6,000 Days: How the Resolve of Pro-Life Doctors Led to a Court Victory against Chemical Abortion

In the wake of last Friday’s district court decision ruling that the Food and Drug Administration (FDA) illegally ignored its own rules to fast-track the approval of the abortion pill regimen, legal experts are calling the judgment one of the most momentous rulings in the history of the pro-life movement and vindication for doctors and medical associations who spent two decades pointing out the dangers of the drugs for women’s health.

In Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, four doctors and four medical associations challenged the legality of the FDA’s approval of the abortion drug regimen based on proven dangers to the health of women that the drugs presented. On Monday, Lathan Watts, Alliance Defending Freedom’s vice president of Public Affairs, joined “Washington Watch” to describe how his client’s lawsuit came about.

“Our clients … presented the science to the FDA all the way back in the year 2000, when the FDA first started the approval for these chemical abortion drugs, and by filing a petition challenging the approval of it,” he explained. “And the FDA by its own rules, was supposed to respond to that petition within 180 days. And they stonewalled our clients. For over 14 years, the FDA has abandoned, in this case, its responsibility to protect the health and safety of consumers in order to promote basically a political agenda of creating a nationwide mail-order abortion drug market.”

Chris Gacek, a senior fellow at Family Research Council, reiterated how the tireless efforts of concerned medical practitioners led to a first of its kind court victory against the FDA.

“For over 20 years, there have been phenomenal pro-life doctors laboring away, arguing that this drug regimen is unsafe,” he told “Washington Watch” guest host Jody Hice Monday. “They had been documenting it and telling the FDA about it and that the FDA was ignoring them and ignoring them. … [T]hey stonewalled for 6,000 days. … [T]hese big agencies that just think they can abuse you and kind of mistreat the process and just get away with everything, and you finally have a judge who actually look[s] at the rules and says, ‘Well, I’m going to make you actually stick with these things.’”

Gacek further recounted how in the 1990s, Senator Ron Wyden (D-Ore.) started putting pressure on the Clinton administration to get chemical abortion in the U.S. market, which eventually led to the drug regimen being fast-tracked for FDA approval amid controversial circumstances.

“If you go back to basically 1993-94, [Wyden] was politically putting a heavy hand on the FDA and the Clinton administration to push the drug through the approval process, not only in 1995 when they were trying to transfer the rights to the drug from this French-German consortium over to some American company or to the federal government. He was pushing this, threatening to hold hearings. Then he did the same thing in 2000 when the FDA got to the final furlong of the race. And they realize that they’ve got a dog here in this drug company that they’ve picked. They’re not doing what they’re supposed to do. And then this ton of political pressure is brought to bear on the FDA, and they caved in.”

Gacek continued, “One of the things about this opinion that shows you how this judge [Matthew Kacsmaryk] is really good is that he picked this out and he was able to discern that in 2000 there was this pressure campaign and that the FDA realized that the drug was not safe.”

Watts went on to describe how the FDA seemingly further gave in to political pressure in 2014 by removing the safety protocols that had been put in place when the abortion pill regimen was approved in 2000.

“They removed the in-person doctor requirement visit, reduced the number of visits from three to one, and lifted the requirement that only a doctor can prescribe it. [They also] authorized it to be sent through the mail, which violates the Comstock Act, and lifted the requirement that doctors report any sort of adverse impacts of the drug unless it actually resulted in death. So at every step along the way, they have violated their own rules.”

“This litigation is the only way to bring some sort of accountability to an executive branch agency,” Watts continued. “No one gets to vote on these bureaucrats. So when they violate their own rules, this [lawsuit] is what has to happen in order to get the FDA to actually fulfill its mission and protect the health and safety of women in this country.”

Watts further emphasized that one in five women who undergo a chemical abortion experience serious health complications as a result.

“At the end of the day, when this litigation is successful, women and girls in this country are going to be safer,” he concluded. “I mean, that’s really what it’s all about. These drugs are dangerous. They create all sorts of complications for women when they take them. And they should never have been put on the market in the first place. And so to be able to finally hold the FDA accountable — it was a great day on Good Friday to get that decision.”