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.

add to favorites email to friend print save as pdf

Related Stories

Execution drugs spark controversy as supplies dwindle

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

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)

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

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

Health care M&A leads global deal surge

16 hours ago

In a big year for deal making, the health care industry is a standout. Large drugmakers are buying and selling businesses to control costs and deploy surplus cash. A rising stock market, tax strategies and ...

US approves new, hard-to-abuse hydrocodone pill (Update)

Nov 20, 2014

U.S. government health regulators on Thursday approved the first hard-to-abuse version of the painkiller hydrocodone, offering an alternative to a similar medication that has been widely criticized for lacking ...

Soaring generic drug prices draw Senate scrutiny

Nov 20, 2014

Some low-cost generic drugs that have helped restrain health care costs for decades are seeing unexpected price spikes of up to 8,000 percent, prompting a backlash from patients, pharmacists and now Washington ...

Only half of patients take their medications as prescribed

Nov 20, 2014

The cost of patients not taking their medications as prescribed can be substantial in terms of their health. Although a large amount of research evidence has tried to address this problem, there are no well-established ...

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.