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FDA Update: Week Of September 6, 2010

September 8, 2010

By Lori Clapper, Web Editor

Another Advertising Crackdown
According to a Reuters report, a group of "busy moms" met for a brunch in February 2009. One of the featured speakers was a nurse who sang the praises of the birth-control device Mirena, manufactured by Bayer Healthcare. As it turns out, the nurse was employed by Bayer.

Along with the website Mom Central, Bayer organized a series of events for young mothers. The pharmaceutical company provided the nurse with a script about Mirena and a survey to fill out before the mothers left. The FDA rebuked Bayer for these sessions, since no risks of the device were addressed. Under President Obama's vow for transparency, the FDA has been cracking down on such advertising techniques.

Find out what the FDA had to say in the Reuters Report.

FDA Getting On TRACK
Last Tuesday, the FDA launched the FDA-TRACK system, which will monitor more than 100 FDA program offices through data from key performance measures established each year. That data will be gathered monthly, analyzed, and presented each quarter to FDA senior leadership. The public will also be able to track this data and the agency's progress through the FDA-TRACK website.

Update On Cough Syrup
Should the FDA put restrictions on Robitussin, NyQuil, and other over-the-counter cough medicines to curb abuse? That's the question regulators are trying to answer after the FDA posted its review of dextromethorphan, an ingredient found in more than 100 OTC medications, last Tuesday.

Medications containing dextromethorphan are often abused for its euphoric effects. According to the Associated Press, the FDA reported that the ingredient was linked to almost 8,000 emergency room visits in 2008. The agency also concluded that dextromethorphan is abused less often than codeine, but more often than pseudoephedrine, which is used to make methamphetamine. In response to these findings, the FDA plans to re-evaluate how it regulates dextromethorphan, possibly even making the drug available only by prescription.

Read more in the Associated Press report.

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