On March 26, doctors and medical associations represented by Alliance Defending Freedom asked the U.S. Supreme Court to hold the U.S. Food and Drug Administration accountable for eliminating its crucial safeguards for women using high-risk chemical abortion drugs. The most shocking takeaway from the argument was the FDA’s claim that no one could challenge its deregulation of mifepristone. The media has been singing a similar tune.
The Washington Post speculates about the harms of “increasing legal and political attempts to undermine the science that informs modern medicine.” The Wall Street Journal suggests that reviewing an agency determination under the Administrative Procedure Act makes judges into a “Super FDA.” And an op-ed from the The New York Times questions “whether courts should have any role in reviewing the F.D.A.’s scientific decision-making at all.” These are scary propositions. No agency is infallible.
The FDA oversells its claims to be the gold standard of scientific virtue. No agency is immune from capture by industry, political pressure, or bias. Indeed, the FDA has a long track record of sacrificing science and Americans’ safety to chase political and financial interests.
Take just one example. The FDA is responsible for the conditions under which opioids were approved. In 1995, under pressure from drug manufacturer Purdue Pharmaceuticals, the FDA approved the narcotic OxyContin for chronic pain (among other things). This meant that the drug would be prescribed to people to take long-term. The FDA’s label stated that addiction risk was “rare.” But the tens of thousands of families who’ve lost loved ones to these drugs know the devastating reality.
As early as 2001, victims groups asked that opioids no longer be approved to treat chronic pain because of the high addiction risk. Instead, the FDA approved a label that continued to allow opioids to be used “for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time.” Unsurprisingly, opioid prescriptions (and overdoses) skyrocketed. In 2002, the FDA was given another chance to place safeguards on opioids but instead deferred to a 10-member “expert panel” in which eight of the experts had financial ties to the pharmaceutical industry, including Purdue. The panel recommended no changes to the opioid labels.
Many examples show that the FDA is not immune from financial conflicts of interest. In 1996, Curtis Wright, one of the FDA officials who spearheaded the approval of OxyContin, took a $400,000-per-year job with Purdue. An National Public Radio report found that, between 2000 and 2010, more than a quarter of the FDA reviewers in the hematology-oncology field who left the federal agency went to work or consult for the drug companies whose products they had previously reviewed. And in 2019, an FDA whistleblower exposed the FDA’s financial conflicts of interests with the pharmaceutical companies that manufacture and sell opioids. Perhaps most alarmingly, the FDA division responsible for opioid approvals relies on the drug industry for 75% of its budget.
Nearly 50,000 Americans—136 every day—died from opioid overdose in 2021. But the FDA still won’t admit that it was wrong to approve these drugs for chronic pain.
Sadly, the FDA is repeating many of the same regulatory errors with chemical abortion drugs.
In 2016, the agency eliminated two of its three required in-person doctor visits to check women for serious complications like severe bleeding and life-threatening infections. It also removed the requirement that prescribers report non-fatal adverse events, choosing to be ignorant about the inevitable harm to women that flowed from its decision to remove the ongoing, in-person care of a doctor.
Then, in 2021, the FDA relied on the resulting absence of serious adverse event data to find that the drug was “safe.” And based on studies the FDA conceded were “not adequate,” it removed the last remaining in-person visit to screen women for ectopic pregnancies and obtain their individualized, informed consent.
The FDA recklessly removed these critical safety standards despite its own label stating that these high-risk drugs send roughly one in 25 women to the emergency room. The agency misleadingly claims the drug is as safe as ibuprofen, but ibuprofen doesn’t send one in 25 people to the ER.
Many in the media choosing to champion the FDA in this moment have forgotten their recent criticisms of the agency. As recently as January 2020, The New York Times ran an editorial titled “The F.D.A. is in Trouble,” expressing concerns that “too many prescription drugs and medical devices are being approved with too little data on how safe or effective they are” and that “[the FDA] has also become profoundly vulnerable to political interference and other special interests.”
Thank goodness that, despite what the government says, the FDA is not above the law. Congress intended for agency actions like the FDA’s removal of essential safeguards for high-risk drugs to be judicially reviewable. Those decisions put women in harm’s way. The agency should be held accountable.
Erin Hawley is senior counsel and vice president of the Center for Life and Regulatory Practice at Alliance Defending Freedom (@ADFLegal). She argued before the U.S. Supreme Court on March 26 in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine.
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