FDA finalizes rule for Canadian drug importation

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FDA finalizes rule for Canadian drug importation

By Sandra Levy - 09/25/2020

President Trump on Thursday unveiled his America First healthcare plan, signing an executive order the administration said is designed to deliver Americans better care, lower costs, and more choice, continuing the work that HHS has been doing under his leadership.

As part of the President’s plan HHS issued a final rule from the Food and Drug Administration to implement a provision of the Federal Food, Drug, and Cosmetic Act to allow the importation of certain prescription drugs from Canada.

Under this final rule, states and tribes — and in certain future circumstances pharmacists and wholesalers — may submit importation program proposals to the FDA for review and authorization. An importation program may be co-sponsored by a state, tribe, pharmacist or wholesaler. The final rule contains all requirements necessary for a sponsor to demonstrate that their importation program will pose no additional risk to the public’s health and safety. In addition, the final rule requires that the sponsor explain how they will ensure their program will result in a significant reduction in the cost of covered products to the American consumer.

“The president’s plan delivers better care, more choice, and lower costs for all Americans,” said HHS secretary Alex Azar. 

The move was met with opposition and skepticism from the industry, with both the American Pharmacists Association, the Pharmaceutical Research and Manufacturers of America, and the National Community Pharmacists Association expressing concerns. 

APhA contended that the move is a risk to patient safety. 

“Today’s final rule threatens our drug supply by creating opportunities for mischief that could introduce unsafe drugs into the U.S.," said Ilisa Bernstein, APhA senior vice president of pharmacy practice and government affairs. "The lack of clarity around unknown, unproven cost savings does not justify jeopardizing U.S. supply chain integrity and patient safety."

In addition to noting the potential for the move to create supply chain vulnerabilities that might lead to the introduction of counterfeit or unsafe drugs, APhA also said it undercuts track-and-trace safeguards in the Drug Supply Chain Security Act.

A spokesperson for PhRMA said, "We are reviewing the final rule and guidance that were released; however, we continue to have grave concerns with drug importation that exposes Americans unnecessarily to the dangers of counterfeit or adulterated drugs. It is alarming that the administration chose to pursue a policy that threatens public health at the same time that we are fighting a global pandemic.”

Also as part of the effort, HHS also has solicited private-sector proposals called for in Trump's July executive order, which allowed Americans to get low-cost, FDA-approved drugs and insulins from American pharmacies via importation and reimportation. Additionally, the Health Resources and Services Administration has issued a notice of proposed rulemaking related to enabling steep insulin and epinephrine discounts at community health centers for uninsured patients or those who have high cost-sharing plans. 

NCPA submitted comments to the FDA, urging the agency "to not approve any state importation program, or SIP that cannot offer meaningful evidence to back up importation cost savings estimates and demonstrate its SIP would not pose additional risks to health and safety. NCPA asks that FDA withdraw the Importation Proposed Rule, or at the very least, ensure several minimum requirements for independent community pharmacies are met."

NCPA continued, "Canada does not have sufficient drug supply to fill America’s needs. Canada has expressed that it fears drug shortages and higher prices of its own, and its supply is wholly insufficient to provide drugs for the U.S. market. The Alliance for Safe Online Pharmacies Canada stated the following, “Canadians are sympathetic to the struggles that our American neighbors face in accessing affordable medicine but importing prescription drugs from Canada is not a safe solution. Our drug supply is meant for Canadian citizens, not a country with a population 10 times our size. Canada already faces shortages for a range of life-saving diabetes, cancer and other medicines.”

HHS also has released the 2021 Medicare Advantage and Medicare Part D Premium landscape, showing that average 2021 premiums for Medicare Advantage plans are expected to decline 34.2% from 2017 while plan choice, benefits, and enrollment continue to increase and that Part D premiums will be down 12% from 2017, with over 1,600 drug plans offering insulin at no more than $35 per month. 

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