Lesley Ann Skillen quoted in pharma industry “bible” The Pink Sheet on whistleblower cases and manufacturing violations
An August 18 article in The Pink Sheet entitled “GMP False Claims Case Falters, But Pharma Isn’t In Clear Yet” quoted Ms. Skillen on the current hot topic of the role of whistleblowers in reporting violations of pharmaceutical manufacturing standards and regulations (known as cGMPs) to the government. Earlier this year the Fourth Circuit Court of Appeals dismissed a qui tam case in which the whistleblower had disclosed the packaging of non-penicillin products in the same facility as penicillin products, a direct cGMP violation, leading to a massive recall and a Warning Letter from the FDA. The whistleblower has asked the Supreme Court to review the decision. In the article, Ms. Skillen said that cGMPs “should be a province for the False Claims Act because the FDA can’t be in every single factory” so whistleblowers “play a very crucial role in bringing to light the kind of manufacturing violations that the FDA is just not going to find when they are doing inspections.”
“The Pink Sheet” provides in-depth coverage of the prescription pharmaceutical industry. Known as “The Bible” to the prescription pharmaceutical industry, this publication covers regulatory activities of the FDA, FTC and CMS; Congress; industry news, such as mergers and acquisition, new product introductions, and executive changes; and financial news.
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