Biden Administration reports in no rush to allow Canadian drug imports



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The Biden administration said on Friday it did not have a timeline for allowing states to import drugs from Canada, an effort that was approved under President Donald Trump as a key strategy to control costs.

Six states have passed laws to launch such programs, and Florida, Colorado, and New Mexico are furthest along in their plans for federal approval.

The Biden administration said states still have several hurdles to overcome, including a review by the Food and Drug Administration, and such efforts could face pressure from the Canadian government, which has warned its pharmaceutical industry. not to do anything that could cause drug shortages in this country.

“Although two proposals have been submitted to the FDA, there is no time limit for the agency to make a decision. Thus, the possible future injuries of the members of the plaintiffs are too speculative and not imminent, ”the Biden administration wrote on Friday in a court filing seeking to dismiss a lawsuit against Pharmaceutical Research and Manufacturers of America, a trade group of the United States. industry. The drugmakers are asking the court to overturn the rule established by the Department of Health and Human Services in October that, for the first time, allowed states to import drugs from Canada.

The Biden administration said the lawsuit was moot because it’s unclear when or if states would get approval for an import plan.

Importing drugs has been hotly debated for decades, with many states and advocates believing it would help lower the prices Americans pay, while the pharmaceutical industry claims it would undermine the security of supply. in drugs in the United States. Critics note that most brand name drugs sold in the United States are manufactured overseas.

Friday’s court case was eagerly awaited, as it was the first time the Biden administration weighed in on the matter. Promises to cut high drug prices have been a standard sound clip of political campaigns, and import benefits broad public support. Supporters of the import range from Progressive Sen. Bernie Sanders (I-Vt.) To conservative Republican Governor of Florida, Ron DeSantis. They argue that Americans should not pay more for drugs than consumers in other countries.

Rachel Sachs, a health law expert at Washington University in St. Louis, said the rhetoric in the court case is likely “disheartening” for DeSantis and other supporters hoping that state import programs would soon be approved. “They say there is no time limit for the FDA and that there are many steps states must take before approval,” she said.

Supporters of the drug importation say they still have hope, especially if the court accepts the administration’s efforts to dismiss the complaint.

“While exposing possible obstacles that could prevent the state’s drug import programs from moving forward, the Biden administration’s motion to dismiss the PhRMA lawsuit maintains opportunities for more Americans benefit from importing drugs, ”said Gabriel Levitt, president of Pharmacychecker.com, which checks online foreign pharmacies for customers.

Importing drugs from Canada, where government controls keep prices low, has been the subject of debate for decades in the United States. A 2003 federal law authorized the executive branch to do so, but only if it is certified safe and cost effective by the secretary of the HHS. Then HHS secretary Alex Azar announced in September that he would become the first to do so, and the department released its regulations in October.

Florida, Colorado, Maine, New Hampshire, New Mexico and Vermont continue their efforts to import drugs.

PhRMA filed his complaint in November in U.S. District Court for the District of Columbia. In court filing Friday night, the Biden administration said the FDA could reject the state’s import plans for a number of reasons, including safety concerns and lack of significant savings for consumers.

In an emailed statement, PhRMa spokeswoman Nicole Longo said: “We continue to believe that the Trump administration violated federal law when it finalized its rule allowing the importation of sponsored drugs. by the state from Canada without proper certification and in doing so endanger the health and safety of Americans.

Canada has opposing efforts to send its drugs to the United States, fearing exacerbating the shortages there. Last year, Canadian health regulators informed companies against the export of drugs that could lead to shortages.

During the presidential campaign, Joe Biden supported the importation of drugs. Its HHS secretary, Xavier Becerra, voted for Canada’s 2003 Drug Importation Act as a member of Congress.

In most cases, the FDA declares that it is illegal for individuals to import drugs for their personal use.

Yet for nearly 20 years, store windows in Florida have helped people buy drugs online from drugstores in Canada and other countries at typically half the price in the United States. The FDA has periodically cracked down on operators, but allowed stores to remain open.

The Florida legislature in 2019 approved the state’s drug importation program, and the state submitted its proposal to the federal government last year. While DeSantis bragged about the strategy during press conferences in the retirement community of The Villages, the state’s program would have little direct effect on most Floridians.

This is because the state effort is aimed at providing cheaper drugs to state agencies for prison health programs and other needs and for Medicaid, the federal health program for the poor. . People enrolled in Medicaid already pay little or nothing for drugs.

Florida has identified about 150 drugs – many of which are expensive drugs for HIV / AIDS, diabetes and mental health – that it plans to import. Insulin, one of the most expensive and widely used drugs, is not included in the program.

DeSantis said the import plan would save the state between $ 80 million and $ 150 million. The state has a budget of $ 96 billion, he said.

“This has been given sufficient consideration,” DeSantis said Friday, hours before the Biden administration filed the complaint. “We followed all the regulations. We have met all the requirements that we were asked to meet and now we want to be able to get that final approval so that we can finally move forward.

Christina Pushaw, spokesperson for DeSantis, said the governor was disappointed with Biden’s court record.

“Governor DeSantis calls on the Biden administration to step away from innovation and act immediately to endorse Florida’s plan that provides safe and effective drugs to lower prescription costs,” she said in an email to KHN.

The governor appeared at LifeScience Logistics in Lakeland, Florida, where state regulators worked with the company to build an FDA-compliant warehouse to process pharmaceuticals from Canada.

“We’re ready, willing and able, and I think it could be really, really important,” DeSantis said.

He said the warehouse could start receiving drugs from Canada within 90 days if the state gets approval from Washington.

LifeScience Logistics officials said they were working with Methapharm Specialty Pharmaceuticals, which has offices near Toronto and Fort Lauderdale, Fla., To act as a Canadian wholesaler. Quality checks would be performed on drugs in Canada and again in Florida, said Richard Beeny, CEO of LifeScience Logistics.

LifeScience has entered into preliminary price negotiation discussions with the drug makers who would deliver the drugs to Methapharm, which in turn would ship the drugs to the Lakeland warehouse. “There is a lot of interest in the program,” Beeny said of pharmaceutical companies wishing to participate. “But the pending lawsuit is a bit of a roadblock, so we have to wait and see how it plays out.”

Unlike Florida’s plan, Colorado’s Canadian Import Program would help individuals purchase the drugs at their local pharmacy. Colorado would also give health insurance plans the ability to include imported drugs in their benefit designs.

Mara Baer, ​​a health consultant who worked with Colorado on its proposal, said the Biden decision leaves open the question of whether the state’s import plans could possibly be approved. “The HHS could have dropped the rule and they didn’t, which is important given the challenges Congress faces in advancing major drug pricing reform in the short term,” he said. she declared.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism on health issues. Together with Policy Analysis and Polling, KHN is one of the three main operational programs of KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization that provides information on health issues to the nation.

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