PHARMACY

FDA investigation suggests online drug sales driven by lax prescription rules

BY Allison Cerra

WASHINGTON A yearlong Food and Drug Administration investigation has found that consumers may be purchasing drugs online to avoid the need for a prescription from their physician.

Although several drugs are mailed to the United States from foreign countries more often than not, the FDA sampling of imported drugs also indicates that consumers continue to spend money unnecessarily on potentially risky drug products bought over the Internet.

The investigation found 88 percent of the 2,069 drug packages examined appeared to be prescription medicines available in the United States. Among the remaining products were dietary supplements, foreign products with “incomprehensible labeling”, and some were medications not available in the United States.

The FDA stressed the risk of purchasing drugs online, as they may be a front for an illegal operation. Unregulated Internet drug sellers, they said, might have products which might not contain the correct ingredients and could contain toxic substances.

“The data lead us to believe that many people are buying drugs online not to save money but to bypass the need for a prescription from their doctor since these Web sites typically do not require the purchaser to have a prescription,” said Randall Lutter, FDA’s deputy commissioner for policy. “In essence, they seem to be getting and using prescription drugs without a prescription, an intrinsically risky practice.”

Meanwhile, more than half (53 percent) of the products sampled have FDA-approved generic versions, likely sold at lower costs, according to earlier studies that have shown generics in the United States to be generally cheaper than a comparable drug in Canada or Western Europe. Approved generic versions of nearly half (47 percent) of the sampled products can be bought for $4 at several national chain pharmacies, a price often lower than the shipping costs for the same drugs purchased online.

These data are based on surveys conducted from September 2006 to August 2007 in international mail facilities and courier facilities across the country. At each city, all parcels suspected by customs and border patrol of containing pharmaceuticals were stopped for a period of 24 hours. The FDA then recorded data on the contents of these packages, before handling them in accordance with its usual procedures.

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N.J. Rep. criticizes FDA over weaker antidepressant warnings for children

BY Drew Buono

WASHINGTON Rep. Mike Ferguson, R-N.J., is criticizing the Food and Drug Administration, for its revised antidepressant medication guides because the warnings for children take the medications have been weakened compared to the old guide.

Ferguson said the guides include more generalized information regarding the risks for children, teenagers and young adults taking antidepressants. He also stated that the new guides use a generic warning that combines all three age groups into one category and abbreviates safety information. 

In October 2003, the FDA issued an advisory warning of the increased risk of suicide in pediatric patients taking selective serotonin reuptake inhibitors for depression. After reviewing more data from pediatric studies, the agency told antidepressant manufacturers to revise their product labeling to include the risk of suicide in children and adolescents.

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Herbert Luther appointed Perrigo’s VP of global regulatory affairs

BY Drew Buono

ALLEGAN, Mich. Perrigo has announced that Herbert Luther will become the company’s vice president, global regulatory affairs.

In this role, Luther will be responsible for developing and executing regulatory-submission strategies, ensuring best practices, and implementing technologies to enhance efficiency.

Luther has over 20 years experience in the development of regulatory and clinical strategies. Before joining Perrigo, he worked at KV Pharmaceuticals, where he was vice president of regulatory/clinical affairs. Before that, he served as director of regulatory affairs at Barr Laboratories.

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