FDA to Allow States to Import Prescription Drugs From Other Countries
WEDNESDAY, Dec. 18, 2019 (HealthDay News) — Federal well being officers have unveiled plans to permit prescription drug imports from Canada and different international countries.
The U.S. Food and Drug Administration is proposing a rule below which states may just import some pharmaceuticals from Canada, U.S. Health and Human Services Secretary Alex Azar introduced Tuesday.
The company additionally plans to make it more straightforward for drug producers to import their very own FDA-approved medication which might be manufactured out of the country and supposed on the market in different international locations.
“This would potentially allow for the sale of these drugs at lower prices than currently offered to American consumers, giving drug makers new flexibility to reduce list prices,” Azar advised journalists.
Azar touted the proposals as “historic.”
All imported medication would have to be FDA-approved, examined to make certain high quality, and relabeled to meet U.S. labeling necessities, added Admiral Brett Giroir, the assistant secretary for well being.
State methods created to import drugs can be restricted to capsules that sufferers would generally get from a pharmacy, Azar stated. Injectable merchandise, managed ingredients, biologic merchandise and intravenous medication would no longer be allowed.
States would create those methods, perhaps at the side of wholesalers or pharmacies, after which publish them to FDA for approval, Giroir stated.
However, drug producers can be in a position to import any of their very own merchandise from different international international locations, Azar stated. That would come with merchandise similar to insulin, which has just lately been matter to steep worth hikes.
“Every product is available for importation from every country by a manufacturer,” Azar stated. “There is no restriction there, if a manufacturer is willing.”
The producer pathway is meant to cope with the “bizarre” gadget of drug rebates that some pharmaceutical corporations have blamed for top costs, Azar stated.
“Even if the drug company would like to lower the list price of their drug, they may actually be precluded from doing so because of their arrangements with these middle men, where they have to funnel a certain amount of rebate money to those middle men,” Azar stated.