Johnson & Johnson is coming under more fire for the recent recall of children’s over-the-counter medicines manufactured by its McNeil Consumer Healthcare unit. At a Congressional hearing yesterday, officials from the U.S. Food & Drug Administration (FDA) indicated that the agency is considering seeking criminal penalties against McNeil.
Last month, McNeil recalled more than 40 varieties of Tylenol Infant Drops, Children’s Tylenol Suspensions, Children’s Tylenol Plus Suspensions, Motrin Infant Drops, Children’s Motrin Suspensions, Children’s Zyrtec Liquid in Bottles, and Children’s Benadryl Allergy Liquid. At the time, the company said some drugs might contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles.
According to a Reuters report, the recall was the largest involving children’s medicines in the history of the FDA, and involved 70 percent of the market for over-the-counter pediatric liquid medicines.
Both the FDA and McNeil have said the risk of adverse effects from the recalled drugs was remote. But a memo prepared by Congressional staffers that was released earlier this week revealed that between January 2008 and April 2010, the FDA received 775 reports of adverse events – including 30 deaths – involving the recalled drugs. After the recall, the agency received several hundred more complaints, including seven deaths, the memo said. The FDA is still investigating some of the adverse event reports to determine if the events were related to a child taking one of the recalled medicines.
At a hearing before the House Oversight Committee yesterday, Joshua Sharfstein, the FDA’s principal deputy commissioner testified that McNeil had a “pattern of noncompliance” with good manufacturing practices. According to The Wall Street Journal, Sharfstein said the FDA is mulling a number of possible enforcement actions. An aide also said the agency’s criminal investigations office is looking into the matter.
Sharfstein also criticized McNeil for waiting a year to notify the FDA of a musty odor problems with adult Tylenol pills made at a Puerto Rico plant. Those problems resulted in a recall last November of 5 lots of Tylenol Arthritis Pain Caplet 100 count bottles. That recall would be expanded on two occasions, and eventually came to include various lots of Tylenol, Rolaids, Benedryl and St. Joseph’s Aspirin. In total, the recall involved about 50 million bottles of the medications.
At yesterday’s hearing, McNeil and Johnson & Johnson were also accused of hiding a recall of defective Motrin. According to The Washington Post, documents released by the Committee showed that McNeil hired contractors to buy Motrin IB caplets under orders not to mention the term “recall” after learning in November 2008 that the drugs were not dissolving properly.
According to The Wall Street Journal, a memo instructed the contractors to “on your schedule to locate and purchase” all of the Motrin eight-count packages. The document further instructed them to “‘act’ like a regular customer in making these purchases.” Neither the public nor the FDA was informed of the action.
McNeil finally recalled 88,000 packages of the drug after the FDA learned of the effort because one of the contractors accidentally dropped an instruction sheet on the floor of a store, the Post said.
“Who at McNeil and Johnson & Johnson knew about this scheme?” Rep. Edolphus Towns (D-N.Y.), chairman of the committee, asked during the hearing. “How high up in the corporate suite was this scheme hatched?”
Towns promised that his committee would continue investigating the Motrin incident, something that he termed a “phantom recall.”
