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State of Vermont

House of Representatives

Montpelier, Vermont

Joint House Resolution

Offered by: Representatives DePoy of Rutland City,Connell of Warren, Endres of Milton, Keogh of Burlington, Kirker of Essex, Kitzmiller of Montpelier, Koch of Barre Town, Mullin of Rutland Town, Severance of Colchester, Stevens of Essex, Vincent of Waterbury and Woodward of Johnson

Whereas, the cost of prescription drugs is now unaffordable for a large number of Vermonters, and

Whereas, among the persons who are most reliant on prescription drugs are Vermontís senior citizens whose Medicare insurance does not include prescription coverage, and who frequently cannot afford to purchase a Medigap plan with prescription drug benefits, and

Whereas, many senior citizens are reluctantly adopting unhealthy and potentially dangerous practices of reducing their physiciansí prescribed prescription drug dosages, or traveling to Canada to obtain their prescription drugs for lower costs, and

Whereas, one of the significant factors contributing to the increasing costs of prescription drugs is the growth of direct consumer promotional campaigns sponsored by the nationís pharmaceutical companies through the print, broadcast, and internet media, and

Whereas, under Section 201(m) of the Food, Drug and Cosmetics Act, the Food and Drug Administration is responsible for regulating the promotional activities associated with prescription drugs, and

Whereas, although the act does not define a prescription drug advertisement, the federal regulations at 21 C.F.R. ß 202.1 describe a prescription drug advertisement as consisting of "information (other than labeling) that is sponsored by a manufacturer and that is intended to supplement or explain a product", and

Whereas, the media in which prescription drug advertising can appear includes magazines, newspapers, radio, television and the internet, and

Whereas, the regulations require that prescription drug advertisements include brief summaries of information relating to possible side effects, contraindications and effectiveness, and

Whereas, this information is often overshadowed by the attractive and promotional character of the advertisement that has the potential to lure a layperson into accepting the positive claims and ignoring the less prominently promoted and possibly dangerous side effects, and

Whereas, until the early 1980s, pharmaceutical companies directed the vast majority of their prescription drug advertising toward licensed physicians, and

Whereas, in 1983, the pharmaceutical companies agreed to the Food and Drug Administrationís request for a voluntary moratorium to explore the effects of direct consumer advertising, and

Whereas, in 1985, the moratorium was withdrawn without promulgating regulations to address the unique nature of direct consumer prescription drug advertising, and

Whereas, television ads have grown swiftly since 1997, when the Food and Drug Administration issued more relaxed guidance for direct consumer broadcast advertising, and

Whereas, most consumers do not have the expertise to evaluate prescription drug advertising, and

Whereas, prescription drug advertising may be misleading by not adequately communicating risk information, and may damage physician-patient relationships, increase prescription drug prices, increase liability actions, and lead to overmedication and drug abuse, and

Whereas, the National Institute for Health Care Management, a nonprofit and nonpartisan organization, recently conducted a study that documented the multiple impacts of increased consumer advertising of prescription drugs, and

Whereas, the study documented that retail spending on prescription drugs rose to $111.1 billion in 1999, up from $93.4 billion in 1998, while the comparable advertising increase, during the same one-year period, rose from $1.3 billion to $1.8 billion, and

Whereas, while the instituteís study did not specifically examine the accuracy of prescription drug advertising, the Food and Drug Administration has repeatedly reprimanded drug companies for false or misleading advertising of prescription drugs that are prescribed for many maladies, including allergies, reduction of high blood pressure or cholesterol levels and sexually-transmitted diseases, and

Whereas, if the cost of prescription drugs is to be substantially reduced, and the numerous and complex medical claims directed at consumers more closely reviewed, then the Food and Drug Administration must adopt new, more stringent and effective regulatory restrictions on direct consumer prescription drug advertising, now therefore be it

Resolved by the Senate and House of Representatives:

That the General Assembly urges the federal Food and Drug Administration to institute a moratorium on the promotion of prescription drugs directly to consumers, and that during the moratorium, the Food and Drug Administration promulgate more effective regulations to address prescription drug advertisements directed to consumers, and be it further

 

 

 

 

Resolved: That the Secretary of State be directed to send a copy of this resolution to Dr. Bernard A. Schwetz, Acting Principal Deputy Commissioner of the Food and Drug Administration in Washington, D.C., and to the members of the Vermont Congressional Delegation.

 

___________________________ Attested to:

Speaker of the House

___________________________ ___________________________

President of the Senate Donald G. Milne

Clerk, House of Representatives