FDA’s Office of Dietary Supplement Programs (ODSP) recently lost its No. 2 official to a law firm, but an agency employee is slated to fill the position around Thanksgiving.
Cara Welch, Ph.D., is returning to ODSP as deputy director, a position previously held by Robert Durkin, a long-time FDA employee who recently departed the agency to join a law firm, Arnall Golden Gregory LLP (AGG). Since July 2018, Welch has been serving a detail as special assistant to FDA’s deputy commissioner for policy, legislation and international affairs.
Welch “played a critical role in ODSP’s creation and, as the office is poised to take the next step in our growth, her background and experience make her the ideal person to help shape ODSP’s next chapter,” Steven Tave, director of ODSP, said in an emailed statement.
Tave previously made the same remarks in an earlier letter to the United Natural Products Alliance (UNPA) shared with Natural Products INSIDER.
In the same letter, Tave revealed Sibyl Swift, Ph.D., has been named associate director for research and strategy.
“Swift has played a leading role in some of ODSP’s most significant and cross-cutting initiatives over the past few years, including our work to protect consumers from the dangers of pure and highly concentrated caffeine and the creation of the Botanical Safety Consortium, in addition to managing the office’s research portfolio,” Tave stated in the letter. “In this new capacity, she will help ensure strategic alignment between our scientific and research activities and our compliance, enforcement and policy initiatives, and she will continue to serve as a principal liaison with both internal and external partners.”
Return of Welch
Welch will rejoin ODSP amid growing pressure on the agency to identify a legal pathway for a hemp-based ingredient—CBD—in dietary supplements. The agency also has been working to foster innovation in the industry, encourage new dietary ingredient notifications, alert the public to dangerous substances and improve its internal processes and procedures.
And under its former commissioner, Scott Gottlieb, M.D., FDA expressed interest in starting a public dialogue over modernizing the Dietary Supplement Health and Education Act of 1994 (DSHEA), which was signed into law by President Bill Clinton 25 years ago.
Since DSHEA was passed into law, dietary supplement sales have skyrocketed as the majority of Americans have embraced the products to promote their health and wellbeing. But FDA’s office responsible for policing the $46 billion-a-year industry has a relatively modest number of employees, and industry groups have lobbied for years to increase its budget.
ODSP had a budget of $7.3 million in fiscal year (FY) 2018 and a planned budget of the same amount in FY19, according to an FDA spokeswoman, Marianna Naum, in a May 1, 2019 email.
In an email last month, an FDA spokeswoman, Lindsay Haake, said ODSP has 27 full-time employees. The number of positions allocated for the office hasn’t changed since then, she said in a recent email sharing Tave’s remarks on Welch’s return to ODSP.
Durkin left FDA in mid-October, creating a vacancy in the No. 2 position at ODSP. He first joined FDA in 2008 as a compliance officer in the Center for Drug Evaluation and Research (CDER), then he moved on to other roles within different FDA offices.
Durkin first joined the then-Division of Dietary Supplement Programs in April 2015 as the acting division director. He was among several FDA employees who temporarily held the top position following the April 2014 departure of Daniel Fabricant, Ph.D., who left FDA to rejoin and lead the Natural Products Association (NPA).
In an interview last month at SupplySide West alongside Fabricant and an AGG colleague, Kevin Bell, Durkin said his move to AGG provides an opportunity “to have a positive impact on industry.”
Asked about the biggest misperception of how ODSP functions, the lawyer cited a significant change or “transition” during his tenure in the dietary supplement office. In December 2015, FDA announced that its Division of Dietary Supplement Programs was elevated to an "office."
“At first, the perception of industry was that the agency was antagonistic [to] stakeholders,” said Durkin, who was the sixth acting director to join the division following Fabricant’s departure. “I think that’s transitioned over time to where we now partner with stakeholders to help establish a safe space for good players to operate in and focus our resources on bad players and taking them off the market.”
As leadership in the office stabilized—Tave, for example, has been overseeing ODSP since 2016—industry and FDA were able to build a stronger rapport.
Asked how he reconciled FDA’s duty to protect the public health with attempting to help industry innovate, Durkin responded: “I don’t think they’re different. I think they’re one and the same. I think when good players do good things in the industry, it makes the industry stronger and works to isolate bad players.”
Bell—and several other attorneys in Washington previously with Porzio, Bromberg & Newman P.C.–recently made the move to join AGG, a law firm founded in 1949 with more than 160 attorneys in Atlanta and Washington. Durkin also was recruited to join the firm as of counsel to AGG.
AGG has a number of attorneys who previously worked in different parts of FDA, including ODSP within the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Chief Counsel and Office of Regulatory Policy within CDER.
Commenting on Durkin’s background at FDA, Bell suggested the best counsel a client can get sometimes is practical—not strictly legal—advice to help them achieve their objectives while working with a government agency.
Someone with Durkin’s perspective can say to a client, “Here’s what you should be thinking about if you want to move the process along” at FDA, Bell said.