FDA to Strengthen Drug Safety
The FDA has made recommendations to Congress for the next reauthorization of the Prescription Drug User Fee program that are designed to broaden and upgrade the agency's drug safety program, increase resources for review of television drug advertising, and facilitate more efficient development of safe and effective new medications for the American public. To carry out its proposed agenda, the agency is proposing that the annual user fee collections be increased by $87.4 million to $392.8 million.

The user fee program, which was first authorized by the Prescription Drug Use Fee Act (PDUFA) in 1992, adds industry's funds to the agency's appropriations to help FDA's human drug review program. PDUFA programs have to be reauthorized by Congress every five years.

Infants' Fluoride Consumption Should Be Monitored
The FDA's recent announcement that it will permit bottlers to make claims that fluoridated water may reduce the risk of tooth decay is prompting some dentists to warn their patients that the fluoridated water is not intended to be used by infants for whom lesser amounts of fluoride are appropriate. "Parents who are using baby formula in the first year of a child's life want to closely evaluate the amount of fluoride in the water," said Dr. Dick Wiberg, President of the Minnesota Dental Association.

While fluoride is essential to help prevent tooth decay, intake above optimal levels creates a risk for enamel fluorosis which, while not a disease, can affect the way teeth look. The usual result of enamel fluorosis is faint white lines or streaks on tooth enamel. Some studies suggest that infants could receive higher than optimal amounts of fluoride through liquid concentrate or powdered baby formula that has been mixed with fluorinated tap water or fluoridated bottled water.

Orthopedic Surgeons Say FDA Approvals Too Slow
An overwhelming majority of orthopedic surgeons (76%) who took part in a recent survey conducted by The Polling Company believe the FDA is too slow in approving new drugs and medical devices. Also, 80% of the surgeons also want to see Vioxx, which was voluntarily withdrawn in 2004, return to the market.

Other key findings include: 60% believe the FDA hinders their use of new therapies; 73% believe the FDA approval delays hurt patients; and 70% favor changing the law to give physicians access to unapproved therapies if they carry a warning about their unapproved status.

FDA Defends Panel's Recommendations on Birth Control Safety
The Reproductive Health Drugs Advisory Committee, an FDA advisory panel, recently recommended that the agency expand its post-marketing survelliance of oral contraceptives and require that manufacturers study safety and efficacy in wide-ranging populations. The FDA criticized the media for creating "misconceptions about the effectiveness of newer generation hormonal contraceptives." In a statement released by the agency following the panel's recommendations the FDA said the stories are inaccurate and that "the newer generation products are highly effective in preventing pregnancy."

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