Drug Industry Must Consider Teens’ “Risk-Taking” Nature – Researcher

Limits on adolescents' access to potentially harmful products because of the high-risk behaviors associated with the age group should be considered, according to psychology researcher Laurence Steinberg, who will speak at FDA's public workshop on adolescents' decision making skills and their use of over-the-counter drug products.

Steinberg, a professor at Temple University, will present information from a study he wrote on why adolescents take risks at FDA's "Adolescent Over-The-Counter Drug Product Use" workshop Dec. 6 and 7 in Bethesda, Md.

The workshop, also sponsored by the National Institutes of Health and the Consumer Healthcare Products Association, will include discussions on promoting safe and efficient use of OTC drugs by adolescents, a topic FDA says has not been adequately explored (¹ (Also see "FDA Delves Into Unexplored Issue: Adolescent Use Of OTC Drugs" - Pink Sheet, 5 Nov, 2007.), p. 6).

Information gathered at the workshop will be used to identify appropriate consumer studies on OTC drugs and adolescents, and to define the type of consumer research needed to support OTC drug product approval for that population, FDA says.

In his "Risk Taking in Adolescence: New Perspectives From Brain and Behavioral Science" study, Steinberg says health-compromising behaviors tend to decrease among teens when changes in the context of risks occur, such as increases in cigarette prices, broader distribution of condoms and stronger enforcement of alcohol laws. These strategies are more effective than working at educating the age group on the issues.

"Efforts to provide adolescents with information about the risks of substance use, reckless driving and unprotected sex typically result in improvements in young people's thinking, but seldom change their actual behavior," Steinberg wrote.

"Some things just take time to develop, and, like it or not, mature judgment is probably one of them."

In an e-mail to "The Tan Sheet," Steinberg said he is not relating his findings "to OTC drug use in particular. Just to the fact that adolescence is a time of heightened risk-taking and that we need to make sure we limit their access to potentially harmful situations/substances."

The meeting will begin Dec. 6 with a general overview of the regulatory and marketing of OTC drugs by adolescents followed by panels on the decision-making skills of the group, their development and behaviors, according to an agenda FDA issued Nov. 28.

The second day will include a panel focused on promoting safe and effective use of OTC drugs to adolescents followed by a discussion by researchers, physicians and federal officials on opportunities for regulators, industry and NIH to enhance safe and effective use of OTCs by adolescents, the agenda says.

Richard Cleland, assistant director of the Federal Trade Commission's Division of Advertising Practices, will discuss the FTC's perspective of marketing OTCs. Cleland said he plans to include in his presentation information on FTC's enforcement action against Global World Media's Herbal Ecstacy .

According to the presentation Cleland provided to "The Tan Sheet," the product was an ephedra- and caffeine-containing supplement that was promoted to young people as giving a natural "high" and is "absolutely safe, no side effects."

In 1997, FTC ordered a ban on promoting the product to persons under 21 and began requiring strong warnings on ephedra products because of the potentially harmful effects of the substance.

However, FDA has banned the use of any amount of ephedra in supplement products. FDA's February 2004 final rule banning all ephedrine alkaloid-containing products was overturned by a federal district court but upheld by an appeals court before the Supreme Court declined to hear the case in May 2007 (² (Also see "Supreme Court Refuses Ephedra Case, Battle Against Risk-Benefit Continues" - Pink Sheet, 21 May, 2007.), p. 3).

Other speakers on the agenda include an Office of National Drug Control Policy executive who will discuss OTC-relevant lessons from the agency's National Youth Anti-Drug Campaign.

CHPA has partnered with the Community Anti-Drug Coalitions of America to educate consumers about cough medicine abuse in response to a growing problem with adolescent abuse of OTC products containing the ingredient dextromethorphan.

Sen. Joe Biden, D-Del., has introduced legislation to set a nationwide 18-and-older age limit on purchases of DXM-containing OTCs (³ (Also see "Biden DXM Bill Includes Age Limit, Bulk Ingredient Scheduling" - Pink Sheet, 5 Nov, 2007.), p. 6).

- Katie Stevenson ([email protected])