In a 2-1 decision, a federal court of appeals in Washington, DC struck down the US Food and Drug Administration’s (FDA) ban on electrical stimulation devices (ESDs) used at a single facility in Massachusetts to treat self-injurious behavior (SIB) or aggressive behavior (AB).   The US Court of Appeals for the DC Circuit, in siding with the plaintiffs, found that FDA’s ban on the devices for their particular use is not supported under statute and infringes on the practic...

The US Food and Drug Administration (FDA) says it intends to ban electrical stimulation devices (ESDs) used to treat aggressive and self-injurious behaviors after an advisory panel recommended banning the devices in 2014. According to FDA, ESDs are only used to treat aggressive and self-injurious behaviors at a single US facility, the Judge Rotenberg Educational Center in Canton, MA. FDA proposed the ban in a notice appearing in the Federal Register on Friday, saying ...

A federal court has ruled that Arizona's attempts to limit access to an abortion drug known as RU-486 (mifepristone) are unconstitutional, drawing on the US Food and Drug Administration's (FDA) authority to support its ruling. Background The case involved Arizona's attempts to restrict the use of RU-486, which is approved by FDA for use in terminating pregnancy within 49 days of the start of a woman's last menstrual period. As FDA explains on its website , the ...

Just hours after approving an application from Teva Women's Health allowing the company to market its product over-the-counter (OTC) to women as young as 15 years of age, the US Food and Drug Administration (FDA)-by way of the US Department of Justice-filed an appeal in the US District Court of New York seeking to overturn an earlier ruling that ordered the agency to approve the drugs for girls as young as 10 years of age. Background In December 2011, Kathleen Sebelius,...

US medical device regulators scored a minor legal victory on 9 November 2012, prevailing at least temporarily against the National Whistleblower Center (NWC), which is representing several current and former employees of the US Food and Drug Administration (FDA) in a lawsuit alleging the agency violated their rights to privacy by engaging in surreptitious surveillance against them. NWC has been fighting FDA in the court system to obtain documents about the case, and ...

A lawsuit filed by KV Pharmaceuticals against the US Food and Drug Administration (FDA) was thrown out of court on 6 September 2012 after a judge ruled the company could not challenge activities falling under FDA's enforcement discretion. KV filed its suit against FDA in July 2012 over FDA's allowance of compounded versions of its anti-premature pregnancy drug Makena (17P / hydroxyprogesterone caproate injection) to remain on the market. A Long-Running Saga The long...

A group of 15 states is calling on the US Department of Justice (DOJ) and the US Food and Drug Administration (FDA) to appeal a Judge's decision in a lawsuit against both FDA and the states' ability to obtain a drug commonly used in the execution of convicted criminals. CNN reports the states, all of which use lethal injection as their preferred method of execution, are having trouble obtaining sodium thiopental-an anesthetic commonly used as part of a multi-drug execu...

A federal judge refused to dismiss a case against Pfizer and five former executives for allegedly violating federal securities law by concealing clinical trial results, reports The Courthouse News Service . The class action lawsuit, filed by the Teacher's Retirement System of Louisiana, accuses the company and executives of violating federal securities laws by omitting the results of unfavorable clinical trials from public filing statements made by Pfizer. The defendan...