OTC manufacturers face wave of challenges
WASHINGTON —Last month, the Food and Drug Administration officially banned the use of cough-cold medicines in infants and toddlers under the age of 2; two Congressmen called for a renewed Government Accountability Office review of a behind-the-counter class of drugs; and a prominent baseball executive criticized enforcement of the Dietary Supplement Health and Education Act in reference to a steroid hearing. (See story p. 65.)
All in all, not a particularly good month for purveyors of OTC and natural health products, especially given the implications—there is still no word from the FDA on whether it will ban the use of cough and cold medicines in children under 6, as has been requested by Joshua Sharfstein, Baltimore commissioner of health; there is still a concern that BTC class of drugs, if created, could potentially restrict access to medicines already available OTC; and legitimate and responsible dietary supplement manufacturers continue to be linked to controversy, in this case the distribution of what would be illegal steroids.
The FDA’s decision to ban the use of cough-cold medicines was whole-heart-edly supported by the industry, which voluntarily pulled those medicines off the shelves last fall, despite the fact that the news came just as the cold and flu illness rates began gaining traction. “I think the reason the FDA made their announcement [last month] was they felt that parents were not getting the message,” Linda Suydam, president of the Consumer Healthcare Products Association, commented during a press briefing held by CHPA last month. “[Those parents] needed to hear that these medicines should not be used for children under 2. We very strongly support that message and we will continue to reinforce that message.”
The CHPA press briefing, however, was held not to support the FDA ban on cough-cold medicines for toddlers, but to highlight a recent Centers for Disease Control and Prevention report, published in the American Academy of Pediatrics journal Pediatrics, that found that only a small percentage of emergency-room visits on account of medicines were attributed to the misuse or overdose of kids cough-cold medicines.
“This CDC review puts the overall discussion of pediatric cough and cold remedies into perspective by focusing on concrete data that address the real issue. These medicines are safe when used as directed,” Suydam stated.
According to the report, an estimated 7,091 patients nationwide aged 12 years and younger were treated in emergency rooms for adverse drug events from cough-cold medications, accounting for 5.7 percent of emergency room visits for all medications in this age group. Almost two-thirds, 64 percent, were for children age 2 to 5 years. Unsupervised ingestions accounted for 66 percent of estimated emergency department visits, meaning that the child was not necessarily overdosed by their guardian, but happened upon the medicine and consumed it without supervision.
The CDC, in the report, expressed concern that if cough-cold medicines for children younger than 6 years old were pulled off the market in an effort to reduce those adverse events, parents may be inclined to administer cough and cold medicines indicated for older children or for adults, anyway. “Even after the recall of products for children age 2 years, 64 percent of parents responding to a national survey still considered these medications very safe or somewhat safe and 20 percent plan to continue to use OTC cough and cold medication for their children age 2 years,” the report read.
On the BTC front, a 1995 GAO report studying the potential feasibility of a BTC class of drugs in the United States based on experiences abroad found that BTC medicines would neither necessarily increase access to medicines nor save healthcare payors any money.
House Energy and Commerce Committee Chairman John Dingell, D-Mich., and Oversight and Investigations Subcommittee Chairman Bart Stupak, D-Mich., last month requested an update of that evaluation. “Given FDA’s proposal and its recent public meeting on the issue, it is imperative that more data be provided to assess accurately the true benefits, if any, of a “Behind-the-Counter” class of drugs,” the letter, dated Jan. 16 reads. “We do not expect on-the-ground investigations in countries that have established a “Behind-the-Counter” class as in the previous study, but rather a rigorous examination of any additional data since the original study that may allow us to evaluate the effects of a third class of drugs.”
Of course, that first report was 10 years ago, when a large swath of medicines now available OTC were Rx-only, including Claritin and Prilosec. Now that more and more medicines have gravitated toward the self-care arena, the parameters may have changed. Couple that with the intense pressure on Congress to cut healthcare costs, and you have the makings for a potentially different report.