Overview

David Rosen is a partner and public policy lawyer with Foley & Lardner LLP. Mr. Rosen has extensive experience in health law, life sciences, and food and drug regulation, including a range of Food and Drug Administration (FDA) regulatory issues affecting prescription and over-the-counter pharmaceuticals, medical devices and biologics. He is co-chair of the firm’s Life Sciences Industry Team and is also a member of the firm’s Government & Public Policy Practice and the Health Care and Food & Beverage Industry Teams.

Mr. Rosen was formerly a partner with two other law firms. He was also employed by the FDA for 14 years, progressing to various supervisory positions involving virtually all aspects related to the drug approval process, combination products, jurisdictional issues and related compliance activities.

Recognition

Mr. Rosen has been Peer Review Rated as AV® Preeminent™, the highest performance rating in Martindale-Hubbell's peer review rating system. In 2012 - 2016, The Legal 500 recognized Mr. Rosen for his work in life sciences. In 2015 and 2016, he was named an IP Star by Managing Intellectual Property magazine. He has been a frequent speaker before national and international pharmaceutical industry associations on the ANDA submission and review process and on the IND and expedited drug development, review, and approval processes. Mr. Rosen has made presentations before investment analysts and managers of venture capital on the impact of FDA on the drug and biotech industry.

Affiliations

Mr. Rosen is a member of the University of Connecticut School of Pharmacy Advisory Board.

Education

Mr. Rosen earned his J.D. at The Catholic University of America, Columbus School of Law (1991). He also holds a Bachelor of Science degree from the University of Connecticut School of Pharmacy (1978).

Admissions

Mr. Rosen is admitted to practice in the District of Columbia and Maryland.

Publications

  • “How to Respond to Consent Decrees,” BioPharm International, Vol. 25, Issue 5, May 1, 2012
  • “FDA Getting Tougher at the Border,” Pharmaceutical Compliance Monitor, December 14, 2011
  • “MX: Device Reuse and Safety,” Medical Device and Diagnostic Industry, October 19, 2011
  • "Next Steps for the U.S. Biosimilar Regulatory Scheme," Pharmaceutical Technology, March 2011

Representative Matters

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Foley assisted Spectra Medical Devices on FDA related issues, including FDA inspections, business and regulatory matters.
In January 2014, Dainippon Sumitomo Pharma Co., Ltd entered into an agreement with Edison Pharmaceuticals, Inc. ("Edison") that amends the license agreement between the two companies relating to EPI-743 and EPI-589, which are therapeutic agents under development for mitochondrial disease. On the same date, a joint research agreement for discovery of novel candidate pharmaceutical compounds targeting cellular energy metabolism and a stock purchase agreement relating to DSP’s purchase of an equity interest in Edison were also entered into. Foley & Lardner LLP client Dainippon Sumitomo Pharma Co., Ltd. manufactures and sells pharmaceuticals, food ingredients, food additives, veterinary medicines, diagnostics, and others in Japan, China, North America, and internationally. The company offers various pharmaceutical products and develops and sells ingredients and additives and offers veterinary medicines for companion animals, including dogs and cats; and farm animals, such as cattle, swine, horses, and cultured fish. Additionally, the company develops point-of-care testing diagnostic products for infectious diseases. The company was founded in 1897 and is headquartered in Osaka, Japan. Dainippon Sumitomo Pharma Co., Ltd. operates as a subsidiary of Sumitomo Chemical Co., Ltd. Edison Pharmaceuticals is a biotechnology company based on the discovery and development of low-molecular therapeutic drugs for the treatment of Mitochondrial disease. Founded in 2006, it is headquartered in Mountain View, California, USA.
Represented H&P Industries Inc. with respect to FDA seizure of goods, consent decree, and remediation plan.

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