Monthly Archives: May 2016

Death Penalty Dilemma

In 1994, the state of Ohio convicted Warren Keith Henness for aggravated murder.  The Ohio Supreme Court later set an execution date for Henness for January, 2015.  However, the Ohio Department of Rehabilitation and Corrections has pushed Henness’ execution date and the dates of many others, because they have been unable to obtain the necessary drugs to carry out the executions.  This problem is not limited to Ohio. More than 20 states will face great difficulty obtaining the specific drugs in the future.  As of January 1, 2016, there were 2,943 death row inmates in the United States.  The number of executions completed in 2015 was the lowest in 25 years, and half of the stays of execution were due to states’ inability to obtain the necessary drugs.

On May 13, 2016, Pfizer, an American global pharmaceutical corporation, announced that it will now enforce a distribution restriction on the specific drugs which are included as part of the lethal injection protocols.  Lethal injection procedures vary by state, but several use a one, two, or three-drug protocol, which requires an anesthetic or sedative, typically followed by pancuronium bromide to paralyze the inmate and potassium chloride to stop the inmate’s heart.  There are seven specific drugs that will now only be distributed to certain wholesalers, distributors and direct buyers, and all are required to agree to not resell the drugs to prisons.  The seven drugs: propofol, pancuronium bromide, midazolam, hydromorphone, rocuronium bromide, vecuronium bromide, and potassium chloride, are FDA-approved drugs used every day in efforts to treat illnesses and save lives.  Companies like Pfizer believe that these products should no longer be used for capital punishment.

Pfizer’s move is the last step in closing off the remaining FDA-approved manufacturers of drugs used in executions as all of the major pharmaceutical companies in the United States now stand together on this issue.  While the announcement is probably partly a public relations move and partly a business decision, Pfizer, along with other drug makers, say that their products are supposed to be used to save lives, not take them.  The companies believe that drugs have a certain value, but if associated with death due to the use in capital punishment, those drugs will lose that value.

Pfizer’s decision poses many questions for states that use lethal injection.  States may continue to search for the drugs needed to administer executions.  However, the 31 states that still impose lethal injection as capital punishment will possibly end their search by violating the law.  Some states have already looked to state-regulated compounding pharmacies that mix individual ingredients in the strength and dosage required to perform the procedure.  Though these compounding pharmacies distribute drugs for lethal injection, they often do not want their identities known to avoid lawsuits for contractual liability.  Few states allow methods such as electrocution, and even fewer states allow the gas chamber, hanging, and firing squad, but with the position taken by pharmaceutical companies, more states could resort to such procedures.  For example, Tennessee said in 2014 that if the drugs for lethal injection are unavailable, the state can use the electric chair.  A year later, Utah reintroduced firing squads.  Though it is difficult now to say how much of an impact Pfizer’s decision will have, states that use lethal injection will have to start looking for alternatives.

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HLJS Spring Symposium: Drug Promotion in the 21st Century

On March 31, the Health Law and Justice Society hosted its spring symposium “Drug Promotion in the 21st Century: Off-Label Marketing and First Amendment Concerns.”

Although the Food and Drug Administration (FDA) approves drugs for specific medical purposes, many treatments approved for one use are also effective for other diseases and conditions. The FDA has traditionally prohibited the promotion of medical products for uses other than those approved by the agency and reflected in the labeling. This restriction, however, has recently been weakened by successful legal challenges based on the First Amendment guarantee of freedom of speech. The symposium provided an overview of these issues and assessed recent legal developments, including several important cases decided in the past year. The panelists also discussed the implications of expanding the right to off-label promotion for the FDA, the drug industry, and medical practice. Professor Lewis Grossman, Professor of Law at American University Washington College of Law and food and drug law scholar, introduced and moderated the panel.

 

The speakers for the symposium were 1) Allison Zieve, J.D., Director, Public Citizen Litigation Group; 2) Richard Samp, J.D., Chief Counsel, Washington Legal Foundation; 3) Adriane Fugh-Berman, M.D., Associate Professor and Director of PharmedOut, Georgetown University Medical Center; and 4) Anne K. Walsh, J.D., Director, Hyman, Phelps & McNamara, P.C.

 

Ms. Zieve offered an illustrative history of how FDA’s authority over drugs has evolved. Her comments focused on the FDA’s requirements of safety and efficacy for new drugs before approval for sale on the market and balancing that with what is considered “truthful” speech. She emphasized that laypeople may not be able to properly evaluate truthful scientific statements in terms of safety and efficacy for human use. Furthermore, she stated that allowing industry to successfully use the First Amendment to discuss truthful statements about off-label uses of drugs could potentially have severe consequences for the public.

Mr. Samp’s comments focused on truthful speech, and regulations of commercial speech. He emphasized that the current trend in courts is to apply closer First Amendment scrutiny to restrictions on non-misleading commercial speech.

Ms. Fugh-Berman brought a physician’s and academic perspective on this issue. Among many things, she discussed the fact that while off-label uses of drugs can sometimes be rational and inevitable, most of the time, it is not. She focused on scientific support for off-label uses of drugs. She said that industry controls what information and studies the public sees and that companies usually have a great deal of information regarding off-label uses of their drugs.

Finally, Ms. Walsh’s comments discussed the interplay between the Federal Food, Drug, and Cosmetic Act, and the False Claims Act.

The symposium was an incredible event with truly esteemed speakers. The AUWCL community was incredibly lucky to have such knowledgeable speakers come and offer their expertise. To watch the event and hear further details, please visit: http://media.wcl.american.edu/Mediasite/Play/5a8de06dc577415b84aee30771df3e111d.

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