FDA Associate Chief Counsel Vernessa Pollard Joins Arnold & Porter

August 11, 2008

WASHINGTON, DC, August 11, 2008 -- Arnold & Porter LLP announced today that Vernessa Pollard, former Associate Chief Counsel in the US Food and Drug Administration's Office of Chief Counsel, has joined the firm's FDA and Healthcare Practice in Washington as a counsel. During her tenure at the agency from 2002 to 2008, Ms. Pollard represented the FDA in a variety of major litigation matters, and advised agency clients on compliance and regulatory issues involving drugs, medical devices, dietary supplements, cosmetics, pharmacy compounding, good manufacturing practices (GMP), Congressional inquiries and disclosure of records under the Freedom of Information Act.

"Vernessa's skills will complement our existing practice and growing demands in FDA regulation and enforcement," said Daniel Kracov, head of Arnold & Porter's FDA and Healthcare Practice. "Her in-depth experience in FDA enforcement litigation will be a particularly valuable asset to our clients."

Among the highlights of her career at the FDA, Ms. Pollard represented the agency in a recent enforcement action that resulted in a comprehensive consent decree of permanent injunction against a leading medical device manufacturer; handled the agency's first administrative action seeking civil penalties for violations of the medical device report (MDR) requirements; defended against challenges involving the FDA's interpretation and application of the "intended use" doctrine (the use of labeling and promotional materials to establish a product's regulatory status); defended against First Amendment and APA challenges involving the agency's authority to regulate drugs compounded in pharmacies and to inspect state-licensed retail pharmacies; and handled the FDA's first legal action enforcing the 1997 Animal Feed Rule, which was implemented to prevent the spread of Mad Cow disease. She received the FDA Commissioner's Award of Excellence, the Department of Health and Human Services Secretary's Award for Distinguished Service and an FDA Commissioner's Outstanding Service Award for Legal Representation and Dedication in Conducting Enforcement and Defensive Litigation.

The firm's healthcare practice has recently expanded with the addition of a four-person healthcare regulatory team: Alan Reider, Allison Shuren, Paul Rudolf and Thomas Gustafson who joined the firm in Washington last month, along with associates Anthony Choe and Nicole Liffrig Molife (Washington), and Chandra Branham (Northern Virginia). Additionally, two healthcare lawyers, Jeffrey Ruggiero and Andrew Bogen, experienced in advising hospitals and other healthcare providers in regulatory compliance and enforcement, transactional and litigation matters, joined the firm in New York last week.

With the addition of these 10 healthcare team members, some sixty lawyers from the firm's FDA and Healthcare group are now practicing in the US and Europe, many of whom have government agency experience or have previously served as medical doctors, nurses, scientists and public policy specialists. The group serves clients in the pharmaceutical, biotechnology and medical device industries, as well as hospitals, physician groups and other healthcare services providers. The team has in-depth experience in advising on complex regulatory and compliance challenges, with the ability to handle transactional matters and commercial litigation.

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