(From the Delaware Attorney General’s Office)
Drugmaker GlaxoSmithKline will pay Delaware $1.2 million and make changes to its drug marketing practices as part of an agreement to settle allegations that the company illegally marketed its diabetes drug Avandia. The payment to Delaware is part of a settlement with Attorney General Beau Biden and 37 other Attorneys General The total settlement was $90 million to the states.
The Attorneys General allege that GlaxoSmithKline engaged in unfair and deceptive practices in promoting Avandia to doctors and other healthcare professionals. Specifically, the states allege that GlaxoSmithKline claimed that the drug had a positive cholesterol profile when, in fact, the company did not possess competent and reliable scientific evidence to substantiate the claim. Moreover, the states allege the company misrepresented that Avandia had cardiovascular benefits when it does not and, in fact, may actually increase cardiovascular risks.
“This settlement makes clear that we will not stand by when companies fraudulently market their products,” Biden said. “Pharmaceutical drugs can save lives and improve the quality of life for many thousands of Delawareans, but the manufacturers of these drugs must be held accountable for marketing their benefits accurately and truthfully to doctors and to consumers who rely on them.”
Avandia is the brand name of GlaxoSmithKline’s oral diabetes drug known as thiazolidinediones, which lower blood sugar levels by sensitizing the body to use insulin more efficiently and effectively. Avandia was approved by the Food and Drug Administration for sale in the United States in May, 1999.
In addition to making payments to the states, the settlement requires GlaxoSmithKline to reform how it markets and promotes diabetes drugs by prohibiting it from:
· Making false, misleading, or deceptive claims about any diabetes drug;
· Making comparative safety claims not supported by substantial evidence or substantial clinical experience;
· Presenting favorable information previously thought of as valid but rendered invalid by contrary and more credible recent information;
· Promoting investigational drugs; or
· Misusing statistics or otherwise misrepresent the nature, applicability, or significance of clinical trials. In addition, under the terms of the Consent Judgment, which was filed late yesterday in the Delaware Superior Court and requires Court approval to take effect, GlaxoSmithKline (GSK) must also abide by the following terms for at least eight years:
· GSK shall post summaries of all GSK-sponsored observational studies or meta-analyses conducted by GSK that are designed to inform the effective, safe, and/or appropriate use of its diabetes drugs;
· GSK shall post summaries of GSK-sponsored clinical trials of diabetes products within eight months of the primary completion date;
· GSK shall register and post all GSK-sponsored clinical trials as required by federal law; and
· GSK shall comply with the ICMJE Uniform Requirements for Manuscripts submitted to Biomedical Journals.