FDA Updates

Starting this month, the Patient Protection and Affordable Care Act requires employees with tax-advantaged health accounts to have a prescription for an OTC drug to qualify for account reimbursement and preferred tax treatment. Insulin and OTC medical devices and supplies are exempt.

OTC Product News

In this section we showcase products and product news that ran up against space limitations or fell outside the parameters of recently featured categories in the print edition. Look for more OTC Product News in upcoming issues of the Drug Topics e-newsletter.

Lip care products

To help provide consumers with some protection against winter ailments, manufacturers have introduced a number of new treatments and preventives for dry lips and cold sores, as well as cold and flu medicines for children.

Does she or doesn't she? Only her drugstore knows for sure. Even in today's racy culture, certain products are not discussed in polite company. Yet even blushworthy personal care products are essential, and their manufacturers are tuned to the preferences of 78 million style-conscious Baby Boomers.

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.

Heading off scalp problems

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

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.

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.

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.

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.

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.