US Rx reimport law not to be implemented

Legislation enacted last year which would have allowed the reimportationof prescription drugs back into the USA cannot be implemented, largely because of concerns over safety, Health and Human Services Secretary Tommy Thompson has said.

The reimportation of prescription drugs by pharmacies and wholesalers, as would be permitted under the Medicine Equity and Drug Safety Act, would remove them from safety and effectiveness oversight by the Food and Drug Administration, says the HHS Secretary in a letter to James Jeffords, the Independent Vermont Senator who is the MEDS Act's key backer. "Opening our borders as required under this program would increase the likelihood that the shelves of pharmacies in towns and communities across the nation would include counterfeit drugs, cheap foreign copies of FDA-approved drugs, expired drugs, contaminated drugs, and drugs stored under inappropriate and unsafe conditions," Sec Thompson writes.

His conclusions echo the concerns of his predecessor, Donna Shalala (Marketletter January 1 & 8), who had refused to sanction "the allocation of taxpayer dollars to implement such a system" on the grounds that the legislation had "serious flaws and loopholes" which she said made it impossible for her to demonstrate that the system was safe and cost-effective.