Medical Marketing and Media - Clarinex approval sets FDA precedent
Mo. The FDA’s approval of Schering’s Clarinex (desloratadine) on December 21 for “the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 12 years of age and older” broke an internal policy precedent by being based not on an FDA preapproval inspection of the plant that will make the drug, but on an audit of that plant done for Schering by an outside consultant. The facility, in Las Piedras, Puerto Rico, was audited by Lachman Consultant Services Inc., of Westbury, N.Y. The FDA has not said why it did not inspect the plant itself. However, at the time of the approval the agency was reported by Schering to be negotiating a federal court consent decree over manufacturing quality problems at a number of the company’s other facilities. The FDA’s last inspection of the Las Piedras plant was in June, 2001 and it resulted in a list of 15 manufacturing deficiencies being drawn up by the inspectors.
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A Schering-Plough press release on the day of Clarinex’s approval stated that the approval was apart and separate from those GMP problems still being negotiated as the basis for the consent decree and a possible $500 million penalty. The release furthermore noted that the resolution of these GMP problems would be “subject to substantial risks and uncertainties.”
Copyright CPS Communications Feb 2002
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