Federal Judge Rules that Plan B Must Be Made Available to 17-Year-Olds Without Prescriptions; Labels FDA’s Actions Political

On March 23, 2009, U.S. Federal District Judge Edward Korman, writing for the U.S. District Court of the Eastern District of New York, ordered the Food and Drug Administration (the FDA) to permit Barr Pharmaceuticals, the manufacturer of Plan B, to make Plan B available to 17-year-olds without a prescription in the same manner as the drug is currently available to women age 18 and over.  (For the full opinion, click here)

The Court ruled that the FDA’s denial of nonprescription status was a political one that went against the recommendations of a panel of medical and scientific experts the FDA had appointed.  According to Judge Korman, under the Bush administration, the FDA had “repeatedly and unreasonably” delayed issuing a decision on the nonprescription status. 

The Court remanded to the FDA final determination on age and prescription requirements, but mandated that the drug be made available to 17-year-olds without prescription in light of the evidence that was presented at trial:

[T]he matter is remanded to the FDA for reconsideration of whether to approve Plan B for over-the-counter status without age or point-of-sale restrictions.  While the FDA is free, on remand, to exercise its expertise and discretion regarding the proper disposition of the Citizen Petition, no useful purpose would be served by continuing to deprive 17 year olds access to Plan B without a prescription.  Indeed, the record shows that FDA officials and staff both agreed that 17 years olds can use Plan B safely without a prescription.  The FDA’s justification for this age restriction, that pharmacists would be unable to enforce the prescription requirement if the cutoff were age 17, rather than 18, lacks all credibility.

The lawsuit was filed in 2005 by the Center for Reproductive Rights and others after the FDA denied a petition asking it to make Plan B available without a prescription to women of all ages. 

“Today’s ruling is a tremendous victory for all Americans who expect the government to safeguard public health,” said Nancy Northup, president of the center.

Plan B reduces the chance of pregnancy if taken within three days after sex. It works by preventing ovulation or fertilization and interfering with implantation of a fertilized egg, which some people consider the equivalent of abortion.

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FDA approves human embryonic stem cell research study

embryos_stem_cell2The US Food and Drug Administration (FDA) has approved California based Geron Corporation to carry out the world’s first human embryonic stem cell (hESC)-based clinical. Geron will test the stem cells on eight to 10 patients with severe spinal cord injuries.

The trials are set to begin at seven medical centers aims to mainly determine the safety of the cells in human subjects. Researchers will also look for any signs that the therapy restored sensation or movement.

“This is obviously an extraordinarily exciting event,” Geron chief executive Thomas B. Okarma said. “It marks the dawn of a new era in medical therapeutics. This approach is one that reaches beyond pills and scalpels to achieve a new level of healing.”

President Barack Obama is set to lift restrictions on federal funding for such research imposed by former President George W. Bush in 2001. Geron’s work had not been restricted by the Bush administration policy. The cells being used by the company were derived from leftover embryos at fertility clinics before 2001.

Trials Begin in China for Those Accused in Melamine Scandal

Trials began in China on Friday, December 26, 2008, for six men allegedly involved in China’s tainted milk scandal.   Melamine, a compound used in making plastics, had been added to artificially increase the amount of protein found in watered-down milk.  Though not toxic, melamine can cause kidney stones and renal failure.

The tainted milk lead to the death of six children and illness in 300,000 others in China.  Parents of children that had been sickened from melanine intended to hold a press conference in China, but were detained by Chinese police. 

One of the men on trial, Zhang Yujun, 40, was the owner of a company that was allegedly the country’s largest source of melamine.  Prosecutors in the Shijiazhuang Intermediate People’s Court accused Zhang of producing 776 tons of the additive powder from October 2007 through August.  According to the Associated Press:

[Zhang] allegedly sold more than 600 tons with a total value of 6.83 million yuan (about $1 million).

Zhang Yanzhang, 24, a second man on trial, was accused of buying and reselling 230 tons of melamine powder.

Both Zhang Yujun and Zhang Yanzhang were shown on state television in handcuffs while being questioned by the judges.   An intermediate court in China rejected requests by some foreign journalists to attend.

Four other men were being tried in three separate courts across China for their alleged involvement in the melamine scandal. 

In a separate trial, Ms. Tian Wenhua, a high ranking corporate executive at Sanlu–a company at the center of the melamine scandal–plead guilty to selling tainted powdered baby formula and acknowledged that the company knew of the problem months before alerting local officials.  Ms. Tian Wenhua could face life imprisonment or even the death sentence if convicted. 

In 2007, the former head of China’s State Food and Drug Administration, Zheng Xiaoyu, was executed for corruption after a scandal-plagued time at his position.  Zheng Xiaoyu was convicted of taking 6.5m yuan ($850,000) in bribes.

U.S. Food and Drug Administration opens office in China

The US Food and Drug Administration on Wednesday opened an inspection office in Beijing to help China export safer products to America and the world an to boost consumer confidence in products imported from China, reports the LA Times.

 

The new FDA field office, one of three to be opened in China, is the first outside the U.S. and comes during a dip in U.S. consumer confidence in Chinese-made products after reports of counterfeit drugs, melamine-laced milk and toys covered in potentially lethal lead paint.


Chinese officials urged the U.S. to lift new restrictions on imported foods from China, insisting that Beijing has taken effective measures to improve food safety standards since the recent tainted-milk scandal that killed four children and sickened tens of thousands of people.

 

Last year, the U.S. imported $321.5 billion in Chinese products, establishing China as America’s second-largest trading partner after Canada.

FDA Commissioner Dr. Andrew C. von Eschenbach said: We’re not here to superimpose our system on China…We’re here to be partners and collaborators, and offer our expertise as they request it. But consumers want to know the products they use are safe and are subjected to rigorous scrutiny. This will help ensure that.” James Rice, head of the China operations of Tyson Foods Inc said, “These FDA officials here are not going to inspect everything coming from China into the U.S. But it’s better than nothing.”

The U.S. hopes to work with China as part of a global product safety strategy that would eventually involve opening similar inspection offices in India, South America, Europe and the Middle East, U.S. Health and Human Services Secretary Mike Leavitt told a gathering of Chinese manufacturers.