A Bill to Ban Advertisement of Pharmaceuticals Background Information I. Current Advertising Regulations A.

Federal Food, Drug and Cosmetic Act 1. general standards for FDA’s regulation of prescription drug advertising directed to consumers and physicians (“FDA”) 2. require that advertisements present accurate information and fairly represent both the benefits and the risks of the advertised drug (“FDA”) 3. pharmaceutical companies are required to submit all drug advertisements to FDA when they are first disseminated to the public (“FDA”) B. FDA Regulatory Letters 1. FDA sends regulatory letters to companies that are in violation of its regulations (“FDA”) 2. letters are of two types—untitled letters and warning letters (“FDA”) 3. Untitled letters address violations such as overstating the effectiveness of the drug, suggesting a broader range of indicated uses (“FDA”) 4. Warning letters address more serious violations, including safety or health risks, or continued violations of the act (“FDA”) 5. Warning letters advise a pharmaceutical firm that FDA may take further enforcement actions, such as seeking judicial remediation (“FDA”) C. Requirements for Pharmaceutical Ads 1. cannot be false or misleading and must present a fair balance between the risks and the benefits of a drug product (“FDA”) 2. must reveal facts that are material to the representations made in the advertisement (“FDA”) 3. disclose all the risks listed in the product’s labeling (“FDA”) D. Types of Advertisements 1. reminder advertisements disclose the name of the product and dosage form or cost information, but they are not permitted to present its intended use (“FDA”) 2. reminder advertisements exempt from risk disclosure requirements (“FDA”) 3. help-seeking advertisements, which are not regulated by FDA, do not identify drugs by name and generally discuss a disease or condition (“FDA”) 4. product claim advertisements usually mentions a drug’s name and the condition it is intended to treat and describes the risks and benefits associated with taking the medication (“FDA”) E. Review by FDA's Office of Chief Counsel

1. in 2002 the Secretary of Health and Human Services began requiring that all FDA regulatory letters be reviewed and approved by the FDA's Office of Chief Counsel before they are issued (Donohue) 2. legal review has led to a reduction in the number of letters issued (Donohue) 3. FDA warning letters are frequently sent out long after the false or misleading advertising campaign has run its course (Donohue) II. Pharmaceutical Advertising Information and Facts A. Financial 1. Advertising campaigns generally begin within a year after the introduction of a pharmaceutical product (Donohue) 2. pharmaceutical companies spent $30.3 billion on research and development and $19.1 billion on all promotional activities (“FDA”) 3. Between 1997 and 2001, DTC advertising spending increased 145 percent, while research and development spending increased 59 percent (“FDA”) Affirmative Arguments I. Consumers and Regulators A. Increase in drug usage 1. clinical trials required for drug approval not designed to detect rare but significant effects (Donohue) 2. patients often self-diagnose and push doctors to prescribe unnecessary medications (Shin) 3. approximately 61.1 million consumers asking about specific medications they had seen on television (“FDA”) 4. about 8.5 million consumers received a prescription after viewing a DTC advertisement and asking their physician for the drug in 2000 (“FDA”) B. FDA’s current regulation inadequate 1. FDA cannot verify that it receives all newly distributed advertisements from pharmaceutical companies (“FDA”) 2. does not identify all advertisements that are broadcast on smaller networks, such as some cable television stations, or in some local markets (“FDA”) 3. in one case a misleading advertisement was broadcast in 2 years in Florida before FDA became aware of it (“FDA”) 4. takes about 45 days for violation letter to be reviewed and approved before sent out (“FDA”) II. Pharmaceutical Companies and Doctors A. Drug ads persuade rather than inform 1. leaves many people with exaggerated perceptions of the benefits of drugs (Mansfield)

2. nearly 84% of regulatory letters regarding direct-to-consumer advertising cited advertisements for either minimizing risks or exaggerating effectiveness (Donohue) 3. only 35% of ads encouraged viewers to obtain additional information from the company (Shin) B. Companies are wasting money and time 1. spending on promotion grew from $11.4 billion to $29.9 billion from 1996 to 2005 (Donohue) 2. Doctors must spend unnecessary time convincing patient that there is nothing wrong with them (Shin) 3. each 10 percent increase in DTC spending within a drug class increased sales in that class by 1 percent (“FDA”) Negative Arguments I. Consumers A. Informs consumers about potential medical conditions 1. average person spends at least 19 hours and 40 min watching TV every week (Shin) 2. ads spark interest so that potential patients will go to doctors (“FDA”) 3. the phrase “consult your doctor” is required to be placed on ads (Donohue) 4. strengthens doctor-patient relationships and trust in healthcare system (“FDA”) II. Pharmaceutical Companies and Doctors A. Doctors not heavily influenced by pharmaceutical ads 1. majority of doctors did not feel pressured to prescribe inappropriate medications (Shin) 2. advertised drugs recommended less than 40% of the time (Shin) 3. in every case, doctors also recommended lifestyle changes and alternative treatments (Shin) 4. advertised drugs discussed 31% of the time with only about one patient a week (Shin) B. Crucial for innovation and profit 1. companies make over $4.00 for every $1.00 spent in direct to consumer advertising 2. major cost driver increasing payments for health care for its workers (Mansfield) 3. companies would have less money to develop potentially life-saving medications 4. profits allow pharmaceutical companies to compete with generic brands that do not have to spend years and substantial amounts of money for research 5. politicians and toy companies spend same amount of money if not more on advertisements than drug companies (Mansfield) C. Removing ads will not lead to a more informed public 1. even with balanced and accurate information, public can still be confused and have false perceptions about drug’s effectiveness (Shin)

2. In countries where DTC is illegal, companies bypass regulations with disease oriented advertising, public relations campaigns, reminders, and unbranded direct to consumer advertising (Mansfield) III. Alternate solutions A. Increase regulations and funding to FDA 1. over the past few years, the FDA has been poorly regulating the drugs and their ads (Donohue) 2. number of reported violations in the past few years has decreased from 142 to only 21 (Donohue) 3. FDA and not FCC has more involvement with drug companies and their ads (Donohue) 4. FCC already promised increase in funding while FDA still understaffed (Donohue) 5. In 2002, three FDA staff members were dedicated to reviewing direct-to-consumer advertisements (Donohue) 6. mandatory waiting period on advertising for new drugs (Donohue)

Works Cited Donohue, J. M., M. Cevasco, and M. B. Rosenthal. "A Decade of Direct-to-Consumer Advertising of Prescription Drugs." New England Journal of Medicine 357.7 (2007): 673-81. Print. "FDA Oversight of Direct-to-Consumer Advertising Has Limitations." United States General Accounting Office. Oct. 2002. Web. 13 Sept. 2010. Mansfield, Peter R. "Direct to Consumer Advertising." BMJ. BMJ Publishing Group, 2005. Web. 15 Sept. 2010. Shin, Jaeun, and Sangho Moon. "Direct-to-consumer Prescription Drug Advertising: Concerns and Evidence on Consumers' Benefit." Journal of Consumer Marketing 22.7 (2005): 397403. Print.

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