A Tissue Please?

Cough and cold products, hacked by government actions, are seeing sales declines.

Looks like the cough and cold category has caught a nasty case of the sniffles, and now the supermarket industry is looking to the feds for some relief.

Well, not exactly.

According to The Nielsen Company, sales in food, drug and mass outlets combined, including Walmart, in the overall cough and cold category dropped 4.5 percent in the 52 weeks ending Oct. 30, 2010, compared with the same period in 2009. Units dropped a whopping 7.7 percent.

The huge cold remedy category, with $3.2 billion in sales, was off 7.4 percent, with children's remedies plummeting by 9.1 percent. Cough and cold throat sprays were off 5.2 percent, following a decline of 8.9 percent for the same period a year ago. Nasal products, cough and cold throat sprays, cough syrups, and tablets all were down significantly — despite massive advertising efforts by the industry for everything from products to fight mucus to an online “Relief Finder” by Robitussin.

Is America getting healthier? Do we have fewer colds? Probably not. But one contributing factor could be recent publicity that casts doubt on the efficacy of over-the-counter cough and cold products.

“We want to believe these remedies will work because we're so desperately uncomfortable when we're sick,” John E. Heffner, MD, a pulmonologist and immediate past president of the New York-based American Thoracic Society, said in a recent WebMD feature article. “But clinical trials have not found that cough medicines are any better than a placebo.”

The Consumer Healthcare Products Association (CHPA) begs to differ. “The important role of OTC medicines in the treatment of many conditions is demonstrated by their presence in the treatment guidelines of many leading U.S. medical associations, in the high frequency at which the medicines are recommended by health care professionals, and in the wide use of the products by consumers,” the Washington-based CHPA says in a white paper published in Pharmacy Today.

One of the factors that may be attributed to the drop-off in sales of children's products is action by the Food and Drug Administration (FDA) in 2007 that resulted in new labeling for some children's cough and cold products, and spurred removal of some formulations from the market. FDA issued guidance that there is no evidence the products work in children under 2 years of age, and said some medicines could even be harmful to young children.

A new study by the Centers for Disease Control and Prevention (CDC) shows that emergency department visits because of adverse events from cough and cold medicines declined substantially among children younger than 2 after the voluntary withdrawal of nonprescription infant products in 2007.

The Atlanta-based CDC examined U.S. hospital emergency-room visits for cough and cold medicine-related adverse events among children under 12 for the 14 months before and after the product withdrawal. While the overall number of visits remained steady, they were reduced by more than 50 percent among children under age 2.

Other Problems

Now FDA is considering whether to restrict in-store access to cough and cold medicines containing the cough suppressant dextromethorphan, because of the number of youths who have overdosed from seeking the “buzz” that it can provide.

Additionally, the industry received a blow from the Patient Protection and Affordable Care Act, the new health care reform law, which removes OTC meds from the list of eligible medical expenses for reimbursement by flexible spending accounts (FSAs) and health savings accounts (HSAs).To fight back, the CHPA has led a coalition — including the Food Marketing Institute (FMI) and the National Grocers Association (N.G.A.) — that urges Congress to repeal that provision.

“The supermarket industry invested considerable resources into developing a system to make it convenient for our customers to use FSA debit cards for OTC medications,” says Leslie G. Sarasin, president and CEO of Arlington, Va.-based FMI. “Removing cough and cold medicines and other OTC products from the list of eligible nonprescription items in the FSA plan will certainly put an additional tax on our customers.”

Peter J. Larkin, president and CEO of Arlington-based N.G.A., concurs: “At a time when America's middle-class families are struggling to make ends meet, the new government restrictions that require a prescription to purchase an over-the-counter medicine using FSA funds is counterproductive and unfairly reduces consumers' health care benefits.”

Without action by Congress either to repeal or delay implementation of the provisions, they were to become effective Jan. 1, 2011, at presstime. In addition to requiring a prescription for OTC medicines to be eligible for coverage under FSAs and HSAs, the rules no longer allow consumers to purchase OTCs with their FSA debit and credit cards beginning Jan. 15.

“The supermarket industry invested considerable resources in a system for customers to use FSA debit cards for OTC medications.” —Leslie G. Sarasin, FMI

The coalition sent a letter to congressional leaders in mid-November urging the legislative body to take action on the issue during the December lame-duck session. FMI also submitted comments to the Internal Revenue Service (IRS) in early December, complaining that the agency's notice regarding treatment of OTC drugs under FSAs and health reimbursement arrangements appears to prohibit use of FSA debit cards for OTC drug purchases — even if the customer has a prescription. FMI at presstime was urging the IRS to issue additional guidance clarifying that prescribed OTC drugs substantiated at the point of sale in accordance with IRS standards can continue to be purchased with an FSA debit card.

The letter, signed by Jennifer Hatcher, FMI's SVP for government relations, also urged the IRS to consider a one- to two-year delay of the new requirements, to give retailers adequate time to make necessary technology changes and educate customers.

Of course, educating customers is an important role for in-store pharmacists, who are increasingly consulted on how to treat cold symptoms by customers.

According to a new honesty and ethics survey by Gallup, pharmacists placed in the top three among professionals for the eighth consecutive year. Druggists or pharmacists ranked third behind nurses, who ranked first, and military officers, who ranked second. Among respondents, 71 percent ranked the honesty and ethical standards of pharmacists as “very high” or “high” — an increase from 66 percent in 2009.