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In the year 1937 SE Massengill Co. A certain drugmaker came up with what appeared to be an improvement in an effective drug. For a sore throat: a liquid composition that tastes like raspberry.
The only problem: the new formulation, called sulfanilamide, used mainly toxic diethylene glycol. More than 100 people, many of them children, have died after taking it.
The company didn't know that diethylene glycol would be so dangerous, but it wasn't required to conduct toxicity studies before launching a new product, and it didn't, according to the US Food and Drug Administration. Account The accident.
The deaths prompted Congress to pass the federal Food, Drug and Cosmetic Act the following year, which gives the FDA the authority to require drugs to be safe before they go on the market. In 1962, Congress added It is spread After the FDA official confirmed that the drug thalidomide can cause serious birth defects – this time to ensure that the drugs are effective.
That dual mandate, which has lasted more than 60 years, has created a trusted drug licensing process that could be overhauled in the case of the abortion drug mifepristone, which is being argued before the U.S. Supreme Court on Tuesday. Commissioners, legal scholars and pharmaceutical industry executives and investors.
“If the court ends up … ruling in favor of the plaintiffs either way, it basically says that anyone who opposes the ideology of an FDA-approved drug can go to court and try to overturn the scientific decisions of the experts,” he said. Dr. Daniel GrossmanProfessor at the University of California San Francisco and Director of the University's New Standards in Reproductive Health Program.
Tuesday's case focuses on mifepristone, one of two drugs used for medical abortions — which account for 63% of abortions in America. According to 2023 Data From the Guttmacher Institute, a research and policy organization focused on sexual and reproductive health.
District Court Judge in Texas last year agreed Along with the plaintiffs, a group of doctors who oppose abortion, the FDA improperly approved mifepristone in 2000 and expanded how it can be used since 2016.
That decision would have taken mifepristone off the market, but the decision was stayed while an appeals process began. US 5th Circuit Court of Appeals found In the year He said the 2000 approval was too long to reverse, but agreed to the expansion tests that began in 2016.
If the Supreme Court agrees with the Court of Appeals, mifepristone's license could be restored to its pre-2016 status, which would limit the use of telehealth services for medication abortions and implement other restrictions.
“This is going to be a significant change and a restriction on access,” Grossman said.
But he and others argue the possibility of a broader erosion of the FDA's authority.
In addition to opening up any drug to challenges on ideological grounds, weakening the FDA's authority could lead to challenges from drug companies trying to remove competitors' products or to reverse the agency's own rejections, a group of former FDA commissioners wrote in a friend. – The court A brief description of the law.
“This new paradigm poses a serious threat to public health,” they wrote.
The pharmaceutical industry and investors have warned that Shaker's regulatory system will reduce investment in the development of new drugs.
“Biopharmaceutical research and development is expensive, time-consuming and risky,” writes the Pharmaceutical Research and Manufacturers of America, or PhRMA. Short. However, drug developers invest in new drugs because the FDA's rigorous drug approval and ongoing regulatory measures are sufficient to facilitate reliable returns if their investment is successful.
“If upheld by this Court,” PRMA continued, “the Fifth Circuit's weakened standing analysis exposes every drug license and subsequent action to greater risk of litigation, reducing the revenues that drive investment and reducing incentives to innovate in the first place.” He said.
Different Short Pharmaceutical companies, executives and investors have warned of “seismic changes in clinical development, drug approval and post-approval processes” if the Supreme Court allows the appeals court decision to stand.
“This additional uncertainty makes the high risk in these investments intolerable,” they wrote. “And without the necessary investment, drug development will slow down, stifle innovation and limit treatment options for patients.”
Of course, if the Supreme Court of Appeals upheld its decision, the most immediate effect would be to undo itself.
“That means they put the original REMS” — restrictions on how mifepristone is used — “right back to work,” I. Glenn Cohen, a Harvard Law School professor and academic who filed a friend-of-the-court brief on the Food and Drug Act, told . They wrote in an email. Changes from 2016 and 2021 will make mifepristone and abortion more difficult.
GenBioPro, which manufactures the generic version of mifepristone, said in its own court friend Short The company said it will not be able to sell the drug until it “makes significant changes to its manufacturing and marketing practices necessary to comply with pre-2016 conditions and obtain FDA approval of these changes.”
“Overall, the Fifth Circuit's opinion of GenBioPro's current customers and partners casts a cloud of uncertainty over the legal status of current inventory, particularly the legal status of inventory in the hands of distributors, distributors and patients,” the company said. “The court-ordered unprecedented changes to approved drug labeling and commercial stream products will cause confusion and confusion for all parties who purchase, distribute, prescribe and use mifepristone.
Cohen said he expects the court to “dismiss the case” because the plaintiffs lack standing to challenge the FDA's decisions to expand access, but if the court upholds the appeals court's decision, the FDA may seek to revise the expansion process again. Access to the drug. But he said this could be a tough battle and the agency's interest may depend on the outcome of the US presidential election.
“It is neither my hope nor my 'desperation' that the Court upholds the 5th Circuit on standing arguments,” Cohen wrote. But I understand that the Supreme Court is often difficult to predict.