Congressman Darrell Issa is dissatisfied with the FDA's oversight of the J&J/McNeil plant in Puerto Rico and its investigation into the last year's phantom Motrin recall. He will not be placated by the lack-of-resources excuse.
Issa says in a letter to FDA Commissioner Margaret Hamburg that he visited with district director Maridalia Torres in Puerto Rico last week. He learned that she and her staff have yet to revisit the McNeil plant in San Juan following their last stop in September 2010.
And he says they have yet to "even review the corrective actions undertaken by McNeil and have instead relied on a third-party compliance officer employed by McNeil to provide them with information," according to a report in The Hill.
Torres played the lack-of-resources card to Issa, but to no avail. McNeil is on the hook to reimburse the agency for its costs under terms of the consent decree, the congressman says.
Few are elaborating, but not all is necessarily awry here. First, the FDA had a say in the selection of that "third-party compliance officer employed by McNeil." The agency very likely has great faith that the compliance officer, assuming it's the GMP-expert consultancy required in all consent decrees concerning manufacturing violations, will deliver.
Its job is to help the company build and implement the plan that gets the plant back in compliance, as that responsibility has been judicially stripped from the company. So the third-party compliance officer is a kind of once-removed FDA omnipresence on site, ensuring that McNeil will ultimately demonstrate the GMP compliance the FDA requires.
McNeil probably hopes the FDA stays far away from San Juan until the third party says it's time for the agency to visit. And that's probably fine with the FDA. It appears the only one who sees it as an issue is Issa, who perhaps is unfamiliar with the pace of FDA/drugmaker consent decrees. But then again, as a member of Congress, the pace can't seem too unfamiliar to him. - George Miller