The Biden administration said Friday that it has no timeline on whether to allow states to import drugs from Canada, a move approved by President Donald Trump as a key spending control strategy.
Six states have passed legislation to launch such programs and Florida, Colorado and New Mexico are the farthest from the plan to gain federal approval.
The Biden administration said the state still faces a number of hurdles, including a review of the Food and Drug Administration, and that such efforts could put pressure on the Canadian government, which has warned the pharmaceutical industry not to do anything that could lead to a shortage. That country
“Even though two proposals have been submitted to the FDA, the agency is not in a position to make a decision. Therefore, the potential injuries to members of the plaintiffs are highly substantial and not even imminent, “the Biden administration wrote. Filed a case in court Late Friday, the U.S. sought to dismiss the issue from Pharmaceutical Research and Managers of America, an industry trade group. Drug traffickers are urging the court to overturn a rule set by the Department of Health and Human Services in October that allowed the state to import drugs from Canada for the first time.
The Biden administration said the issue is heartbreaking because it is unclear when or whether any state will approve the import plan.
Drug imports have been hotly debated for decades, with many states and attorneys believing it could help lower the prices Americans pay, while the pharmaceutical industry claims it could reduce the security of US drug supplies. Critics say most brand-name drugs sold in the United States are manufactured abroad.
Filing a lawsuit in court on Friday was eagerly anticipated, as the Biden administration weighed in on the case for the first time. Promises to curb high drug prices will cut a standard sound of political campaigns, and import fun Extensive public support. Proponents of the import range the political spectrum from the progressive Sen. Bernie Sanders (I-Vt.) To Florida’s Conservative Republican governor, Ron Descentis. They argue that Americans should not pay more for drugs than consumers in other countries.
Rachel Sachs, a health lawyer at the University of Washington in St. Louis, said the statements to be filed in court would “disappoint” Descentis and other supporters in the hope that the state’s import program would soon be approved. “They said from the outside that the FDA is not on time and there are several steps that the state must take before approval,” she said.
Proponents of drug trafficking say they still have hope, especially if the court agrees to the administration’s efforts to file a lawsuit.
“While the state expresses potential obstacles to preventing the drug import program from moving forward, the Biden administration’s proposal to dismiss the PHRMA issue gives many Americans a living opportunity to benefit from drug imports,” said Gabriel Levitt, president of Pharmaceutical.com. Overseas pharmacies for customers.
Drug imports from Canada, where the government keeps prices low, have been debated in the US for decades. A federal law of 2003 allowed the executive branch to do so, but only if the HHS secretary certified it to be safe and cost-effective. Then-HHS Secretary Alex Azar announced in September that he would be The first to do that, And the department issued its rules in October.
Florida, Colorado, Maine, New Hampshire, New Mexico, and Vermont are trying to import drugs.
PhRMA Its filed In U.S. District Court for the District of Columbia in November. In a lawsuit filed late Friday, the Biden administration said the FDA could reject the state’s import plan for a number of reasons, including security concerns and a lack of significant consumer savings.
In an emailed statement, PHRMA spokeswoman Nicole LaGo said: “We believe that the Trump administration violates federal law by finalizing state-sponsored drug import permits from Canada without proper certification, thereby protecting health and safety.” Americans are at risk. ”
Canada is Protest attempts To send its medicine to the United States, for fear that it may increase the shortage there. Last year, Canadian health regulators Warning companies There may be a shortage in the export of any medicine.
During the presidential campaign, Joe Biden supported drug imports. His HHS secretary, Xavier Besera, voted in 2003 to pass the Canadian Drug Import Act as a member of Congress.
In most cases, the FDA says it is illegal to import drugs for personal use.
However, for nearly 20 years, Florida’s storefronts have helped buy over-the-counter medications online from pharmacies in Canada and other countries at half the price of the United States. The FDA has periodically cracked down on operators but allowed stores to remain open.
In 2019, the Florida Legislature approved the state drug import program, and the state submitted a proposal to the federal government last year. While Descentis prides himself on strategy at news conferences in The Villages ’retirement-heavy community, the state program doesn’t directly affect most Florida residents.
This is because of the state’s efforts to get low-cost medicines in prison health programs and other needs and state agencies for Medicaid, the state-federal health program for the poor. Medicaid enrollments already pay little or nothing for medicines.
Florida has identified about 1,150 drugs – mostly expensive HIV / AIDS, diabetes and mental health drugs – that it plans to import. Insulin, one of the most expensive widely used drugs, is not included in the program.
Descentis said the import plan would save the state between $ 10 million and 7 million. The state has $ 1 billion, he said.
“This is being adequately reviewed,” DeSantis said Friday, hours before the Biden administration filed the lawsuit. “We have followed all the rules. We’ve met every need to meet, and we now want to be able to get this final approval so we can finally move on. ”
Dissentis spokeswoman Christina Pushav said the governor was disappointed when the Biden court filed the case.
“Governor Descentis urged the Biden administration to step out of the way of innovation and take immediate steps to approve Florida’s plan to provide safe and effective drugs to reduce the cost of drugs,” she told KHN in an email.
The governor appeared at Life Science Logistics in Lakeland, Florida, where state regulators worked with the company to build an FDA-compliant warehouse for processing pharmaceuticals from Canada.
“We’re ready, willing and capable, and I think it can be really, really important,” Descentis said.
He said the warehouse could start buying drugs from Canada within 90 days if the state approves it from Washington.
Life Science logistics officials said they are working with Methapharma Specialty Pharmaceuticals, which has offices near Toronto and Fort Lauderdale, Florida, and operates as its Canadian wholesaler. The drugs will be tested in Canada and again in Florida, said Richard Benny, CEO of Life Science Logistics.
LifeScience has begun preliminary negotiations with pharmaceutical manufacturers to negotiate an agreement with drug manufacturers to deliver the drug to Methfirm, which will eventually ship the drug to a warehouse in Lakeland. “There is widespread interest in the program,” Benny said of the pharmaceutical companies that want to participate. “But the pendy suit is a bit of an obstacle, so we have to wait and see how that pan is out.”
Contrary to Florida’s plan, the Colorado Canadian import program helps people buy medicine at their local pharmacy. Colorado health insurance plans will also have the option to include imported drugs in their benefit designs.
Mara Bayer, a health consultant working on the proposal with Colorado, said Biden’s decision raises the question of whether the state’s plan could be approved. “The HHS could have overturned the rules and they didn’t, which is important because of the challenges Congress faces in improving major drug pricing in the short term,” he said.