DirecttoConsumer Advertising of Prescription Drugs Aaron Stoddard Ms

Direct-to-Consumer Advertising of Prescription Drugs: Aaron Stoddard Ms. Whitney College Composition II Period: 5 A

Requirements for Ads Per FDA (Food and Drugs Advertising) regulations issued in late 1960’s, ads: n Must not be false or misleading n Must present “fair balance” between benefits and risk information n Must disclose “material” facts in light of claims made about product

What Does this Mean? n Accurately communicate indication(s) including context for any claim n Limitations on indication(s) Relevant patient population n Concomitant therapies/treatments n Likelihood of benefit(s) Communicate most important risks in a manner reasonably comparable to benefits (presentation and language) Cannot omit important information n Ø In plain language Ads must communicate an accurate and balanced picture of the drug product

How DTC Evolved n Up to 1980’s: consumer communications through “learned intermediary” n 1980’s: saw 1 st DTC ads and fallout --1983 -1985: FDA voluntary moratorium --1985: lifted, regulations provide “sufficient safeguards to protect consumers” n 1990’s: print ads proliferated n mid 1990’s: broadcast ads enters mix

Does DTC advertising. . . n Increase demand for advertised drugs? n Cause patients to pressure doctors for advertised drugs? n Cause inappropriate prescribing? n Increase the price of drugs or the cost of health care? n Harm the relationship between patients and doctors? n Is DTC advertising appropriate at all?

Does DTC advertising increase demand for advertised drugs? n DTC not primary driver of visits to doctor n DTC plays a role in generating questions for doctor n Patients still use their doctors as #1 information source when looking for more information about a drug or treatment n Pharmacists, nurses also highly ranked as sources

Does DTC advertising cause patients to pressure doctors for advertised drugs? n Some patients do expect a prescription because of a DTC ad n Asking about prescription drugs constant across time n Brand-specific requests are likely to be accommodated n n n Patients who ask about a brand are more likely to be prescribed that brand than patients who ask in general General Practitioners are more likely to prescribe a requested brand than Specialists General Practitioners report feeling more pressured to prescribe

Does DTC advertising cause inappropriate prescribing? n Vast majority of patients who ask about a brand have the condition that drug treats n Among physicians who did not prescribe requested drug, most common reasons were: drug not right for patient n different drug more appropriate n

Does DTC advertising increase the price of drugs or the cost of healthcare? n Patients rarely discuss cost of drugs with doctor n Certain groups are more likely to discuss cost: Women n Patients in poor health n Patient taking one or more prescription drugs n Patients without prescription drug payment plan n

Does DTC advertising harm the relationship between patients and doctors? n Patients report their doctors generally respond positively to questions n Greater percentage of doctors say patient having seen a DTC ad had positive impact on interaction, as opposed to negative impact n General Practitioners report more negative beliefs about potential negative effects of DTC ads than Specialists n n Physicians are evenly divided in opinions about overall impact of DTC ads on patients and practice- 1/3 positive, 1/3 no effect, 1/3 negative General Practitioners report a more negative overall impact of DTC ads on patients and practice than Specialists

Is DTC advertising appropriate at all? n DTC ads increase awareness of possible treatments n DTC ads do not convey information about risks and benefits equally well Physicians believe patients understand benefits much better than risks n Physicians believe DTC ads confuse patients about relative risks and benefits of drugs n Patient attitudes about many aspects of DTC advertising have become less positive over time n