Archive for the FDA Category

Group vows to defy FDA, continues dispensing abortion pills illegally

Posted in Abortion pill, Abortion Pill Connections, Abortion Pill Horrors, Abortion Pills Illegal, DANCO, FDA, Illegal abortion, Population Control with tags , , , , , , , , on June 1, 2019 by saynsumthn

abortion pill

Just days after 100 lawmakers sent a letter to the Food and Drug Administration (FDA) — which oversees drug safety — requesting that the FDA monitor abortion group Aid Access for illegally dispensing abortion pills, Aid Access announced its intent to defy the FDA’s warnings to “immediately cease” dispension of the drugs.

Aid Access founder Rebecca Gomperts published her response on Aid Access’s website as well as on Women on Waves, another organization Gomperts founded in 1999. Gomperts claims, “Last year, I prescribed 2,581 medical abortions out of 11,108 women who consulted me.”

Gomperts states in part:

On March 8, 2019, I received a letter from the FDA ordering my new (since 2018) organization, Aid Access, to stop providing telemedical abortion services to women who cannot otherwise access safe abortions because of costs, domestic violence, distance, or other reasons, and who do not have access to other doctors willing or able to prescribe misoprostol and mifepristone.

This letter was applauded by Republican members of Congress, of whom 92 percent are male.

But I will not be deterred. When U.S. women seeking to terminate their pregnancies prior to 9 weeks consult me, I will not turn them away. I will continue to protect the human and constitutional right of my patients to access safe abortion services.

Notably, the Congressional letter was signed by a number of women in Congress, including Reps. Martha Roby, Carol D. Miller, Virginia Foxx, Liz Cheney, Ann Wagner, Jenniffer González Colón, Debbie Lesko, and several medical doctors who also serve in the House of Representatives, among many others.

Rebecca Gomperts founder of Aid Access defiant to offer illegal abortion pills online

In a statement to Live Action News, the FDA wrote:

As noted in the FDA warning letter to AidAccess issued on March 8, 2019, failure to correct the violations of the law may result in FDA regulatory action, including seizure or injunction, without further notice. We cannot comment on a potential future action at this time, but we remain very concerned about the sale of unapproved mifepristone for medical termination of early pregnancy on the Internet, because this bypasses important safeguards designed to protect women’s health. Unapproved drugs purchased from foreign internet sources are not the FDA-approved versions of the drugs, and therefore, they are not subject to FDA-regulated manufacturing controls or FDA inspection of manufacturing facilities. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.

The statement went on to say that “The FDA’s regulation and oversight of the drug approval process and drug distribution helps to protect patients by applying rigorous scientific and safety standards, requiring labeling review for accuracy and completeness, and working to ensure that counterfeit and unsafe medicines do not enter the U.S. drug supply. When these requirements are not met, FDA can step in to help protect consumers.” The FDA reiterated that it has warned AidAccess.org and Rablon that they are in violation of the Federal Food, Drug, and Cosmetic Act for causing the introduction of unapproved new drugs into U.S. commerce.

Drugs are tightly regulated by the FDA for a reason, and under current requirements, the abortion pill — also known as Mifeprex or Mifepristone — is only permitted to be dispensed in hospitals or clinics by medical personal who are approved prescribers of the pill. FDA placed Mifeprex under a tighter regulatory system known by the acronym REMS (Risk Evaluation and Mitigation Strategy), “a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use.”

Under the Mifepristone REMS Program, the FDA states, “Mifeprex and the approved generic version of Mifeprex” may:

  • [O]nly be supplied directly to healthcare providers who are certified to prescribe the drug product and who meet certain qualifications.
  • [T]he products are only available to be dispensed in certain healthcare settings, specifically, clinics, medical offices and hospitals, by or under the supervision of a certified prescriber.
  • They are not available in retail pharmacies and are not legally available over the Internet.

The FDA has warned women against purchasing these dangerous pills online: “Do Not Buy Mifeprex Over the Internet.

FDA warns consumers to not buy abortion pills over the internet

The FDA adds, “You should not buy Mifeprex over the Internet because you will bypass important safeguards designed to protect your health (and the health of others). Mifeprex has special safety restrictions on how it is distributed to the public. Also, drugs purchased from foreign Internet sources are not the FDA-approved versions of the drugs, and they are not subject to FDA-regulated manufacturing controls or FDA inspection of manufacturing facilities.”

READ: AWFUL: Abortion groups tell women to lie about abortion pill, claim miscarriage

Weeks ago, the FDA updated its adverse events report through 2018, documenting “24 deaths of women associated with Mifeprex since the product was approved in September 2000….” The FDA also noted at least 4,200 additional adverse effects. Under 2016 changes, the drug’s manufacturer, Dancono longer has to report non-fatal adverse effects, so we can only imagine what the number really is.

Abortion Pill Deaths December 2018

Dec 2018 abortion pill deaths FDA

Live Action News previously documented a larger push by pro-abortion organizations to lift the FDA’s REMS requirements, to expand abortion pill dispension to mail order and online sales, via self-managed abortions. And we also documented the secretive history of Danco’s investors, which include organizations such as the Packard Foundation and other abortion philanthropists, who appear to stand to gain financially from a broad abortion pill expansion. The original drug, Mifeprex, was approved in 2000 after being brought to the U.S. by the eugenics-founded Population Council.

The defiance by Aid Access comes on the heels of multiple pro-life bills being passed in several states. Pro-abortion organizations, who used to claim that self-abortions injure and even kill women, now appear willing to place them in harm’s way. In addition, when these same women experience serious complications from these dangerous pills, they are instructed to present to the ER and lie, claiming they had a miscarriage. Ironically, while the abortion lobby shows support to Aid Access, they simultaneously want to discredit the science behind abortion pill reversal.

Editor’s Note 5/17/19: This article was edited to include a statement from the FDA.

  • This article is reprinted with permission. The original appeared here at Live Action News.

$1 million to abortion clinics and Planned Parenthood for aborted fetal tissue from ABR

Posted in Aborted Baby Body Parts, Advanced Bioscience Resources (ABR), Center for Medical Progress, Chimeras, FDA, fetal research, Fetal Tissue, Planned Parenthood sells aborted baby parts with tags , , , , , , , , on September 6, 2018 by saynsumthn

Planned Parenthood got over $300,000 in 6 years from one fetal tissue harvester

Planned Parenthood

Live Action News recently reported about how the FDA is contracting with Advanced Bioscience Resources (ABR) to obtain “fresh human tissues” — aborted fetal body parts — “for implantation into severely immune-compromised mice to create chimeric animals that have a human immune system.” ABR’s history with fetal tissue research goes back years. According to the Center for Medical Progress, ABR is “the largest and oldest fetal tissue seller in the U.S.” It was founded in 1989, and is the primary supplier of fetal tissue for the U.S. government. And it has paid numerous abortion facilities a great deal of money for this tissue — including a number of Planned Parenthood centers.

The stunning graphic below from the House Select Investigative Panel report summarizes known ABR payments to various Planned Parenthood facilities for fetal tissue — totaling more than $350,000 over the course of six years, from 2010 to 2015:

Image: ABR 2015 Fetal Sales to Top 5 Customers Product and Totals (Image credit: Congressional Investigation)

ABR 2015 Fetal Sales to Top 5 Customers Product and Totals (Image credit: Congressional Investigation)

According to a 2015 report from Politico:

The Food and Drug Administration has also paid about $73,000 to the company since 2009… mostly for liver and thymus tissue that are used largely to develop a human-like immune system in mice…. The NIH, with a $30 billion budget for research nationwide, funded about $76 million in dozens of fetal tissue projects in 2014.

Image: FDA Chimeric fetal tissue research

FDA Chimeric fetal tissue research

The FDA has a dozen contracts with ABR for various items, including lab equipment and supplies, according to the General Services Administration’s Federal Procurement Data SystemOnline records at the National Institutes of Health (NIH) indicate ABR is regularly granted federal dollars for various projects.

READ: FDA buys ‘fresh’ aborted body parts from company referred for criminal charges

The 2015 Congressional investigation regarding the illegal sale of fetal body parts, following undercover videos released by CMP, led to a report. In this report, quoted below, it was revealed that ABR had been contracting with universities and abortion facilities for years:

  • Before [founder and CEO Cate Dyer] began StemExpress, she worked for Advanced Bioscience Resources, Inc. (ABR)
  • The University of Minnesota (UM)… obtains fetal tissue from procurement companies—in this case, Advanced Bioscience Resources (ABR) and StemExpress—in addition to an area clinic.
  • The University of Wisconsin, School of Medicine and Public Health (UW SMPH)… more recently obtained fetal tissue for research from the Albert Einstein College of Medicine, UW, and ABR.
  • Colorado State University (CSU)… receives a significant amount in federal grants and obtains much of its fetal tissue from ABR and StemExpress. Between 2010 and 2015, CSU received seven NIH grants to support their projects using fetal tissue, at a taxpayer expense of $3.5 million.
  • According to productions made by 25 clinics from which ABR has received fetal tissue, ABR paid them a total of $1,002,147 from 2010 to 2015…. The chart below shows ABR facility fee payments from 2010 through 2015 to the abortion clinics from which it obtained fetal tissue:
Image: ABRs abortion clinic facility fees 2010 to 2015 (Image credit” Select Panel investigation of fetal tissue)

ABRs abortion clinic facility fees 2010 to 2015 (Image credit” Select Panel investigation of fetal tissue)

The panel then detailed ABR’s 2015 fetal parts sales to its top five customers:

Image: ABR 2015 Fetal Sales to Top 5 Customers Product and Totals (Image credit: Congressional Investigation)

ABR 2015 Fetal Sales to Top 5 Customers Product and Totals (Image credit: Congressional Investigation)

In a letter from Rep. Marsha Blackburn to the then-District Attorney of Riverside, California, the Congresswoman detailed ABR’s relationship with Planned Parenthood:

Image: ABRs interactions with Planned Parenthood fetal tissue

ABRs interactions with Planned Parenthood fetal tissue (Image credit: Letter from Rep. Marsha Blackburn)

In 2016, Houston attorney Briscoe Cain claimed he found evidence of four Texas medical schools purchasing fetal tissue from ABR. Invoices from to one of the schools, given to KFOX14 Investigates and reported by CBS4, show the school paid at least $4,000-$5,000 for fetal parts including livers, spleens and thymuses.

Image: ABR invoices for fetal tissue to Texas Universities

ABR invoices for fetal tissue to Texas Universities

Image: ABR invoices for fetal parts to Texas Universities

ABR invoices for fetal parts to Texas Universities

“The research being done is humanized mice. Scientists inject the mouse with fetal tissue so the mouse is genetically altered to accept the graphing of human tissue,” Cain said at the time.

In 2011, the University of Minnesota contracted with ABR for “human fetal pancreas tissue” between 16-24 weeks.

Image: ABR contract with U of Minnesota for fetal tissue 2011

ABR contract with U of Minnesota for fetal tissue 2011

In 2000, the Government Accountability Office (GAO) was tasked to study “the involvement of federal agencies under the jurisdiction of the Senate Committee on Appropriations, Subcommittee on Labor, Health and Human Services, and Education in the acquisition of human fetal tissue for biomedical research.” The Department of Health and Human Services (HHS) told GAO that “NIH is the only federal agency under the Labor, HHS, and Education Subcommittee’s jurisdiction that sponsors research using human fetal tissue.” But Live Action previously showed that the EPA used aborted fetal tissue for research in the 1970’s.

According to that report, NIH sponsored three central human fetal tissue supply organizations:

  • The Birth Defects Laboratory at the University of Washington, which distributed 2,869 human fetal tissue samples and collected $52,035 in fees directly from researchers in fiscal year 1999.
  • The Brain and Tissue Banks for Developmental Disorders at the University of Maryland and the University of Miami School of Medicine/Children’s Hospital of Orange County, primarily to serve as suppliers of human nonfetal tissue…. The University of Maryland Bank provided 195 human fetal tissue samples to investigators in fiscal year 1999, and the University of Miami Bank provided approximately 40 samples between March 1 and August 31, 1999.

GAO states that researchers also obtained human fetal tissue from private organizations that did not directly receive federal funds, including ABR.

Obama FDA approves Abortion Pill Vending Machine

Posted in Abortion, Abortion pill, FDA, Morning After Pill, Plan B with tags , , , , on January 30, 2013 by saynsumthn

The Hill is reporting that Federal regulators will let a Pennsylvania university continue to dispense Plan B — also known as the morning-after pill — through a vending machine.

PlanBVendingMachine

The Food and Drug Administration decided not to intervene following a “politically motivated uproar” over the vending machine Shippensburg University installed in its nurses’ office.

Vodpod videos no longer available.

Baby Killing Vending Machines on Campus, posted with vodpod

SHIPPENSBURG, Pa. — Vending machines at one Pennsylvania University doesn’t just dispense soda and snacks — it sells the morning-after pill.
At Shippensburg University, getting access to Plan B, the emergency contraception pill is as easy as getting a soda. Students can now buy the pill at a vending machine on campus.
“We had some conversations with them and did a survey of the student body and we got an 85 percent response rate that the students supported Plan B in the House Center,” said Dr. Roger Serr, Vice president of Student Affairs at Shippensburg.
The university does not profit from the sales. It pays $25 for one dose and that’s exactly what the student has to pay.
Dr. Serr says that somewhere between 350 and 400 doses are sold each year to the female population. The pill can be legally sold over-the-counter to anyone 17 or older.

U.S. Marshals seize ultrasound gel containing dangerous levels of bacteria

Posted in FDA with tags , , , , , , , , on April 20, 2012 by saynsumthn

H/T

The FDA in July raised concerns over cleanliness and sterilization during an inspection at a New Jersey company which had a batch of its ultrasound gel seized by federal agents Wednesday because the FDA says tests showed it was tainted with dangerous levels of bacteria and which may have infected babies in a neonatal intensive care unit (NICU).

In a warning letter in September, FDA investigators said that Pharmaceutical Innovations did not test product adequately to ensure it was sterile and did not make sure equipment used to sterilize the product was properly maintained and calibrated.

The letter also says Pharmaceutical Innovations did not thoroughly investigate a complaint that babies in a NICU were infected by Pseudomonas. “The hospital’s investigation led to culturing your ultrasound 8 oz bottles and 5 liter gel which tested positive for the Pseudomonas organism.” The company told the FDA the hospital had not properly used the product but failed to establish a procedure to make sure that same thing didn’t happen again.

U.S. Marshals seized all lots of Other-Sonic Generic Ultrasound Transmission Gel manufactured by the Newark, NJ, company Wednesday that are believed to contain dangerous levels of bacteria.

The FDA says that 16 patients on whom the gel was used during surgery have gotten sick. In an email today, FDA spokeswoman Sarah Clark-Lynn said the 16 patients were at a hospital in Michigan. They developed colonization or infection with the bacteria Pseudomonas aeruginosa after undergoing cardiovascular surgery. As a result of the ongoing investigation, the hospital tested both open and closed ultrasound gel. Testing by the hospital confirmed Pseudomonas aeruginosa in both opened and unopened bottles.

The FDA was contacted on Feb. 15 by the State Department of Health, where the infections occurred. There was also a MedSun Adverse Event Report submission on March 2, she said.

Tests on the product in February revealed unsafe levels of two bacteria: Pseudomonas aeruginosa and Klebsiella oxytoca, the FDA says, citing a filing in the U.S. District Court in New Jersey.

The product, manufactured by Pharmaceutical Innovations, was seized at the company’s operations in Newark and has been embargoed by the New Jersey Department of Health and Senior Services at FDA’s request.

“This ultrasound gel presented serious health risks to patients, particularly vulnerable ones,” said Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs, in the release. “Therefore, FDA, with the assistance of our state partner, is taking aggressive enforcement action to protect the public health.”

Gilbert Buchalter, president of the company, initially played dumb when asked about the raid, and then said he had no comment. An office worker, who declined to be identified, acknowledged agents had been to the facility.

The affected gel products include 250 milliliter and 5 liter containers of Other-Sonic Generic Ultrasound Transmission Gel manufactured from June 2011 through December 2011.

The FDA’s New and Improved Cigarette Warning Labels

Posted in FDA, Tobacco with tags , , , , , on November 8, 2011 by saynsumthn

Vodpod videos no longer available.

The FDA’s New and Improved Cigarette Warning La…, posted with vodpod

UPDATE 2-U.S. judge blocks graphic cigarette warnings
Mon Nov 7, 2011 2:51pm EST

* Judge sides with tobacco companies in free speech fight
* Finds them likely to prevail against FDA
* Companies argue new graphic labels unconstitutional

By Alina Selyukh and Jeremy Pelofsky

WASHINGTON, Nov 7 (Reuters) – A federal judge blocked a U.S. rule requiring tobacco companies to display graphic images on cigarette packs, such as a man exhaling cigarette smoke through a hole in his throat.

U.S. District Judge Richard Leon sided on Monday with tobacco companies and granted a temporary injunction, saying they would likely prevail in their lawsuit challenging the requirement as unconstitutional because it compels speech in violation of the First Amendment.

The Food and Drug Administration in June released nine new warnings to go into effect in September of 2012, the first change in U.S. cigarette warning labels in 25 years. Cigarette packs already carry text warnings from the U.S. Surgeon General.

The new warnings must cover the top half of the front and back of cigarette packs and 20 percent of printed advertisements and must contain color graphics depicting the health consequences of smoking, including diseased lungs, dead bodies and rotting teeth.

Congress instructed FDA to impose the new labels as part of 2009 legislation making the agency responsible for regulating tobacco products.

“The sheer size and display requirements for the graphic images are anything but narrowly tailored,” Leon wrote in a 29-page opinion.

Just because Congress ordered the size and placement of the new warnings before charging the FDA with carrying out the mandate, “doing so does not enable this requirement to somehow automatically pass constitutional muster,” he said.

The content of the images would also not likely survive constitutional muster because the FDA did not attempt to narrowly tailor those either, the judge said.

The tobacco lawsuit is the latest effort by corporations to assert a right to free speech, a high-profile legal battle that could end up before the U.S. Supreme Court.

Reynolds American Inc’s R.J. Reynolds unit, Lorillard Inc , Liggett Group LLC and Commonwealth Brands Inc, owned by Britain’s Imperial Tobacco Group Plc , sued the FDA in August.
They argued the new graphic warnings force them to “engage in anti-smoking advocacy” on the government’s behalf, breaching their right to free speech.

The Obama administration’s options include appealing Leon’s ruling or the FDA could try to rewrite the rules.

FDA spokeswoman Stephanie Yao said the agency did not comment on proposed, pending or ongoing litigation. Justice Department spokesman Charles Miller said the department was aware of the decision and was reviewing it.

Read Rest here

More Gardasil deaths discovered

Posted in FDA, Gardasil with tags , , , , , , , , on October 21, 2011 by saynsumthn

Judicial Watch Uncovers FDA Gardasil Records Detailing 26 New Reported Deaths
Other Adverse Reactions Include: Seizures, Paralysis, Blindness, Pancreatitis, Speech Problems and Short Term Memory Loss

WASHINGTON, Oct. 19, 2011 /Standard Newswire/ — Judicial Watch, the public interest group that investigates and prosecutes government corruption, announced today that it has received new documents from the U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act (FOIA), detailing reports of adverse reactions to the vaccination for human papillomavirus (HPV), Gardasil. The adverse reaction reports detail 26 new deaths reported between September 1, 2010 and September 15, 2011 as well as incidents of seizures, paralysis, blindness, pancreatitis, speech problems, short term memory loss and Guillain-Barré Syndrome. The documents come from the FDA’s Vaccine Adverse Event Reporting System (VAERS) which is used by the FDA to monitor the safety of vaccines. The documents were obtained pursuant to a September 15, 2011 FOIA request for reports made from September 1, 2010 through September 15, 2011.

Adverse Gardasil events reported to the FDA include:
• The information was received from the patient’s mother…concerning her healthy 14 year old daughter who in August 2007, January 2008, and June 2008, was vaccinated with a first, second and third dose of GARDASIL…It was reported that the patient experienced several symptoms including numbness and tingling in her fingers and toes, fatigue, a really hard time falling asleep, urinary tract infections, ovarian cyst, moody, trouble getting out of bed and seizures. The patient had upwards of 150 seizures following her third shot in June 2008. During her seizures she stopped breathing for periods of 30 to 40 seconds. The patient was diagnosed with Neurocardiogenic syndrome and seizures. It was reported that the patient died due to ovarian cyst. The reporter felt that the patient’s symptoms were related to vaccination with GARDASIL.

• Additional information was received from a newspaper article concerning a 18 year old female…who on 10-MAY-2007 was vaccinated with GARDASIL…in the right arm…The patient who was a college freshman travelled on 05-OCT-2007 to visit her family for the weekend. The patient reportedly felt “slightly ill” upon her arrival and subsequently took an aspirin and went to bed awakening at 1:30 PM the following afternoon “appearing refreshed”. The patient became feverish again that night and woke at 1:00 AM the morning of 07-OCT-2007 with chills and a severe headache complaining that “my headache is about to explode”. The patient was taken to a local hospital, where a brain computed axial tomography (CAT) scan was performed and the brain revealed meningococcal disease in her brain and brain stem. The patient was immediately transferred to another hospital and died the evening of 07-OCT-2007 due to complications of meningitis.

• Information has been received from a physician regarding a 15 year old female who on 26-SEP-2007 was vaccinated with her second dose of GARDASIL for prevention of HPV…Thirty minutes after the vaccination, the patient experienced a headache and that night went home and slept until the next morning. The patient woke up the next day and went to school. The school nurse called the patient’s mother and informed her that the patient felt tingling in both hands. Later that day, the patient was again sent to the nurse’s office due to a shaking sensation all over. Later that evening, things became worse and the patient started crying from the pain and burning in her back. The patient was taken to the emergency room by her parents. In the emergency room, the patient collapsed and was not able to walk; she was paralyzed from the waist down. It was reported that the patient was hospitalized for two months.

In response to the concern about death reports among those who received Gardasil, the Centers for Disease Control (CDC) insists that “there was no unusual pattern or clustering to the deaths that would suggest that they were caused by the vaccine.”
http://www.cdc.gov/vaccinesafety/vaccines/hpv/gardasil.html

“These reports raise additional concerns about Gardasil’s questionable safety and provide ample reason to end the push to give it young girls and boys. And the CDC’s continued caginess on reported deaths is disturbing,” said Judicial Watch President Tom Fitton. “Federal, state, and local officials need to stop promoting this vaccine for children.”

In 2008, Judicial Watch launched an investigation of the FDA’s reporting on adverse reactions to vaccinations for HPV. All previous FDA documents uncovered by Judicial Watch, as well as a Judicial Watch special report, entitled “Examining the FDA’s HPV Vaccine Records: Detailing the Approval Process, Side-Effects, Safety Concerns & Marketing Practices of a Large Scale Health Experiment,” are available on Judicial Watch’s website,
http://www.judicialwatch.org/gardasil.

The federal raid of Amish milk farms

Posted in FDA with tags , , on September 1, 2011 by saynsumthn

Amish farm banned from selling unpasteurised milk after sting operation by Feds
By Daily Mail Reporter
Last updated at 8:26 PM on 29th April 2011

An Amish farm in Pennsylvania has been stopped from selling contraband milk after a year-long federal government sting operation.

The Rainbow Acres Farm was found to have been smuggling banned unpasteurised milk to customers in Maryland.

Raw milk drinkers claim that pasteurisation eliminates good bacteria and changes the taste.

But the Food and Drug Administration say unpasteurised milk can carry harmful bacteria such as salmonella, E.coli and listeria.

Sales are illegal in 11 states and the District, with other states having varying restrictions on purchase or consumption.

Illegal: Food and Drug Administration say unpasteurised milk can carry harmful bacteria such as salmonella

The FDA began to look into the farm, owned by Dan Allgyer, when an investigator used aliases to sign up to the farm’s internet group and placed orders for raw milk to be delivered to Maryland.

Read more: http://www.dailymail.co.uk/news/article-1381995/Fed-cracks-Amish-selling-contraband-milk-undercover-sting.html#ixzz1WjrKN254