Florida scores drug import win — but many hurdles remain

The Food and Drug Administration's decision to allow Florida to import some prescription drugs from Canada marks a major shift in U.S. drug policy, as the state seeks ways to rein in high drug prices and others. It could also open the door to other states.

The approval took three years and only came about after the state of Florida sued the FDA for alleged inaction. The state estimates it will save about $150 million in the first year of implementation, but the plan has a long way to go before realizing these savings.

Still, the approval represents a political victory for both President Biden and Republican presidential candidate Florida Gov. Ron DeSantis, who have made lowering drug prices a priority.

“After years of obstruction by federal bureaucrats, Florida can now import low-cost, lifesaving prescription drugs,” DeSantis said in a statement. “It's time for the FDA to put patients over politics and the interests of Floridians over Big Pharma.”

The Biden administration has touted its financial situation and emphasized ways to reduce health care costs, such as capping insulin costs and allowing Medicare to negotiate some drug prices.

“For too long, Americans have been forced to pay the highest prescription drug prices of any developed country in the world. “We are focused on actions to reduce costs,” White House press secretary Kelly Scully said Friday.

“Today's FDA action is a step in the right direction that could help other states apply for import plans.”

Experts say the approval itself shows that the government is serious about lowering drug prices, and that in the past few years importing medicines has been deemed risky, potentially harmful to patients, or He said that this shows a significant difference from the authorities who have been claiming that it is a “contraption”.

The FDA said it is willing to work with any state or Indian tribe to develop an import plan.

FDA Commissioner Robert Califf said in a statement that the proposal “needs to demonstrate that the program provides significant cost savings to consumers without increasing the risk of exposure to unsafe or ineffective drugs.” “There is,” he said.

Supply chain experts and medical analysts say there are major obstacles to Florida's import plans and that drug imports are not the answer to high drug prices as politicians claim.

Chris Meekins, a Raymond James analyst and former politician, said, “What is being perceived as a panacea to lower drug costs in places like Florida is wishful thinking on the part of politicians and the way they portray it to the public. “It's not going to happen in the way it's currently going,” he said. A health and human services official during the Trump administration.

Parliament first passed the law in 2000 allowing wholesalers and pharmacists to import medicines from other countries, but it was amended to Canada only in 2003, along with other requirements.

Drug importation was a late Trump administration priority, and rules were promulgated in 2020 that allowed states to submit approved plans. The first state to apply was Florida. Biden's 2021 executive order gave new momentum to the policy, directing federal agencies to work with states on import plans.

But the agency's inaction led DeSantis to accuse the agency of “reckless delay” in approving the request.

Individuals are allowed to buy from Canadian pharmacies, but provinces have long sought to buy cheaper drugs directly from Canadian wholesalers. Like most other countries, prescription drugs are cheaper in Canada. This is because the government can negotiate prices directly with pharmaceutical companies.

Genevieve Canter, an associate professor of public policy at the Sol Price School of Public Policy at the University of Southern California, said U.S. prices will remain high because the federal government does not broadly allow drug companies to negotiate costs.

“Medicare has been stalled in negotiations so far. The Inflation Control Act changed things a little bit, but it only covers a small number of drugs,” Kanter said.

The law's price negotiation provisions are expected to save the federal government an estimated $98.5 billion over 10 years.

Another hurdle is opposition from drug companies and the Canadian government, which oppose allowing cross-border wholesale prescription drugs.

Canadian officials have expressed concern that the country does not have enough medical supplies to supply its own citizens and Floridians.

“The Government of Canada is taking all necessary steps to protect the supply of medicines and ensure that Canadians have access to the prescription drugs they need, and bulk imports are an effective solution to Canada's problem of high drug prices. “The United States has made clear that this is not a viable solution,” Health Canada said in a statement.

Kevin Schulman, a professor of medicine at Stanford University, said Canadian authorities “will be desperate to maintain the price that is being imposed.” So they're going to work with the pharmaceutical industry to keep supplies in Canada. ”

“If the pharmaceutical industry complies, the Canadian government will have every possible incentive to stop this,” he added.

More than 22 million people live in Florida, compared to about 39 million in Canada. In 2020, the Canadian government passed an order banning the export of drugs that could cause or worsen drug shortages.

Pharmaceutical companies have also said they will not increase supplies to Canada just to be able to export their products to the United States, meaning Canadians will be left short.

“Canadians have experienced significant drug shortages in recent years, and attempting to import medicines from Canada could further exacerbate an already fragile drug supply,” the Canadian Pharmacists Association said in a statement.

The Pharmaceutical Research and Manufacturers Association (PhRMA), an industry group, and two other groups sued the Trump administration over the import efforts in 2020, but the lawsuit was thrown out by a federal judge last year.

While the group is likely to sue again, Meekins said the industry has options to effectively block implementation of the plan, even without a court.

“[Importation] It has been a hot topic for several decades. Pharmaceutical companies understand there are risks in the possibility of policymakers moving in this direction… so even if the courts allow this to proceed, companies will limit the potential impact. We have the tools in our toolbox to do that,” Meekins said.