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HHS Issues New Rule for Importing Prescription Drugs

A regulation that will allow certain prescription drugs to be imported from Canada was finalized by the U.S. Department of Health and Human Services (HHS). Officials could not predict, however, how much money consumers might save or when programs to lower drug costs might begin.

The rule paves the way for Florida, Colorado, Maine, Vermont, New Hampshire and New Mexico to begin the process of implementing laws they have passed to allow certain prescription drugs to be imported. The states must get approval from the HHS to begin their programs.

"We believe this proposed rule is a potentially effective tool to implement the laws that several states have now enacted to make certain drugs more affordable,” David Certner, AARP’s legislative counsel and legislative policy director for government affairs, said in a March letter to Food and Drug Administration (FDA) Commissioner Stephen Hahn, M.D. Certner’s letter commenting on the proposed rule called on the Trump administration to make other proposals “to help lower drug prices and ensure access to needed medications.” In addition, the letter strongly urged the federal government “to continue working with Congress towards the enactment of meaningful prescription drug legislation that will lower drug prices and out-of-pocket costs.”

The final regulation will allow specific drugs to be imported, as long as they meet federal standards for safety and saving money. Though the rule goes into effect in 60 days, HHS officials could not say when actual importation plans would take effect. The regulation also states that federal officials cannot estimate how much money will be saved, because it’s not yet known how many and which drugs will be imported. The plan has faced strong objections from the Canadian government and drugmakers, which have said they will go to court to prevent the regulation from taking effect.

Insulin is not included in the new regulations. HHS officials on Thursday put out a call for proposals on how the private sector might create programs that would allow Americans to get less expensive insulin imported from other countries. Because insulin is a biologic drug, it is not eligible to be imported under the final regulation on drug importation. The agency is seeking proposals that would allow insulin originally manufactured in the United States and then shipped to other countries to be reimported to the U.S. and distributed to consumers at a lower cost than what they now pay.

HHS Chief of Staff Brian Harrison told reporters that the agency is also seeking proposals that would allow individuals to get imported FDA-approved prescription drugs for personal use. Under the proposal, authorized pharmacies would be allowed to dispense the approved drugs from certain foreign countries, including the European Union, Great Britain, Switzerland and Canada. Individuals could apply for a waiver to obtain a specific drug and receive the medicine through approved pharmacies.

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