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Lawsuit questions safety, savings of DeSantis prescription drug import plan

by | Nov 24, 2020


 

Just one day after Florida Governor Ron DeSantis announced that his administration had taken a key step toward lowering prescription costs by importing prescription drugs from Canada, a coalition of pharmaceutical safety groups and manufacturers filed suit to block the move, citing safety and regulatory concerns.

Early Tuesday, the Pharmaceutical Research and Manufacturers of America (PhRMA), Partnership for Safe Medicines (PSM) and Council for Affordable Health Coverage (CAHC) filed the complaint in federal court challenging the authority of the U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) to permit states to let phamacists and wholesalers import certain prescription drugs from Canada without the drug manufacturers’ authorization or oversight.

“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,” said PhRMA Executive Vice President and General Counsel James C. Stansel. “FDA has noted it is struggling to keep up with approving medicines while working around the clock to support COVID-19 therapeutics and vaccine development. Despite this, the administration is willing to divert precious FDA resources away from these efforts and to expose Americans to the risks that come with drug importation schemes.”

The DeSantis plan, submitted to the federal government by Florida’s Administration for Health Care Administration (AHCA), has the backing of President Donald Trump, and is one of the president’s top priorities. Trump and DeSantis say the plan was implemented to save money by importing cheaper prescription drugs from Canada.

In 2019, DeSantis and the Florida Legislature initiated the program to lower prices of prescription drugs. Completed in collaboration with the Department of Business and Professional Regulation and other state agencies, the administration says the proposal is the next step in reducing costs for prescription drugs in Florida.

DeSantis says prescription drug prices are cheaper in Canada because their government regulates the prices, while the U.S. allows drug manufacturers and distributors to set their own prices.

“For far too long, Floridians have been paying exorbitant prices for prescription drugs,” DeSantis said yesterday. “[It’s] another step towards lowering those prices by submitting a proposal to the U.S. Department of Health and Human Services for a first of its kind Canadian Prescription Drug Importation Program. My administration will continue to work collaboratively in an effort to bring affordable prescription drugs to all Floridians.”

But in addition to calling attention to safety concerns with foreign drug imports, the lawsuit alleges that there is no evidence that the move by Trump and DeSantis will reduce costs to actual American patients. The pharmaceutical groups point out that HHS has already admitted that it cannot quantify the savings, if any, that would result from the federal government’s plan, and went so far as to suggest the savings are “not economically significant.”

The Council for Affordable Health Coverage, one of the parties bring the lawsuit, blasted the plan as an “importation scheme,” and calling it a “false promise to Americans that it will result in lower cost.”

“Providers, pharmacists and the patients they serve may no longer trust the medicines they prescribe and dispense are safe and effective,” said CAHC President Joel White. “There are better ways to lower costs through increased competition, paying for outcomes, and price transparency for consumers.”

The complaint specifically alleges the the federal government’s plan, which Florida is taking steps to implement, disregards key protections of the Federal Food, Drug, and Cosmetic Act that are designed to ensure patient safety. The act authorizes HHS to permit both the importation of drugs by pharmacists and wholesalers for commercial distribution and the importation of drugs by individual patients.

The lawsuit alleges that the law is only effective if the federal government’s Health and Human Services Secretary certifies to Congress “that the implementation of this section will pose no additional risk to the public’s health and safety; and result in a significant reduction in the cost of covered products (including certain prescription drugs) to the American consumer.”

A spokesman for Governor DeSantis did not immediately answer a request for comment on the lawsuit. This story will be updated if or when the Governor’s Office issues a response.

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