💊FDA Aboshan Pil Ruling: Drug Bosses Beef, Industry Shakas ⚖️
Drug Company Big Kahunas Kʻapana Da FDA Approval ʻAʻole Pono 💊 Moa Dan 400 Bosses Say No Make Sense, Cuz Science an Law Stay Ignored. Da Pill Ruling Goin Make Stink Fo Da Drug an Biotech Kine Industries 💉
Da pharmaceutical ohana stay beefing ova da aboshan pil mifepristone afta one federal judge say “eh, no can!” fo da FDA’s okaz an da 400+ big kahunas from da drug an biotech companies wen sign one letta asking fo change ’em back.
Da letta wen get sign by all kine companies, but no make da pil, da first one in da two-pil aboshan package. Dis kine case stay impacting plenny moa dan jus aboshan. No like da befo Roe v. Wade, dis one goin test da foundation of da medicine rules in da US. 🇺🇸
Da letta stay saying “If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone.”
Da Justice Department wen ask da US Court of Appeals fo da Fifth Circuit fo wait on da ruling by Judge Matthew J. Kacsmaryk till dey can hear da appeal. 🏛️ Da Judge, one Trump appointee who no like Roe v. Wade, wen give ’em seven days fo let da gov appeal.
Da motion stay say dat da court’s orda goin mess up FDA’s judgement an make it moa hard fo women, especially wen mifepristone stay helping fo miscarriages. 🤰
Da motion say “This harm would be felt throughout the country, given that mifepristone has lawful uses in every state. The order would undermine health care systems and the reliance interests of businesses and medical providers.”
Da appeals court wen give da peopo against aboshan, made up of groups an doctors, till midnight Tuesday fo respond.
One lawyah fo da peopo against aboshan say, “Chemical abortion drugs don’t provide a therapeutic benefit — they can cause serious and life-threatening complications to the mother, in addition to ending a baby’s life.” She say da FDA wen put women in danger an da agency goin get in trouble fo reckless actions. 😠
Da Justice Department also wen file one motion fo one odda lawsuit ova mifepristone. Dass in Washington State against da FDA by 18 Democratic attorneys general who wen challenge da extra rules da agency get on top da drug. Dis motion get one dif’rent ruling less dan one hour afta da Texas ruling.
Da judge, one Obama appointee, no lift da extra rules, but wen tell FDA no do anything fo limit da access fo mifepristone in da places dat wen file da suit. Dass most of da states wea aboshan still legal.
Da two dif’rent rulings from da judges goin set up one legal showdown dat goin end up in da Supreme Court.
Da Attorney General of Colorado say “This is absolutely a test of our legal system’s ability to function.” He say da Texas decision wen break da “basic principles” bout how fo make judgments an da authority of agencies. He say da problem stay wen you start mess up da rules fo one case, you goin mess up fo odda cases too. 🤯
Da big potential fo mess up from da Texas ruling stay da reason why da biotech an pharmaceutical executives wen sign da letta.
Dr. Jeremy Levin, da CEO of Ovid Therapeutics an da former head of BIO, one biotech trade association, say he an odda industry leaders wen worry bout da Texas lawsuit from da start. Da Judge’s ruling, he say, “completely upends the FDA’s authority” an “opens it up to a political determination of what a medicine is or isn’t, and that is deeply harmful for vaccines, Alzheimer’s drugs, all the others.”
Dr. Shehnaaz Suliman, da CEO of ReCode Therapeutics, say she an Dr. Amanda Banks, da former CEO of Blackfynn Therapeutics, wen start making da letta afta da March 15 hearing. “Da primary message is the concern about the court’s overreach and how it might apply to other disease areas or products regulated by the F.D.A.,” said Dr. Suliman. 📃
Da FDA, she say, stay da gold standard fo evaluating safety an effectiveness fo products. “An our industry relies on this to foster the kind of innovation that has resulted in drugs that have saved millions.”
Afta da ruling, Dr. Suliman an Dr. Banks wen share da draft wit Dr. Levin an odda executives, fo make ’em moa betta. Den, dey wen pull one all-nighta, working Friday night thru Saturday fo finish da letta. 🌙
Da group wen email da draft to about 100 industry leaders, who wen sign an share wit dea employees an odda executives. Most signatories no stay involved wit reproductive health.
Legal scholars say da Texas ruling stay da first time one court wen try fo invalidate one drug’s approval wen FDA stay against. Fo years, Congress wen give da FDA power fo decide if drugs stay safe an effective. 💪
Da ruling get so far reach dat da letta from industry leaders prob’ly jus da start of da industry’s actions fo fight ’em, say one law professor. “Dey’re going to heavily lobby state legislatures, Congress and get involved in the courts in these battles going forward because it threatens their livelihood,” she say. 🗣️
So, dis aboshan pil case get plenny kine ripple effects fo da whole drug an biotech industries. Da legal showdown stay coming, an da outcome goin change how da FDA, da gov, an da companies do dea jobs. 🌊🏄♂️ Stay tuned fo moa updates on dis story.
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💊 FDA Abortion Pill Ruling: Drug Execs Protest, Industry Shaken ⚖️
Drug Company Leaders Oppose FDA Approval Rejection 💊 More than 400 executives say it doesn’t make sense, as science and law are ignored. The pill ruling will create problems for the drug and biotech industries 💉
The pharmaceutical family is fighting over the abortion pill mifepristone after a federal judge said “no!” to the FDA’s approval, and more than 400 leaders from drug and biotech companies signed a letter asking for it to be reversed.
The letter was signed by all kinds of companies, but none make the pill, the first one in the two-pill abortion package. This case has an impact far beyond just abortion. Unlike before with Roe v. Wade, this one will test the foundation of medicine regulations in the US. 🇺🇸
The letter states, “If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone.”
The Justice Department asked the US Court of Appeals for the Fifth Circuit to wait on the ruling by Judge Matthew J. Kacsmaryk until they can hear the appeal. 🏛️ The Judge, a Trump appointee who dislikes Roe v. Wade, gave them seven days to allow the government to appeal.
The motion states that the court’s order will disrupt the FDA’s judgment and make it more difficult for women, especially when mifepristone is helpful for miscarriages. 🤰
The motion says, “This harm would be felt throughout the country, given that mifepristone has lawful uses in every state. The order would undermine healthcare systems and the reliance interests of businesses and medical providers.”
The appeals court gave the people against abortion, made up of groups and doctors, until midnight Tuesday to respond.
A lawyer for the people against abortion says, “Chemical abortion drugs don’t provide a therapeutic benefit — they can cause serious and life-threatening complications to the mother, in addition to ending a baby’s life.” She says the FDA put women in danger, and the agency will be held accountable for reckless actions. 😠
The Justice Department also filed a motion for another lawsuit over mifepristone. That’s in Washington State against the FDA by 18 Democratic attorneys general who challenged the extra rules the agency has on top of the drug. This motion got a different ruling less than an hour after the Texas ruling.
The judge, an Obama appointee, didn’t lift the extra rules but told the FDA not to do anything to limit access to mifepristone in the places that filed the suit. That’s most of the states where abortion is still legal.
The two different rulings from the judges will set up a legal showdown that will end up in the Supreme Court.
The Attorney General of Colorado says, “This is absolutely a test of our legal system’s ability to function.” He says the Texas decision broke the “basic principles” about how to make judgments and the authority of agencies. He says the problem is when you start messing up the rules for one case, you will mess up for other cases too. 🤯
The big potential for disruption from the Texas ruling is the reason why the biotech and pharmaceutical executives signed the letter.
Dr. Jeremy Levin, the CEO of Ovid Therapeutics and the former chairman of BIO, a biotech trade association, said in an interview that he and a few other industry leaders had been worried about the Texas lawsuit since it was first filed in November. “It completely upends the FDA’s authority,” Dr. Levin said of Judge Kacsmaryk’s ruling. “And then, much more importantly, it opens it up to a political determination of what a medicine is or isn’t, and that is deeply harmful for vaccines, Alzheimer’s drugs, all the others.” 💉
Dr. Shehnaaz Suliman, the CEO of ReCode Therapeutics, said that she and Dr. Amanda Banks, the former CEO of Blackfynn Therapeutics, began drafting the letter a few weeks ago, after a March 15 hearing in the case in Judge Kacsmaryk’s courtroom in Amarillo, Texas. 🏛️
“The primary message is the concern about the court’s overreach and how it might apply to other disease areas or products regulated by the FDA,” said Dr. Suliman, who was involved in organizing a “call to action” among members of the industry in response to the Supreme Court’s decision last year to overturn Roe v. Wade.
“The FDA’s evaluation of safety and effectiveness for products is the gold standard in the world,” she said, “and our industry relies on this to foster the kind of innovation that has resulted in drugs that have saved millions.” 💊
On Friday evening, after the ruling was issued, Dr. Suliman and Dr. Banks shared their draft with Dr. Levin and three other executives, meeting with them virtually to fine-tune it. Then, Dr. Banks and others “pulled an all-nighter,” Dr. Levin said, working Friday night through Saturday to complete it. 🌙
The group emailed the draft to about 100 leaders in the industry, many of whom signed and also circulated it to their employees and other industry executives, Dr. Levin said. Asked whether anyone declined to sign, he said, “In our experience, people don’t decline — they just don’t respond.”
Most of the signatories are not involved in reproductive health. One signatory, Pfizer, makes a small percentage of the U.S. supply of the second drug in the medication abortion regimen, misoprostol, which is approved for other medical conditions but used off-label for abortion. 💊
A spokeswoman for Pfizer said that the company did not support off-label use of any of its medicines, but that the FDA “serves a critical role in the U.S. public health system — bringing new medicines to patients and conducting ongoing safety reviews that support the continued use of them — that must be maintained.”
Legal scholars said the Texas ruling appeared to be the first time a court had tried to invalidate the approval of a drug over the objection of the FDA. For decades, Congress has given the agency authority to determine whether drugs are safe and effective. 📚
The ruling could be so far-reaching for pharmaceutical companies that the letter from industry leaders is probably just the beginning of the industry’s actions to oppose it, said Jennifer Oliva, a professor of law at the University of California College of the Law, San Francisco, who signed a brief submitted to Judge Kacsmaryk’s court by drug policy scholars in support of the FDA.
“They’re going to heavily lobby state legislatures, Congress and get involved in the courts in these battles going forward because it threatens their livelihood,” Ms. Oliva said. 🗣️
