The pill that’s roiling US drug regulation

The fuss is over a pill—an abortion pill that has been used safely for nearly a quarter-century, but has now become a political, medical, legal and regulatory hot potato. It’s an intense legal battle with profound ramifications. Not only is it leading to more vociferous protests and campaigns in a society deeply divided on the matter, but it is undermining the very basis of regulation by an independent federal agency in the US.

The case that is roiling the US is a suit by a group of doctors who are seeking to curtail the availability of the nation’s most used abortion drug, mifepristone. Approved in 2000 by the US Food and Drug Administration (FDA), its usage has increased steadily over the decades after it has proven to be safe and effective. According to the Guttmacher Institute, a non-governmental organisation that promotes reproductive rights worldwide, there were approximately 642,700 medication abortions in the US last year, accounting for 63 per cent of all abortions in the formal healthcare system. The numbers would be
higher since the institute did not take into account the usage outside the formal system. In combination with misoprostol, the two-drug regimen is the most widely prescribed abortion therapy. As such, millions of women are anxious about the outcome of the doctors’ lawsuit, as is FDA, since a hard right judiciary has passed orders that undercut its role in approving drugs and setting the rules for their usage.

The anti-abortion doctors and organisations in this suit claim participating in the care of women who have resorted to the use of the abortion pill “to end the life of the embryo or foetus would cause them emotional and moral harm”. And how would this occur? They say there would be moral harm because patients who take abortion pills might seek treatment afterwards at emergency departments in hospitals where the doctors work.

This is, however, a bit of a stretch since the prosecutor in the case points out that the federal conscience protection rules of the US allow doctors and other healthcare providers to opt out of treating cases that they object to on moral or religious grounds. As the prosecutor appearing for the government scathingly said in the Supreme Court, the plaintiffs did not “come within 100 miles of the kinds of circumstances this court has previously identified” as grounds for
standing. As a matter of fact, these doctors did not prescribe abortion pills and are not forced to treat women who take abortion pills. Besides, with serious complications from abortion pills being very rare, these doctors are not likely to encounter such a patient. What the litigants are actually hoping to secure through their lawsuit filed in 2022 to overturn the approval of mifepristone, it appears, is a verdict that supports their ideological stand. As a lawyer
representing Danco Laboratories, manufacturer of the original brand-name mifepristone, told the court, the anti-abortion plaintiffs are “individuals who want to prevent anyone from using it in line with FDA’s considered scientific judgment”.

While the Supreme Court justices ponder the claims made by these doctors and consider if the litigants have a locus standi in the matter, damage has already been done. Access to generic mifepristone has been cut off. After FDA approved mifepristone in 2000, it made changes in the way the drug could be used in more recent times. In 2016 and 2021, the regulatory agency approved the use of the pills for up to 10 weeks of pregnancy, allowed physicians to prescribe the medication remotely and also getting the pill by mail, measures that significantly improved access to mifepristone. The anti-abortion
federation secured a victory in the Northern District Court of Texas when a Donald Trump-appointed judge, known for his staunch opposition to abortion, issued a preliminary ruling pulling the medicine off the market. It was the first time in US history that a court had overruled FDA judgement in approving or regulating a drug. There was immediate alarm in the pharma industry because such a verdict had broader implications than for just one pill. There was some relief when later a panel of the appeals court restored the initial drug approval but rolled back changes instituted by FDA in 2016 and 2021, thereby severely crimping access to the drug.

Regulatory policy experts and the pharma industry warn that if such court rulings that second-guess FDA’s scientific judgment are allowed to stand, it would discourage companies from developing new medications, not exactly a situation that any government will countenance.

Industry is making its apprehensions clear. “If allowed to stand, the court’s approach could render drug development unworkable and freeze approved conditions of use in time, depriving patients of the benefits of evolving science and imposing outdated, unnecessary burdens on health care providers,” the pharmaceutical industry’s amicus briefsaid. “Far from being limited to a single drug,” the brief said, such a decision “will create chaos in the processes for drug development, approval, and modification.”

In an interesting twist, one of the generic manufacturers of the drug, GenBioPro, has filed a case against FDA seeking to bar the agency from complying with any ultimate court order taking mifepristone off the market. To me, this is a vital lawsuit since it seeks to reinforce the constitutional mandate of FDA. When a federal appeals court panel had last year said mifepristone could remain in the market while the case was being litigated, it had rolled back all regulatory decisions on mifepristone since 2016. This included the 2019 approval of GenBioPro’s generic version of the drug, which is the most popular abortion pill
in the US.

The GenBioPro lawsuit claims that FDA has repeatedly failed to stipulate that it would follow a regulatory process established by Congress and afford the drug company the due process rights guaranteed by the US Constitution, if the agency was ordered to suspend or revoke its approval of GenBioPro’s product.

Mifepristone is actually a generic drug—it was discovered some 40 years ago—and is a component in both the patented drugs marketed by the innovator companies and also by the generic manufacturers. This is why GenBioPro’s version is the most soughtafter, since the patent protection enjoyed by the original maker after adding other components make the drugs expensive.

The mifepristone case is important because it tests a core tenet. Can religious and political lobbies undercut the constitutional role of independent agencies when a hard right judiciary that is aligned with their ideologies is also in the majority? This has lessons for India,which is facing similar challenges.  

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