Regulators around the world can be strict when it comes to protecting children against the accidental use of meds. India's Dr. Reddy's is getting up close and personal with two U.S. agencies over that issue right now.
In a quarterly filing with the SEC Tuesday, the generic drugmaker said that two years ago, the U.S. Consumer Product Safety Commission (CPSC) sought out info on special packaging for child-resistant blister packs for 6 products. In an April 30 letter, the agency said it determined that the packaging used from Aug. 14, 2008, through June 1, 2012, not only violated the Consumer Product Safety Act, but that the company also ran afoul of the Poison Prevention Packaging Act for not admitting to the violations.
The drugmaker says it disagrees with the allegations and is talking things over with the CPSC. But adding to Dr. Reddy's troubles, the Department of Justice (DOJ) is also investigating a complaint related to the same matter under the federal False Claims Act.
Dr. Reddy's didn't say what the products were, or the original source of the complaint. It said it has yet to put any money aside to pay for penalties that might arise, although it did warn investors that there is a chance they would be substantial enough to have a material effect, and not a good one.
Other drugmakers have run into their own issues over child-resistant packaging. Last month, GlaxoSmithKline ($GSK) said it was voluntarily recalling four lots of its Panadol Advance product in 100-count bottles in Puerto Rico because the bottles do not have child-resistant packaging to protect against overdoses. The over-the-counter painkiller contains acetaminophen, and so the bottles should have child-resistant packaging or be labeled as a product "for households without young children," the drugmaker said. Two years ago, J&J revamped its Tylenol product line for infants and children, standardizing the dosing so that parents made fewer errors, as did several generics makers that sell private-label versions.
- here's the SEC filing