Copley Will Plead Guilty To Criminal Charges

Copley Pharmaceuticals of the USA, a generics subsidiary of the Germancompany Hoechst, will plead guilty to a one-count criminal charge of conspiring to defraud the USA and its agency, the Food and Drug Administration, and will pay a fine of $10.6 million.

If the plea is accepted by the Court, the associated fine will be the largest ever paid by a generic drug manufacturer in the USA, according to a statement issued by the US Attorney's Office for the District of Massachusetts, the Department of Justice, and the FDA.

Copley is charged with defrauding the FDA by changing manufacturing methods from those approved by the FDA for drugs, including prescription and over-the-counter medicines; falsifying manufacturing batch records to cover up these manufacturing deviations; submitting false annual reports to the FDA for FDA-approved drugs which did not disclose the manufacturing changes; and failing to seek prior FDA approval for certain manufacturing changes.