The problem we have here is that for eight years, pharmaceutical companies went from random FDA inspections to free-market “self reporting.” This is actually a good sign, because it means the FDA has gone back to doing its job:
Just a month after a top executive of Johnson & Johnson promised a “cooperative and transparent dialogue” with the Food and Drug Administration, FDA inspectors found themselves stymied when seeking records at J&J’s Lancaster plant.
According to an inspection report for the plant released Wednesday by the FDA, inspectors said they were confronted by numerous delays when seeking records concerning drug production and controls.
Even something as basic as an organizational chart for the plant was not readily available, according to the report.
“Organizational charts were requested on 06/28/10 and requested approximately 10 times before receiving full information on the structure/organization on 07/01/10,” according to the report.
In all, the report identified 11 shortcomings at the plant, including unavailability of records, inadequate procedures for properly cleaning equipment, and failure to adequately follow through on consumer complaints of “multiple and repeated” instances where the wrong product wound up in retail packages.
In a written statement concerning the FDA report, J&J said it “takes the issues raised by the agency seriously and is fully committed to addressing their concerns as rapidly as possible. We will provide a detailed response to the FDA and work diligently to address all observations.”
The problems, while notable, did not rise to the level of those found at the McNeil Consumer Healthcare plant in Fort Washington, said an FDA official who asked not to be identified. McNeil is a subsidiary of Johnson & Johnson.
Those problems, identified during an FDA inspection in February, triggered a temporary closing of the plant and the recall of 146 million bottles of children’s medications, including pediatric Tylenol, Motrin, and Benadryl. Last week, McNeil announced that it was laying off 300 of more than 400 employees of the plant. On Tuesday, Louise Mehrotra, J&J’s vice president for investor relations, told financial analysts that the company had been served a federal grand jury subpoena in regard to the plant.
The Lancaster facility is a joint venture with Merck & Co. Inc. It is operated by J&J’s McNeil unit. Like the Fort Washington plant, it produces over-the-counter medications. Among the products made there are heartburn medications Pepcid and Mylanta.
The Lancaster plant was inspected between June 22 and July 9, about a month after Colleen A. Goggins, worldwide chairwoman for J&J’s consumer group, testified before the U.S. House of Representative’s committee on Oversight and Government Reform that McNeil was committed to revamping its operations to ensure the quality of its products. It was then that she also promised continued cooperation with the FDA.