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Most Clicked FDLI SmartBrief Stories


1. FDA promotes drug-review chief

FDLI SmartBrief | Nov 18, 2009

Bob Temple was named deputy director for clinical science at the FDA's Center for Drug Evaluation & Research. With the assignment, Temple's role as acting director of the Office for Drug Evaluation I will no longer include drug promotion and marketing. TheRPMReport.com (11/16)


2. Genzyme plant encounters more manufacturing problems

FDLI SmartBrief | Nov 16, 2009

The FDA said it discovered bits of steel, rubber and fiber in five genetic-disorder drugs produced at Genzyme's plant in Allston Landing, Mass. Products affected include Cerezyme and Fabrazyme, which are being rationed after a viral contamination at the same facility during the summer. A Genzyme official said the foreign particles probably came from moving parts and sterile gowns that "can shed microscopic fibers or pieces of stainless steel that get into the vials," but the company throws out those adulterated products during its finishing process. Yahoo! (11/13) Boston Globe, The (11/14)


3. Study links moderate drinking and heart protection

FDLI SmartBrief | Nov 20, 2009

Moderate drinking can cut the risk of heart disease in men by as much as one-third and benefit women as well, a Spanish study has found. Researchers said the type of alcohol doesn't matter. HealthDay News (11/19)


4. 5 Democrats seek investigations into higher drug prices

FDLI SmartBrief | Nov 19, 2009

Four House Democrats wrote a letter asking the Government Accountability Office to review price increases implemented by the drug industry in light of reports of higher wholesale prices for prescription drugs. Sen. Bill Nelson, D-Fla., made a similar request to the HHS inspector general, saying the issue should be investigated at "the extent to which these increases may affect the Medicare and Medicaid programs." New York Times, The (11/18)


5. FDA: Some MRI contrast agents might cause serious skin disease

FDLI SmartBrief | Nov 18, 2009

Some contrast agents, including GE Healthcare's Omniscan, Bayer's Magnevist and Covidien's Optimark, appear to increase the risk of nephrogenic systemic fibrosis, a potentially fatal skin disease, in patients undergoing magnetic resonance imaging scans, the FDA said. The agency plans to raise the issue in a meeting of expert advisers in December. Reuters (11/17)


6. Drug executives list pros, cons of health reform

FDLI SmartBrief | Nov 19, 2009

Health reform legislation could increase drug benefits and decrease the cost of medications, potentially improving the public's perception of the pharmaceutical industry, said Jane Horvath, Merck & Co.'s senior director of public policy. However, the bill could mean more contribution from the industry through "Medicaid-style rebates" and also compromise relationships with academic researchers, said Horvath, whose concerns were echoed by other drug executives at a biotech conference in Philadelphia. Wall Street Journal, The (11/18)


7. FDA rejects painkiller by CombinatoRx, Neuromed

FDLI SmartBrief | Nov 17, 2009

Exalgo, a pain drug from CombinatoRx and Neuromed Pharmaceuticals, failed to gain FDA approval because of inadequacies in its regulatory application. The drug is an extended-release version of hydromorphone and a potential replacement for Purdue Pharma's Palladone, which was pulled from the market in 2005. Boston Globe, The (11/17)


8. FDA investigates safety of alcoholic energy drinks

FDLI SmartBrief | Nov 17, 2009

The FDA has requested proof from the companies that make alcoholic energy drinks, increasingly popular among young people, that the products are safe. A task force of state attorneys general and other officials says the combination of alcohol and caffeine is dangerous and should be banned, and the FDA is now asking drink makers for "their side of the story." Los Angeles Times (11/15)


9. FDA warns against mixing Plavix with Nexium, Prilosec

FDLI SmartBrief | Nov 18, 2009

Heartburn drugs Prilosec and Nexium should not be taken with Plavix because they reduce the effectiveness of the blood thinner by 50%, the FDA said. Instead, patients should use H-2 blockers, such as Johnson & Johnson's Mylanta and Boehringer Ingelheim's Zantac, for upset stomach caused by Plavix, the agency said. Los Angeles Times (11/17) Google (11/17)


10. FDA accuses Web sites of selling fake, unapproved drugs

FDLI SmartBrief | Nov 20, 2009

The FDA warned 136 Web sites as well as their Internet service providers and domain-name registrars for allegedly selling fake or unapproved prescription drugs, ranging from anxiety treatment Valium to weight-loss pill Acomplia. At least 90 of the sites were taken down, FDA spokeswoman Karen Riley said. Washington Post, The (11/19)




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