The lawsuit alleges the FDA is holding the Criminal Justice Department’s import of thiopental sodium.
Texas Attorney General Ken Paxton recently filed a lawsuit against the FDA alleging that the agency has illegally delayed the import of the state’s thiopental sodium.
The drug was purchased by the Texas Department of Criminal Justice and has been detained for more than 17 months, according to Paxton. This detainment has taken place without a final decision being made by the FDA.
Thiopental sodium is used only by law enforcement to enforce capital sentences that require a lethal injection with the drug. In particular, this drug has been used for anesthetic purposes even before 1938 when the Federal Food Drug and Cosmetic Act was created, the attorney general’s office said. The attorney general’s office is alleging that by not issuing a ruling, the FDA is violating its legal obligation to deliver a ruling within a reasonable amount of time, according to the lawsuit.
The lawsuit asks the court to find the FDA’s dealing unlawful, and to expedite a final ruling about the admissibility of the drugs ordered by Texas’ Criminal Justice Department.
The agency is withholding thiopental sodium due to allegations that the drug is in violation of 3 provisions of new drug approval requirements, according to the lawsuit. However, the drug is not for patient use, and will only be used by law enforcement, thus is considered exempt from those rules.
The Criminal Justice Department previously submitted legal statements to the FDA that explains why the import is not illegal, but the agency has not replied with a final decision, according to the lawsuit.
The department also previously filed intent to import the drug with the DEA, explaining that the drug was to be used for law enforcement purposes only, and was not intended for public use. The DEA notified customs of the import, but the FDA still held the shipment, citing that it violated several laws, according to the lawsuit.
Due to the detainment, the Criminal Justice Department may not utilize the drugs for lethal injection, although they have purchased and own them, according to the lawsuit. The office of the attorney general is asking that the courts make the FDA issue a ruling regarding the drugs, and end the detainment.
“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.”