DANIEL VAUGHAN: The Controversial Politics of FDA’s Approval of Perrigo's OTC Birth-Control Drug Opill

 July 14, 2023

The FDA approved the first over-the-counter birth control pill by Perrigo, Opill. The decision came after a multi-month-long pressure campaign from abortion advocates to open access to the drug after the Supreme Court struck down Roe v. Wade and Planned Parenthood v. Casey in the Dobbs v. Women's Whole Health case.

While the political pressure to approve this drug was strongest in the last year, the approval process goes back decades. Notably, the FDA decision overruled concerns raised by its staff scientists tasked with reviewing claims from these companies.

Politico's coverage of these events said the White House was between a rock and a hard place. On the one hand, they claimed they wanted to follow the science. On the other hand, the pressure bow to far-left activist groups was intense. In the end, the lobbying campaign won.

Scientific Concerns Over Opill’s Efficacy and Safety

The safety and efficacy of Perrigo's claims regarding Opill are at the root of the conflict. FDA scientists had two concerns: "FDA staff warned that consumers may not be able to understand and follow the pill's instructions, which include taking it at the same time every day, potentially lowering its effectiveness. The FDA also raised concerns about the pill's manufacturer relying on 50-year-old data from when the pill was approved for prescription use in 1973."

Most importantly, the FDA was concerned that women who didn't need to would use this drug, causing health complications down the road. FDA staff pointed to a host of possible outcomes:

[T]his product has important risks that are different from the risks associated with currently available nonprescription contraceptive methods, including risks associated with a history of breast cancer or other progestin-sensitive cancers, vaginal bleeding of undiagnosed etiology, and use of medications that may interact with norgestrel (drug-drug interactions).

The Potential Health Risks of Misusing Opill

The key was ensuring that women didn't overuse or misuse the drug. Opill is a progestin-only hormone drug. That compound has a long history of side effects if taken incorrectly.

In its fact sheet on progestin, the Mayo Clinic says, "Along with their needed effects, progestins used in high doses sometimes cause some unwanted effects such as blood clots, heart attacks, and strokes, or problems of the liver and eyes. Although these effects are rare, some of them can be very serious and cause death. It is not clear if these problems are due to the progestin. They may be caused by the disease or condition for which progestins are being used."

FDA Scientists Challenge Perrigo's Use of Old Data

Note the point the Mayo Clinic makes about other diseases or conditions involved. That brings us to the second concern from FDA scientists, the old data used by Perrigo in its approval request. The FDA staff scientists "also questioned whether the company's submission of data used to approve Opill for prescription use would still apply today, when a dramatic rise in obesity over recent decades is a much bigger health issue than it was in the early 1970s."

Additionally, Perrigo "didn't submit protocols for some of the supporting studies to the agency ahead of time, although it did submit a protocol for its study of whether participants correctly followed the pill's instructions. Agency scientists flagged that a 'substantial portion' of participants in that study said they took more pills than they had received — casting doubt on its rigor."

Obesity is a much larger problem for modern men and women than it was in the 1970s. Understanding the impact it has on drug interactions is critical, and we don't have a clear idea of that. Additionally, there are other broader issues too, such as the widespread contamination of the environment from microplastics, which are causing other health issues.

For a drug pushing for over-the-counter approval for decades, these aren't points you want to see getting brought up this late in the process. It's a stark difference from when the Biden administration paused the Johnson & Johnson COVID-19 vaccine over considerably fewer concerns than what FDA scientists raised with Opill.

FDA Opens the Door to Mass Tort Claims for the Future

The "party of science" is working overtime to ensure that science aligns with its political priorities. In everyday political hackery, that's fine. But when you bring in people's health, the calculations should change.

It's not out of the question for us to go down this road and end up with a widespread mass tort lawsuit against Perrigo, having to pay significant health damages for this drug. By then, it's too late to stop the negative health impacts of the drugs in question. Mass tort lawsuits can only hope to pay medical expenses, not fix widespread health issues. That's a worst-case scenario, obviously. But we must consider it when the FDA overlooks the problems its scientists raise.

Democrats Ignore Science

Recent massive settlements, like those related to Johnson & Johnson's talc powder and broader opioid litigation involving numerous companies, remind us that the FDA can make mistakes, even without political pressure. This decision was clearly impacted by political pressure from everyone involved, which created approval of a drug with grave questions about it.

Sometimes, the long-term price of a political victory is too high to pay. It's hard to call this a push to defend women's health when more significant health questions about the safety and efficacy of the drug, without doctor supervision, go unanswered.

We can only hope that the advocates for this are correct and that women will remain healthy while taking this drug. One this is for sure, though, we can't say we're following the science on this decision. It will be incumbent on Americans to monitor the health impacts of this drug, even if the FDA won't.

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