news States Push Federal Government to Plan to Import OK Drugs
The Biden administration is facing increasing pressure from states to allow drug imports from Canada to lower the cost of prescription drugs.
On Dec. 5, Colorado became at least the fourth state to seek federal permission to use the strategy, after Florida, New Hampshire and New Mexico.
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.
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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 US government has declared that it is safe to import drugs from Canada. This meets the requirements set by the Federal Drug Importation Act of 2003. The Trump administration finalized rules for states to apply in September 2020.
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 his speech last year, he quoted estimates of how much money Coloradoans could save by importing how he’s trying to bring drug prices down.
Despite the administration’s official endorsement, early applicants were frustrated by the FDA’s inaction.
In August, nearly two years after submitting its drug proposal, Florida sued the federal government, blaming the Biden administration for its slow 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.
Florida said in a December court filing that “suddenly evoking so many supposed flaws” in its proposal was another “stall tactic” by the government.
Jake Leon, a spokesperson for the New Hampshire Department of Health and Human Services, said New Hampshire’s proposal was rejected because it did not identify a Canadian wholesaler to provide the drug. He said he was told he could reapply if he found 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. .
America’s Pharmaceutical Research and Manufacturers, a pharmaceutical industry lobbying group known as PhRMA, sued the federal government in 2020 to block drug imports. That lawsuit is 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.
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.
The Colorado proposal uses a wholesaler in Ontario, Canada, to ship drugs across the border in Buffalo, New York, to an importer headquartered in Boise, Idaho. After being tested, they are sent to Colorado pharmacies and sold 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.
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