Some OTC drugs were not manufactured, processed, packed or held in line with the federal mandates and there were reports of contamination
The settlement, pending approval, has been submitted to the Fourth Judicial District Court in Ada County, Idaho USA
Idaho Attorney General Lawrence Wasden has announced a $33m multi-state settlement with Johnson & Johnson Consumer and Johnson & Johnson, concerning the way they represented certain over-the-counter drugs between 2009 and 2011. Idaho’s portion of the settlement is just more than $430,000.
“It’s important that companies like these play by the rules, especially when we trust our health to their products,” Wasden said “This settlement helps hold the companies in question accountable for their actions.”
The settlement resolves allegations against McNeil-PPC, a subsidiary of Johnson and Johnson. The company was accused of unlawfully promoting drugs as complying with federally-mandated current Good Manufacturing Practices (cGMP), despite FDA findings that some McNeil manufacturing facilities did not comply with cGMPs between 2009 and 2011.
The alleged quality control lapses resulted in drug recalls for McNeil brands such as Tylenol, Motrin, Benadryl and Sudafed.
The complaint filed alleges that McNeil violated Idaho’s consumer protection laws by misrepresenting the cGMP compliance and the quality of its over-the-counter drugs; and by representing to consumers that these drugs had sponsorship, approval, characteristics, ingredients, uses, benefits, quantities, or qualities they did not actually have.
Pharmaceutical giant Johnson & Johnson will pay $33m to at least 40 states and the District of Columbia to settle consumer-fraud allegations involving at least 10 popular over-the-counter drugs, including children’s medications.
State attorneys general announced the multimillion-dollar settlement with Johnson & Johnson and Johnson & Johnson Consumer on Wednesday after launching a multistate investigation. The states accuse Johnson & Johnson of promoting over-the-counter (OTC) drugs as compliant with federal manufacturing procedures when, in fact, they were not.
“When a consumer purchases over-the-counter drugs, they should be able to trust that the medication is produced in a safe facility,” Florida Attorney General Pam Bondi said in a statement. “Thanks to collaborative multistate efforts, this settlement will help us better protect consumers buying OTC drugs across the country.”
According to the multistate investigation, Johnson & Johnson and Johnson & Johnson Consumer acted through then subsidiary McNeil-PPC to mislead consumers into believing they were buying over-the-counter drugs that were manufactured in a facility that was compliant with US Food and Drug Administration (FDA) standards.
However, the FDA found that, between 2009 and 2011, some McNeil manufacturing facilities did not comply with mandated practices.
“This meant some of the OTC drugs were not manufactured, processed, packed or held in conformance with the [federal] mandates,” Illinois Attorney General Lisa Madigan said in a statement. “In addition, between May 2009 and April 2010, there were reports of foreign material, particulate matter or contamination in some of the OTC drugs.”
The lapse in quality control resulted in recalls of products manufactured between 2009 and 2011, including children’s medicines, according to Madigan’s office. Recalled medications include Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Sudafed, Pepcid, Mylanta, Rolaids, Zyrtec and Zyrtec Eye Drops.
“Johnson & Johnson’s disregard for proper manufacturing practices of children’s medications was unacceptable,” Madigan said.
McNeil was formerly a subsidiary of Johnson & Johnson but is now a division of Johnson & Johnson Consumer.As part of the settlement, Johnson & Johnson and Johnson & Johnson Consumer are required to:
Provide information to participating attorneys general within 60 days of a written request regarding the identity of wholesalers or warehouses where any recalled OTC drugs were distributed in their state;
Ensure not to represent on its websites that McNeil’s OTC Drug Product facilities meet federal manufacturing practices as outlined by the FDA if McNeil has had a Class I or Class II Recall of OTC drug products within the prior 12 months; and
Follow internal standard operating polices regarding whether to open a Corrective Action and Preventive Action plan during the manufacture of an OTC drug.
The settlement is pending judicial approval; the settlement has been submitted to the Fourth Judicial District Court in Ada County.