The FDA is calling for a series of new measures to protect the nation's drug-distribution system from counterfeit pharmaceuticals. In issuing a report outlining those actions, agency officials said that, although "counterfeiting is not now widespread in the US drug market, the FDA is investigating more cases of such activity, often involving well-organized criminal operations working to introduce finished drug products that resemble legitimate drugs but may contain only inactive ingredients, incorrect ingredients, improper doses, or be otherwise contaminated."
In order to counter the threat from these products, the report called for the adoption of stronger anti-counterfeiting measures by the state regulators of drug wholesalers and distributors, coupled with increased criminal penalties to punish drug counterfeiters.
The FDA called on pharmacies and other "participants in the drug supply chain" to adopt more secure business practices as a safeguard against Rx counterfeiting. Additionally, the report recommends "collaboration with foreign stakeholders to develop strategies to deter and detect counterfeit drugs globally," as well as steppedup efforts to educate health professionals about how to respond if they encounter bogus medication.
The FDA's new game plan drew praise from the American Pharmacists Association (APhA), which pledged to cooperate with the new anticounterfeiting initiative. The APhA "will be disseminating information to pharmacists about counterfeit drugs and the pharmacists' role in identifying, reporting, and stopping the flow of counterfeit drugs to pharmacists," association officials said. "The APhA applauds the efforts by the FDA to stem these illegal activities, which are straining our regulatory system and are putting American patients at risk," the officials said.