FDA Updates

A survey of new Rx, new generic, and new OTC products

Underlying a recent FDA-hosted public meeting and workshop was the question of how FDA as a regulatory agency should increase its current oversight of clinical laboratories, specifically those developing genetic tests that may be offered at their own facilities or made available through direct-to-consumer channels.

Annoying hair and scalp problems distress many families. Manufacturers offer a number of over-the-counter products that can help.

A survey of new Rx, new generic, and new OTC products

Pharmacists are in a good position to tell patients that sand, water, snow, and clouds reflect and intensify the sun's rays, causing unsuspected sun damage, even in shade, and that protecting skin from sun damage should be incorporated into a daily routine.

Summer brings picnics, hikes, and trips to the water, along with sunburn, bug bites, and dry, itchy skin. For all that exposed skin, manufacturers offer several new skin-care aids.

A survey of new Rx, new generic, and new OTC products

The Dietary Supplement Health and Education Act of 1994 greatly reduced FDA involvement in assessing the safety of dietary supplements, leaving pharmacists with the problem of obtaining accurate information with which to advise patients.

A survey of new Rx, new generic, and new OTC products

As Americans increasingly turn to vitamins and herbal supplements as alternatives to prescription drug use, medical professionals and government leaders worry that few realize the implications.

A survey of new Rx, new generic, and new OTC products

Our feet contain one-fourth of all the bones in our bodies, 33 joints, and a network of more than 100 tendons, muscles, and ligaments, to say nothing of blood vessels and nerves. Small wonder that foot ailments afflict millions of Americans. Fortunately, manufacturers offer an arsenal of relief.

On May 11th the news that Walgreens, partnering with Pathway Genomics, was going to offer customers a genetic testing kit made headlines almost as fast as a world peace announcement. Then Pathway received a letter of inquiry from the FDA, and Walgreens decided to halt the initiative until more clarity was reached. However, when genetic testing kits do become available at retail outlets, there will be a need for plenty of patient education, which pharmacists can best provide.

New OTC packaging intended to enhance patient safety began appearing on pharmacy shelves after a new rule for OTC internal analgesic, antipyretic, and antirheumatic drug products took effect on April 29, 2010.

A survey of new Rx, new generic, and new OTC products

More than 50 million Americans, including up to 40% of children, suffer from indoor and outdoor upper respiratory allergies. This year, several manufacturers have new offerings to control and treat asthma, allergy, and sinus symptoms.

A survey of new Rx, new generic, and new OTC products

Aging boomers and couch potatoes returning to spring outdoor activities need help for their aching backs, creaky joints, sore muscles, and headaches. Some new products designed to help have arrived on the market.

Eye and ear-care products are important to patients ranging from children with earaches to aging baby boomers with dry eyes.

A survey of new Rx and new OTC

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

A survey of new Rx, new generics, new indications, and new OTC

'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.

A survey of new Rx, new generics, new indications, and new OTC

A survey of new Rx, new indications, and new OTC

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.