BU Now » FDA

The FDA and antibiotics for animals

Dick Taffe — Wed, 14 Jul 2010 20:54:33 +0000

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. School of Public Health associate Professor Wendy Heiger-Bernays, in a BU Today interview, says until a major food-related illness alerts Americans to the dangers of the industrialized food suply, it’s a battle that agribusiness will continue to win.

“If the public wakes up and looks at where their food is coming from, I suspect there’ll be a significant push … But I don’t think we’re going to see something significant until we have numbers of cases of illness in the human population traced back to factory farms.”

Contact Wendy Heiger-Bernays, 617-638-4620, whb@bu.edu

FDA and outsourced drug making

Dick Taffe — Tue, 15 Jun 2010 22:15:03 +0000

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 will have little effect because branded drug manufacturers put their reputations on the line every day with their drugs already.

“I’d be surprised if the FDA requirements are a great improvement over what Pfizer and Merck already do to protect the integrity of their supply chain.”

Contact Kevin Outterson, 617-353-3103, mko@bu.edu

Drug firm snoops on FDA officials

Dick Taffe — Wed, 31 Mar 2010 21:53:24 +0000

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, says it’s disturbing.

“I don’t know what is more disturbing: that Amphastar hired the private detectives or that they are unapologetic about it after being caught.”

Contact Kevin Outterson, 617-353-3103, mko@bu.edu

Cookie dough recall

Dick Taffe — Fri, 19 Jun 2009 15:09:16 +0000

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

Dick Taffe — Tue, 16 Jun 2009 14:27:57 +0000

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 break down the battle lines.

Contact Tracey Maclin, 617-353-4688, tmaclin@bu.edu

FDA rule over tobacco just smoke?

Dick Taffe — Fri, 12 Jun 2009 13:14:18 +0000

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

Ron Rosenberg — Tue, 09 Jun 2009 18:35:44 +0000

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

Ron Rosenberg — Wed, 03 Jun 2009 18:40:05 +0000

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 health groups, notably the Campaign for Tobacco-Free Kids, as there is no mandate to eliminate nicotine, and limited reduction of toxins and carcinogens in tobacco.

Contact Michael Siegel, (617) 638-5160, mbsiegel@bu.edu

Could smokeless e-cigarettes derail FDA tobacco regulation?

Ron Rosenberg — Tue, 12 May 2009 21:29:18 +0000

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 stay off of conventional cigarettes. But because they look like cigarettes and simulate the act of smoking, these health groups, led by Sen. Frank Lautenberg (D-N.J.), want them removed, a reason that Michael B. Siegel, Professor of Social and Behavioral Sciences finds foolish and twisted.

“What’s behind the FDA regulatory scheme? Philip Morris, to be exact. The nation’s largest cigarette company is pushing this legislation because it would protect the existing cigarette market from potential competition like the e-cigarettes that are becoming popular….This is precisely why Philip Morris was brilliant in enticing ….health groups into supporting the FDA regulation of tobacco products.”

Contact Michael Siegel, 617-638-5160, mbsiegel@bu.edu

Congress moving closer for the FDA to regulate tobacco

Ron Rosenberg — Mon, 11 May 2009 14:02:49 +0000

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 chemicals, and eliminate the use of such terms as “light,” “mild” and “low.” School of Public Health Professor Michael Siegel , MD, has researched and written about tobacco control and smoking policies. He is familiar with the differences between the House and Senate versions and can discuss the proposed regulations.

Contact Dr. Michael B. Siegel, 617-638-5160, mbsiegel@bu.edu