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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Coronavirus ‘circuit breakers’ and ‘firebreaks:’ What are they and do they work?

  • The term “circuit breaker” has become common parlance in the U.K. in recent weeks.
  • The country is searching for a way to curb the second wave of the coronavirus in a short, sharp way.
  • The term was coined by scientific advisors to the British government.



a person wearing a costume: A man wears a face mask as he walks past a Wales souvenir store on October 19, 2020 in Cardiff, Wales. Wales will go into a national lockdown from Friday until November 9.


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A man wears a face mask as he walks past a Wales souvenir store on October 19, 2020 in Cardiff, Wales. Wales will go into a national lockdown from Friday until November 9.

The term “circuit breaker” has become common parlance in the U.K. in recent weeks, as the country searches for a way to curb the second wave of the coronavirus in a short, sharp way.

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The term was coined by scientific advisors to the British government who have recommended a two or three-week “mini lockdown. ” This time-limited set of strict restrictions would be designed to act as a “circuit breaker” to the infection rate, as the name implies.

Northern Ireland was the first part of the U.K. to announce that a “circuit breaker” lockdown would start on Oct. 16 and last for two weeks. Meanwhile on Monday, Wales announced a similar lockdown that will come into effect on Friday and last until Nov. 9.

Speaking at a press conference, Wales’ First Minister Mark Drakeford said the mini lockdown, what he called a “firebreak,” would be “a short, sharp, shock to turn back the clock, slow down the virus and buy us more time.”

Scotland has already ramped up restrictions, and is reported to be considering a circuit breaker, whereas the U.K. government has still not decided whether to impose a mini lockdown on England to coincide with the half-term school holiday next week.

What are circuit breakers?

Essentially, circuit breakers are lockdowns but for a limited amount of time. They are designed to break the chain of infection, and bring the infection rate down. It’s hoped that circuit breakers will help to reduce pressure on health services as hospitalizations due to Covid-19 rise.

This is crucial for the U.K., which has the third-highest number of coronavirus cases in Europe, with its tally now standing at just over 744,000 cases with 43,816 fatalities, according to data from Johns Hopkins University. It is currently battling a dramatic second wave of infections, like the rest of Europe, particularly in northern England.

On Monday, 18,804 new daily infections were reported, up from 16,982 on Sunday. The seven-day average number of cases on Oct. 16 was 17,649, according to government data, compared to 14,588 a week before.

Scientists advising the government seem to favor circuit breakers, as does the opposition Labour Party, with both encouraging the government to implement a mini-lockdown.

Papers released last week showed that the Scientific Advisory Group for Emergencies (SAGE) — a group of leading scientists that provides scientific advice to the U.K. government at times of crisis — had advised the government to go further with the restrictive measures it had implemented (such as restricting social

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