June 23rd, 2009

President Obama signed into law Monday legislation that gives the U.S. Food and Drug Administration unprecedented power to help reduce the appeal of tobacco products to children and first-time smokers. Read more.
TAGS: Family Smoking Prevention and Tobacco Control Act, FDA, tobacco
May 11th, 2009
If a longtime smoker, who happens to be president of the United States, is also pushing for a bill to regulate the marketing and manufacturing of tobacco products, it only seems likely that it would become the law of the land before long. While President Bush sought to squash the bill, under pressure from the $89 billion tobacco industry, Obama, who admittedly has struggled to quit smoking, wants the measure passed. Under a bill proposed in the Senate by Henry Waxman (D-Calif.) and Edward Kennedy (D-Mass.), the tobacco industry would have to disclose the ingredients in its products, and the Federal Drug Administration would then have a clear path toward banning a sizable chunk of the most harmful of the estimated 6,000 chemicals used in cigarettes, cigars and other tobacco products. And would also be able to reduce the amount of nicotine, likely making it easier for smokers to quit. Supporters of the bill say they have more than the 60 votes to avoid a filibuster in the Senate. Many of the bill’s proponents say the law is long overdue. They site statistics from health and medical experts who say that some 400,000 people die from tobacco-related causes each year. “If this happens, and if the FDA uses its powers, it will be an enormous public health achievement,” said Matthew L. Meyers, president of the Campaign for Tobacco-Free Kids, who has been pushing the legislation for 15 years.
TAGS: Edward Kennedy, FDA, Henry Waxman, nicotine, tobacco
April 23rd, 2009
‘Women no longer have to be 18 and older or have a prescription to purchase the controversial morning-after contraceptive pill, the Food and Drug Administration said Wednesday. Last month, a federal court ordered that the emergency contraception pill be made available over the counter to those 17 and up, the agency said in a statement on its Web site. U.S. District Judge Edward Korman had also asked the FDA to consider whether the pill should be available to women of all ages without a prescription. He said that this decision was best left to the agency rather than a federal district judge. He also blasted the FDA for abandoning its own procedures with respect to making decisions on the pill’s over-the-counter status, noting the “unusual involvement of the White House in the Plan B decision-making process.” He said that the plaintiffs in the case presented “unrebutted evidence of the FDA’s lack of good faith” toward the application to switch Plan B from prescription to non-prescription use. “This lack of good faith is evidenced by, among other things, (1) repeated and unreasonable delays, pressure emanating from the White House, and the obvious connection between the confirmation process of two FDA commissioners and the timing of the FDA’s decisions; and (2) significant departures from the FDA’s normal procedures and policies … as compared to the review of other switch applications in the past 10 years,” Korman wrote. In his order, Korman wrote that, “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-year-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.” That decision, according to Planned Parenthood Federation of America President Cecile Richards, is “a strong statement to American women that their health comes before politics. And that’s the way it should be. This decision is common-sense policy that will help reduce the number of unintended pregnancies and protect the health and safety of all women.”
TAGS: contraceptive, FDA, Judge Edward Korman, morning-after pill, Plan-B
April 1st, 2009

Don’t even think about eating a pistachio right now. And that goes for pistachio ice cream, pistachio candy and anything else that contains the tasty little nuts. The U.S. Food and Drug Association says to wait until a report comes back as to whether the treat is responsible for the recent spread of salmonella. Read more.
TAGS: FDA, Pistachios, Salmonella
December 12th, 2008

Two asthma drugs are under scrutiny. Two widely used asthma drugs may pose more risks than benefits for both children and adults, a U.S. Food and Drug Administration advisory panel said Thursday. Under scrutiny are GlaxoSmithKline’s Serevent and Foradil, made jointly by Novartis AG and Schering-Plough, HealthDay reported Thursday. The health experts did not say that the use of Serevent and Foradil should be abandoned altogether. Instead, they said the medications’ labeling should be reworded to urge doctors to use the drugs along with an inhaled corticosteroid – as guidelines already recommend. For more on controlling asthma, go to BET.com/Body & Soul.
TAGS: asthma, drugs, FDA, Foradil, GlaxoSmithKline, risks, Serevent
December 8th, 2008
Four popular asthma drugs are under fire. Asthma sufferers risk death if they continue to use four hugely popular asthma drugs — Advair, Symbicort, Serevent and Foradil – say two federal drug officials. But their views are not universally shared by other government scientists, The New York Times reports. The written assessment of the two officials from the safety division of the Food and Drug Administration, which appeared on the agency’s Web site on Friday, said that asthma sufferers of all ages should no longer take the four treatments. A third drug-safety official said Advair and Symbicort could be used by adults, but none of the four should be used for young people under age 17. Dr. Badrul A. Chowdhury, director of the division of pulmonary and allergy products at the agency, cautioned in his own assessment that the risk of death associated with the drugs was small and that banning their use “would be an extreme approach” that could lead asthmatics to rely on other risky medications. Please consult your doctor if you are using any of the four drugs and have questions.
TAGS: Advair, Asthma Drugs, FDA, Foradil, Serevent, Symbicort