AP ENTERPRISE:
FDA helps states get execution drug

[[January 11, 2011]  BEIJING (AP) -- The Food and Drug Administration helped Arizona and California obtain a quick overseas source of a hard-to-find execution drug even as the agency declared it would not regulate or block imports, records show.

The shortage of the drug, sodium thiopental, has disrupted executions around the country. Newly released documents show the FDA helped Arizona import a supply of the drug from an English company last fall as it prepared to execute a condemned killer.

California prison officials also say the agency last week released a batch of the drug the state bought, also from England. The FDA would not comment on its role in helping either state.

Three states - Alabama, Oklahoma and Texas - plan executions this week. Alabama and Texas use sodium thiopental, an anesthetic in short supply in the U.S. because of manufacturing issues, and have enough of the drug for now. Records obtained by The Associated Press show, though, that Texas may soon run out. Oklahoma uses a different drug.

Missouri and Texas have executions next month, as does Ohio, which has hinted it could be run short after Feb. 17. "Beyond that, we will not be commenting on our supply," said Ohio prisons spokeswoman JoEllen Smith. Missouri may also be running out.

In response to state queries, the FDA has announced it will not stop overseas shipments to the U.S. of the drug sodium thiopental, because the agency does not regulate products used in lethal injection. A pending federal lawsuit in Arizona challenges the use of overseas drugs, saying they may be substandard and could lead to botched executions if they don't render an inmate properly unconscious.

"Reviewing substances imported or used for the purpose of state-authorized lethal injection clearly falls outside of FDA's explicit public health role," said agency spokesman Christopher Kelly.

The FDA has long maintained that a 1985 U.S. Supreme Court ruling freed it from any authority to regulate drugs used in executions.

The new FDA documents reveal the agency's role in helping Arizona get sodium thiopental as the state prepared to execute Jeffrey Landrigan for the 1989 murder of a Phoenix man.

After Arizona officials explained to the FDA the need to bring the drugs in quickly, the FDA official recommended "the shipment be processed expeditiously to us as it was for the purpose of executions and not for use by the general public." The information is contained in an e-mail from an Arizona prisons official to the California prisons agency obtained by the American Civil Liberties Union through a public records request and posted publicly.

The ACLU accused the FDA of trying to hold two contradictory positions at once.

"The FDA is actively assisting these states, but they're not enforcing the law, and they're not doing anything to determine that the drugs are what they're claimed to be and that they work properly," said Natasha Minkser, death penalty policy director for the ACLU's Northern California chapter.

Kelly, the FDA spokesman, declined to comment.

Most state prison systems use sodium thiopental to put condemned inmates to sleep before administering pancuronium bromide, a paralyzing agent, and potassium chloride, which stops the heart.

Sodium thiopental has been in short supply since last spring, when Ohio nearly had to postpone a May execution because it didn't have enough.

The drug's sole U.S. manufacturer, Hospira Inc. of Lake Forest, Ill., has blamed supplier issues for its inability to make the drug, which it markets as an anesthetic. Any remaining batches expire this year. Hospira has repeatedly deplored states' use of the product in executions.

Oklahoma has switched from sodium thiopental to pentobarbital, a drug commonly used to put animals to sleep. The state has conducted two executions successfully with the new drug. Two states, Washington and Ohio, use a single powerful dose of sodium thiopental to carry out executions.

At least three states - Arizona, Arkansas and Tennessee - appear to have gotten supplies of the drug from England, according to recently released records. California also got its supply indirectly from England after Arizona provided California with 12 grams of sodium thiopental in September. In December, the state paid $36,415 to acquire 521 grams of the drug manufactured by Archimedes Pharma of Great Britain. The drug has yet to arrive.

Arizona acknowledged last fall getting drugs from an English company. To date it is the only state known to have used a drug imported from overseas.

"We have followed the lead of Arkansas and purchased the drugs from a company in London," Charles Flanagan, the deputy director of the Arizona Department of Corrections, said in a Sept. 28 e-mail to John McAuliffe, a California prisons official.

Arkansas prisons spokeswoman Dina Tyler declined to comment.

Records show several states have scrambled to find enough of the drug, lending the FDA's announcement renewed importance.

In Washington state, officials "called every community hospital in the state" until they found one willing to provide the drug last year, according to an internal California prisons department e-mail released by the ACLU.

It's common practice when the prison system is looking for drug supplies to contact local pharmacies, many of which are at community hospitals, said Washington prisons spokeswoman Maria Peterson.

Missouri told the AP in the fall that its supply was to expire this year. Documents released by the ACLU said the state has enough for five executions, but it's unclear when that stock expires.

Without explanation, Gov. Jay Nixon spared a Missouri inmate who had been scheduled to die Wednesday; the state's next scheduled execution is Feb. 9.

Texas, with the country's busiest death chamber, is scheduled Tuesday to put Cleve Foster to death for a 2002 abduction, rape and shooting death. The state's supply of the drug, enough for 39 executions, expires in March, according to records obtained by The Associated Press through a public records request.

Alabama said it has enough unexpired sodium thiopental to carry out Wednesday's execution of Leroy White for the 1988 shotgun slaying of his 35-year-old wife, Ruby.

Virginia, which executed a woman in late September, had an expired batch in early August that it tried unsuccessfully to get the FDA to approve, according to e-mails obtained by the ACLU from the California prison system.

It's not clear whether the FDA would bother to approve the use of an expired batch, given its position that it has no regulatory power over drugs used in executions. Death penalty opponents have argued that expired drugs could be weakened and hence less effective.

"They ran into brick wall when they tried this with the FDA," the California e-mail said. Virginia executed a woman about six weeks later and said at the time it was in the same position as other states when it came to its supply. A Virginia prisons spokesman declined to comment.

Early last year, Tennessee shared its sodium thiopental with Georgia and Arkansas but scrambled by midyear to find its own supply, with a fall execution pending. In September, Ricky Bell, the warden of Riverbend Maximum Security Institution, where Tennessee's executions are held, ordered sodium thiopental, apparently from a British company, that was delivered by Oct. 26, just days before a scheduled execution.

Reprieve, a British rights group, said Tennessee received the drugs. In the meantime, the Tennessee Supreme Court halted executions while hearings are held on the constitutionality of the state's new injection procedures.

California tried to recruit private doctors who could procure the drug and went from state to state looking for supplies, including Arizona, Indiana, Nevada, Oklahoma, Texas and Virginia, records show.

The state also contacted dozens of hospitals and general surgery centers, Veterans Administration hospitals and the federal Bureau of Prisons and even looked into obtaining a supply from Pakistan.

[Associated Press; By ANDREW WELSH-HUGGINS]

Welsh-Huggins reported from Columbus, Ohio. Associated Press writers Bob Johnson in Montgomery, Ala., Kristin Hall in Nashville and Jim Salter in St. Louis contributed to this report.

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