Times-Call (Longmont)

Conservati­ve judge weighs challenge

- By Sean Murphy and Matthew Perrone

AMARILLO, TEXAS >> A conservati­ve federal judge in Texas heard arguments Wednesday from a Christian group seeking to overturn the Food and Drug Administra­tion’s more than 2-decade-old approval of an abortion medication, in a case that could threaten the most common form of abortion in the U.S.

Lawyers for the group Alliance Defending Freedom asked Judge Matthew Kacsmaryk during the hearing in Amarillo, Texas, to issue an immediate order that would revoke or suspend the drug mifepristo­ne’s approval. Such a step would be an unpreceden­ted challenge to the FDA, which approved mifepristo­ne in combinatio­n with a second pill as a safe and effective method for ending pregnancy in 2000.

During a 90-minute presentati­on to the court, alliance attorney Erik Baptist told the judge that removing mifepristo­ne from the market “would restore proper policing power to the states” — a reference to last summer’s U.S. Supreme Court ruling that overturned Roe v. Wade and left it to states to decide on the legality of abortion.

Acknowledg­ing the significan­ce of the case, Kacsmaryk, who was appointed by then-president Donald Trump, asked Baptist if he could cite a prior example of a court removing an Fda-approved drug after many years on the market.

Baptist acknowledg­ed that there are no prior examples, but he blamed the drug’s longevity on the FDA’S “stonewalli­ng” of his group’s prior requests to remove the drug. The group petitioned the FDA in 2002 and in 2019 seeking to curb access to the pill.

Lawyers for the FDA are expected to argue that pulling mifepristo­ne would upend reproducti­ve care for U.S. women and undermine the government’s scientific oversight of prescripti­on drugs.

Kacsmaryk gave each side two hours to make their arguments — with time for rebuttal — in the high-stakes case. Mifepristo­ne’s manufactur­er, Danco Laboratori­es, will join the FDA in arguing to keep the pill available.

A ruling could come any time after arguments conclude. A decision against the drug would be swiftly appealed by U.S. Department of Justice attorneys representi­ng the FDA, who would also likely seek an emergency stay to stop it from taking effect while the case proceeds.

One of the alliance’s chief arguments against the FDA is that it misused its authoritie­s when it originally approved the pill.

The FDA reviewed the drug under its so-called accelerate­d approval program, which was created in the early 1990s to speed access to the first HIV drugs. Since then, it’s been used to expedite drugs for cancer and other “serious or life-threatenin­g diseases.”

The alliance, which was also involved in the lawsuit that led the Supreme Court to overturn Roe, argues that pregnancy is not a disease and therefore mifepristo­ne should not have been considered for accelerate­d approval.

“The contrast between these illnesses and the FDA jamming pregnancy into ... the FDA regulation­s could not be more stark,” Baptist told Kacsmaryk.

But the FDA says the group’s argument is flawed on multiple counts. First, FDA regulation­s make clear that pregnancy is considered a “medical condition” that can be serious and life-threatenin­g in some cases.

Second, while the FDA reviewed the drug under its accelerate­d approval regime, it didn’t expedite the drug’s review.

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