J&J settles OTC manufacturing issue for $33M
- Johnson & Johnson has agreed to pay $33 million in a settlement with 42 states and the District of Columbia to resolve allegations one of its subsidiaries deceptively marketed over-the counter drugs as if they were in compliance with manufacturing standards even though several facilities were, in fact, not up to code.
- McNeil-PPC, Inc., a wholly owned subsidiary of the pharma giant, produced and distributed a wide range of OTC products between 2009 and 2011 that it claimed met cGMP requirements. But an investigation by the Food and Drug Administration and state Attorneys General found a number of manufacturing plants were in violation of federal standards.
- In addition to the fine, McNeil-PPC will be required to comply with a number of corrective actions, the office of New York State Attorney General Eric T. Schneiderman said in statement Thursday.
According to a complaint filed today by the Schneiderman's office in New York County Supreme Court, McNeil violated consumer protection laws by misrepresenting the quality of its OTC products and falsely reporting the drugs met cGMP requirements.
The consent judgment reached with J&J puts the matter to rest, though, stipulating that McNeil will no longer advertise its facilities meet cGMP standards if a drug produced at the site has had a Class I or Class II recall within the past 12 months.
Class I recalls indicate there is a reasonable probability use of the drug could result in either serious detrimental health consequences, while Class II signifies potentially temporary or reversible health consequences, the NY Attorney General said.
The investigation into McNeil by the FDA and state Attorneys General led to recall of several drugs classified as adulterated for not meeting cGMP production standards. Many of the brands were widely used OTC allergy and pain drugs such as Tylenol, Motrin, Benadryl, Sudafed and Zyrtec.
Under the settlement, McNeil also has to follow internal operating procedures for taking preventative actions during drug manufacturing and identify to the involved Attorneys General within 60 days of a written request about vendors through which the recalled drugs were distributed.
J&J has had other, related legal troubles involving OTC drugs, as well. The pharma company recently agreed to pay Oregon $400,000 to resolve a lawsuit which claimed the drugmaker sought to buy back tainted Motrin medicine rather than announce a recall. Oregon was one of the eight states not represented in Thursday's settlement announced by the New York State Attorney General .
- New York State Attorney General Press release
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