THE FOOD AND DRUG ADMINISTRATION investigation into quality-control problems at Johnson & Johnson's McNeil Consumer Healthcare division has shined a critical light on the OTC industry at a time when it can least afford such scrutiny.
“Although the public risk from these quality problems is low, these problems should never have occurred,” stated Joshua Sharfstein, FDA deputy commissioner, in remarks prepared for a recent congressional hearing, noting that “the failures that caused them were unacceptable.”
The problems, which came to light in April with the largest known recall of over-the-counter children medicines, is of special concern because of the impact on consumers: J&J's represents approximately 70% of the market for such products, all of which were pulled from store shelves. The products have included Children's Tylenol, Motrin, Benadryl and Zyrtec.
“The fact that the FDA is out there inspecting and enforcing is a good thing. Consumers, as well as the industry, need a tough cop on the beat because that helps reassure confidence,” said David Spangler, senior vice president of policy and international affairs for the Consumer Healthcare Products Association. “The other thing to remember is that there are very detailed Good Manufacturing Practices regulations and requirements that all companies — prescription and OTC — have to follow.”
The issue is further complicated by the very company involved. Johnson & Johnson secured a sterling reputation for its response to the 1982 deaths of seven people caused by Extra-Strength Tylenol maliciously laced with cyanide. Public officials praised the company for its transparency and honesty in handling the crisis.
In this case, however, company' executives have had to spend time before the FDA and Congress defending its good name. More recently, Colleen Goggins, who chairs J&J's consumer products division, testified that the company's tradition of quickly removing recalled products from retail outlets and alerting consumers has not changed.