New paper calls upon states to cease experimenting with lethal injection drugs and comply with FDA regulations

by Susan Sperry

The Johns Hopkins Clinic for Public Health Law and Policy at the Bloomberg School of Public Health has crafted an evidence-based paper that presents a new perspective on the legality of the lethal injection process in the United States. The shortage of the combination of the three drugs previously used in States that use lethal injection to carry out capital punishment, in an attempt to comply with the Eighth Amendment prohibition on cruel and unusual punishment, has led to unregulated and experimental protocols in the lethal injection process that violate existing federal laws. The paper argues that state Departments of Corrections are violating U.S. Food and Drug Administration (FDA) investigational new drug regulations by experimenting with lethal injection drugs when carrying out executions. The paper's completion comes on the heels of the botched lethal injection execution that occurred recently in Oklahoma.

Under federal law, state Departments of Corrections are required to submit an Investigational New Drug (IND) application when any is administered, dispensed or used outside of a medical practice on one or more human subjects. The Federal Food, Drug and Cosmetic Act and the FDA's IND regulations cite specific requirements for clinical investigations, which would include a state's experimentation with new lethal drug combinations during executions.

"The IND process – fortified by the FDA's unmatched expertise with drug protocols would ensure that the Department's of Corrections protocols are effective in reducing the risk that will subject a condemned prisoner to pain that would violate the Eighth Amendment," said Stephen Teret, JD, MPH, founding director of the Clinic for Public Health Law & Policy. "FDA law states that an IND application must be submitted when any new drug protocol or experiment is undertaken on a human outside of a medical practice or a doctor's office. The laws are in place, the process just isn't being implemented."

The paper concludes that as states continue to grapple with drug shortages and to experiment with new combinations and dosages of drugs used to carry out executions, they should adhere to the guidelines put in place by Congress over fifty years ago to safeguard the human subjects of clinical investigations, including prisoners on death row. The paper recommends that executions should be halted by the courts until an FDA approved protocol for lethal injection can be established and approved.

Related Stories

Execution drugs spark controversy as supplies dwindle

date Oct 11, 2013

The United States is turning to new drugs for lethal injections as supplies of the current standard dwindle, sparking lawsuits from death row prisoners that the changes will cause undue suffering.

Ethical implications of modifying lethal injection protocols

date Jun 10, 2008

A team of medical, ethical, and legal scholars argues in this week's PLoS Medicine that in some US states the modification of lethal injection protocols is tantamount to experimentation upon prisoners without the prisoners' consen ...

Pharmacists urged not to assist US executions (Update)

date Mar 25, 2014

Several human rights and anti-death penalty groups have asked the American Pharmacists Association to prohibit members from participating in executions, a request that comes as states increasingly turn to pharmacists for ...

US state turns to different lethal injection drug

date Apr 20, 2013

After surrendering its supply of a lethal injection drug to federal agents in 2011, Arkansas turned to a somewhat surprising place to look for another drug: a list from lawyers for several death row inmates.

Recommended for you

Teva to lift bid for Mylan: report

date 5 hours ago

Israeli pharmaceutical giant Teva plans to increase its bid for rival Mylan and could announce the move as soon as this week, according to a US media report Monday.

Vaccine for West Nile Virus enters human clinical trials

date 10 hours ago

A clinical trial of a new investigational vaccine designed to protect against West Nile Virus infection will be sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes ...

FDA clears drug for leading form of cystic fibrosis

date Jul 02, 2015

Federal health officials have approved a new combination drug for the most common form of cystic fibrosis, the debilitating inherited disease that causes internal mucus buildup, lung infections and early death. But it will ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.