Florida Becomes First State to Win FDA Approval to Import Cheap Drugs From Canada

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Florida’s bid to import cheaper drugs from Canadian wholesalers has met with FDA approval, drawing praise from its governor and opposition from the pharma lobby

On Friday, the Food and Drug Administration (FDA) approved Florida’s plan to import cheap drugs from Canada, making it the first state in the country to be granted the authorization to buy certain lower-cost medicines in bulk from outside the United States—sparking pushback from the pharmaceutical lobby.

On Jan. 5, the FDA authorized Florida’s Agency for Health Care Administration’s drug import program, which was backed by the Trump administration and Florida Gov. Ron DeSantis but faced opposition from the pharmaceutical lobby and allegedly slow-rolled by federal regulators.

Even though individuals can buy medications from Canadian pharmacies, where they’re often far cheaper, states have been fighting for permission to import drugs in bulk from wholesalers in Canada.

Under then-President Donald Trump, rules were issued in 2020 that allowed states to apply to import drugs from abroad in what’s known as Section 804 Importation Program (SIP) proposals. The Biden administration later backed this initiative as well, issuing an order of its own for the FDA to work with states on SIP plans.

Florida was the first state to apply under the Trump-era rules, though Mr. DeSantis sued the FDA in August 2022, accusing it of “reckless delay” and lack of transparency and “costing Floridians who are facing rising prices across the board due to inflation.”
Mr. DeSantis hailed the decision in a statement in which he estimated that the approval would save Florida up to $180 million in its first year.

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

When the lawsuit was first filed, Florida Attorney General Ashley Moody estimated that the FDA’s approval of the state’s ability to import drugs directly from Canadian wholesalers would save Florida at least $150 million per year.

“Another win against Biden and his heavy-handed bureaucrats,” Ms. Moody said in a statement on Jan. 5.

The Trump-era drug import effort was met with a lawsuit by the Pharmaceutical Research and Manufacturers of America (PhRMA) and two other groups, but a federal judge dismissed the lawsuit last year, clearing the way for the FDA’s authorization.

The lobby group issued a statement on Friday expressing its opposition to the FDA’s approval, saying it’s “deeply concerned” about the “reckless” decision and is “considering all options” to block it.

More Details

In its letter of authorization to Jason Weida, Secretary of the Florida Agency for Health Care Administration, the FDA said it had “carefully and thoroughly” reviewed Florida’s revised SIP proposal—and is giving it a green light.

“FDA has determined that this SIP proposal meets the requirements of section 804 and 21 CFR part 251, and therefore Florida has demonstrated that it meets the statutory obligation to ensure that importation under section 804 will significantly reduce the cost of covered products to the American consumer without posing additional risk to the public’s health and safety,” reads the letter, signed by Sandi Verbois, director of the FDA’s Office of Drug Security, Integrity & Response.

Florida’s SIP authorization to import cheaper drugs from Canada is being issued for two years. It requires Florida health authorities to submit additional drug-specific information for review and potential approval by the FDA.

The drugs that Florida intends to import under the SIP must also be shown to have been tested for authenticity and compliance with the FDA-approved drug specification standards—and the imported drugs must be re-tagged with FDA-authorized labels.

As part of the authorization, Florida’s Agency for Health Care Administration must also submit a quarterly report on the drugs it’s importing from abroad, providing such information as cost savings and any potential quality and safety issues.

The FDA warned that it could suspend or revoke the SIP authorization entirely or for one or more specific drugs.

Mr. DeSantis’ office said on Jan. 5 that Florida’s proposal would begin by providing prescription medicines in a small number of drug classes, including medications for HIV and AIDS, mental illness, prostate cancer, and urea cycle disorder.

Also, the drugs would be only for certain people, including foster children, prison inmates, certain elderly patients and, eventually, Medicaid recipients.

PhRMA, the pharmaceutical industry group that sued the Trump administration over its importation effort, has argued that the FDA’s authorization represents a health risk to Americans.

“We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan,” PhRMA president and CEO Stephen Ubl said in a statement. “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.”

“PhRMA is considering all options for preventing this policy from harming patients.”

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