GALVESTON – The U.S. Food and Drug Administration has prevented Texas from getting the drug needed for lethal injections for more than 17 months, now and Texas is fighting back.

Texas Attorney General Ken Paxton has filed a lawsuit against the FDA on behalf of the Texas Department of Criminal Justice on Jan. 3 in the Galveston Division of the Southern District of Texas claiming the FDA has delayed a shipment of the drug thiopental sodium for an unreasonable length of time. The drug is used for lethal injections in criminal cases.

“There are only two reasons why the FDA would take 17 months to make a final decision on Texas’ importation of thiopental sodium: gross incompetence or willful obstruction,” said Paxton in a press release obtained by the Southeast Texas Record.

The FDA delayed the import of the shipment at the border in June 2015, claiming it had three legal reasons to refuse to allow the drugs to come into the country, but none of them are valid because drugs used for law enforcement are exempt from certain conditions and it is not being used for patient treatment, the complaint says. The criminal justice department has submitted the legal arguments to the FDA explaining why the drug may be imported, but the FDA has yet to make a decision.

“To make a final decision, FDA only needs to address pure questions of law that the agency itself has raised,” the complaint says. “Nonetheless, the time that FDA has taken to determine whether its own legal theories are valid exceeds the time that the Supreme Court of the United States typically takes to resolve the most complex legal issues facing the nation.”

The Criminal Justice Department is asking the court to declare the delay unlawful and force the FDA to make a decision. It also asks for any other relief the court feels is proper.

The FDA can collect samples of drugs coming into the country and detain the drug by issuing a hold order. The FDA can refuse to allow drugs into the country if it violates the pre-market approval requirements.

“The FDA has an obligation to fulfill its responsibilities faithfully and in a timely manner. My office will not allow the FDA to sit on its hands and thereby impair Texas’ responsibility to carry out its law enforcement duties,” Paxton said in a press release.

The complaint says the FDA is holding the drugs saying they don't meet the labeling requirements and are a “new” drug.

However, the complaint says the department of Criminal Justice falls under the law enforcement exemption when it comes to labeling. They do not need to meet that requirement if the drug will be shipped or sold to law enforcement and used in that capacity.

Labeling requirements include warnings that say they are not to be used by people with certain conditions or children because they can be dangerous to their health, but in this case, the drug is not being used for patient treatment so warnings are not necessary to protect patients, the complaint says. Additional labeling requirements include directions for safely using the drug.

Thiopental sodium causes unconsciousness and anesthesia. It has been used since before 1938 when the Federal Food, Drug and Cosmetic Act was created, the complaint says. It has been used hospitals as a prescription anesthetic alone or with other drugs to carry out capital sentences of lethal injection. It has been used many times by the Texas Department of Criminal Justice before it became unavailable to the Texas prisons. Each vial is labeled with the drug's name and states it may only be used by law enforcement. There are no other conditions for use on the label, the complaint says.

The Criminal Justice Department is asking the judge to require the FDA to issue a final decision, declare the FDA has unlawfully withheld or unreasonably delayed issuing the final decision and award other relief as the court sees fit.

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Organizations in this Story

U.S. Food and Drug Administration (FDA)
10903 New Hampshire Ave
Silver Spring, MD 20903

Texas Attorney General's Office
300 W 15th St
Austin, TX 78701

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