FIRM ANALYSIS REGULATORY
Firm Briefings
PRACTICE BREAKDOWN PER INDUSTRY SECTOR
We asked regulatory attorneys to breakdown their practice by industry. The following represents a percentage of all respondents’ answers.
Agri-tech Medical Devices Pharmaceutical (Generic) Pharmaceutical (Branded) Biotechnology 0 10 20 30 40 50
“We can bring any FDA problem to them,” says one client. “We like the fact that they are a boutique firm for this practice area as it allows us to work with them more directly on specific issues we face in the industry.” King & Spalding “I have never worked with such intelligent attorneys in their field,” is how one client describes their experience working with the FDA medical device team at King & Spalding, while another notes that “their FDA team works diligently and is very responsive to any of our needs at any time of the day.” The firm represents GalaxoSmithKline on all of its FDA-related issues and has worked with other major life sciences companies such as Cephalon and EMD Serano. One key partner on the Washington DC-based team is Mark Brown, who colleagues commend for “his outstanding legal acumen and expansive knowledge of medical devices.” He spent four years serving as lead counsel for large medical device suppliers Medtronic, Baxter Healthcare, and GE. Brown negotiated and litigated consent decrees of permanent injunction with the FDA over manufacturing processes for these clients. Former chair of King & Spalding’s FDA & Life Sciences group, Edward Basile, is also “one of the brightest and thorough attorneys in this space,” according to one peer. With nearly 30 years of experience working with the FDA, he is considered by a contemporary as “a major influence on how FDA law has been constructed for medical devices today.” Basile’s experience spans the entire range of FDA medical device work as he has helped clients obtain expedited marketing clearance to the market and has assisted companies subject to the FDA’s Application Integrity Policy.
Morgan Lewis & Bockius The FDA Healthcare practice at Morgan Lewis & Bockius is considered by colleagues as “a highly skilled team that can handle any regulatory need a client may bring to them.” As chair of the firm’s Life Sciences and Healthcare Interdisciplinary Group, Stephen Paul Mahinka has made an emphasis on adding talent and experience to Morgan Lewis’ industry team. The latest addition, partner Gary Yingling, is seen by peers as, “an attorney who has seen it all and can handle any situation involving the FDA.” He brings over 30 years of industry experience from his previous practice at K&L Gates and also spent time as the director of the Over-the-Counter (OTC) Drug Review in the Bureau of Drugs. Yingling joins a very impressive FDA healthcare team. Partners Kathleen Sanzo and Donna Lee Yesner are both considered “foremost FDA authorities” by their competitors. Sanzo is a leading partner in the firm’s FDA practice and is vice-chair of the Consumer Product Regulation Committee of the American Bar Association Section of Administrative Law and Regulatory Practice. “There is no firm we like working with more than Morgan Lewis,” compliments one client about the firm’s FDA group. “Knowledge and responsiveness is what we look for in a law firm, and no other firm has delivered the same level of quality that Morgan Lewis has given to us.” Olsson Frank Weeda Terman Matz Olsson Frank Weeda Terman Matz is one of the few remaining regulatory boutiques in the country. The firm’s focus on FDA-related issues in both the pharmaceutical and medical device industries have earned them high praise from their rivals. One attorney
LMG LIFE SCIENCES 2013
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