GSK and FDA Agree on Consent Decree

GlaxoSmithKline (GSK, London and Philadelphia) and the US Food and Drug Administration have reached an agreement on a consent decree regarding corrections at the company's Cidra, Puerto Rico, manufacturing facility.

GSK's Cidra plant manufactures the tablets—"Paxil CR" (paroxetinehydrochloride controlled release, for depression) and "Avandamet"(combination rosiglitazone maleate and metformin hydrochloride, fordiabetes)—seized by federal marshals at three locations lastFebruary. FDA had obtained the warrant, citing manufacturing errorsthat produced some tablets with out-of-specification levels of activeingredient.

In a preparedstatement, GSK said that it "has identified the source ofthe manufacturing issues related to both products, and has alreadyimplemented revisions to those manufacturing processes." GSK expects toresume manufacturing and distribution of Avandament and Paxil CR to theUnited States and elsewhere "in mid-year," well ahead of industry analysts'predictions.

The consent agreement also "requires that all corrections and thefirm's compliance with CGMP requirements be certified by a third-partyexpert," in addition to continuing FDA monitoring, according to FDA'sstatement. The agreement holds GSK to a well-defined procedure forreporting and correcting process shortcomings discovered during thisreview.

GSK will post a $650-million performance bond to ensure that theproduct seized in Feburary is "appropriately destroyed orreconditioned."  GSK says that it "anticipates meeting allrequirements of the bond within 90 days following entry of the decree."Although the proposed decree provides for penalties of up to $10 millionper year if the company does not hold to its terms, GSK emphasizes thatFDA is not imposing any fines or penalties at this time.

The draft consent decree was presented to the US District Court of theEastern District of North Carolina on April 27, and will take effectafter it is signed by GSK and FDA and entered by the court.

–Douglas McCormick