Abortion Pill, Vaccine Attacks Spell Trouble for FDA Approvals

Attacks on access to abortion pills and Covid-19 vaccines are on the rise, opening the door to battles over other government-approved products and therapies.

Any day now a Texas federal judge could issue a nationwide ban on decades-old drugs used for abortions. Health providers, drug companies, and others in the medical space await the decision. Meanwhile, Idaho state lawmakers are taking a stab at limiting access to mRNA vaccines, introducing legislation that would criminalize administering shots with the technology behind Moderna’s and Pfizer’s Covid-19 vaccines.

The Food and Drug Administration has reviewed evidence on abortion-inducing medication, along with mRNA vaccines, and deemed them safe to use. Yet repeated attempts to limit access to these products is driving greater distrust in the FDA, an agency that has been criticized by some for fast drug approvals and external pressure from the pharmaceutical industry.

These attacks could have a ripple effect, attorneys warn, by emboldening states, advocacy groups, and others to use legislation and litigation to try blocking other FDA-approved products, including those for gender transition and substance use disorder treatment. Attorneys say this could prompt the FDA to take more time on certain product reviews, potentially delaying when they become available to patients.

Pharmaceutical companies may likewise prove hesitant to back controversial products or treatments, attorneys note.

“The parallels are very clear. You could have a cancer drug, a diabetes drug, a heart disease drug, and an effective vaccine, all of which are there to preserve and safeguard life and health. And all of a sudden states get to say to their residents, ‘no, you can’t have access to it,’” said Lawrence Gostin, director of the O’Neill Institute for National and Global Health Law at Georgetown University.

“In the current environment of fierce anti-science, anti-public health sentiment, everything is up for grabs,” Gostin said.

The FDA said it does not comment on possible, pending, or ongoing litigation.

‘Insane’ Precedent

Brought by conservative legal group Alliance Defending Freedom, the Texas lawsuit against the FDA over abortion medication takes that charged atmosphere to a new level, health workers and attorneys say.

The lawsuit alleges that the FDA used accelerated approval regulations to improperly characterize pregnancy as a serious illness when it approved mifepristone. The agency did this without sufficient scientific evidence, the lawsuit alleged.

The FDA and medical groups like the American College of Obstetrics and Gynecology have long defended mifepristone’s safety. A 2008 Government Accountability Office report also supported the FDA’s view that “the termination of an unwanted pregnancy is a serious condition, and that the drug provided a meaningful therapeutic benefit over existing therapies by allowing patients to avoid the procedure required with surgical termination of pregnancy.”

“No court has ever done what the plaintiffs are asking here, which is to remove an FDA-approved drug, and the precedent that this could set is insane,” said Jessica Nouhavandi, co-founder and president of mail-order pharmacy Honeybee Health. The company in January became the first pharmacy certified to dispense abortion medication under the FDA’s updated safety program for the drug.

“If this goes through, this theoretically could apply to any FDA-approved medication,” Nouhavandi said.

Others, however, are using litigation to make mifepristone even easier to access. In February, a dozen states sued the FDA and the Department of Health and Human Services contending restrictions on prescribing and dispensing the drug are without scientific basis.

Abortion isn’t the only flashpoint in the FDA wars. Other likely targets for state legislatures and lawsuits include contraceptives, Covid vaccines, and hormone therapy and surgical processes for people undergoing gender transition, attorneys say.

In Idaho, lawmakers introduced legislation that would make administering mRNA vaccines—like those issued by Pfizer and Moderna to fight Covid-19—a misdemeanor.

Attorney Brian Festa, co-founder and vice president of We the Patriots USA, said his group would “have interest” in backing litigation attempting to block hormone therapy, particularly its use on minors.

Yet for We the Patriots, “the most dangerous thing that has happened in the last three years was mandating the Covid shot,” Festa said.

“The only way you’re going to make these things like that illegal is a bill saying it’s illegal to mandate,” he said.

Company Impact

Drugmakers will likely be on high alert for the outcomes of battles to drug access, attorneys say, noting the threat of uncertainty for investors.

The idea that a pharmaceutical company could be roped into litigation “is a pretty chilling prospect,” said Susan Lee, a partner in the life sciences group at Goodwin Procter LLP who advises biologic and drug makers on FDA regulations.

“You can be mired in this kind of litigation for a long time, and it’s extremely costly,” Lee said, adding that it could also “raise questions among patients and doctors” about the product’s safety and efficacy.

However, attorneys also note drugmakers would likely mount a fight, ramping up state lobbying efforts and turning to courts to tear down restrictions on their ability to carry out interstate commerce.

Drugmakers would have ample standing to sue, said Kevin Noonan, co-chair of McDonnell Boehnen Hulbert & Berghoff LLP’s biotechnology and pharmaceuticals practice group.

“If I’m Moderna, I have a right to sell my FDA-approved product—you’re infringing on my right to sell my product. I object to that,” Noonan said.

Conversely, an individual could easily bring a lawsuit that would tear down a restriction on a product, such as the one over mRNA vaccines proposed by the Idaho legislators.

“It wouldn’t surprise me if someone went to a federal court and got a federal judge to say, ‘no, it impacts the ability of a person in Idaho who wants to make a medical decision for themself in Idaho,’” Noonan said.

Growing Distrust

When it comes to distrust in FDA processes, it’s the agency’s activity during the US AIDS movement “that’s come back to haunt us a little bit,” said Brook Baker, a Northeastern University law professor.

During the height of the AIDS crisis, activists pressured the FDA to fast-track approval of the drug AZT for AIDS and HIV treatment. Baker said that while he doesn’t “think it was a mistake at the time,” he noted that when it comes to drug approvals, activists “now know there are multiple abbreviated pathways, because pharma loves them—they have lower hurdles to jump over or gain quicker regulatory approval.”

“If you begin to relax regulatory standards, it causes people to think, this is too fast, we don’t know what the long term effects are,” Baker said.

Critics of the government’s rollout of Covid-19 vaccines have repeatedly pointed to the FDA’s emergency use authorizations as reason for doubt. Among them is Idaho state Sen. Tammy Nichols (R), who said in a committee presentation that she had issues with the fast-tracking of the vaccines.

But other FDA drug decisions have stoked skepticism over the agency’s calls as well. Among those calls are the agency’s 2020 emergency use authorizations of chloroquine phosphate, hydroxychloroquine sulfate, and convalescent plasma for treating Covid-19.

These actions have “caused immense damage to public confidence, but even more so to expert confidence in the FDA,” said Yaniv Heled, a Georgia State University law professor focusing on biomedical technologies.

There’s “very significant doubts about how it made those decisions, whether it was subject to pressure, how much science is behind those decisions,” Heled said. “People as a result are a lot more prone to calling FDA decisions into question.”