The U.S. government will move quickly to require "tamper-resistant packaging" for nonprescription drugs, the commissioner of the Food and Drug Administration told Congress yesterday.
The commissioner, Dr. Arthur Hull Hayes Jr., said the FDA would issue a packaging regulation by early next month, but that it would probably take 90 more days before "high-risk products" such as capsules appear in the new containers.
In the meantime, Hayes urged consumers to "have an elevated sense of awareness" of the potential for "willful contamination" of all over-the-counter products, and examine them carefully for signs of tampering.
Both the FDA, drug manufacturing officials and members of the House subcommittee that held yesterday's hearing backed the need for federal legislation, rather than a patchwork of state and local laws, in response to the tragedy in Illinois two weeks ago in which seven persons died after taking Extra-Strength Tylenol capsules which had been tainted by the poison cyanide.
On Thursday, an industry task force proposed legislation that would require packages to have a barrier that, if breached or missing, would alert the consumer to possible contamination. However, companies would be allowed to decide how to achieve that.
Among the options under consideration are plastic film wrappers, individually sealed dosage units in blister packs, plastic bubble packs, shrink seals around the cap, foil, paper or plastic pouches, tape seals, breakable caps, and sealed tubes and cartons.
David Collins, chairman of the board of McNeil Consumer Products Co., the makers of Tylenol, said yesterday that his company plans to reintroduce capsules of the popular pain reliever, but not until new tamper-resistant packages are ready.
But even with new packages, both Hayes and industry spokesmen emphasized, it would never be possible to guard packages completely from tampering; the new packages would only indicate to consumers that some seal had been broken.
Arguing for a federal packaging law, Rep. Henry A. Waxman (D-Calif.), chairman of the House Commerce and Energy subcommittee on health and the environment, said, "Drug safety is a national responsibility. If each locality had a different packaging requirement, there would be endless confusion and added cost to consumers."
Daniel F. O'Keefe Jr., of the Proprietary Association, a trade group that represents over-the-counter drug manufacturers, said that local action is under consideration in Chicago, New York City, Los Angeles County, Massachusetts, California, Connecticut, Pennsylvania, Maryland, New Jersey and Ohio.
O'Keefe said that a bill passed in Cook County, Ill., where several of the deaths occurred, requires that all nonprescription medications sold after next Jan. 2 must be in a container with a separate seal that secures the lid or cap.
But O'Keefe noted that the narrowly written bill -- which was introduced and passed in the wake of the deaths in that area -- would inadvertently prevent the sale of products in sealed individual packets or dosage units, two of the tamper-resistant approaches now available.
O'Keefe maintained that there would "not be any very significant cost to consumers" for a single national packaging standard, but warned that varying laws around the country would be costly "without any real safety justification."
Hayes emphasized yesterday that the government had concluded that the Tylenol tampering "most likely" took place after the product reached retail shelves in suburban Chicago stores.
He said that more than 270 reports of deaths or illnesses have been investigated in the country, but the government has found no proof that the subsequent cases were linked to contaminated Tylenol.