A federal judge heard arguments Monday about whether a new Colorado law regulating the affordability of EpiPens and their generic counterparts should be blocked in part because it potentially violates the U.S. Constitution.
In June, Governor Jared Polis signed a Democratic-backed measure aimed at combating the rising prices of epinephrine auto-injectors, which can save the lives of people experiencing severe allergic reactions. House Bill 1002 included two key requirements starting on January 1, 2024: limiting the out-of-pocket cost for insured consumers to $60 for a two-pack of auto-injectors, and requiring manufacturers to cap the price. -Pharmacies were required to be reimbursed or resupplied with the controlled price. Equipment in some examples.
Teva Pharmaceuticals USA, Inc., which received approval in 2018 to market the first generic version of the EpiPen, took no issue with the $60 limit for customers, acknowledging that price controls through Colorado insurance coverage Was within his rights to impose. However, she argued that the reimbursement-or-re-supply program violated her constitutional rights.
Specifically, Teva believes that requiring pharmacies to provide free products effectively violates the “Takings Clause” of the Fifth Amendment, which prohibits the government from taking private property “for public use, without Prevents taking compensation.
As attorney Jay P. Lefkowitz argued in court, Colorado “could impose a tax on the sale of EpiPens and then use that tax to fund a dedicated fund for people who are uninsured.” “They could just put a price cap and see what market forces do. They could subsidize it more broadly in other ways. I think the state could also decide it wants to sell generic business.” Wants to get in and develop their own EpiPen.”
But, he added, “The only thing he cannot do is take this private property, which is clearly meant for public use, without just compensation.”
U.S. District Court Judge Daniel D. Domenico, who is considering Teva’s request to block part of the law before it takes effect, acknowledged the state’s interest in responding to EpiPen “price gouging.” . However, he seemed to agree with Teva’s concerns that the government has come up with a plan to take over its products.
“Here, you are giving your property to a private party,” he said. “In this case, you’re saying to Teva, ‘To help us solve this problem, we’re going to ask you to provide our assets to someone else.'”
HB 1002 created an auto-injector affordability program for Colorado residents who do not qualify for Medicare or Medicaid and who do not have private insurance subject to a $60 limit for an EpiPen two-pack. In that case, a pharmacy may charge up to $60, but then request the manufacturer to resupply it with new EpiPens for free. Alternatively, the manufacturer may reimburse the pharmacy for the amount paid for the EpiPens that the customer paid over the counter.
During this year’s legislative session, lawmakers heard that, while EpiPens cost about $8 to manufacture, their price for uninsured consumers could exceed $690. HB 1002 acknowledged that approximately 566,000 Colorado residents have life-threatening food allergies.
The Colorado Attorney General’s Office opposed Teva’s request for an injunction and sought to dismiss the lawsuit entirely. It argued that the U.S. Supreme Court has made clear that lawsuits under the Takings Clause can be brought only when “taking” occurs. For Teva, the earliest this will begin is Jan. 1, when pharmacists can ask for reimbursement or restocks.
Additionally, Assistant Attorney General Pawson Nelson argued that the affordability program is a reasonable exercise of the state’s “police” powers to regulate pharmaceuticals.
“We have laws in this country where hospitals can’t turn people away from the emergency room based on their lack of ability to pay,” he said. “That’s the same concept we’re talking about here. People should not be denied access to emergency medical care in an emergency simply because they can’t pay.”
Lefkowitz responded, “If a hotel in the city of Denver is emitting some toxic smoke, the state can obviously use its police power to tell that hotel, ‘You have to close it down until this is resolved. will be.” He argued that the restock-or-reimbursement program is tantamount to telling a hotel it has to set aside 100 rooms per night for homeless people.
Domenico called Nelson’s emergency room example an “interesting analogy.” But even though Teva can’t yet seek an injunction in federal court and needs to file a lawsuit in state court for compensation once the state actually begins taking her property, Domenico worries about ongoing claims. That Teva will have to file until the pharmacists submit. Request for resupply or reimbursement.
“It’s one thing when the state or local government wants to build a road across your property. You know what’s happening there,” he said. “It could be two weeks from now, they suddenly get 200 of these (requests) or they don’t get any for a month.”
Ultimately, Domenico appeared unsure whether he could intervene before the government actually took any of Teva’s assets without compensation.
He said, “There is something different about the Eclipse Clause than the Second Amendment and the First Amendment. Those cases involve a prohibition on doing something.” In contrast, Teva is allowed to continue selling its auto-injectors.
“But when they do that, they have to hand over some of their assets,” he explained. “And there’s something different about it.”
the matter is thisTeva Pharmaceuticals USA, Inc. vs. Weiser et al.
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