The federal government has rejected a push from the blister package industry to revamp rules on child-resistant blister packs, saying that doing so could leave kids with less protection from accidental poisonings.
The Healthcare Compliance Packaging Council, a trade group for the blister industry, argued to the Consumer Product Safety Commission that vague federal rules discourage the pharmaceutical industry from using blisters, and said the agency should update packaging rules that date from the 1970s.
The Falls Church, Va., group argued that blisters are safer than traditional bottles - it said that the CPSC's own statistics from 1983-2003 show 47 deaths of children under 6 from accidentally ingesting drugs in bottles, but zero from drugs packaged in blisters.
CPSC, however, said making the changes that blister pack makers want would leave children less safe because it would remove flexibility in the regulations to deal with more-dangerous drugs. CPSC officials said traditional child-resistant bottles have to meet a similarly tough standard.
``Their recommendation ... would weaken our standard and it wouldn't provide any protection for the most toxic drugs,'' said Suzanne Barone, CPSC project manager.
The agency also said it was not convinced by HCPC's contention that blisters are inherently safer than bottles, arguing that the HCPC analysis of poisoning deaths did not take into account factors like market share of blisters and bottles, or drug toxicity.
Although the details amount to a pretty narrow Washington regulatory issue, what HCPC essentially wanted was for CPSC to set a ``bright line'' standard for blisters to meet.
Current CPSC rules say a blister must prevent kids from opening eight or more individual unit-dose containers in a 10-minute test. But the agency tacks on a provision that says the number has to be less than eight if the drug company decides a lower dose could be toxic.
HCPC wanted the agency to get rid of that provision. The group wanted the agency to set a specific number, probably lower than eight, and contended that doing so would make the U.S. standard similar to the standard in Europe, where blister packs are used more widely.
The U.S. government, on the other hand, argues that there's pressure in Europe to adopt the tougher U.S. standard.
Peter Mayberry, HCPC executive director, said the group was disappointed with CPSC's decision, but the two-year-long debate produced some positives for blister pack makers, like making it clear that some stringent blister pack designs automatically meet a child-resistant protocol.
That protocol, known as ``F=1,'' requires that at least 80 percent of 200 children tested must not be able to remove a single pill within 10 minutes. The agency's clear endorsement of the protocol opens up the market for new designs that meet that standard, Mayberry said.
Mayberry said HCPC sought the regulatory changes in the Poison Prevention Packaging Act because of what the pharmaceutical industry tells blister pack makers.
``The pharma industry says that the [PPPA] provisions are very vague and `they don't give us any sort of comfort level that we won't go to jail, or face liability,' '' Mayberry said.
But Barone said many factors can go into packaging choice, and companies using child-resistant bottles have a similarly tough standard: At least 80 percent of children tested must not be able to open the container within 10 minutes.
Mayberry argues that blisters are safer because if children open a bottle, they potentially have access to all the pills in the container, compared with only one pill from breaking a blister.
Barone said CPSC reviewed the HCPC data and found that while the death figures were plausible, the agency could not say if the group's interpretation is correct.
