A federal judge in Texas ruled on Friday to revoke the Food and Drug Administration’s nearly 23-year-old approval for a safe and effective abortion and miscarriage drug. MifepristoneAs expected, the ruling calls into question the FDA’s authority over all drugs and threatens to undermine the nation’s best drug development pipeline, industry leaders and legal experts say.
of public letter In the document, circulated over the weekend, biotech and pharmaceutical industry executives and leaders condemned the ruling and called for its reversal along with a “proper return” of FDA authority.
As of Monday afternoon, the letter had about 400 signatures and more. Among them are industry heavyweights such as his CEO of Pfizer, Albert Bourla. Alisha Alaimo, president of Biogen. Christopher Tan, Merck & Co. executive. Imran Nasrallah, vice president of Bayer Pharmaceuticals. Nancy Lewis, Senior Clinical Leader, Novartis. Most, however, come from smaller biotech companies, which stand to lose the most from the downstream repercussions of the ruling handed down by District Court Judge Matthew Kaksmalik.
In the letter, leaders of biopharmaceutical companies accused Kaksmalik of being an activist judge, accusing him of having “no scientific training” and that his sentence was “decades old”. Mifepristone “has been found to be safer than Tylenol, nearly all antibiotics and insulin,” he said. The ruling also “fundamentally undermines” the FDA’s authority to approve and regulate medicines that are safe and effective for Americans and “creates uncertainty across the biopharmaceutical industry.”
Fewer drugs, less innovation
That uncertainty will chill investment in drug development and jeopardize innovation, they say. It mentions the inability of most drugs to make it through to successful clinical trials, despite the need for millions of dollars over decades. Manufacturers rely on years of profits from sales to help support riskier research and development programs.
of The US biopharmaceutical industry is unique its size, productivity and innovationIt produces more FDA-approved drugs than any country and has one of the highest percentages of drugs with novel structures and mechanisms. The United States also produces more medicines for unmet medical needs than any other country, relying not only on pharmaceutical companies, but also on biotech companies and academic institutions.
But its dominance depends on a credible regulatory process, which is now in question in last week’s ruling on mifepristone. we are writing “If a court can overturn a drug’s approval without considering the science, the evidence, or the complexities necessary to fully scrutinize the safety and efficacy of a new drug, any drug will have the same consequences as mifepristone.” there is a risk of becoming
Leaders acknowledge that the FDA’s processes and oversight are “not perfect,” but they have “proven decades of unparalleled medical innovation.”
In a statement Friday, President Joe Biden reiterated their concerns about the broader implications of the ruling. “If this ruling is effective, there will be virtually no FDA-approved prescription safe from this kind of political and ideological attack,” the president said.
Legal experts say the same thing. “If only one judge could immediately withdraw your approval, that’s really scaryHarvard Law School professor and bioethics expert I. Glenn Cohen told The New York Times.
Safe and effective, but not the only option
The Department of Justice, on behalf of the FDA, appealing the judgmentThe FDA released a statement on Friday, stating: Be safe and effective for the intended use. ”
For now, mifepristone is available. It is used in combination with another drug called misoprostol to terminate early pregnancies. The FDA has approved it for use in her first 10 weeks (70 days) of pregnancy. (Pregnancy is dated from the first day of the last menstrual period, not the estimated date of conception, which is about two weeks after the first day of the last menstrual period, or when.) However, the World Health Organization says the regimen is 12 months after pregnancy. Up to a week (84 days) is safe.
Mifepristone is a synthetic steroid that blocks progesterone, which plays an important role in maintaining pregnancy by controlling the environment of the uterus. Grandin (hormone-like substance). Consequences of the regimen are cramps, bleeding, and abortion. In the United States, medical abortion is used for more than half of all abortions.
If mifepristone is no longer available in the United States, clinicians should Misoprostol-only protocol, commonly used outside the United States. It is safe, effective, and works more quickly, but tends to have more side effects such as nausea, diarrhea, and vomiting. Law vs Wade Even after it was overturned last June, reproductive health care continues to be under serious threat in the United States.Currently, 12 states Enforcing a total ban on abortionand many others have Limit range.
