States challenge Biden to allow imports from Canada

President Joe Biden has endorsed this approach, but his administration has yet to greenlight the state plan.

“The states are doing their job and the only thing holding them back is the Biden administration,” said Jane Horvath, a health policy consultant who has worked with states on import plans.

Health and Human Services Secretary Xavier Becerra told KHN on Dec. 5 that the Biden administration welcomed applications from Colorado and other states for drug import programs. However, in 2023, he did not commit to ruling on any application by the FDA.

When asked what his message was for the state, he said:

US buyers pay the highest prices in the world for brand-name drugs. Medicines are generally cheap in neighboring Canada, where the government controls prices..

Under President Donald Trump, the U.S. government has declared that the importation of drugs from Canada may be made safe — meeting the conditions detailed in the Federal Drug Importation Act of 2003.The Trump administration finalized the rule in September 2020 as the state applies.

During his campaign at the White House, Mr Biden said he would allow consumers to import prescription drugs from other countries if the federal government certified them as safe.

After Biden takes office in 2021, he will order the FDA to work with states to import prescription drugs from Canada.in speech Last year, he cited an estimate of how much money people in Colorado could save by importing the drug on how they are trying to bring down drug prices.

Despite the administration’s official endorsement, early applicants were frustrated by the FDA’s inaction.

In August, nearly two years after filing the drug proposal, Florida filed a lawsuit. The federal government has accused the Biden administration of neglecting the review. The federal government denied the charges. Florida Governor Ron DeSantis, a potential 2024 Republican presidential nominee, supports the state’s efforts.

In November, about three months after Florida sued, the FDA sent Florida a 15-page letter asking it to fill dozens of gaps in its plans. The letter asked if the state wanted to withdraw its application and file another.

In a December court filingFlorida said that “suddenly evoking so many supposed flaws” in its proposal was another “stall tactic” by the government.

New Hampshire Department of Health and Human Services spokesperson Jake Leung said New Hampshire’s proposal was rejected That’s because we didn’t identify a Canadian wholesaler to supply the drug. He said the FDA has told states they can reapply if they find it.

New Mexico is still in discussions with the FDA, said David Morgan, spokesperson for the state health department.

Other states have expressed interest in importing, but have yet to seek federal approval.

The pharmaceutical industry, wary of government-organized import programs that could eat away at its profits, opposes the strategy, claiming it would circumvent regulations designed to keep drugs safe in the United States. .

Pharmaceutical Research and Manufacturers of America, a pharmaceutical industry lobby group known as PhRMA, has sued the federal government Stop drug imports in 2020. That lawsuit is still pending. The Biden administration argued in court that the lawsuit was void because it was unclear when the government would approve the state’s import plan.

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Many of the branded drugs sold in the United States are already manufactured overseas. In addition, millions of Americans visit online pharmacies and other countries to purchase low-priced drugs from Canada and abroad.

Colorado officials said their proposal aims to save residents and employers an average of 65 percent on the cost of dozens of drugs, including diabetes, asthma and cancer drugs.

Kim Bimestefer, executive director of the Colorado Department of Health Policy and Finance, told KHN that the state wants to disrupt the current drug pricing system, which allows manufacturers to charge as much as the market will bear. The FDA has told state officials it will take six months to consider the proposal, she said.

Colorado’s proposed plan was to use a wholesaler in Ontario, Canada, to send the drug across the border in Buffalo, New York, to an importer headquartered in Boise, Idaho. The drugs are tested in Ohio labs before being sent to Colorado pharmacies for sale to residents and employers.

Bimestefer said Colorado plans to have its safety checks on drugs brought in from Canada exceed those on drugs sold in the United States. “We are very confident in its quality and bullish on savings,” she said of the Canadian drug.

Colorado’s filing said the state’s import strategy has faced resistance not only from pharmaceutical companies, but also concerns from pharmacies and the Canadian government.

Canadian officials have opposed US import plans. This is because we fear that this effort could lead to drug shortages in Canada. But Bimestefer said Colorado will only bring the drug if both countries have sufficient supplies.

Colorado Business Group on HealthCoalition forces, including big business, strongly support imports, but the Biden administration recognizes that it is under pressure from groups that would benefit from the status quo, said Coalition Executive Director Robert Smith. rice field. He called patient safety concerns a “red herring.”

“One of the things we know about healthcare is that it’s driven by economic self-interest,” he said.