PHARMACY

FDA appoints Torti principal deputy commissioner

BY Drew Buono

WASHINGTON The Food and Drug Administration has appointed Frank M. Torti as principal deputy commissioner and the first chief scientist. The position of chief scientist was created as part of the FDA Amendments Act of 2007.

As chief scientist and a member of the agency’s senior leadership team, Torti will support the launch of the FDA Fellowship Program, which has the potential to attract up to 2,000 professionals of varying disciplines for a two-year training program to help bridge the processes from scientific discovery through clinical development and regulatory review. As well, the new office will work to ensure the quality and regulatory focus of the intramural research programs of the agency, and place special emphasis on the importance of clinical research trials.

Torti currently is serving as the Charles L. Spurr Professor of Medicine, chairman of the Department of Cancer Biology, and director of the Comprehensive Cancer Center at Wake Forest University School of Medicine.

“Dr. Torti’s impressive clinical and scientific credentials are an excellent match for the work we do on a daily basis to promote and protect the nation’s health as a science-based and science-led agency,” said FDA commissioner Andrew von Eschenbach. “FDA’s Chief Scientist will ensure that the foundation of the FDA’s regulatory structure will always be state-of-the-art science.”

Torti will join the agency in May.

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Kaiser grows My Health Manager personal health records program

BY Drew Buono

Oakland, Calif. Kaiser Permanente, an integrated health plan has announced that is has more than two million members using its personal health record, My Health Manager

My Health Manager provides features including online appointment scheduling and prescription refills. In addition, users have 24/7 online access to lab test results, eligibility and benefits information, and even their children’s immunization records. With secure e-mail messaging, members can also communicate with their doctors at anytime from anywhere.

“My health manager is strengthening the doctor-patient relationship by allowing them to more frequently communicate with one another and do so through multiple channels,” said Anna-Lisa Silvestre, vice president for online services. “Despite the fact that it involves sitting behind a computer, consumers feel like their providers are more available to them than ever.”

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Authorities seize over $100,000 in unapproved drugs marketed as natural supplements

BY Drew Buono

Washington U.S. Marshals seized more than 14,000 dosage units of natural supplements, valued at more than $100,000, titled: Shangai Regular, Shangai Ultra, Super Shangai, Naturale Super Plus and Lady Shangai at the request of the Food and Drug Administration. The products were marketed as treatments for erectile dysfunction, impotency and/or sexual enhancement, which caused them to be drugs under the Federal Food, Drug, and Cosmetic Act.

The packages of these products did not list the drug ingredients on the label and when tested by the FDA, it was discovered that the ingredients were FDA-approved drugs for ED. The agency started looking into the supplements after receiving a consumer complaint.

The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin, according to the FDA, and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these medical conditions. Because they may have been advised against taking ED drugs, they may seek out products like these because they are marketed as “all natural” or as not containing the active ingredients in approved, prescribed ED drugs.

Despite being advised of the findings and the potential adverse health risk posed by the seized products and that regulatory action was possible, the company, Shangai Distributors, did not take any action to correct the violations, according to the FDA.

The FDA issued a press release on Dec. 28, 2007 advising consumers not to buy or use the products. Prior to the seizure, the Puerto Rico Department of Health embargoed the seized products to protect the citizens of Puerto Rico and to support the FDA’s enforcement actions.

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