The FDA has had a bruising several months.
First, in September, an advisory panel conceded that an ingredient in hundreds of over-the-counter cold medicines flat-out doesn’t work. About the same time that was playing out, two Democratic U.S. senators sent a warning letter to Commissioner Robert Califf to discourage the FDA from conducting studies of opioid pain drugs that “outside experts have contended…would bias the trial in favor of opioids’ efficacy and, by extension, favor drug companies.” NPR states that about 13-14,000 deaths a year are linked to prescription opioids.
Then in December, the U.S. Supreme Court announced it would hear the ongoing case in which doctors are challenging the FDA’s approval of mail-order abortion drugs.
And now, the multi-billion-dollar biotech company Biogen is throwing in the towel on its relatively new Alzheimer’s drug, Aduhelm, halting sales and studies in progress:
Aduhelm was the first new Alzheimer’s disease drug introduced in nearly two decades. The FDA granted accelerated approval for it in 2021. But regulators required an additional study before they would consider full approval.
Any breakthrough in fighting such a devastating disease would certainly be welcome and exciting. There was just one problem: scant evidence that Aduhelm helped patients, plus risks that include brain swelling and bleeding.
Oh, and that price tag:
Initially priced at $56,000 a year, analysts predicted it would quickly become a blockbuster drug that would generate billions for Biogen.
In approving the drug, albeit conditionally, the FDA ignored the recommendation of its own advisory committee. To many observers, this was a clear disaster in the making. BioPharma Dive wrote back in 2021:
Amid the speedy development and rollout of coronavirus drugs and vaccines, the FDA has faced immense pressure to maintain public trust and show its decisions are rooted in science. But on several occasions last year the agency made calls that appeared driven by politics and were later walked back or re-evaluated. That the FDA went against the recommendations of its statisticians and advisers to approve aducanumab could suggest to critics that it bowed to the demands of patient groups or drug companies…
The controversy sparked a broader review of the agency’s closeness with Biogen and its use of the accelerated approval process:
It had become apparent, in the months leading up to the FDA’s decision, that the agency had worked closely with Biogen during its review process. Recent reports, though, detail just how unusual the relationship was. According to STAT, an off-the-books meeting in 2019 between a top Biogen official and the head of the FDA unit that evaluates new brain drugs laid the groundwork for “Project Onyx,” a secretive Biogen initiative to get Aduhelm approved.
Doctors and insurers, it turns out, were more skeptical than the FDA:
But doctors were hesitant to prescribe the intravenous drug, given weak evidence that the drug slows Alzheimer’s. Insurers have blocked or restricted coverage, and the federal government’s Medicare program imposed strict limits on who could get it.
Biogen reportedly will turn its attention to other treatments that are already fully approved and, crucially, seem to help.
On March 26, the Supreme Court is scheduled to hear oral arguments in the mail-order abortion drug case.
Importantly, we know the Court won’t be revisiting the initial approval of mifepristone, which will remain on the market. Don’t believe the corporate media spin that the Court’s decision will amount to any kind of de facto, nationwide “ban” on abortion. That’s not what this case is about.
What could happen is that the Supreme Court, agreeing with the appeals court, may find that the FDA broke the law. It could require the safety protocols for mifepristone (which carries a Black Box warning) that previously existed for 16 years – before the Obama administration began dismantling them – to be reinstated. Those would include seeing a doctor in person before receiving any drugs to confirm that there is no ectopic pregnancy, later gestational age or other potential serious complication. It could also require a follow-up visit to check for complications, limit the use of mifepristone to seven weeks’ gestation and require that all serious complications – not just deaths – be reported.
In an amicus brief, incredibly, 260 U.S. House and Senate Democrats are still arguing that the FDA’s decisions are sacrosanct beyond question. From The Hill:
If the justices don’t reverse the opinion of a federal appeals court, it would ‘invite federal courts to substitute their judgment for the expert conclusions of FDA’s scientists,’ the lawmakers wrote.
That ship has sailed. In the case of mail-order abortion drugs, as in a mounting pile of other cases, Americans are fortunate that there is a mechanism for holding federal agencies accountable when they ignore their own rules, break the law and gamble with people’s lives and health. We should be able to trust the FDA, but we can’t; its reputation is in the tank, and that will take much more than half-hearted mea culpas to repair.