Association of American Physicians & Surgeons Sues the FDA over Hydroxychloroquine Restrictions

The Association of American Physicians & Surgeons has announced it filed a lawsuit against the Food and Drug Administration “to end its arbitrary interference with the use of hydroxychloroquine.”

“More than 150 million doses have been donated to the strategic national stockpile controlled by the federal government, but unjustified FDA restrictions limit its use to only hospitalized patients for whom a clinical study is unavailable. Hospitals are even returning HCQ to the stockpile because they are not able to use it effectively.”

The lawsuit claims that

“Through a biased, unlawful process described in greater detail below, FDA officials from prior administrations acted contrary to the wishes of President Donald Trump, by arbitrarily limiting use of HCQ from the Strategic National Stockpile (SNS) “to prescribe to adolescent and adult patients hospitalized with COVID-19, as appropriate, when a clinical trial is not available or feasible.”

The lawsuit stresses the importance of Rick Bright, PhD, from the FDA.

“Specifically, a Barack Obama-appointed official who is outspokenly critical of President Trump, Rick Bright, personally opposed making HCQ widely available to the public from the federal SNS, and distorted the agency process to arbitrarily and unjustifiably limit access by patients to HCQ received as donations by the federal government for the purpose of making it available promptly to the public.” 

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Prophylaxis as a means to allow gatherings is an important part of the lawsuit.

“The arbitrary, irrational, and unjustifiable interference by Defendants with the use of HCQ as a prophylaxis interferes with the political process by which the United States selects its president: national political conventions. … Continued, irrational interference by Defendants with a safe prophylaxis for COVID-19 has the effect of infringing on the right of the people to hold national political conventions, which have been an essential part of our presidential elections since at least 1832.”

“There is no legal or factual basis for the FDA to limit use of HCQ,” states AAPS General Counsel Andrew Schlafly. “The FDA’s restrictions on HCQ for Americans are completely indefensible in court.”

See the full lawsuit:

https://aapsonline.org/judicial/aaps-v-fda-hcq-6-2-2020.pdf

See media release

June 2, 2020

AAPS Sues the FDA to End Its Arbitrary Restrictions on Hydroxychloroquine

Today, June 2, 2020, the Association of American Physicians & Surgeons (AAPS) filed a lawsuit, AAPS v. FDA, against the Food and Drug Administration to end its arbitrary interference with the use of hydroxychloroquine (HCQ), which President Trump and other world leaders have taken as a prophylaxis against COVID-19.

Two million doses of HCQ are being sent by the Trump Administration to Brazil to help medical workers there safeguard themselves against the spread of the virus. But at the same time the FDA continues to block Americans’ access to this medication.

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HCQ has been approved as safe by the FDA for 65 years, and the CDC states on its website that “CDC has no limits on the use of hydroxychloroquine for the prevention of malaria.”

More than 150 million doses have been donated to the strategic national stockpile controlled by the federal government, but unjustified FDA restrictions limit its use to only hospitalized patients for whom a clinical study is unavailable. Hospitals are even returning HCQ to the stockpile because they are not able to use it effectively.

“It is shocking that medical workers in Brazil will have access to HCQ as a prophylaxis while Americans are blocked by the FDA from accessing the same medication for the same use,” observes AAPS Executive Director Jane Orient, M.D.

“There is no legal or factual basis for the FDA to limit use of HCQ,” states AAPS General Counsel Andrew Schlafly. “The FDA’s restrictions on HCQ for Americans are completely indefensible in court.”

Many foreign nations, including China, India, South Korea, Costa Rica, United Arab Emirates, and Turkey, use HCQ for early treatment and prevention of COVID-19,  AAPS points out.

“Entrenched, politically biased officials at the FDA should not be allowed to interfere with Americans’ right to access medication donated to the federal government for public use,” Schlafly says. “By preventing Americans’ use of HCQ as a prophylaxis, the FDA is infringing on First Amendment rights to attend religious services or participate in political events such as political conventions, town halls, and rallies in an important election year.”

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“FDA Commissioner Stephen Hahn states that the FDA does not interfere with physicians’ ability to prescribe HCQ, and yet at the same time the FDA denies access by millions of Americans to 150 million doses of it in the national stockpile,” Schlafly adds. “This irrational hoarding by government is an abuse of power.”

The Association of American Physicians and Surgeons (AAPS) has represented physicians of all specialties in all states since 1943. The AAPS motto is omnia pro aegroto, meaning everything for the patient.

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