NRLN Has Advocated Cheaper Drugs from Canada. Now Floridians Will Benefit.

For many years the NRLN has advocated the need to lower the price of prescription drugs, including allowing the importation of safe, lower cost prescription drugs from Canada. On Friday, January 5, Florida became the first state to receive approval from the Federal Drug Administration (FDA) for a plan to import cheaper prescription medicines from Canada.
 
Florida had submitted its application to the FDA around three years ago. The FDA has indicated that approvals for more states may happen. As of 2023, seven states have enacted laws permitting the importation of more affordable drug options from foreign countries, but Florida is the only one so far to gain approval from the FDA.
 
FDA Commissioner Robert Califf said Friday the agency is committed to working with states and Indian tribes that seek to develop successful drug importation proposals that will lead to significant cost savings without any additional health risks. He said the concept of state drug importation aligns with a 2021 executive order on promoting competition.
 
Florida’s Section 804 Importation Program (SIP) has been approved to run for two years from the date the FDA is notified of the first shipment of drugs to be imported.
 
Florida’s Agency for Health Care Administration is required to submit additional drug-specific information for the FDA’s review and approval. This is to ensure the drugs Florida seeks to import have been tested for authenticity and are compliant with the specifications and standards for FDA-approved drugs and relabel the drugs to be consistent with FDA-approved labeling.
 
The state’s health care administration agency also will need to submit a report quarterly to FDA detailing information on the imported drugs, cost savings and potential safety and quality concerns.

Other obligations Florida will need to meet include ensuring supply chain integrity, monitoring and submitting adverse event reports, and complying with drug recall procedures.
 
It should not surprise anyone that the Pharmaceutical Research and Manufacturers of America (PhRMA) called FDA’s approval for Florida “reckless” and “a threat to public health,” and said it is “considering all options for preventing this policy from harming patients.” PhRMA hinted it might file a lawsuit to stop Florida’s program.
 
In addition to supporting the importation of safe, less expensive drugs from Canada, the NRLN  advocates:
 
— Medicare should use the business competitive bidding model wherever two or more generic drugs, or two or more brand drugs, or a generic and brand drugs (upon patent expiration) that treat the same medical condition.

— End pay-for-delay and other brand name drugmakers’ tactics that obstruct generic drugs from the market.
We support passage of S.142, Preserve Access to Affordable Generics and Biosimilars Act. It would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar products.

— Restrict the power of Pharmacy Benefit Managers (PBMs) to control the price of medicines.
We support passage of S.127, Pharmacy Benefit Manager Transparency Act. It would hold PBMs accountable for often deceptive practices that contribute to high drug prices for consumers.

— Minimize drug shortages in the U.S.
 We support passage of S.2510, Rolling Active Pharmaceutical Ingredient and Drug (RAPID) Reserve Act. It would require the HHS to award contracts to quality generic drug manufacturers in the U.S. or a member of the Organization for Economic Cooperation and Development (OECD) to build and maintain reserves of critical drugs.
 
Bill Kadereit, President
National Retirees Legislative Network