FDA Updates

Spotlight on oral care

Since February is National Children's Dental Health Month, it's an appropriate time to introduce new oral care products for children and adults.

'Tis the seasons for coughs, colds, and sore throats. Americans are expected to spend $3.6 billion this season on OTC remedies, 1.7% more than last year. The upsurge is attributed to media exposure of swine flu and a tough economy that has more consumers trying OTC remedies before they see their doctors.

Retail pharmacy managers are discovering that many third-party administrators do not agree that their inventory information approval systems meet compliance requirements set by the Internal Revenue Service for customers' use of flexible spending accounts.

More than 23 million Americans, close to 8 percent of the population, have diabetes. For drugstores, the medical nature of their retail business makes them the outlet of choice for shoppers purchasing diabetes products. Retail pharmacists may choose to maximize patient awareness by placing their diabetes-care display and educational literature near the pharmacy counter.

Nearly a third of all Americans have trouble getting a good night's sleep. Although customers seeking OTC help this year will have to rely on the old stand-by, antihistamines, a few new products are available.

More than 60 million Americans experience heartburn at least once a month, and at least 25 million suffer on a daily basis. A Nielson study reported early in 2009 announced that 94 percent of patients are satisfied with their OTC remedies. The study estimated that OTC medications annually save patients an average total of $174 each in office visits and medication costs. Because of fewer patient visits top physicians, the study attributes $757 million in annual savings to the U.S. healthcare system.

With the settlement of the class-action lawsuit brought against First DataBank and McKesson by third-party payors accusing the companies of conspiring to inflate average wholesale prices (AWP) of hundreds of drugs, AWP values will roll back from 1.25 to 1.20 times the drugs' wholesale acquisition cost (WAC).

Caused by herpes simplex virus type 1, cold sores, also known as fever blisters, are highly contagious and are present throughout the U.S. population in epidemic proportions. Because the stress of the new school year weakens the body's defenses and triggers cold-sore episodes, September may be called the start of the cold sore "season."

The kids are going back to school, and opportunities for exposure to head lice abound. In the U.S., an estimated 6 million to 12 million infestations occur each year among children 3 to 11 years old. This year, some new products offer relief.