Federal regulators reached an agreement Thursday with a unit of Johnson & Johnson that would impose greater federal oversight at three manufacturing plants responsible for recalls of Children’s Tylenol and many other popular over-the-counter medicines.
The regulators say the manufacturing practices failed to comply with federal law.
The proposed consent decree with the Food and Drug Administration stems from recurring problems for more than a year with products made by Johnson & Johnson’s McNeil Consumer Healthcare division at sites in Pennsylvania and Puerto Rico. Lawmakers and regulators have repeatedly criticized the company for its inability to manage production at these plants.
“We’ve had a long engagement with McNeil over the last year with regard to their quality system,” Douglas Stearn, an FDA official who helps oversee compliance by drug makers, said in an interview Thursday. “We think this represents necessary important steps to assuring quality across the board.”
Under the agreement, which needs approval from a federal judge, Johnson & Johnson would be required to hire an independent expert to determine whether operations at all three plants meet federal standards and to ensure quality systems are in place.
The agreement covers a plant in Fort Washington, Pa., that the company closed last year for an overhaul amidst a nationwide recall of children’s medicines; a plant in Las Piedras, P.R., that was the subject of an agency warning letter last year; and a plant in Lancaster, Pa., that makes products like Pepcid for a joint venture with Merck. McNeil cannot reopen the Fort Washington plant until an independent expert determines the plant meets all federal standards and passes an agency inspection, according to the agreement.
The agreement would also give the FDA the authority to require McNeil to stop manufacturing or to institute recalls. While the agency did not levy a fine in this case, McNeil could face fines of $15,000 a day for violating the decree, up to a total of $10 million a year.
While the proposed consent decree covers a civil complaint, the FDA would not comment on the status of any related criminal investigations.
Last year, an FDA official testified at a congressional hearing that the agency had referred the McNeil case to its Office of Criminal Investigations. A spokeswoman for McNeil confirmed that other federal investigations were under way.