Tagged: FDA

The FDA and antibiotics for animals

In hopes of slowing the growing scourge of killer bacteria, the Food and Drug Administration has released a policy document that says agricultural uses of antibiotics should be limited to assuring animal health.  But the FDA again stopped short of banning antibiotics in feed given cattle, chickens and pigs — as European regulators already have.  […]

FDA and outsourced drug making

The Food and Drug Administration reportedly will propose tougher regulations for pharmaceutical companies that outsource manufacturing of drugs, making them more responsible for the safety and purity of the products made by contractors.  Law Professor Kevin Outterson, an authority on food and drug law and director of the Healthy Law Program, says the changes likely […]

Drug firm snoops on FDA officials

Amphastar Pharmaceuticals reportedly paid more than $100,000 to a private investigative firm to snoop on FDA officials they suspected of having a too-chummy relationship with a competitor drug maker.  Amphastar insists it did nothing wrong, but Senate Finance Committee investigators are looking into the case.  Law Professor Kevin Outterson, an authority on drug law and marketing, […]

Cookie dough recall

Nestle USA is voluntarily recalling its Toll House refrigerated cookie dough products after reports of people getting ill from eating the dough raw.  School of Management Professor Michael Salinger, a former director at the Federal Trade Commission, can discuss the mechanics of such recalls. Contact Michael Salinger, 617-353-4408, salinger@bu.edu

Free speech and tobacco regulation

A free-speech fight is brewing over part of the bill, which President Obama will sign, giving the FDA regulatory control over tobacco.  It pits the public interest in preventing young people from smoking against the right of tobacco companies to advertise to adult smokers.  School of Law Professor Tracey Maclin, a Constitutional law expert, can […]

FDA rule over tobacco just smoke?

After decades of trying, Congress now will give the FDA regulatory contol over tobacco.  College of Communication advertising Professor John Carroll explains in a WBUR-FM commentary how the “smoke and mirrors” of cigarette marketing will likely still leave Philip Morris ahead of the pack. Contact John Carroll, 617-353-3493, carroll7@bu.edu

FDA to decide if adult antipsychotic drugs are safe for kids and teens

The FDA will decide this week if three powerful antipsychotic medications approved for adults — Zyprexa, Seroquel and Geodon — can be safely prescribed for children as young as 10 years old. David Barlow, professor of psychiatry and psychology, knows the controversial issues and the “enormous pressure,” facing the FDA. Contact David Barlow,Ph.D., 617-353-9610, dhbarlow@bu.edu

Proposed FDA regulation of tobacco is weak

For Michael Siegel, MD, a long time anti-smoking advocate and professor of social and behavioral sciences, the proposed Food and Drug Administration regulation of cigarettes is really a smoke screen for Big Tobacco. Writing in the Los Angeles Times, he states that the legislation was crafted, in part, by Philip Morris in a deal with […]

Could smokeless e-cigarettes derail FDA tobacco regulation?

The proposed Food and Drug Administration regulation of tobacco products is running into unexpected opposition from such health groups as the American Lung Assn., American Cancer Society and Tobacco-Free Kids. Why? They want to include electronic cigarettes, now sold on line and at mall kiosks, that contain no tobacco, produce no smoke, and help many smokers […]

Congress moving closer for the FDA to regulate tobacco

A Senate committee this week takes up a House-passed version of a bill that will give the FDA broad powers over the marketing and manufacturing of tobacco products — including full disclosure of cigarette, cigar and other tobacco product ingredients. It also would require tobacco companies to expand the size of warning labels, ban harmful […]