Regulatory Focus™ > News Articles > Human Rights Group to FDA: Reglan Needs New Restrictions, REMS to Prevent Use at Guantanamo Bay

Human Rights Group to FDA: Reglan Needs New Restrictions, REMS to Prevent Use at Guantanamo Bay

Posted 05 September 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) is no stranger to political controversy, with its actions placed under the microscope of legislators and political interest groups on a near-constant basis. But a new Citizen Petition filed by a group of social activists could place the agency at the nexus of an infamous prison allegedly housing some of the world's most dangerous terrorists.

The prison in question is the US base at Guantanamo Bay, Cuba, where the US maintains a prison to house many detainees captured in its war on terrorism. The prison has been subject to a large number of controversies, including allegations of substandard treatment of detainees, torture, and inadequate legal provisions for prisoners.

But the latest controversy is one dealing principally with medical ethics. Dozens of the prisoners at the facility are currently engaged in a hunger strike, and US officials at the base have responded by force-feeding detainees.

Force Feeding and Reglan

But force-feeding isn't the only activity officials are engaged in. A recent Citizen Petition filed by the Corporate Social Responsibility Advocate at Reprieve, a legal charity group which advocates on behalf of human rights, contends that officials at the base are forcefully administering the drug Reglan to the detainees, exposing them to potential side effects.

Reglan (metoclopramide) is approved by FDA for the use of gastric esophageal reflux disease (GERD), and also has uses for the treatment of vomiting, nausea and heartburn-all presumably useful attributes if you need to feed someone against their will and make sure the food stays down.

But as the drug's label notes, treatment with the drug runs the risk of patients developing tardive dyskinesia, "a serious movement disorder that is often irreversible" that can occur after prolonged treatment with the drug and for which there is no known treatment. Accordingly, treatment with the drug is contraindicated for longer than 12 weeks "and should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia."

An extensive list of other side effects, including depression, suicidal ideation and Parkinson's-like symptoms are also noted on the drug's Warning Label.

Adverse Event Reports and Requested Actions

Reprieve notes that it has already filed four adverse event reports with FDA on behalf of four prisoners incarcerated at the facility, and is now petitioning Commissioner Margaret Hamburg to "take urgent action to prevent any further forcible administration of Reglan … to hunger-striking detainees at Guantanamo Bay."

"In particular, [Reprieve] requests that the conduct of ANI Pharmaceuticals, the only FDA-approved manufacturer of branded Reglan, be investigated and appropriate enforcement action be taken in respect of any breaches of the Code of Federal Regulations or the Federal Food, Drug and Cosmetic Act (FD&C Act)," the petition states. The group said this investigation should include a look into whether required Medication Guides are included with the dispensed medication per 21 CFR 208.24 and whether a new risk evaluation and mitigation strategy (REMS) is needed to further restrict access to the product.

While Reprieve further requests that FDA suspend approval of Reglan for use in force-feeding at Guantanamo Bay, FDA lacks the legal authority to regulate the practice of medicine-just the medicines themselves.

Complications

FDA's response to the petition may well be complicated by a myriad of factors, the least of which may be the political implications inherent in the request. While President Barack Obama has expressed his desire to see the base closed, Congress has thus far refused to make funds available to facilitate the closing, and many countries refuse to repatriate prisoners contained at the facility, making it all but impossible to shut the base down. FDA, then, may well find itself walking among a political minefield should it choose to address the issue in favor of the petition.

In addition, US officials have sometimes maintained that the base, which is leased from Cuba, is technically considered outside of the US' jurisdiction, though this contention has been at least partially struck down in the courts. FDA's authority to regulate the use of the drugs at the base, then, might well be a tricky question to answer on a legal basis.


Reprieve Petition to FDA


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