Trump Administration Announces FDA-Proposed Rule and Guidance to Allow Prescription Drug Importation
The FDA has done something that prescription drug importation advocates had possibly given up on. Not me. The agency drafted a new proposed rule to allow importation from Canada of lower-cost drugs and industry guidance for drug manufacturers to import their FDA-approved foreign drug versions, for which they can charge lower prices. The proposed rule provides specifics so that states contemplating or already formulating wholesale drug importation programs have a shot at gaining approval for those programs, per Section 804 of the Food, Drug and Cosmetic Act.
Year after year after year, the media has reported Pharma’s talking point: No Secretary of Health and Human Services, Republican or Democrat, has been able to certify the safety of importation from Canada. That’s never been true, at least not exactly. It’s not that they haven’t been able. It’s that they haven’t been willing. Also, it’s not just certifying the safety, it’s certifying that there will be “no additional” safety risk – a high standard. Well, apparently it can be done. The FDA stated:(more…)Tagged with: Drug and Cosmetic Act