FDA Finally Held Accountable for Illegal Approval of Abortion Drugs | Opinion

A federal district court in Texas ruled on Friday that the FDA must be held accountable for its unlawful approval of chemical abortion drugs in 2000. Every American who values safety and science should applaud this decision. For far too long, the FDA has behaved more like a pro-abortion political actor than like the unbiased expert it was established to be.

Congress entrusted and empowered the FDA to ensure that the drugs on American pharmacy shelves are safe. The FDA likes to present itself as a neutral, non-partisan expert; it claims to be objective and to rely on relevant science in its decisions. But in the saga of the FDA's approval and deregulation of chemical abortion drugs, the agency ignored science, skipped required tests, and stripped away common-sense safeguards on dangerous drugs. This has deeply compromised the FDA's credibility.

That is why thousands of Americans—including medical practitioners, 67 members of Congress, and the attorneys general of 23 states—asked a federal court to hold the FDA accountable for its illegal, politically motivated persistence in keeping dangerous chemical abortion drugs on the market. Now the court has done exactly that in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, filed by Alliance Defending Freedom attorneys on behalf of four medical associations and four doctors.

In 2000, the FDA succumbed to political pressure and approved the drugs without the required testing and studies. In the decades since, it has ignored evidence of these drugs' harms and, at the behest of politicians and the abortion industry, has removed even basic safeguards on their use.

Chemical abortions have a complication rate four times that of surgical abortions. As many as 20 percent of women who use chemical abortion drugs end up needing medical help afterwards. The adverse effects from these drugs range from hemorrhage to severe infection to inability to have successful future pregnancies. And, of course, the drugs are specifically designed to kill a human being.

Yet the FDA refuses to require even basic safeguards, like an in-person doctor visit, on these inherently dangerous drugs. In the past, the FDA has pulled drugs from the market for less serious adverse effects. For example, in 1971, it removed the drug DES from the market when a study showed that five milligrams a day increased the risk of non-cancer related death by 36 percent. The FDA pulled Lotronex after less than a year because it caused 49 cases of ischemic colitis (inflammation and injury of the large intestine), 21 cases of severe constipation (10 of which required surgery), and five deaths. (It reintroduced Lotronex in 2002 with greater restrictions.) Other examples include Pondimin, Zelnorm, Cylert, and Raptiva.

Despite reports of many severe adverse effects and deaths, however, chemical abortion drugs remain on the market. Nine women have died from infections after taking chemical abortion drugs, and several dozen women with ectopic pregnancies had serious adverse events.

Horror stories like these have become all too common for doctors like the ones who filed suit, but the true number is unknown because the FDA has failed to require meaningful reporting. We only know that these drugs have harmed many women; we do not know how many, because the FDA's lax guidelines make it impossible to find out.

When the FDA cuts corners, oversteps its authority, and turns a blind eye to the documented harms of a drug, it no longer deserves the deference due to a neutral expert. It deserves to be held accountable by the courts.

Fortunately, that accountability has finally come with the district court's decision on Friday. This is a victory for the emergency room doctors and other health care professionals who filed the lawsuit, but it's also a victory for the American people. And perhaps it will serve as a wake-up call for the FDA to quit cutting corners and playing politics, and start acting like the neutral expert it was designed to be.

Erik Baptist, senior counsel with Alliance Defending Freedom (@ADFLegal), represents four doctors and four medical associations in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration.

The views expressed in this article are the writer's own.