A CONCURRENT RESOLUTION urging the United States Congress, Department of Health and Human Services, and Food and Drug Administration to limit, ban or otherwise impose strict standards on direct-to-consumer advertising of drugs by pharmaceutical companies.

WHEREAS, the United States is the only English-speaking country that allows pharmaceutical companies to advertise their prescription drug products direct to consumers; and

WHEREAS, in 1997, the federal Food and Drug Administration (FDA) relaxed restrictions on the content of direct-to-consumer prescription drug advertising, withdrawing the prior requirement for a summary of side-effect and adverse reaction information and replacing it with a requirement for a statement about "major risks" but not "all" risks; and

WHEREAS, the shorter "major risk" statement made television and radio advertisements about prescription drugs more practicable; and

WHEREAS, pharmaceutical companies spent $1.8 billion on direct-to-consumer advertising in 2000, up from $220 million in 1996; and

WHEREAS, while health care spending generally is expected to increase by an average of 7.2% per year between 1998 and 2010, exceeding the 5.2% annual growth of 1993 to 1998, total prescription drug expenditures will increase by 15% per year as early as 2004; and

WHEREAS, numerous studies have linked the increased direct-to-consumer advertising to the exponential growth in prescription drug expenditures; and

WHEREAS, surveys suggest that 50% of the public believe that direct-to-consumer advertisements of prescription drugs must be submitted to the government for prior approval, 43% believe that only "completely safe" drugs may be advertised directly to consumers, 22% believe that advertising of drugs with serious side effects has been banned, and 21% believe that only "extremely effective" drugs may be advertised directly to consumers, and yet all of these beliefs are untrue; and

WHEREAS, consumers with these mistaken assumptions are placing pressure on their prescribers to prescribe these drugs, causing some patients to: (1) become angry if prescribers refuse to prescribe the drug, even if the drug is medically unnecessary or contraindicated; (2) become angry if the prescribers urge low-fat diets, stress management, or allergen avoidance as lifestyle alternatives to pharmacological therapy; and (3) question the prescriber's trust and the overall patient/prescriber relationship; and

WHEREAS, direct-to-consumer advertising is having a harmful effect on the role of prescribers and on prescriber morale by accelerating an advance toward patient autonomy, supplanting beneficence as the guiding ethical principle of medical practice with acquiescence to the partially informed patients' insistence on a course of drug therapy treatment suggested in misleading or misdirected advertising; and

WHEREAS, a 1997 study of family physicians revealed that 80% believed that direct-to-consumer advertising was "not a good idea"; and

WHEREAS, the federal Food and Drug Administration (FDA) has begun a review of the policy that unleashed an explosive growth of prescription drug advertising;

NOW, THEREFORE, Be it resolved by the House of Representatives and the Senate of the General Court of the Commonwealth of Massachusetts the following:

Section 1.   The General Court of the Commonwealth of Massachusetts urges the United States Congress and the Department of Health and Human Services to recognize the problems caused by direct-to-consumer advertising of prescription drugs by pharmaceutical companies.

Section 2.   The General Court urges Congress, the Department of Health and Human Services, and the Food and Drug Administration to study the effects of direct-to-consumer advertising of prescription drugs by pharmaceutical companies on the health care system, on the prescriber/patient relationship, on the quality of care received by patients, and on the increasing costs of prescription medications.

Section 3.   The General Court urges the Food and Drug Administration to aggressively monitor and regulate direct-to-consumer advertising of prescription drugs by pharmaceutical companies, pending Congressional action to limit, ban, or place increased restrictions on such advertising.

Section 4.    The General Court urges the United States Congress to limit or ban direct-to-consumer advertising of prescription drugs by pharmaceutical companies, or alternatively, to require that advertisements: (1) remind consumers that prescribers and pharmacists are the best sources of information about appropriate medical treatment and drug therapy; (2) explicitly state the success and failure rates of drugs and compare them with other common products and "no treatment"; (3) mention alternate treatments by name and class; and (4) refer consumers to independent sources of drug information.

Section 5.   The Clerk of the Senate is directed to transmit a copy of this Resolution to the Secretary of the United States Department of Health and Human Services, the Director of the Food and Drug Administration, and to each member of Massachusetts's Congressional delegation.