On Wednesday, a federal judge will hear arguments in a high-stakes court case that could threaten access to medication abortion and blunt the authority of U.S. drug regulators.
The lawsuit from Christian conservatives aimed at overturning the Food and Drug Administration's more than 2-decade-old approval of the abortion pill mifepristone is being weighed by Judge Matthew Kacsmaryk of Texas. The drug, when used with a second pill, has become the most common method of abortion in the U.S.
Essentially, there is no precedent for a lone judge overruling the FDA's scientific decisions. And, legal experts have warned of far-reaching consequences if judges begin second-guessing FDA decisions on drug safety and effectiveness.
The first hearing in the case is on Wednesday and it is being closely watched by groups on both sides of the abortion issue. This is because last year Roe v. Wade was reversed. However, few people knew about the hearing in advance because it was only put on the public online docket late Monday. This caused concern because it lacked transparency.
Kacsmaryk told attorneys in the case Friday that he would delay the filing to minimize threats and possible protests, a development first reported by The Washington Post. He also asked the lawyers not to disclose the date of the hearing, according to a transcript of the meeting released Tuesday.
Actions like this from a judge are very rare because court proceedings are usually open to the public and transparency is a fundamental part of the American judicial system.
Supporters of abortion rights say that conservatives are steering cases towards Kacsmaryk's courtroom because they believe that he will rule in their favor. Kacsmaryk was appointed by President Donald Trump and he formerly worked as an attorney for a Christian legal group. He has written critically of laws allowing abortion.
On Wednesday, Kacsmaryk will hear arguments in Amarillo from the Alliance for Defending Freedom, which filed its lawsuit on behalf of several anti-abortion groups and physicians, as well as federal attorneys representing the FDA. The drug's manufacturer, Danco Laboratories, is also a party in the case and set to argue for keeping its pill available.
The Alliance is requesting an injunction that would make the FDA revoke its approval of mifepristone. However, it is not clear how soon that could happen or what the process would be. The FDA has its own procedures for revoking drug approvals which include public hearings and scientific deliberations. This process could take months or years.
If Kacsmaryk rules against the FDA, an emergency stay to stop it from taking effect while the case proceeds is expected to be sought by federal attorneys.
If mifepristone becomes unavailable, clinics and doctors that prescribe the combination say they plan to switch to using only the second drug, misoprostol. That single-drug approach is slightly less effective at ending pregnancies, although it is widely used in countries where mifepristone is illegal or unavailable.
A lawsuit in Texas alleges that the FDA's approval of mifepristone in 2000 was flawed for several reasons, including an inadequate review of the pill's safety risks. The suit also challenges several later FDA decisions that loosened restrictions on the pill, including eliminating a requirement that women pick it up in person.
In its legal response, the government stated that lawyers for the FDA have pointed out that serious side effects with mifepristone are rare and the agency has repeatedly affirmed the drug's safety by reviewing subsequent studies and data. Pulling the drug more than 20 years after approval would be 'extraordinary and unprecedented.'
The FDA's authority to regulate prescription drugs has not been typically challenged. However, more than a dozen states now have laws restricting abortion broadly and the pills specifically following last year's Supreme Court decision overturning Roe v. Wade.
Lawsuits challenging state restrictions in North Carolina and West Virginia are progressing separately and are expected to continue for years.
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The quick brown fox jumped over the lazy dog.The lazy dog was no match for the quick brown fox.