science information.

We represent a broad range of companies and institutions, including pharmaceutical, medical device, pharmacy, pharmacy distribution, biologic, cosmetic, nutritional supplements and more. We have a wealth of first-hand knowledge and experience for successfully handling product efficacy, safety, promotion, compliance, licensing and litigation matters at all stages of product lifecycles. We use that knowledge to provide clients with advice tailored to meet real-world needs. Team members work closely with many different client functions, from executive management teams and legal departments to institutional review boards, safety committees and regulatory affairs departments.

With our focus on scientific evidence, we develop strategies that improve our client’s presence in the marketplace and posture in litigation. We frequently practice before the FDA, DEA, EPA and other federal and state regulatory agencies.

From pre-marketing through post-marketing matters, companies and institutions that need help developing, interpreting and advocating scientific information for resolution of their legal matters look to BakerHostetler for the sophisticated knowledge and real-world experience of our FDA, Products Promotion and Defense team.

Select Experience

  • Advised pharmaceutical companies in assessment of and response to safety signals of potentially life threatening conditions.
  • Represented a compounding pharmacy during a recall of compounded medications following FDA and State Board of Pharmacy inspections.
  • Represented a medical device company on product safety positions taken by the Centers for Disease Control and Prevention and healthcare epidemiology societies.
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Experience

  • Advised pharmaceutical companies in assessment of and response to safety signals of potentially life threatening conditions.
  • Represented a compounding pharmacy during a recall of compounded medications following a FDA and State Board of Pharmacy inspection.
  • Represented a medical device company on product safety positions taken by the Centers for Disease Control and Prevention and healthcare epidemiology societies.
  • Represented a pharmacy during an FDA inspection of the pharmacy’s compounding area and activities.
  • Advised pharmaceutical, medical device and cosmetic companies on advertising claims that required the assessment of clinical trials.
  • Advised private equity funds during the diligence of both FDA manufacturers and licensed pharmacies.
  • Helped academic medical centers to develop policies and procedures for managing conflicts of interest and apply them in specific research projects.
  • Represented pharmacies and wholesale distributors in front of 50 state boards of pharmacy.
  • Defended pharmaceutical companies in nationwide products liability litigation arising from analgesic, cough-cold and colonoscopy preparation products.

Recognition

  • BTI Client Service 30: BakerHostetler advanced 19 positions to #9 (2016)

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