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WASHINGTON 鈥� Leading medical and legal experts submitted last week in FDA v. Alliance for Hippocratic Medicine outlining the need for the Supreme Court to review and ultimately block a ruling issued by the Fifth Circuit Court of Appeals that would severely restrict the use of mifepristone 鈥� a medication used in most abortions in this country 鈥� and threaten drug innovation and access of the American public to life-saving medications. The Supreme Court will likely not decide whether to take this case until sometime in early 2024.

Key amicus briefs and excerpts on the need for the Supreme Court to take the case can be found below:

Department of Justice:

The Department of Justice鈥檚 urged the Supreme Court to review the Fifth Circuit鈥檚 decision, which is riddled with legal errors and would have significant 鈥渄estabilizing practical consequences鈥�:

鈥淸T]he Fifth Circuit countermanded a scientific judgment FDA has maintained across multiple administrations; imposed unnecessary restrictions on the distribution of a drug that has been safely used by millions of Americans over more than two decades; and upset reliance interests in a healthcare system that depends on the availability of mifepristone as an alternative to surgical abortion for women who choose to lawfully terminate their early pregnancies. 鈥�The Fifth Circuit鈥檚 [decision] has especially disruptive implications for the pharmaceutical industry and those who depend upon the drugs it supplies.鈥�

Pharmaceutical Research and Manufacturers of America (PhRMA):

PhRMA, whose members have invested more than $1.2 trillion in discovering and developing new medicines since 2000 鈥� and $100.8 billion in 2022 alone 鈥� explains in its that the Fifth Circuit鈥檚 ruling, based on judicially-created, unworkable requirements untethered to the system for drug approval that Congress created, would significantly undermine drug development and innovation, denying the American public access to life- and health-saving medications.

鈥淭he Fifth Circuit鈥檚 ruling threatens to stifle pharmaceutical innovation by disrupting industry鈥檚 reasonable investment-backed expectations. Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA鈥檚 scientific standards. 鈥� But if every FDA drug approval decision鈥攁nd subsequent supplemental drug approval decision鈥攃an be retroactively invalidated by a court based on extra-statutory, judicially created requirements, biopharmaceutical companies will likely invest less in the advancement of new and existing medicines that benefit patients.鈥�

Pharmaceutical Companies, Executives, and Investors:

Pharmaceutical industry representatives 鈥� including Pfizer, Gilead, and other companies, associations, executives, and investors 鈥� the importance of regulatory clarity and stability for the drug approval process and the harm to the American pubic if the Fifth Circuit鈥檚 decision is permitted to stand:

鈥淸The Fifth Circuit鈥檚] imposition of new and unwarranted restrictions on [FDA鈥檚] decisionmaking processes, threatens to destabilize countless FDA approval decisions. This additional uncertainty would make the already high degree of risk in [pharmaceutical industry] investments intolerable. And without necessary investment, drug development would freeze, stifling innovation and limiting treatment options for patients.

鈥淚n short, absent review by this Court, the Fifth Circuit鈥檚 decision threatens a seismic shift in the clinical development and drug approval processes鈥攅recting unnecessary and unscientific barriers to the approval of lifesaving medicines, chilling drug development and investment, threatening patient access, and destabilizing FDA鈥檚 rigorous, well-established, and long-standing drug approval process, which is rooted in science and law.鈥�

Leukemia and Lymphoma Society:

The Leukemia and Lymphoma Society, American Cancer Society, and other patient advocacy organizations the devastating effect of the decision below for patients across the country suffering from an array of serious conditions 鈥渇rom rare cancers to crippling genetic disorders.鈥�

鈥淭he potential negative ramifications of this [decision] are vast. If FDA鈥檚 risk-benefit assessments are vulnerable to the kind of short-sighted challenges and second guessing at the root of the Respondents鈥� claims, and validated by the decision below, the resulting uncertainty about the ongoing authoritativeness of FDA鈥檚 approval process will cause grave harm to patients. The decision risks needed treatments suddenly becoming unavailable, resulting in physical harm and psychological turmoil. Patients will also be less likely to benefit from innovative treatments made possible by new drugs and new indications of use. Why? Because this new, unprecedented uncertainty about the reliability of FDA approval disincentivizes drug manufacturers from making the huge investments of funds in research and development and manufacturing required to bring to market cutting-edge drugs and improved therapies that benefit patients.鈥�