The maker of the controversial Plan B "morning-after" pill has resubmitted an application to the U.S. Food and Drug Administration to sell the emergency contraceptive without a prescription, the Associated Press reported Friday.
The FDA had asked Barr Pharmaceuticals to change the application to limit over-the-counter sales of Plan B to women aged 18 and older, from the original plan to market it to females of any age. Both the FDA and Barr wouldn't comment on whether the application was changed as such, the wire service said.
Plan B is now available in most states only by prescription. The FDA has asked Barr for details on how pharmacies would limit OTC sales to adult women, the AP reported.
"Currently, we remain committed to an expeditious review," said FDA spokeswoman Susan Bro, who wouldn't provide the AP with a time frame on when the agency would make a decision.
Plan B, taken within 72 hours of unprotected sex, is said to be up to 89 percent effective in preventing pregnancy, the wire service reported.
Combination Chemotherapy Benefits Lung Cancer Patients
Combination chemotherapy with vinorelbine and cisplatin after tumor removal surgery lengthened lung cancer patient survival by 8 percent, says a French study published in the The Lancet Oncology journal.
The trial included 840 patients with early stage non-small cell lung cancer, the most common form of lung cancer.
"Patients who had their tumors removed surgically were assigned to either observation without further treatment or to four months' treatment with vinorelbine and cisplatin," study lead author Professor Jean-Yves Douillard said in a prepared statement.
"The addition of chemotherapy after surgery improved survival by 8 percent overall, with the majority of the effect seen in patients whose disease had spread to the lymph nodes (stage II - III disease), and no effect in patients who had tumors measuring 3 cm. or larger that had not spread to the lymph nodes," he said.
Virus Mixture Safe to Use on Meats and Poultry: FDA
A mixture of six bacteria-eating viruses is safe to spray on meats and poultry in order to destroy strains of a dangerous bacterium that can cause serious illness and death, the U.S. Food and Drug Administration ruled Friday.
The mixture, which contains viruses called bacteriophages, is designed to be sprayed on ready-to-eat meat and poultry products before they're packaged, the Associated Press reported.
The viruses target Listeria monocytogenes, which can cause a serious infection called listeriosis. Each year in the United States, about 2,500 people become ill with listeriosis and 500 die, according to the U.S. Centers for Disease Control and Prevention.
Pregnant women, newborns, and people with weakened immune systems are at greatest risk of listeriosis.
The virus mixture is made by Intralytix Inc. of Baltimore. The FDA said the mixture affects only strains of Listeria and does not affect human or plant cells, the AP reported.
U.S. Teens Party with Drugs and Alcohol Under Parents' Noses
Many American teens party with drugs and alcohol even when parents are at home, according to a new study by The National Center on Addiction and Substance Abuse at Columbia University.
The survey included 1,297 young people, aged 12 to 17. Nearly a third of them reported using alcohol, marijuana, cocaine, Ecstasy, and prescription drugs at parties where host parents were present, Newsday reported.
Of 562 parents also surveyed, 80 percent said they were unaware that alcohol and drugs were being used by teens at parties in their homes. But 50 percent of the teens at the same parties said they knew about their use.
"That shows just how out of touch the parents are," Joseph A. Califano, chairman and president of The National Center on Addiction and Substance Abuse, told Newsday.
The amount of drug and alcohol use apparently was much higher when parents weren't home, the survey found. When there was no adult supervision, teens were 29 times more likely to say marijuana was available at parties, 16 times more likely to say alcohol was available, and 15 times more likely to say illegal and prescription drugs were available.
Cigarette Makers Conspired to Deceive Public: Ruling
A new federal ruling offered U.S. cigarette makers a mix of bad news and good news.
Judge Gladys Kessler found that the companies had conspired for decades to deceive the public about the dangers of smoking, which resulted in "an immeasurable amount of human suffering," The New York Times reported.
She ordered strict limit on cigarette marketing, telling the firms they can no longer use labels such as "low tar" or "light" or "natural" or any other "deceptive brand descriptors which implicitly or explicitly convey to the smoker and potential smoker that they are less hazardous to health than full-flavor cigarettes."
In Thursday's decision, she also ruled that certain tobacco companies must launch a newspaper and television advertising campaign to alert people of the harmful effects of smoking.
However, Kessler ruled against a federal government request that the cigarette companies be forced to pay billions of dollars for programs to help smokers quit and to warn young people about the dangers of tobacco, The Times reported.
Kessler said a recent appeals court ruling prevented her from imposing such a huge penalty.
Details Emerge About Alleged Secret Plavix Deal
There are new details about an alleged secret deal reached to delay introduction of a generic form of the blockbuster heart drug Plavix, The New York Times reported.
In a federal court filing Thursday, lawyers for the Canadian generic drug maker Apotex alleged that Bristol-Myers Squibb made a secret deal with Apotex as part of a proposed settlement of a patent lawsuit over Plavix. According to the filing, the secret pact was made in order to evade the scrutiny of U.S. regulators reviewing the settlement, the Times reported.
The U.S. Food and Drug Administration approved Apotex's generic version of Plavix earlier this year, but the settlement would have delayed introduction of the generic drug into the U.S. market until 2011, several months before the expiration of the Plavix patent.
Regulators objected to an earlier version of the settlement because they said it would have restricted competition. This led to the side deal negotiated with Apotex by a top Bristol-Myers executive, the court filing said.
Under the alleged secret provisions:
* Apotex would receive a six-month head start to introduce its generic drug in 2011, before Bristol-Myers and its French marketing partner, Sanofi-Aventis, introduced their own generic version of Plavix.
* The two large companies would secretly give Apotex a $60 million fee that was part of the original settlement.
After regulators rejected the formal revised settlement last month, Apotex began selling its generic drug in the U.S. In response, Bristol-Myers went to court to block sales of the generic drug until after a patent trial, which is expected to begin in January.