The ‘phantom recall’ scandal last year in which Johnson & Johnson hired contractors to yank over-the-counter meds such as Motrin from store shelves rather than conduct a proper recall prompted congressional hearings and contributed to a consent decree, among many other things. And during one hearing, the FDA agreed to review procedures that allowed the health care giant to, essentially, circumvent agency oversight (back stories here, here and here).

Now, though, Darrell Issa, who chairs the House Committee on Oversight and Government Reform, which held those hearings, has written FDA commish Margaret Hamburg to say the agency has failed to take “promised and necessary corrective actions at its San Juan office.” And he complains that he encountered “great difficulty” gaining access to Maridalia Torres, the FDA district officer in San Juan, Puerto Rico, where the scandal unfolded. As a result, Issa writes he was forced to make a fact-finding trip because the agency would not make her available without supervision.

Torres was of interest because she factored into the behind-the-scenes confusion. A series of emails described a conversation between her and Eddie Carrillo, the quality site leader at the Puerto Rico plant and two other McNeil managers - including Bob Miller, a quality compliance exec, and Paul DiPaulo, senior director for quality assurance. In one email, DiPaulo wrote: “Just received some good news from San Juan FDA District Director. She is in agreement with continuing to pull product from the rest of the stores and NOT consider this a national recall” (back story and emails here).

And so what did Issa learn? He writes that Torres told him that she had not visited the J&J plant where the manufacturing issues began since last September, around the same time the last congressional hearing was held. Moreover, neither Torres nor her staff had reviewed any of the alleged corrective actions the FDA was to have undertaken, but instead was relying on a third-party contractor because her office does not have the resources to do so.

“I find this excuse deeply troubling and inconsistent with the resources made available to the FDA in the consent decree entered into by (J&J’s) McNeil (unit) as a result of problems at its Puerto Rico and other facilities,” he writes to Hamburg (read the letter here). And he notes that the consent decree states that J&J agreed to reimburse the FDA for the expense of all inspections and reviews to determine that J&J is in compliance (read here).