Archive for the FDA Category

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.

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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

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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

Citizens outraged while Feds raid Organic Farm RAWESOME FOODS

Posted in FDA, Food Police, Monsanto with tags , , , , , , , , , on August 4, 2011 by saynsumthn

Swat team descends on farm for selling raw milk. Feds not only seized cash and raw milk supplies (much of which was also dumped out) but also mangos and other fresh, organic produce. Activists have planned a protest tomorrow outside the L.A. County Courthouse MORE HERE http://www.infowars.com/raw-fo​od-raid-armed-agents-bust-raw-​milk-cheese-sellers/

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Citizens outraged while Feds raid Organic Farm…, posted with vodpod

FDA’s eugenics rationing ideology: deny life saving cancer drugs while approving abortion pills

Posted in Abortion, Abortion death, Abortion pill, Death Panels, Ella One, Eugenics, FDA, RU-486 with tags , , , , , , , , , , , on December 17, 2010 by saynsumthn

The FDA seems to be picking and choosing it’s approvals of drugs in an interesting way. The FDA will begin denying Avastin to breast cancer patients but will graciously offer the creator of the drug a final show trial of a hearing in 60 days. Cancer patients claim it saves their lives- but- is this about safety or about rationing?

But controversy is the name of the game for the FDA, they seem to be cutting out drugs that could save or prolong lives, while approving drugs that take lives.

Case in point: Ella One- a new abortion drug approved just weeks ago:

A controversial new form of abortion pills known as “ella” is now available to American women for the first time, the company selling the drug announced Wednesday.

Ella, which can prevent a pregnancy as many as five days after sex, can be obtained by U.S. women who get a prescription from a doctor, according to an announcement by Watson Pharmaceuticals Inc. of Morristown, N.J. The medication can even be obtained through an online pharmacy, the company said. The wholesale price will be $35.75.

The Food and Drug Administration approved Ella in August.

According to the largest woman’s group: Concerned Women for America: Ella or the (ulipristal) abortion drug

• The Food and Drug Administration (FDA) is deliberately misleading women by mislabeling Ella as a contraceptive and not an abortion drug. While women may be comfortable using contraception, many would object to taking an abortion drug.

• Mislabeling Ella deceptively skirts federal laws on abortion. Because it is not defined as an abortion drug, it is likely that federal tax dollars will pay for it.

• Ella is chemically similar to the abortion drug RU-486 (mifepristone) and operates the same way. Ella blocks progesterone receptors, interfering with the uterine lining. Embryos cannot implant or, if already implanted, die from lack of nutrition.

• Advocates for Ella claim it only delays ovulation, but they refuse to acknowledge that the drug is — and acts — like RU-486.

• The FDA information for doctors admits Ella caused abortions in animals. It states, “Embryofetal loss was noted in all pregnant rats and in half of the pregnant rabbits …[Ella] caused pregnancy termination in 2/5 [of pregnant monkeys].”

• Human trials indicate that Ella may cause miscarriages or birth defects in babies that survive. Incredibly, FDA Advisory Committee members recommended that long-term studies not be undertaken to investigate the outcome of existing pregnancies (i.e. if the drug causes birth defects) because negative reports would likely outweigh positive. Instead, the FDA leaves it up to women to find out by experience. It admits on the drug label, “There is little information on whether ella would harm a developing baby.” The FDA put the drug company’s interests above the interest of patients.

And another abortion drug approved by the FDA is RU-486 and was approved without adequate trials and resulted in several women dying from a bacterial infection. Over 1,000 adverse events have been reported, including seven deaths. The FDA is treating Ella in the same careless manner, putting women at risk. CWA reports that, abortion providers flagrantly violate the FDA restrictions on RU-486. It is fully expected that abortionists will give Ella to women beyond the five-day approved usage period, taking advantage of its deadly capabilities to cause an abortion.

Back to Ella One:

• Trials indicate that frequent use of Ella may lead to high levels of toxicity. Yet, proper trials to discover what kind of complications could occur were not performed.

• Ella was tested on women above 16 years old. Yet it will be given to younger girls.

• Women will become victims to Ella being slipped to them without their knowledge or consent by boyfriends who do not want the woman to have a baby. This abuse has already occurred numerous times with other abortion-inducing drugs.

Women need a prescription for ella, but they can “keep a supply at home” — which means administration of the drug won’t necessarily be monitored to prevent someone from, say, taking an elevated dose after the recommended five days, which could result in the abortion of an implanted embryo. Reassurances along the lines that “it probably wouldn’t, if used correctly” are…not all that reassuring.

And then there is the question of who will be paying for Ella:
Critics are already concerned that ella’s approval as a contraceptive will make it eligible to receive federal tax subsidies, which are banned for the abortion pill RU-486. They also are concerned that ella will be included in the services that health plans will have to pay for under the new health-care overhaul law.

“By misclassifying ella as emergency contraception, this administration has paved the way to covertly allow federal funding for abortion,” said Rep. Christopher H. Smith (R-N.J.), who called on Obama to issue an executive order prohibiting federal funds from paying for ella.

The Family Research Council has compiled an article titled “Myth and Fact: The Truth about ella and How It Works” with more information. The gray area in the “it’s contraception, not an abortifacient” argument gets grayer all the time.

So now the FDA has approved a series of “Emergency Contraception” – pills that can be taken “after conception” which are in fact abortive, and they are marketing them as “contraception”.

In other words, they are redefining when life begins from “conception” to “implantation”, and our young people especially are being fooled.

Another such abortion pill approved by the FDA is called: PlanB.

Plan B prevents a pregnancy by administering high doses of a hormone that mimics progesterone. It works primarily by inhibiting the ovaries from producing eggs. Critics argue that it can also prevent a fertilized egg from implanting in the womb, which some consider equivalent to abortion.

And this does not take into account the many risks associated with the various birth control pills the FDA has approved without proper testing- read this: Dying for birth control?

So..we have to ask: Why is the FDA approving all these abortion drugs while pulling cancer drugs?

Can you say – Death Panels and Eugenic?

Just Say’n !

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Historical Information on RU-486: Abortion pill RU-486 created as an inexpensive drug for eugenic “population control” has connection to Nazi gas Zyklon B

September 28, 2010, marked the ten-year anniversary of the U.S. Food and Drug Administration’s (FDA) approval of Mifepristone (popularly known as RU-486).

These following quotes/facts are from the powerful documentary : Maafa21 which shows how the US government and other Elites are using abortion to limit black births:

When three pro-choice researchers investigated the original motive behind the creation of the abortion pill, RU486, what they discovered was that the scientific basis for it was actually developed in United States during the 1960s by the National Institutes of Health at the U.S. Department of Health and Human Services. In their 1991 book, these researchers claimed to have found data showing that this agency was looking for an inexpensive and effective drug to control the populations of foreign countries that the government had classified as “under-developed.” The abortion pill was to be tested in these environments and, if successful, the plan called for it to then be introduced into Black, Hispanic and Native-American communities in the United States.

After the abortion pill, RU486, was approved for sale in the U.S., the controversy surrounding it kept the abortion lobby from being able to find an American company to produce it. That forced them to look for a foreign manufacturer and, after an eight-year search, a company owned by the Chinese government agreed to manufacture the drug for the U.S. market. The company’s management made this decision after the Rockefeller Foundation agreed to provide financial backing for the project.

Minute 3 and 8 Minutes

Connection between Rockefeller and RU486. At the end of World War II, the German chemical manufacturer, I.G. Farben, was identified as the company that supplied the gas used in the Nazi concentration camps. The gas was called Zyklon-B and evidence later showed that Farben’s executives knew how it was being used. In fact, evidence was uncovered to indicate that Farben engineers had actually designed the gas chambers. This led to some of them being tried at Nuremberg for crimes against humanity including genocide and slavery.

After the war, I.G. Farben would change its name and become known as Hoechst AG. One of Hoechst’s subsidiaries, Roussel Uclaf, is the French company that developed RU486. The same company that produced the gas used in the Nazi death camps also produced the abortion pill RU-486

In June of 2006, shortly after a FOIA Act granted Judicial Watch uncovered government documents on RU-486, called “The Clinton RU-486 Files,” the Interim reported that, In his first official act as president, Clinton ordered the Department of Health and Human Services and the Food and Drug Administration to co-ordinate the marketing of abortion drug RU-486 on American soil.

Clinton had previously received advice from Ron Weddington, whose wife argued the pro-abortion side in the landmark 1973 Roe v. Wade case. In a January 1992 letter supporting the legalization of RU-486, Weddington made a Brave New World-style pitch on socio-economic grounds, arguing: “Something’s got to be done very quickly. Twenty-six million food stamp recipients is more than the economy can stand.”

Weddington went on to write that the next president should “start immediately to eliminate the barely educated, unhealthy and poor segment of the country,” as “our survival depends upon our developing a population where everyone contributes. We don’t need more cannon fodder. We don’t need more parishioners. We don’t need more cheap labour. We don’t need more babies.”

The report brings to light a number of disturbing revelations, including the use of official U.S. political, economic and diplomatic pressure that was used to persuade the RU-486 manufacturer, Roussel Uclaf, to make the drug available to American consumers. In one confidential memo, then-HHS Secretary Donna Shalala mentioned that she and then-FDA Commissioner David Kessler personally changed Roussel Uclaf’s position.

Interestingly, the documents also show that Roussel Uclaf offered to give the RU-486 patent to the U.S. government at no cost, in order to protect itself from legal liability in case anything went wrong.

Clinton obtained the patent by writing an official letter to Roussel Uclaf, saying the U.S. required “safe and effective medical treatment,” and thanking the company on behalf of “the women of America.”

According to Judicial Watch president Tom Fitton, the drug has claimed the lives of 560,000 children and at least six women in the United States, in part because the Clinton administration pressured the FDA to circumvent the usual requirements for certifying a drug as “safe and effective” in order to bring RU-486 to market. “This dangerous abortion pill needs to be pulled off the market immediately,” he said.

From Maafa21, Exerts from the Letter Ron Weddington sent to President Bill Clinton (Clip below) “ … 26 Million food stamp recipients is more than the economy can stand.” • “… you can start immediately to eliminate the barely educated, unhealthy and poor segment of our country. No, I’m not advocating some sort of mass extinction of these unfortunate people. Crime, drugs and disease are already doing that.” • “I am not proposing that you send federal agents armed with Depo-Provera dart guns to the ghetto. You should use persuasion rather than coercion.” • “Our survival depends upon our developing a population where everyone contributes. We don’t need more cannon fodder. We don’t need more parishioners. We don’t need more cheap labor. We don’t need more poor babies.