I have selected just four (of the dozens) of amicus briefs filed with the Supremes already by yesterday evening, in answering the call of Justice Alito — to help keep mifepristone, branded as Danco’s Mifeprex on the market — and free from local Texans’ political interference — in matters of well-established drug and device science. Indeed, every one I read was excellent (excepting the two preposterously seeking to support USDC Judge Matthew Kacsmaryk’s loony opinion below).
Here is one from the trade group, PhRMA (with excerpts in blue below) — and here is one from the NAACP Legal Defense Fund… and one from a group of concerned doctors and pharmacists… and one from former FDA officials.
…PhRMA members have invested nearly $1.1 trillion since 2000 in the search for new treatments and cures, including $102.3 billion in 2021 alone…. The United States’ biopharmaceutical industry is the world leader in the development of new medications, due in no small part to the stability that Congress cultivated through the framework it created in the Federal Food, Drug, and Cosmetic Act (“FDCA”). The rigorous statutory scheme assures patients, healthcare providers, and drug developers that the drugs approved by the Food and Drug Administration (“FDA”) are safe and effective….
Congress made clear that FDA is the expert when it comes to evaluating the safety and efficacy of drugs. For decades, biopharmaceutical companies, healthcare providers, patients, and other stakeholders have relied on FDA’s expert judgments on drug approval, labeling, and post-approval marketing requirements. Indeed, biopharmaceutical companies invest tens of billions of dollars every year against the regulatory backdrop that Congress established.
They reasonably expect that when a drug becomes one of the tiny few that receives FDA’s stamp of approval — at the tail end of a process that typically stretches over a decade or more and involves multiple stages of preclinical and clinical trials absent exigent circumstances, the drug will be marketable for a period that justifies the sizeable investment. Of course, companies and the public fully expect that the risk-benefit analysis of the product will continue to be evaluated, monitored, and assessed by the company and FDA throughout its lifecycle….
PhRMA members have a significant interest in maintenance of the status quo during the resolution of the pending appeal, in order to protect against disruptions to the significant investments in drug development. The district court’s analysis threatens to derail the development and approval of new drugs because it departs from the statutory framework created by Congress for FDA’s drug approval process, and is an unprecedented assault on FDA’s approval decisions….
As I’ve said, for Kacsmaryk’s opinion to be any more unhinged, one would have to have set a phalanx of wooly monkeys (bright though they are — for monkeys!) in front of a series of keyboards and screens… and offered them bananas — for every vowel typed. Damn.
That is how it reads. We will know more by Wednesday night. Out.
नमस्ते
This is the first ever recorded Marburg outbreak in two countries at once. But the good news is that the one in Tanzania seems to have been arrested (or is at least subsiding). No new cases in weeks.
