“He’s totally out of his depth,” Fabricant said of Times reporter Anahad O’Connor Wednesday morning. In the piece, O’Connor quotes several doctors and other sources claiming the FDA was aware of dangers associated with the amphetamine compound BMPEA and did nothing. The headline goes further, saying warnings were “kept quiet” by the agency. Fabricant led FDA supplements enforcement during the events O’Connor describes. The piece follows a widely reported study published online in the journal Drug Testing and Analysis.
Fabricant, who is quoted in the piece, says O’Connor simplifies the process to make the agency look ineffective. Reports and complaints from doctors don’t necessarily create a case that agents can use to order recalls and seek charges or injunctions, Fabricant says, citing “chain of evidence and due process” procedures. Believing otherwise indicates that O’Connor may not have studied the issues well enough to make the statements in Tuesday’s article, Fabricant said. “Don’t pretend like you understand my job and what I did,” Fabricant said, later adding, “He didn’t do his homework.”
Fabricant rejected the article's suggestion that his history at the NPA prior to the FDA post kept the agency from acting. “We can run through the hundreds of actions I took at the agency,” Fabricant said, pointing out that the absence of a recall for BMPEA was an unfair shot. “He wants to talk about recalls? The first time the agency used it (recall authority) was me.” Fabricant has long advocated for more funding for better enforcement, both during his tenure at the FDA post and as head of the NPA.
However, Fabricant said, BMPEA is clearly a new dietary ingredient (NDI) situation and, lacking NDI notification, it constitutes adulteration. Fabricant said the FDA sent at least one warning letter to a company using the compound while he was in charge. He called out the irony that he was accused of overzealous enforcement by the industry but is now being pilloried as an industry friendly reluctant regulator. “It can’t be both,” Fabricant said.
Fabricant’s enforcement record at the FDA may be less important than the perception created by his move from the NPA to the Agency and then back, said Washington veteran and crisis PR specialist Jeff Nedelman, explaining that the challenges facing the supplement industry require a clear message and an unimpeachable spokesman. “The revolving door problem is an albatross, no question about that,” Nedelman said. That history makes it difficult for the NPA to legitimately come out against BMPEA as CRN did Monday with a call for the FDA to demand a product recall, Nedelman said. “It’s the whole Watergate question of “What did he know and when did he know it?”
Nedelman also questioned the tactic of attacking the media. In supplements or any other industry, such a response may resonate with insiders but it will do nothing to change public perception, he said.
Wednesday morning, Fabricant appeared confident that his record would stand up against the hinted allegations in O'Connor's piece. “I’ve been called worse," Fabricant said.