Smoking cessation new delivery systems, indications may aid quit attempts -- consultant.

SMOKING CESSATION PRODUCT NEW DELIVERY SYSTEMS, EXPANDED INDICATIONS may help facilitate and increase consumers' quit attempts, Jack Henningfield, PhD, Pinney Associates, suggested at a Food & Drug Law Institute conference on tobacco dependence at Georgetown University April 9. The current FDA-approved indications for nicotine replacement drugs, such as "aid to smoking cessation," is "so narrow that is limits the focus" and the "appeal" of the OTC products, Henningfield said. The indication "turns people that are interested in action, which is the vast majority of smokers...to `light' cigarettes as their only alternative because they're not ready, willing or able" to attempt quitting, he added.

Increased access to nicotine replacement gum and patches through OTC availability "already appears to be expanding the health benefit" of the products, Henningfield noted. "But for other people, new products and...indications are needed to engage them in a treatment by giving them an alternative other than so-called `light' cigarettes."

Other possible indications for nicotine replacement aids include: treatment of withdrawal; decreased use of cigarettes and/or abstinence; prevention of relapse; prolonged abstinence; reversal of chronic effects; reduction of risk; and exposure reduction, Henningfield advised. "Two-thirds of the American public use what they believe are exposure reduction products -- cigarettes," he added, noting expanded indications for nicotine replacement products also potentially could divert users from attempting cessation.

Henningfield suggested increasing smoking cessation product use through "new nicotine formulations, improved palatability of existing drugs, better simulation of cigarette nicotine delivery, new delivery systems, new chemical entities" and new product combinations. The consultant noted, however, that although sensory effects and palatability can be improved, it may result in "increased abuse potential....How palatable do you want to make it?"

Henningfield presented one of three papers drafted for the conference on tobacco dependence medications. John Slade, MD, Robert Wood Johnson Medical School, New Brunswick, N.J., reviewed his discussion paper, "Tobacco Dependence: Innovative Regulatory Approaches to Reduce Death and Disease," and Joseph Page, Georgetown University Law Center, reviewed regulatory schemes for tobacco products and dependence therapies.

Slade maintained use of "light" cigarettes does not reduce illness; the products are seen by consumers as alternatives to quitting and their existence contributes to continued use. He noted that when using these products, consumers compensate for the lower levels of nicotine by smoking more intensely, so the theoretical risk reduction is not realized.

Participants at the meeting grappled with the inequality the current lack of regulation of cigarette claims presents to the pharmaceutical industry. Cigarette marketers are not required to have claims such as "light," "mild" or "low tar" approved prior to marketing. Approval of indications for reduction of risk from cigarettes for pharmaceutical nicotine replacement products must be approved by FDA at an expense that may serve as a disincentive to seek this expanded use.

The lack of social acceptance of long-term nicotine use also presents barriers to pharmaceutical company innovation, Kenneth Warner, PhD, University of Michigan, commented. The group discussed possible avenues to spur pharmaceutical innovation for smoking cessation products, such as "fast track" approval of new products or indications.

The panelists also debated the value of so-called "reduced-risk" tobacco products, such as R.J. Reynolds' Eclipse device, and whether tobacco companies should receive incentives to continue the development and testing of these products. Henningfield queried whether encouraging development of reduced risk tobacco products will "give even greater development and marketing advantages to tobacco companies." He continued: "It would not seem to me to be in the interest of public health to give the most liberalized system to the companies with the worst public health record in history." FDA approval of "reduced risk" products is a provision included in Sen. John McCain's (R-Ariz.) tobacco legislation (S 1415), which passed the Commerce Committee April 1 ("The Tan Sheet" April 6, p. 8).

"Failing to provide incentive for a less toxic product doesn't make much sense," Curtis Wright, MD, Adolor Corp., commented. Wright, a former deputy director of FDA's Division of Anesthetic, Critical Care & Addiction Drug Products said: "You could try to regulate this product out of existence, and you would fail. We have had very strong laws against other controlled substances on the books, and we enforce them vigorously with harsh and punitive sentences, and we have failed to substantially reduce their availability" Alternative nicotine delivery systems can be "regulated as tobacco-like product[s]" but should be "monitored" for potential long-term harm, he added.

Yale University School of Medicine Dean David Kessler, MD, commented that "reduced risk" products may "become more prominent." The former FDA head suggested it would be regrettable to allow the use of reduced risk products without rigorous scientific data to prove their value; the presence of "health claims" on products "should require the kind of rigor that one has with regard to all pharmaceutical products," he said. A vocal advocate of increased tobacco regulation, Kessler suggested the products might be allowed to enter the market with appropriate post-marketing surveillance of their usage, risks and benefits.

FDA Associate Commissioner for Policy Mitchell Zeller noted the agency has a "tremendous amount of discretion" under current law to regulate tobacco products. Zeller painted a "scenario" in which cigarettes are deemed Class II devices, allowing FDA to set forth performance standards for the products, ultimately leading to product modifications. He also requested panelists' input in establishing data requirements for approval of risk reduction claims.

The FDAer stressed the agency's "discretion" and "authority" to regulate tobacco products even without new tobacco legislation. A legal challenge to the agency's August 1996 tobacco final rule is under appeal and likely will end up being considered by the Supreme Court. Under the 1996 final rule, FDA would regulate tobacco products as devices. However, this scenerio has drawn considerable criticism from both the device industry and agency officials. McCain's legislation would require regulation of tobacco products under a separate category from other FDA-regulated products.

The one-day conference was sponsored in part through an unrestricted grant from SmithKline Beecham, which markets Nicorette nicotine polacrilex gum and the NicoDerm CQ transdermal patch; Bethesda, Md.-based Pinney Associates serve as consultants to the company. In addition to FDLI, meeting sponsors included the Georgetown University Center for Drug Development Science; the Society for Research on Nicotine and Tobacco; and the American Society of Addiction Medicine.