Food and Drug Administration Archives

FDA Claims It Needs 55 Years Before Revealing Data on Approval of Pfizer Vaccine

November 23, 2021December 3, 2021 Admin

On Monday, the Food and Drug Administration (FDA) requested that the courts allow the agency to wait until the year 2076 to release all of the relevant documents regarding the approval of the vaccine developed by Pfizer and BioNTech, as reported by the Daily Caller.

The FDA made its request after a lawsuit was filed against the agency by the group Public Health Medical Professionals for Transparency (PHMPT). The PHMPT had previously made a Freedom of Information Act (FOIA) request on September 9th asking for the release of the vaccine approval documents; after the FDA denied the request, the group filed its lawsuit on September 16th.

The FDA concluded that there were roughly 329,000 pages in total that would qualify under this FOIA request. In its appeal to the courts, the agency said that, at most, employees would be able to “process and produce the non-exempt portions of responsive records at a rate of 500 pages per month.” Under this process, the FDA said that it would hand over prioritized documents to the plaintiff, and release non-exempt documents on a “rolling basis.”

Biden Announces Former Obama FDA Commissioner Robert Califf to Lead FDA Again

November 15, 2021November 14, 2021 Admin

President Joe Biden on Friday announced the nomination of Robert Califf to head up the Food and Drug Administration again, urging the Senate to quickly confirm him a second time.

Califf, who served in the same role near the end of then-President Barack Obama’s second term, is “one of the most experienced clinical trialists in the country, and has the experience and expertise to lead the Food and Drug Administration during a critical time in our nation’s fight to put an end to the coronavirus pandemic,” Biden said in a statement announcing the pick.

“I am confident Dr. Califf will ensure that the FDA continues its science and data driven decision-making,” the president added, pointing out that Califf enjoyed “strong bipartisan support in the Senate in 2016.”

Proposed Law Would End Ohio Sales Tax on Guns, Ammunition, Knives

October 28, 2021October 27, 2021 Admin

Sales tax would no longer be collected on guns, ammunition and knives in Ohio if a bill planned for introduction in the state House of Representatives becomes law.

State GOP Rep. Al Cutrona recently announced he will introduce legislation that would exempt those items from sales tax, saying the move would help make gun, ammunition and knife retailers and manufacturers more competitive with neighboring states.

Brnovich Requests Restraining Order Against Biden Vaccine Mandate

October 27, 2021October 26, 2021 The Center Square

Arizona Attorney General Mark Brnovich asked the U.S. District Court in Arizona for a temporary restraining order and nationwide preliminary injunction against the Biden Administration’s COVID-19 vaccine mandates.

“The COVID-19 vaccine mandate is one of the greatest infringements upon individual liberty, federalism, and the separation of powers by any administration in our country’s history,” Brnovich said in a news release Friday.

Commentary: Defense Department Pulls a Bait and Switch on Vaccines

October 21, 2021October 24, 2021 Admin

On August 24, Secretary of Defense Lloyd Austin issued a memo to senior Pentagon leadership announcing that he was implementing a mandatory COVID-19 vaccination policy for all military service members. The day before, the FDA had issued full authorization to Pfizer for their Comirnaty COVID-19 vaccine product (the nomenclature of which is meant to be a mashup of the words “COVID”, “mRNA”, and “community”) . At first glance it would seem that the mandatory vaccination policy, while scientifically unsound and strategically foolish, was at least a policy being implemented according to both the letter of the directive and in accordance with the law. But a further examination of the facts and the manner in which this order is being implemented makes clear that the military’s implementation of this order is illegal and highly unethical.

In the memo, Secretary Austin issued a directive and a promise, that “Mandatory vaccination against COVID-19 will only use COVID-19 vaccines that receive full licensure from the Food and Drug Administration (FDA), in accordance with FDA-approved labeling and guidance.” The problem with this is that the Comirnaty vaccine product that was approved by the FDA is not available anywhere in the Military Health System. It is not even in production, according to the military’s TRICARE healthcare providers. If a soldier goes to a military hospital or a private provider to receive an approved Pfizer COVID vaccine, he will be administered the unapproved Pfizer-BioNTech vaccine which is a vaccine that is not approved but has been administered under an Emergency Use Authorization (EUA). We are told that this is but a brand name difference, that the formulation is the same, and they can be used interchangeably. But as the FDA was approving the Comirnaty product, they were renewing the authorization for the Pfizer-BioNTech product. If it’s just a matter of brand name, why issue an approval for one brand name and an EUA renewal for the other? This is because they are not actually the same.

Sidney Powell Sues Defense Department over Vaccine Mandate

October 11, 2021October 10, 2021 Admin

Former Trump attorney Sidney Powell announced Wednesday that she is suing the Defense Department in regards to their vaccine mandate.

According to The Hill, Powell is representing the Texas-based group “Defending the Republic” in a lawsuit against Defense Secretary Lloyd Austin in regards to the military’s mandatory vaccination requirements.

Minnesota Lawsuit Forces Company to Accept Blood Donations from Transgender People

October 10, 2021October 9, 2021 Admin

The recently announced outcome of a Minnesota lawsuit forces one of the nation’s largest plasma companies to accept blood from transgender donors who were previously considered too high risk.

CSL Plasma is one of three companies that are responsible for collecting over 75% of the total plasma donated in the U.S. For decades, the FDA has recommended caution when collecting blood and plasma from men who have sex with other men, as these individuals pose a higher than average risk of transmitting bloodborne diseases like AIDS. CSL apparently adhered to this guidance by not collecting plasma from biological men who identify as transgender women or nonbinary people, since these individuals are likely to engage in sexual relationships with other men.

Law Professor Accuses University of Violating Federal Trade Commission Rules with Mask Mandate

September 21, 2021September 20, 2021 Admin

A business law professor who has been put on paid leave for refusing to wear a mask in class is defending his actions with an unexpected authority: the Federal Trade Commission (FTC).

“[B]y requiring employees to wear a mask, you are promoting the idea that the mask can prevent or treat a disease, which is an illegal deceptive practice,” David Clements, who teaches consumer law at New Mexico State University (NMSU), told provost Carol Parker in a Sept. 13 letter.

Telehealth Abortions Are Available to Virginians

September 21, 2021September 20, 2021 Eric Burk

Planned Parenthood of Metropolitan Washington, D.C., (PPMW) is now providing telehealth abortions to people with addresses in Virginia, Maryland, and D.C., according to a September 10 press release. After a phone screening and an online consultation, PPMW mails abortion drugs to the patient. Total cost for the service is $525, including a follow-up consultation and pregnancy test.

FDA Says It Does Not Buy Fetal Tissue – Any More

September 20, 2021September 19, 2021 Admin

The Food and Drug Administration assured the Daily Caller News Foundation Friday that it has not entered into any contracts “for the purchase of human fetal tissue” since 2018.

The agency’s response follows the release of documentation obtained by Judicial Watch showing that the FDA procured fetal organs, tissue, and heads for research that involved “humanized mice.” Previous documents uncovered by Judicial Watch found that the FDA requested “fresh and never frozen” fetal organs.

“I’ve been doing this for 23 years. These documents we’ve gotten from the FDA and our other lawsuit…they are the worst things I’ve ever seen,” Judicial Watch President Tom Fitton told the Daily Caller News Foundation Friday. “The most troubling documents I’ve ever seen.”

FDA Will Need More Time to Decide If Juul Can Sell E-Cigarettes

September 14, 2021September 14, 2021 Admin

Health officials delayed a decision Thursday on whether e-cigarettes made by Juul and other top companies can stay on the U.S. market.

The Food and Drug Administration (FDA) said it needs longer than the Thursday deadline to determine if Juul and other select companies’ products can continue to be sold in the U.S., according to a press release.

Report: Top Health Officials Tell White House to Pause Vaccine Booster Plan

September 6, 2021September 5, 2021 Admin

Top U.S. health officials told the White House pandemic coordinator on Thursday to scale back the Biden administration’s plan to administer the coronavirus booster shots to individuals in September, The New York Times reported.

Dr. Janet Woodcock, the acting commissioner of the Food and Drug Administration (FDA), and Dr. Rochelle P. Walensky, the director of the Centers for Disease Control and Prevention (CDC), told White House Coronavirus Response Coordinator Jeffrey D. Zients that they need more time to collect and analyze the necessary data relating to the booster shots, The New York Times reported.

The doctors told Zients that their agencies might be able to determine whether to recommend boosters for recipients of the Pfizer-BioNTech vaccine in the coming weeks, according to the Times.

The two doctors presented their argument to Zients at a meeting on Thursday. It is unclear how Zients responded to the news.

FDA Bans 55,000 Flavored E-Cigarette Products

August 30, 2021August 29, 2021 Admin

The U.S. Food and Drug Administration banned 55,000 e-cigarette products on Thursday for their failure to prove they didn’t pose a threat to public health.

The FDA announced that thousands of products from three vape companies, JD Nova Group LLC, Great American Vapes, and Vapor Salon, didn’t prove the benefit to adult smokers negated the “well-documented, alarming levels of youth use of such products.”

Texas Gov. Abbott Bans Vaccine Mandates Statewide Despite FDA Approval

August 27, 2021August 26, 2021 Admin

Texas Gov. Greg Abbott on Wednesday banned government-issued vaccine mandates despite the Food and Drug Administration’s recent approval of Pfizer’s coronavirus vaccine.

Abbott’s executive order applies to all government-run entities with the exception of nursing homes and assisted living facilities. “Vaccine requirements and exemptions have historically been determined by the legislature, and their involvement is particularly important to avoid a patchwork of vaccine mandates across Texas,” Abbott said in an accompanying statement.

Fully Vaccinated Do Not Need Booster for Delta Variant, CDC and FDA Say

July 12, 2021July 11, 2021 Admin

Fully vaccinated Americans do not need to receive a booster shot to protect against the Delta variant, the Centers for Disease Control and Prevention and Food and Drug Administration said in a press release.

“People who are fully vaccinated are protected from severe disease and death, including from the variants currently circulating in the country such as Delta,” a joint statement said on Thursday.

Study Finds Novavax COVID-19 Vaccine 90 Percent Effective

June 15, 2021June 14, 2021 Admin

Novavax announced on Monday that its two-dose COVID-19 vaccine is 90% effective, according to a press release on Novavax’s website.

The phase-3 trial enrolled 29,960 participants ages 18 and older in the U.S. and Mexico. The study found that 77 of the participants tested positive for COVID-19, with 63 testing positive in the placebo group and 14 in the vaccine group, according to the press release.

“Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines. These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection,” Stanley C. Erck, President, and CEO of Novavax said in the press release.

At Least 40 Percent of NIAID and FDA Employees Have Not Been Vaccinated, According to Fauci and Marks

May 18, 2021May 17, 2021 Admin

At least 40 percent of National Institute of Allergy and Infectious Diseases (NIAID), and Food and Drug Administration (FDA) employees are refusing to get the COVID-19 vaccine according to NIAID Director Dr. Anthony Fauci, and FDA official Dr. Peter Marks.

During a Senate Health, Education, Labor, and Pensions Committee hearing Tuesday on efforts to combat the COVID-19 pandemic, Senator Richard Burr (R-Va.) asked Fauci, Marks, and Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky what percentage of their own employees were vaccinated.

Both Fauci and Marks estimated that a little more than half—perhaps around 60 percent of their employees—have been vaccinated. Walensky waffled, saying only that she was “encouraging employees to get vaccinated,” but couldn’t say how many have actually done so.

Virginians 16 and Older Eligible for COVID-19 Vaccine

April 20, 2021April 19, 2021 Eric Burk

All Virginians 16 years old and older are now eligible to receive the COVID-19 vaccine, as of Sunday.

“Over the past few months, we have made tremendous progress vaccinating Virginians as quickly, safely, and equitably as possible, and we need to keep up the good work,” Governor Ralph Northam said in a press release.

Coronavirus Vaccines Can Guard Against New, More Contagious UK Strain, Experts Say

December 22, 2020December 21, 2020 Admin

The two coronavirus vaccines that have been approved for emergency use authorization in the U.S. will be able to combat a new, more contagious strain of the virus in the U.K., experts said Monday.

Vaccines made by pharmaceutical companies Pfizer and Moderna will be effective against the new strain, which is “very similar” to previous strains at the genetic level, University of Washington’s Institute for Health Metrics and Evaluation affiliate assistant professor Vin Gupta told CNBC. The Food and Drug Administration has approved both vaccines for emergency use authorization after large-scale human trials showed efficacy of more than 90%.

Judge Theodore Chuang Rules Women Can Get Abortion Pill Without Doctor Visit

July 14, 2020July 13, 2020 Admin

A federal judge agreed Monday to suspend a rule that requires women during the COVID-19 pandemic to visit a hospital, clinic or medical office to obtain an abortion pill.

U.S. District Judge Theodore Chuang, an Obama appointee based in Maryland, concluded that the “in-person requirements” for patients seeking medication abortion care impose a “substantial obstacle” to abortion patients and are likely unconstitutional under the circumstances of the pandemic.

FDA Revokes Emergency Use of Malaria Drugs to Treat Coronavirus, Cites ‘Potential Risks’

June 16, 2020June 15, 2020 The Associated Press

U.S. regulators on Monday revoked emergency authorization for malaria drugs promoted by President Donald Trump for treating COVID-19 amid growing evidence they don’t work and could cause deadly side effects.

The Food and Drug Administration said the drugs hydroxychloroquine and chloroquine are unlikely to be effective in treating the coronavirus. Citing reports of heart complications, the FDA said the drugs’ unproven benefits “do not outweigh the known and potential risks.”

FDA Issues Emergency Authorization Of Anti-Malaria Drugs As Doctors Herald Results For Coronavirus Patients

March 31, 2020March 30, 2020 Admin

The United States Food and Drug Administration issued an emergency use authorization for donated anti-malaria drugs hydroxychloroquine sulfate and chloroquine phosphate as doctors say the drugs are showing positive results for coronavirus patients.

The FDA issued the authorization to allow doctors to distribute and prescribe the anti-malaria drugs to hospitalized teen and adult patients who have coronavirus, the Department of Health and Human Services said in a press release. Doctors may distribute and prescribe the drugs “as appropriate, when a clinical trial is not available or feasible.”

The emergency authorization was issued to the Assistant Secretary for Preparedness and Response’s Biomedical Advanced Research and Development Authority, which is working with the National Institute of Health to plan clinical trials of the drugs.

FDA Warning: Bone Treats Making Dogs Sick, Causing Death

November 29, 2017November 29, 2017 Admin

Federal authorities are warning dog owners against giving their pets packaged bones as treats or chew toys after receiving complaints of at least 15 deaths and dozens of illnesses. The Food and Drug Administration says it has received 68 reports of pet illnesses related to “bone treats,” which are processed…