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In a letter to FDA, Jarrow L. Rogovin asks that Daniel Fabricant, PhD, be removed from his post as director of FDA’s Division of Dietary Supplement Programs and for FDA to extend the NDI guidance comment period by a year.
Jarrow L. Rogovin, founder, president, and chairman of dietary supplements marketer Jarrow Formulas, sent a letter to FDA Commissioner Margaret Hamburg on August 24, criticizing the agency’s hiring of Daniel Fabricant, PhD, a former top executive of dietary supplements trade association the Natural Products Association.
According to Rogovin, Fabricant’s past interest in representing the industry as well as past access to proprietary, insider industry knowledge creates a conflict of interest now that Fabricant is working on the regulators’ side. Moreover, in the lengthy letter, Rogovin posits that the currently ongoing process of FDA’s new current new dietary ingredient (NDI) guidance highlights this conflict of interest.
“In particular at this juncture…it has become clear that Dr. Fabricant has an irreconcilable conflict of interest…Dr. Fabricant has demonstrated a disregard for the concerns of the industry on whose behalf he once advocated and has taken positions directly contrary to those positions he previously espoused.”
Rogovin concludes, “Dr. Fabricant’s capabilities should be employed elsewhere in the agency, not in the area of dietary supplements.” Moreover, the letter says that Fabricant should not be involved any further in the NDI guidance process.
Drawing a metaphor on Fabricant’s alleged conflict of interest, Rogovin said, “…Jarrow has no doubt that the agency would not consider for a moment hiring the science director and former acting executive director/CEO of, for example, the Drug Manufacturers’ Association to be its director of any ‘Drug Manufacturing Programs.’ The hue and cry would be deafening.”
Rogovin’s letter also informs that Jarrow Formulas will file a Freedom of Information Act request, soliciting information from FDA about how Fabricant’s FDA hiring came to be, such as how many applicants there were for the job position and whether the agency published the position’s availability.
Jarrow Formulas also made public a letter the company sent to FDA requesting that the agency extend the guidance comment period by a year, until July 5, 2012.
“FDA’s NDI Draft Guidance is far more complex than the Proposed Rule for Dietary Supplements Good Manufacturing Practices (GMP regulations), for which FDA granted an extension of the comment period, to a full year. As detailed below [in the letter], the NDI Guidance, if anything, would have an even greater impact on the supplement industry and the American people,” the letter states.
The letter also notes the company’s specific concerns with the guidance, including a comment that “this draft guidance seeks to rewrite DSHEA [the Dietary Supplements Health and Education Act of 1994], and radically departs from previous FDA policy.”