The Consumer Product Safety Commission this week faces a choice between motherhood and apple pie.
At issue is a proposed ban on reversible caps for prescription pill bottles. Put on one way, these caps are almost impossible for children to pull off; reversed, the tops are easy to open, especially for the elderly and handicapped who long have complained about being unable to use the childproof tops.
If the commission votes to keep the caps on the market, it could be accused of being oblivious to the possibility that these tops could increase infant poisonings.
But should the commission agree to ban the caps--as the staff has recommended--the agency may be charged with trying to block innovation and competition in the pharmaceutical-supply industry.
The vote on the proposed ban is scheduled for Wednesday. Agency and industry sources say the outcome is uncertain.
The issue has been before the commission for several years. It first surfaced in 1975 after Glenn H. Morris, president of M&M Plastics of Chattanooga, Tenn., came up with a reversible cap, called Pharmacy Mate. Excited that his product would met the CPSC's packaging requirements issued to comply with the Poison Prevention Packaging Act as well as the complaints of adults who had problems using the existing childproof caps, Morris sought the CPSC's blessing before he began to market the product.
At the time, the CPSC staff said it had no problem with the product and, in fact, was glad to see it on the market to help reduce the increasing number of complaints it had been receiving about the caps, Morris now recounts.
As a result, Morris went ahead and spent $3.8 million to develop and promote his new and unique product. Within a year after it came on the market, Morris's firm had captured 10 percent of the $90 million plastic-bottle market.
It was the first time in 25 years that a new company successfully entered the plastic-container industry, which has been dominated by Owens-Illinois Inc., Kerr Glass Manufacturing Corp. and Brockway Glass Co.
Needless to say, these competitors were none too pleased with M&M's success. According to commission documents obtained by M&M, various officials at these companies complained to the staff about the inroads M&M was making in their market. They also expressed the concern that M&M's product would increase the incidence of poisoning.
After these complaints were received, the CPSC staff began investigating the caps. That probe resulted in the staff's recommendations that the tops be banned.
"It is the staff's judgment that future efforts to reduce the existing burden of childhood ingestions of prescription drugs will be blunted or rendered ineffective by a major presence of dual-purpose packaging in the marketplace," the staff argues in its briefing package submitted to the five CPSC commissioners.
Morris, however, disagrees with this assessment, saying it is only speculation that his product would increase childhood poisonings. In fact, he argues that Pharmacy Mate may decrease poisonings. The reason: Many adults who hate to grapple with the current child-resistant caps often just leave them off or half-closed. Not only does this make it easier for children to gain access to the drugs, but it also can ruin the drugs by letting air and moisture get into the container.
Noting that 40 percent of all prescription drugs now are dispensed in standard tops as a result of consumer requests, Morris argues that his product at least is an improvement because it offers consumers the option of making pill bottles child-resistant when infants are around.
What's more, if the product is banned, it would be doubtful that any new improved cap would be introduced, he argued in recent congressional testimony.
"Since the new products have generally been introduced by new entrants in the past, I expect that we would see virtually no change in the child-resistant containers now on the market and, frankly, I think that would be a shame," Morris said.
The CPSC staff will dispute that argument Wednesday. Just how receptive the commissioners will be to the staff or Morris, though, remains to be seen.