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INCREASING OPPOSITION TO HHS WHOLESALE IMPORTATION RULE


There is increasing opposition to a “Final Rule” issued by the U.S. Health and Human Services (HHS) on importation. The rule threatens to deny access to the personal importation of critical medications that millions of American lives depend on, and could increase the costs of imported drugs.



The price of prescription drugs in America is higher than anywhere else in the world. For decades FDA guidance has allowed Americans to safely import prescription drugs from licensed Canadian pharmacies, where brand name drugs are 50-90% cheaper than the best U.S. prices.


A new HHS regulatory rule that took effect on November 30, could block American access to personal prescription importation denying Americans their medications and the savings they depend on.


On Friday, November 27, the Canadian government joined CPPI and a course of voices saying that the new HHS regulation is no good. Canadian health minister Patty Hajdu on Friday, November 27, announced new measures to protect the country’s drug supply from the hasty HHS regulation and bulk importations that could worsen drug shortages.


“The measures announced today builds on consultations started in 2019 with the healthcare community to respond to the United States (U.S.) Importation of Prescription Drugs rule, which comes into effect November 30, 2020. This rule creates a pathway to allow licensed U.S. pharmacists or wholesalers to import in bulk certain prescription drugs intended for the Canadian market. Canada has repeatedly stated that this rule would not be an effective approach to reducing drug prices in the U.S.,” said the statement from the Canadian Health Ministry.


On November 17, U.S. Senators Debbie Stabenow and Gary Peters sent a letter to HHS expressing their own concerns that the Final Importation Rule would have negative impacts on Americans who depend on personal importation for access to critical medications at affordable prices.


“We strongly believe that Americans should be able to import safe and lower-priced FDA-approved prescriptions from licensed Canadian sellers. We are concerned that the Department of Health and Human Services (HHS) September 24 “Request for Proposals Regarding Waivers for Individual Prescription Drug Importation Programs” will not bring down drug prices for American families, and instead could ultimately prevent millions of Americans who currently rely on personal importation from getting the medications they need,” stated the Senators in their letter.


Now is the time to make access to affordable prescriptions medications easier, not harder for Americans. Any new importation regulations, guidance, or legislation should allow for continued if not expanded ease of access to safe and affordable medicines for the millions of Americans that are currently importing medicines for personal use.


You can lend your voice to the cause and submit a letter to HHS Secretary Azar opposing this new regulation and calling on support for personal prescription importation.


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