Wiley offices in Washington, D.C. (Courtesy photo)

Wiley Rein is adding two lawyers to its Food and Drug Administration regulatory practice, amid growing demand for expertise in the practice area.

Ann Begley is joining Wiley as a partner who will chair its food and drug practice, while Gary Yingling is joining as senior counsel. The pair, who previously practiced together at Morgan, Lewis & Bockius, will help Wiley build out its policy, regulatory and enforcement offerings of environmental and consumer products, the Am Law 200 firm said.

The duo's hire in Washington, D.C. comes as life sciences practices across the country have been busy amid the coronavirus pandemic. Begley said that her practice area is dominated by questions of the FDA's current and future dealing with the pandemic.

"There's a lot going on in the food and drug space, much of which is obviously Covid-related," she said in an interview. "Right now, we're dealing with changes the FDA has made in the way it is making exceptions for public health reasons, such as allowing more companies to make hand sanitizer amid a national shortage."

Ann Begley, FDA partner at Wiley (Courtesy photo)

An eventual next stage in the practice, she said, will be shifting focus to a post-coronavirus reality, when clients need help navigating rules and regulations as the FDA inevitably scales back exemptions.

"In terms of how the FDA has handled this pandemic, all of this is just historic," she said.

She advises clients concerning conventional foods; dietary supplements; drugs and cosmetics products industries, and she has also worked on regulatory aspects of life sciences transactions.

Begley counsels clients in several areas, including product notification and approval pathways; formulation; advertising; and legal and regulatory issues pertaining to industry-sponsored and federally funded clinical research.

Yingling, who early in his career worked in the FDA general counsel's office as a trial attorney and deputy chief counsel for administration, advises individuals, partnerships and corporations on FDA-related matters such as new drug applications, food ingredient markets, product labeling, importation, regulatory marketing strategy, recalls and seizures. He focuses on clinical research, contract research organization and sponsor matters.

Peter Shields, Wiley's managing partner, said in a statement that the duo "have impressive regulatory experience across every sector of FDA-regulated industries." Under Begley's leadership, he said, "we will strengthen our ability to meet the increasingly complex needs of the life sciences industry."

Begley praised Wiley attorneys for their knowledge of food and drug laws, but she said she was also excited to work with attorneys who have a wide range of expertise.

"Through my training under [Yingling], I was exposed to multiple practice areas within the FDA specialty," she said, adding she appreciates that "everyone is in one office that has a focus on plugging into all things D.C. regulatory."

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