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medicine

NCLA Brief Asks DC Circuit to Stop FDA’s Improper Attempt to Regulate the Practice of Medicine

Washington, D.C., Nov. 24, 2020 (GLOBE NEWSWIRE) — The New Civil Liberties Alliance, a nonpartisan, nonprofit civil rights group, filed an amicus brief in the U.S. Court of Appeals for the District of Columbia Circuit supporting a challenge to a Final Rule issued by the Food and Drug Administration (FDA). The Rule bans “electrical stimulation devices” (ESDs) for aversion therapy, currently in use in only one treatment facility in the United States—the Judge Rotenberg Educational Center in Canton, Massachusetts.

NCLA argues that the statute on which FDA relies does not provide FDA the rulemaking authority it seeks to exercise. Congress adopted the statute to permit FDA to move swiftly to prevent manufacturers from continuing to distribute fraudulent or hazardous medical devices commercially during the time it would take for FDA to prevail in a court proceeding. That rationale is inapplicable when, as here, no manufacturer is seeking to distribute the devices targeted by FDA commercially.

The Center’s professional staff seeks only to continue to use the devices it manufactured many years ago to deter severe self-injurious or aggressive behavior in its own patients. Under those circumstances, the sole enforcement measure available to FDA is a lawsuit seeking an injunction and seizure of the devices—a course of action that would at least have provided Petitioners the hearing rights they were denied in the rulemaking proceeding.

For decades, Massachusetts courts have deemed that the Center’s aversion therapy is both safe and effective for hundreds of patients. Thus, fearing that a federal court would reject its “unreasonable and substantial risk” claim, FDA opted to pursue a rulemaking proceeding. By proceeding in this fashion, for only the third time in its history, FDA was able to prevent the Center from cross-examining FDA’s witnesses and from effectively responding to the assertions FDA made to support its finding.

FDA seeks to prevent the Center from continuing to use its ESDs, but FDA’s rule will allow substantially similar medical devices to continue being used to treat other medical conditions, such as for smoking cessation. NCLA is deeply concerned that FDA has violated the petitioners’ procedural rights and has arrogated to itself powers not delegated to it by Congress. NCLA is asking the court to vacate the rule. 

NCLA released the following statement: 

“Not only is the FDA acting in bad faith, but it’s interfering with the practice of medicine by attempting to dictate how the Center must treat its patients. The law that permits hearing-less bans would violate due process rights—and thus would be simply unconstitutional.”

Rich Samp, Senior Litigation Counsel, NCLA

ABOUT NCLA

NCLA is a nonpartisan, nonprofit civil rights group founded by prominent legal scholar Philip Hamburger to protect constitutional freedoms from violations by the Administrative State. NCLA’s public-interest litigation and other pro bono advocacy strive to tame the unlawful power of state and federal agencies and to foster a new civil liberties movement that will help restore Americans’ fundamental rights.

 

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health

EU urges quick WHO reform, asks for more transparency in pandemics

By Francesco Guarascio and Caroline Copley

BRUSSELS/BERLIN (Reuters) – The World Health Organization (WHO) should be quickly overhauled, get more powers to handle pandemics and expose its member states’ shortfalls in health emergencies, European Union officials said on Friday.

The comments were made at a video conference of EU health ministers that endorsed an EU document on the reform of the U.N. agency which outlines a series of sweeping changes needed to boost WHO’s powers and resources, as exclusively reported by Reuters in September.

The moves followed criticisms that China and other countries did not share information on the COVID-19 pandemic in a timely fashion at its onset.

“The current pandemic challenges us very acutely (…) but it is very important that the (WHO) reform debate is held in parallel,” Germany’s Health Minister Jens Spahn told a news conference.

He did not say when the reform process should begin, but stressed that as a result of the overhaul the WHO should become faster in its reaction to health crises, while its member states should share more information in emergencies.

WHO officials did not immediately respond to an email request for comment.

“It is extremely important we move ahead with this reform,” EU Health Commissioner Stella Kyriakides told the same news conference.

After months of international pressure, an independent panel was set up in September to review the global handling of the pandemic. The process to reform the WHO would begin after that, officials had said.

The EU draft document, which will represent the EU’s position at a WHO assembly in mid-November, urges the U.N. agency to make public more quickly how and whether its member states respect their obligations on sharing information on health crises.

The United States has accused the WHO of being too close to China in the first phase of the pandemic, when critics say Beijing was slow in sharing crucial information on the new coronavirus which first appeared in the city of Wuhan.

The WHO has repeatedly dismissed these accusations.

“Transparency on who complies with the rules is fundamental,” Kyriakides told ministers at the video conference, according to her speaking notes.

The draft document also says WHO countries should allow independent epidemiological assessments on-site in high risk zones during health crises.

(Reporting by Francesco Guarascio @fraguarascio; Editing by David Holmes and David Evans)

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fitness

24 Hour Fitness COO touts COVID-19 protocols; asks California leaders to ease restrictions

24 Hour Fitness Chief Operating Officer Karl Sanft gave state and local officials a guided tour of the chain’s downtown Sacramento location Wednesday, highlighting the facility’s COVID-19 provisions while asking policymakers to consider easing capacity restrictions.

Mayor Darrell Steinberg asked questions of Sanft and his staff as they made their way through the 48,000-square-foot facility, which is next to Golden 1 Center in the Downtown Commons. City Council members Angelique Ashby and Eric Guerra, Assemblyman Jim Cooper and Danielle Stumpf from the California Department of Health and Human Services also participated in the tour.

“It’s more important than ever to take care of your physical health and your mental health,” Steinberg said. “I’ve said oftentimes over the past seven or eight months that COVID-19 is the pandemic, but mental health and mental illness might be the epidemic because this has been an extraordinarily difficult time for people.”

Sanft said 24 Hour Fitness is adapting after its industry and so many others were decimated by the coronavirus pandemic. He noted the company has closed more than 140 gyms since filing for Chapter 11 bankruptcy is June, including the Carmichael location on Arden Way.

“The impact to the business has been tragic,” Sanft said. “… The impact on our team members and members alike has been nothing short of tragic.”

Sanft said protocols put in place at 24 Hour Fitness locations have been effective. He pointed to the fitness center’s touchless check-in system, social distancing measures and safety-first approach to reopening amid the pandemic. General manager Tony Cigliutti said staff and members undergo temperature checks and health screenings before entering the facility. Masks are required at all times and areas including the swimming pool, steam room and sauna are closed.

The downtown location is currently limited to a capacity of 102 members under red-tier restrictions, 10% of the building’s normal capacity. Sanft is asking state and local leaders to increase that number to 25%, saying the building is big enough to safely accommodate 250 members while maintaining proper social distancing.

“We believe that we can operate at higher levels of occupancy,” Sanft said. “Our request, candidly, is 25%” within the red tier.

24 Hour Fitness provided data showing nearly 9.5 million people have checked in at 24 Hour Fitness locations across the country since the pandemic began in March. From June 12 to Oct. 15, 44 employees and 38 members of 24 Hour Fitness tested positive for COVID-19, but none of those cases were contracted at 24 Hour Fitness facilities, the company said.

“What’s really interesting about the fitness industry is, unlike many other businesses, everybody checks in,” Sanft said. “So it’s really simple for us to not only know who was here, but know who was here at the same time.

“Contact tracing is very easy for us to do. Across the clubs that we operate in the 13 states where we do business, we have yet to have a COVID case be traced back to one of our clubs,

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