22-03-2024 07:00
7:00
March 22, 2024
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A Supreme Court case on whether to tighten restrictions on mifepristone — one of two drugs used in the medication abortion regimen — could destabilize the U.S. pharmaceutical industry, deterring companies from developing new drugs and even inspiring copycat lawsuits aimed at reversing the approval of other politically controversial medications.
Pharmaceutical and biotech companies have been sounding the alarm, arguing that a decision restricting access to mifepristone will have implications for a wide range of drugs and devices, including but not limited to intrauterine devices, HIV prevention pills, emergency contraception and vaccines.
“A precedent has been set,” said Dr. Amanda Banks, chief executive of Banks Advisory, which works with companies to develop therapies. “This can be applied to any drug, device, diagnostic or vaccine.”
The case, set to be heard on March 26, concerns whether the U.S. Food and Drug Administration erred in a 2016 decision that expanded when and how mifepristone can be used. That decision allowed doctors to prescribe it up to 10 weeks into a pregnancy, rather than seven, and to prescribe it during online visits and send it by mail, rather than requiring in-person appointments. The court declined to hear an even broader challenge, in which a coalition of anti-abortion doctors had argued that the agency’s original approval of the drug in 2000 should be blocked.
The FDA itself has revoked its own drug approval: last year… revoked its Makena authorizationwhich had initially received approval through a special fast-track and was believed to reduce the risk of premature birth. But there is no precedent for the courts overturning the decision of the agency, which is known worldwide for its scientific rigor. The decision to approve mifepristone in the United States It took several years and it came after the drug was already available in many other countries.
Although the issue the court will hear is relatively narrow — it focuses on the 2016 decision to expand the circumstances of mifepristone’s use, rather than its actual approval — a ruling against the FDA could send shockwaves through the industry if similar lawsuits target the approval of other highly politicized drugs or medical devices.
Former government officials and industry veterans are particularly concerned about efforts to roll back vaccine approvals, especially after the partisan backlash to COVID-19 vaccines and data suggesting a Rising vaccine skepticism More broadly, industry veterans have suggested potential risks for intrauterine devices, which anti-abortion activists incorrectly characterize as abortifacients. There are five IUDs available in the United States. The oldest, the copper Paragard, was approved in 1988. The newest product, a hormonal IUD called Kyleena, received FDA approval in 2016.
But the implications could be even more serious, according to some pharmaceutical industry executives. If the court rules against mifepristone, “other cases will quickly emerge,” said Jeremy Levin, chief executive of Ovid Therapeutics, which develops treatments for neurological diseases.
“If the court can overturn any decision by any agency, but particularly a health and safety agency, then we don’t have a situation with just mifepristone,” said Elizabeth Jeffords, chief executive of Iolyx Therapeutics, which focuses on ophthalmology and autoimmune diseases. “It doesn’t matter what the drug is. If this precedent is set, we’ll see a lot of litigation around drugs that are considered more ‘political,’ which could be anything from women’s health to gender-affirming care to lifestyle drugs, and maybe Viagra will be included among them.”
A court decision undermining an FDA approval could also stifle biotech and medical innovation. The potential reward of approval — which essentially guarantees several years of exclusive sales — provides a critical incentive for companies to pursue the development of risky and expensive drugs.
“Companies investing in the development of potentially life-saving drugs must be able to trust that courts will uphold the scientific judgments of FDA experts. If a court can overturn those judgments many years later through a process lacking scientific rigor, the resulting uncertainty will create intolerable risks and undermine incentives for investment, regardless of the drug in question,” Jeffords, Levin, Banks and other pharmaceutical executives wrote. In an amicus curiae brief filed with the Supreme Court in the case known as Food and Drug Administration (FDA) vs. Hippocratic Medicine Alliance.
If companies suspect that FDA approvals could be overturned through litigation — rather than because of new clinical data — they will feel less confident about investing resources in developing new drugs, said Jim Stansel, executive vice president of the Pharmaceutical Research and Manufacturers of America, an influential trade and lobbying group.
“The FDA’s gold standard of review and approval provides our members with the predictability they need to deliver innovative new medicines to patients,” Stansel said.
The threat to the pharmaceutical industry at large depends not only on the court’s decision, but also on the rationale it cites. If the court overturns the FDA’s 2016 decision, it could find that the agency failed to adequately consider the risks of mifepristone — a decision that could have implications for a range of pharmaceutical products.
But it could also rule on the basis of an 1873 anti-obscenity law known as the Comstock Law, which prohibits the mailing of materials “intended to produce abortions or any indecent or immoral use.” Although it has not been enforced in decades, the organization challenging the FDA has argued that the agency’s expansion of mifepristone approval is invalid because it contradicts that law.
A ruling focused on the Comstock Act could help create case law that could be used to restrict access to forms of birth control, such as IUDs, or to emergency contraception. But the specificity of its anti-abortion provisions means it would likely have far fewer implications for the pharmaceutical industry at large, said Greer Donley, an associate professor of law at the University of Pittsburgh. For example, it likely wouldn’t apply to drugs unrelated to sexual health, such as vaccines.
“If the court says something like, ‘Well, we’re going to invalidate the FDA’s decision to remove the in-person dispensing requirement (for mifepristone) because there’s not enough evidence of safety and effectiveness,’ that puts the FDA in the crosshairs,” he said. “If it’s Comstock, it’s different because it doesn’t directly implicate other products in the same way.”
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