Any day now, federal investigators expect to receive from McNeil Consumer Healthcare a plan for the drug company to fix glaring quality control problems revealed by its recall of 136 million bottles of children's over-the-counter medicines. But Congress needs a plan for strengthening federal law so the U.S. Food and Drug Administration can properly inspect drug manufacturing plants and force recalls of potentially defective drugs.
The McNeil case deserves the intense scrutiny it is getting from the FDA and Congress. Among the accusations against McNeil, a division of Johnson & Johnson, is that it once dispatched contractors to stores to buy up bottles of a defective medicine in order to avoid a recall. The FDA is investigating numerous quality problems with national brand medicines made by McNeil — medicines found in most American homes.
The company has announced at least five recalls since September, including the April 30 recall of 136 million bottles of children's liquid Tylenol, Motrin, Benadryl and Zyrtec that could be contaminated with metal particles or have incorrect amounts of active ingredients. The company announced that recall after FDA inspectors found violations of manufacturing quality standards at McNeil's Fort Washington, Pa., plant.
Unfortunately, McNeil also produced other companies' products at the plant. Blacksmith Brands, which distributes PediaCare children's medicines, soon recalled some of its products because they were made in the Fort Washington plant.
During a congressional hearing, the House Committee on Oversight and Government Reform grilled McNeil and Johnson & Johnson executives, asking why the defective products were allowed to leave the manufacturing plant. McNeil shut down the plant and it has not yet reopened.
Committee Chairman Edolphus Towns, D-N.Y., charged during the hearing that in 2008 McNeil allegedly attempted to avoid a recall by using private contractors to go to stores and buy Motrin caplets the company had learned would not dissolve properly. Other allegations against McNeil, which Towns said would be explored in future congressional hearings, include sloppy manufacturing procedures and brazenly ignoring consumers' adverse drug reactions.
Americans may be surprised to learn that the FDA can't order a recall, even when it knows drugs are defective. The revelations in the McNeil case should convince Congress that the FDA needs the manpower and regulatory muscle to regularly inspect drug manufacturing facilities, pull dangerous drugs off the market immediately and hold their manufacturers accountable.