Executive Summary

PROFITS FROM DRUGS WITH "TAINTED" ANDAs/NDAs "should be returned to the government," the National Association of Pharmaceutical Manufacturers recommended in a May 1 position statement on legislative approaches to respond to the generic drug scandal. The association maintained that profits should be returned because "neither individuals nor their employers should be allowed to profit from wrongdoing related to the FDA approval process." NAPM also said that NDAs or ANDAs that are "materially tainted" should be "withdrawn and the product recalled." Furthermore, the "recall should be at the consumer level" if the action that taints the application "affects safety of the product." Actions that would taint an NDA or ANDA include product switches during testing, fraudulent recordkeeping or submission to FDA of false or misleading information in support of an ANDA. NAPM urged that legislation to expand FDA's enforcement authority provide sanctions against innovator companies as well as generic firms. "Any legislative or regulatory response to wrongdoing should be directed at all drug activities, including NDA as well as ANDA," the association maintained. A bill being introduced by House Commerce/Oversight Subcommittee Chairman Dingell (D-Mich.) applies only to ANDAs and their sponsors; a legislative proposal by the Bush Administration applies to all industries whose products are subject to premarket review by FDA. The association supports debarment penalties imposed following due process. "Individuals who have intentionally violated the FDA process should be debarred from all FDA activities for a finite period of time," the statement asserts. "Corporations which have been found to condone wrongdoing in the approval process or have patterns of wrongdoing should be sanctioned." NAPM urged that "any sanctions or withdrawals/suspensions should be consistent with the American principles of due process and should not deprive one of its property prior to the exercise of those rights." Explaining its general support for increased penalties for actions that compromise FDA review, NAPM said, "Those engaged in illegal and unethical activities relating to the drug approval process are committing a disservice to the American public and to the great majority of manufacturers who honor and respect the public trust confided in them." The association said it "abhors those activities and feels that there is no room in our industry or our membership for those that practice them."