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Texas Sues FDA — Again — to Obtain Sketchy Execution Drugs From Overseas

Texas Sues FDA — Again — to Obtain Sketchy Execution Drugs From Overseas
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Texas is not giving up on its shipment of execution drugs that the U.S. Food & Drug Administration has already deemed illegal.

On Wednesday, the state sued the FDA — for the second time — in an attempt to get its lethal injection drugs back from the feds, who confiscated 1,000 vials of thiopental sodium in July 2015 when they arrived at Bush Intercontinental Airport. After the FDA still had not returned the drugs by this January, Texas sued, demanding a decision on whether it could have its execution drugs back. This month, in a meticulous 26-page letter, the FDA released its final decision: No.

Here's why: Several years ago, death row inmates in three states sued the FDA for allowing thiopental sodium to be arbitrarily imported from a foreign manufacturer even though the drugs were unapproved and misbranded. In 2012, a federal court agreed with the inmates, forever barring the FDA from allowing prisons to receive foreign shipments of thiopental sodium for legal injection unless the drug was approved by FDA and properly branded. The FDA claims Texas's July 2015 shipment of execution drugs was neither. And here's the deal: According to the FDA's letter, "in fact, there are no FDA-approved sodium thiopental products that are currently being marketed for any use."

That's why execution states like Texas have been having such a hard time getting lethal injection drugs, and instead must resort to importing them from overseas, from mysterious suppliers.

This year, BuzzFeed News was the first to identify where Texas's execution drugs were coming from, adding some context to why the FDA wouldn't let the drugs into the country.

According to Drug Enforcement Administration documents and correspondence obtained by BuzzFeed, the Texas Department of Criminal Justice ordered the drugs from a man in India by the name of Chris Harris, of Harris Pharma LLC. BuzzFeed's investigation of Harris's operation revealed a sketchy track record. First, the man has no pharmaceutical background and is just a salesman who gets his drugs from a different Indian drug maker, Health Biotech Limited. While Harris Pharma is registered with the FDA as a drug manufacturer, it's actually just a small office, BuzzFeed found, and the company's DEA-registered address is an apartment where Harris no longer lives. Harris has sold the execution drug to Texas, Nebraska and Arizona, but all shipments were seized by the FDA.

The documents BuzzFeed released from the DEA contain dates consistent with the timeline in Texas's lawsuit against the FDA: In early June, Texas notified the DEA of a shipment of 1,000 vials of thiopental sodium from Harris Pharma, and the DEA responded that it would notify U.S. Customs and Border Patrol of the shipment, arriving in July 2015. Which is when the FDA seized the shipment.

Texas Department of Criminal Justice spokesmen did not respond to requests for comment in response to BuzzFeed's investigation or about how TDCJ vets execution drug makers, but he had told BuzzFeed its story was "highly speculative" and "inaccurate."

That same BuzzFeed report also found that, according to DEA documents in January 2015, TDCJ attempted to obtain lethal injection drugs from another Indian supplier, Provizer Pharma. Months later, the Indian government raided the Provizer Pharma office — in a strip mall next to a jewelry store and ice cream shop — and arrested drug makers for illegally selling party drugs to people in the United States and Europe. Perhaps unsurprisingly, TDCJ business with the company apparently ceased.

The Texas Attorney General's Office did not respond to a request for comment about why the state is using taxpayer dollars in a federal lawsuit to obtain the lethal injection drugs, particularly in light of the reported supplier.

In its lawsuit, the state claims that the FDA's rules about seizing misbranded or unapproved drugs don't apply to TDCJ because the thiopental sodium falls under the law enforcement use exemption. But the FDA counters that the "law enforcement exemption" is moot here because the drug would still be used on humans.

On the package that arrived allegedly from Chris Harris, the drug was labeled: "Thiopental Sodium USP," "Sterile," "For law enforcement purposes only," plus marketing information from the manufacturer.

"The thiopental sodium that TDCJ is attempting to import includes no directions for those who would administer the drug or receive it," the FDA wrote in the letter. "Specifically, it lists no recommended dose and offers no instructions for reconstituting the powder inside the vials. Its labeling includes no precautions...or warnings...required in prescribing information for health professionals."

Better hope Texas prison officials know what they're doing.

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