The Department of Health and Human Services has proposed a rule to lower the prices of drugs for consumers by allowing pharmaceutical manufacturers to import certain prescription drugs from Canada.
The Administration has announced the availability of a new draft guidance for the industry that explains about the procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products that are approved by FDA. Drugs that are manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.
This proposed FDA rule is required to get around the present system in this country in which pharmacy benefit managers get rebates off the list price of drugs and give those rebates to insurers.
Insurers use this rebate to lower premium costs for all consumers. HHS Secretary Alex Azar said that drug companies have asked to get a new drug code to lower the prices. They haven't been able to do so because of middlemen.
To be eligible for importation, a drug needs to be approved in the U.S. and meet conditions in a FDA drug application.
Other countries pay lower prices for the same drugs. Azar said that the aim of this policy is to provide consumers with lower prices on drugs that have the same standard of high quality.
People go to Canada to get drugs or order them online, a system that has no verification for safety, said Azar. The rule should lead to reduction in price to the American consumer and not just the government.
Individual states can come forward with plans for importation when the rule is finalized. Other non-federal government entities may submit importation program proposals to the FDA for review and authorization. An importation program can be co-sponsored by a pharmacist, a wholesaler or another state or non-federal governmental entity.