^®: CRE Regulatory Action of the Week

HHS' Opportunity to Crack Down on Drug Diversion: An Open Letter to Secretary Thompson
April 1st will mark a crucial milestone in the government's campaign to protect Americans from counterfeit, adulterated and diverted pharmaceuticals. Unless federal action to the contrary, an FDA Final Rule will take effect in April establishing pedigree paper requirements. These pedigree papers will document the complete distribution chain for drugs and allow wholesale purchasers to verify that they are buying products with a clear legitimate history. The increasing public health consequences from diverted, counterfeit, and otherwise unfit drugs that do not have such a documented history has been widely documented. By allowing the pedigree paper requirements to go into effect as scheduled, Secretary Thompson will have taken an important step in fulfilling his stated goal of "ensuring a safe and healthy America."