Attorney General Ken Paxton today announced that his office filed a lawsuit against the U.S. Food and Drug Administration (FDA) for illegally delaying the state’s importation of thiopental sodium. The drug, purchased by the Texas Department of Criminal Justice, has been detained by the FDA for over 17 months without the FDA issuing a final decision on the admissibility of the drug, in gross violation of the FDA’s legal obligation to issue a ruling within a “reasonable” time period. The attorney general’s office is asking the court to declare the FDA’s delay unlawful and compel the FDA to make a final decision on the admissibility of the drugs.
“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 Attorney General Paxton. “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.”
The FDA is withholding the importation of thiopental sodium based on allegations that the drug violates three provisions of the new drug approval requirements. The drug, however, falls squarely within the “law enforcement” exemption of that rule and is not for patient use. Thiopental sodium is used solely by law enforcement as part of enforcing lawfully imposed capital sentences through lethal injection. The drug has been used for these anesthetic purposes since before the Federal Food Drug and Cosmetic Act was enacted in 1938.