US: Pharma slams FDA’s approval of Florida’s drug import plan

The FDA’s decision to allow Florida to import some lower-cost prescription medicines from Canada has been given short shrift by groups representing the pharmaceutical industry, which claim it will put American patients at risk.

The agency has approved what it says is the “first step” in authorising Florida to import drugs – subject to several conditions – after a lawsuit filed by state governor Ron DeSantis forced it to make a decision after around three years of deliberations.

Florida is the first US state to get a green light from the FDA for such a programme, and according to DeSantis it will save the state $180m in the first year.

“After years of federal bureaucrats dragging their feet, Florida will now be able to import low-cost, life-saving prescription drugs,” said Governor Ron DeSantis. “It’s about time that the FDA put patients over politics and the interests of Floridians over Big Pharma.”

The state said it will begin by providing prescription drugs in a small number of drug classes which will include maintenance medications to help individuals who have chronic health conditions such as HIV/AIDS, mental illness, prostate cancer, and urea cycle disorder.

Trade organisation PhRMA – which has used legal action to block other attempts by US states to import drugs from Canada  – said it was “considering all options for preventing this policy from harming patients.”

“We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan, said PhRMA president and chief executive Stephen Ubl.

“Ensuring patients have access to needed medicines is critical, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious danger to public health,” he added. “Politicians need to stop getting between Americans and their health care.”

That view was echoed by the industry-backed Partnership For Safe Medicines (PSM), which said the plan “breaks our closed loop system and opens the door to counterfeiters and others who will be more than happy to meet demand.”

The policy has been welcomed by the Biden Administration, which has been implementing a series of controversial and unpopular measures to try to drive down drug prices in the US, including setting caps on insulin costs and allowing Medicare to negotiate drug prices.

“For too long, Americans have been forced to pay the highest prescription drug prices of any developed nation in the world,” remarked White House spokesperson Kelly Scully after the FDA approval was announced.

“President Biden believes this is unacceptable and is laser-focused on actions to cut the cost of medicine families need,” she added.

There are some restrictions under the policy. For example, the FDA wants detailed information about how Florida will conduct visual inspections and laboratory testing to detect any potential counterfeit drugs and preserve the integrity of the US prescription drug supply. Drugs will also have to be re-labelled to come into conformity with FDA regulations.

It also wants an analysis of how the expected cost savings will accrue, via a quarterly report that should also detail any potential safety and quality issues.

Initially, Florida intends to source drugs from Canadian wholesalers for use in institutions like prisons, public health and social care settings but eventually plans to expand the programme to include the state’s Medicaid programme.

The authorities in Canada have questioned the feasibility of the plan, saying it could create domestic shortages, increase drug prices for Canadian citizens, and is unlikely to have a material impact on drug prices in the US.

“The Government of Canada is taking all necessary action to safeguard the drug supply and ensure Canadians have access to the prescription drugs they need and has been clear in its position: bulk importation will not provide an effective solution to the problem of high drug prices in the US,” medicines regulator Health Canada.

by Phil Taylor

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