Fears the US FDA is mismanaging oversight of J&J in Puerto Rico are “deeply troubling”, said a US Congressman.
Following a series of quality control concerns the US Food and Drug Administration (FDA) promised to keep a “close eye” on McNeil Consumer Healthcare, a Johnson & Johnson (J&J) subsidiary. However, a US Congressman has raised doubts about the level of oversight.
FDA officials last visited the McNeil plant in San Juan, Puerto Rico in September 2010 and have relied on a third-party compliance officer hired by McNeil for information, said Darrel Issa, chair of the Committee on Oversight and Government Reform.
Issa gained this information during a meeting with Maridalia Torres, FDA Puerto Rico district director. The FDA promised to cooperate with the Committee, said Issa, but accessing Torres was problematic and eventually the chair chose to visit the agency in San Juan.
Talking oversight in San Juan
During the meeting, attended by four other FDA officials, Torres detailed the level of oversight. In her defence, “Torres repeatedly offered the excuse that her office [lacks] the “resources” to monitor McNeil Puerto Rico’s facility with the “close eye” watch promised”, said Issa.
“I find this excuse deeply troubling and inconsistent with the resources made available to the FDA in the legal consent decree entered into by McNeil”, said Issa. The consent decree says McNeil will cover the costs of all FDA inspections, investigations and other compliance oversight actions.
Meeting with Torres “raised several questions about the mismanagement of safety concerns at the FDA’s San Juan office”, said Issa. As such, Issa has requested documentation on what staff disciplinary actions, if any, the FDA has taken or considered in relation to McNeil in Puerto Rico.
Issa raised the concerns in a letter to Margaret Hamburg, FDA Commissioner, which can be viewed here (via Pharmalot ). In November 2010 Issa sent Hamburg a letter questioning if the FDA was “having difficulty exercising oversight on the numerous…facilities on the island”.