PHARMACY

PhARMA urges quick appointment of new FDA commissioner

BY Michael Johnsen

WASHINGTON On the day after the elections, the Pharmaceutical Research and Manufacturers of America called on president-elect Barack Obama to quickly fill the post of Food and Drug Administration commissioner—a role that has experienced quite a bit of turnover in the past eight years. Reports published Friday speculated that Janet Woodcock, presently director of the Center for Drug Evaluation and Research, is the top choice of drug makers, citing people associated with the industry.

Presidents traditionally name a secretary of Health and Human Services before appointing an FDA commissioner. Former Sen. Tom Daschle, D-S.D., and Democrat Kansas Gov, Kathleen Sebelius are contenders for health secretary, reports stated, citing people in contact with Obama’s healthcare advisers.

“Due to the vital nature of the FDA’s public health oversight, identifying a strong, independent FDA commissioner should be among the first accomplishments of the new administration,” stated Billy Tauzin, PhRMA president and chief executive officer and a former prominent Democrat-turned-Republican Louisiana politician. “The ideal candidate should embrace the need to advocate for an empowered FDA that is adequately resourced to carry out its crucial mission. The individual also must have strong managerial skills that are essential for directing science-based activities at an agency that has just expanded its ranks with thousands of new employees. These skills are particularly important to an agency that is striving to implement groundbreaking reforms to better position itself to tackle future challenges, including modernizing FDA methods for evaluating safety and efficacy throughout a product’s life cycle.”

Among other FDA commissioner candidates being pitched to the president are Baltimore City health commissioner Joshua Sharfstein, the principal person behind a citizen’s petition filed to the FDA requesting that children’s cough-cold medicines indicated for children under the age 6  be removed from the market. Sharfstein previously worked for Rep. Henry Waxman, D-Calif.

Obama campaigned for president promising to overhaul the U.S. healthcare system, and he spoke at times about the need to improve food and drug safety.

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FDA announces recall of Tyco ReliOn single-use syringes

BY Alaric DeArment

ROCKVILLE, Md. Food and Drug Administration said Wednesday that Tyco Healthcare Group is recalling a lot of its ReliOn single-use syringes for diabetics.

The recall affects lot number 813900, which contines 100 31-gauge ReliOn hypodermic syringes containing 1 milliliter of U-100 insulin. Tyco distributed 4,710 boxes in the recalled lot, totaling 471,000 individual syringes. Wal-Mart sold the syringes at its stores between Aug. 1 and Oct. 8, and Tyco voluntarily recalled the lot Oct. 9. Wal-Mart has sent letters to 16,500 customers notifying them of the recall and posted an announcement on its Web site.

Can-Am Care distributes the syringes and sells them through Wal-Mart and Sam?s Club stores under the Reli-On brand. The mass-merchandiser has requested that all users of this type of syringe return those that come from the recalled lot.

The FDA said that during the packaging of the syringes, some syringes labeled for use with U-40 insulin were mixed with syringes labeled for use with U-100 insulin and then packaged individually and in boxes as 100 units for use with U-100 insulin. Tyco has received one report of complications due to use of a syringe from the recalled lot.

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Medical information leaks prompt added awareness about records security

BY Alaric DeArment

CHICAGO News reports about high-profile victims of personal medical information security and privacy breaches highlight the need to educate and inform healthcare professionals, their employees, the media and consumers on privacy protection, an professional organization for the health information management industry said Thursday.

The American Health Information Management Association said that educating healthcare professionals on privacy and security issues is an ongoing concern within the health information industry.

“It’s critical for healthcare professionals to receive more education about good privacy practices and appropriate interpretation of HIPAA and other regulations,” AHIMA president Wendy Mangin said.

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