Paul Hastings hires ex-FDA policy director

Firm hires former Food and Drug Administration staffer from King & Spalding | Washington DC office gains nearly a decade of FDA experience.

Paul Hastings has welcomed the arrival of Food and Drug Administration (FDA) and life sciences partner Eva Temkin in Washington, DC, as chair of the firm's FDA practice.

Joining from King & Spalding, Temkin's practice focuses on regulatory, litigation, and transactional matters involving biomedical products regulated by the FDA.

With nearly a decade of experience in the agency, Temkin’s role will be to help clients solve problems and execute strategies related to drugs, biologics, and combination products from development and approval through post-market regulation.

"The rapidly evolving life sciences sector, particularly in the sphere of the FDA, makes it critically important to have premier regulatory talent that understands the life cycle and needs of pharmaceutical and biotech companies," said Paul Hastings chair Frank Lopez.

"Eva's strong FDA experience and market credibility, paired with our existing life sciences team, will be instrumental to enhancing our life sciences, corporate, and litigation practices. We are thrilled that she has joined us."

Temkin works on matters spanning product development and clinical trials, regulatory exclusivities, orphan drugs issues, manufacturing and facilities issues, post-approval study requirements and REMS, drug-use-related software and digital technologies, licensing and supply arrangements, the Administrative Procedure Act, and the Inflation Reduction Act.

"I'm excited to join this sophisticated practice and contribute to the firm's continued focus on serving key industry sectors," said Temkin. "My FDA and private practice experience creates synergies that will benefit my clients while also enhancing the firm's offerings."

At the FDA, Temkin led policy development across a broad spectrum of issues relating to biological products as acting director of policy for the Office of Therapeutic Biologics and Biosimilars.

As associate chief counsel at the FDA's Office of Chief Counsel, she helped direct the agency's regulators on complex biomedical product issues and legislative initiatives, including the 21st Century Cures Act and over-the-counter monograph reform.

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