fb tracking

Outrage of the Month: Revolving Door at FDA Undermines Public Confidence

Health Letter, May 2014

By Michael Carome, M.D.

outrage

If you’re not outraged,
you’re not paying attention!

Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.

Government officials often retire or resign from their public sector positions and take jobs in the private sector. Most of the time, such moves do not raise eyebrows. But, on occasion, they do foster real concerns about conflicts of interest and stir doubts about whether the exiting federal official always was acting in the public’s best interests when carrying out his or her duties.

Take, for example, the exceptional case of Dr. Daniel Fabricant, whose career path in just a few short years has taken him from being a leading advocate for the dietary supplement industry to being the chief dietary supplement regulator at the Food and Drug Administration (FDA) and back again.

In February 2011, Fabricant joined the FDA as director of the agency’s Division of Dietary Supplement Programs (DDSP).[1] In this position, Fabricant was the principal FDA official responsible for overseeing the development and enforcement of regulations and policies related to dietary supplements sold in the U.S. Although the regulations for these products are extremely lax in comparison to those for drugs and medical devices, robust enforcement of dietary supplements regulations is essential for protecting consumers from unsafe supplements.

Before joining the FDA, Fabricant actively represented the interests of the dietary supplements industry, most recently serving as the vice president of the Natural Products Association (NPA), which the FDA characterized as “the largest nonprofit in the United States that’s dedicated to the makers and distributors of natural products”[2] and whose own mission statement reads:[3]

As the leading voice of the natural products industry, the Natural Products Association’s mission is to advocate for the rights of consumers to have access to products that will maintain and improve their health, and for the rights of retailers and suppliers to sell these products.

On April 8, slightly more than three years after Fabricant joined the FDA, the NPA announced that he would be returning to the organization as its chief executive officer.[4] Commenting on his new post-FDA position, Fabricant stated:[5]

“NPA is the leading association in the industry, and my top priority is ensuring NPA remains the [premier] organization for advocacy and regulatory engagement. NPA is made up of leaders, and we are going to dedicate ourselves to strengthening that leadership position through hard work and membership growth. Now is the time to take our productivity to the next level, and that is precisely what we will do.”

While federal conflict-of-interest laws impose restrictions on Fabricant with respect to lobbying the FDA on any matters that he worked on during his tenure with the agency, it nevertheless is unseemly for the senior FDA official responsible for regulating the dietary supplement industry to move so quickly back and forth between the leading trade group that advocates and lobbies on behalf of that industry and the FDA. The public justifiably is left wondering whether regulatory decisions made by Fabricant were in any way influenced by his past and future close connections to the industry he was charged with regulating.

While existing federal law allows the revolving door between government and regulated industry to remain open, FDA Commissioner Margaret Hamburg must do more to earn the public’s trust in the agency by selecting senior leaders, including the next DDSP director, whose motivations are not so easily called into question.


References

[1] Food and Drug Administration. For consumers: Fabricant: Supplement safety is priority. Posted October 6, 2011. http://www.fda.gov/forconsumers/consumerupdates/ucm274599.htm. Accessed April 21, 2014.

[2] Ibid.

[3] Natural Products Association. Mission statement. http://www.npainfo.org/NPA/About_NPA/MissionandVision/NPA/AboutNPA/MissionandVision.aspx. Accessed April 21, 2014.

[4] Natural Products Association. Nation’s largest association for natural products names FDA official Dr. Daniel Fabricant as new CEO. April 8, 2014. http://www.npainfo.org/NPA/NewsRoom/NPA_Names_New_CEO.aspx. Accessed April 21, 2014.

[5] Ibid.