Extensions of Remarks 11147

Mr. STARK. Mr. Speaker, I rise today to introduce the Fair Balance Prescription Drug Advertisement Act, a bill to deny tax deductions for unbalanced direct-to-consumer (DTC) pharmaceutical advertising placing more emphasis on product benefits than risks or failing to meet Federal Food, Drug and Cosmetic Act requirements. This bill will ensure that prescription drug advertisements provide the public with balanced information concerning product risks and benefits. For example, the bill requires that pharmaceutical ads utilize equivalent space and type size in print ads and equal air time in broadcast media—such as television, radio and telephone communication systems— for risks and benefit descriptions. Today, most drug advertising emphasizes product advantages while failing to clearly—if at all—explain often numerous potential disadvantages. By denying any tax deduction for such advertising, this bill will encourage drug companies to halt these harmful practices that have been shown to increase health care expenditures, mislead the public, adversely affect physician prescribing practices and lead to unnecessary injuries and deaths. Responsibilities of the FDA and Treasury Departments are to be clearly delineated through regulation. Since the FDA loosened its DTC advertising requirements in 1997, drug companies have doubled their advertising budgets and spent billions extolling the benefits of their products. DTC advertising increased nearly 20-fold during the 1990s. Last year, drug companies spent nearly $2 billion advertising to consumers, with $1.1 billion for television ads alone. As one would expect, such advertising has a direct impact on drug expenditures. DTC advertising leads to more physician office visits, increased patient requests for expensive, brand name drugs—even where a generic drug is available—and over-prescribing of optional ‘‘lifestyle’’ drugs. Americans spent more than $100 billion on prescription medicines last year—i.e., about 10 cents in every health care dollar. U.S. sales for the antihistamine Claritin, No. 1 in DTC advertising, were $2.3 billion last year, while the well-advertised heartburn medication, Prilosec, brought-in $3.8 billion in sales. Not surprisingly, drug spending increased at a rate of about 15%–18% last year and is on the rise. Contributing to overall increased expenditures, drug prices continue to soar. On average, prices for the 50 most-prescribed drugs for senior citizens increased at twice the rate of inflation over the past six years—with some drug prices increasing at four times the rate of inflation. Business Week reports that the hikes in drug prices are not only tied to new ‘‘wonder pills,’’ but also to the drug industry’s bloated advertising budget. Such spending is particularly troublesome since consumers receive inadequate information about the drugs they purchase. More and more commonly, both television and print ads have become the subject of ridicule due to their inaudible or illegible short list of warnings. A recent cartoon in the Washington Post mocked the typical concluding remarks of a prescription drug TV ad: ‘‘WARNING: This drug commercial will be followed by a disclaimer that may cause nausea, disgust, and serious doubts.’’ A typical Washington Post newspaper ad for Prilosec highlights the drug benefits on a full-page, large print, color ad, and includes a prominent $10 rebate offer. Yet the most important drug information—warnings, contraindications, indications, usage, precautions and adverse reactions—appear on the next page of the paper, separated by two, full columns of World News and in type size that is almost too small to be read by the naked eye. Unfortunately, such advertising has become the norm. Although the Federal Food, Drug and Cosmetic Act and the Food and Drug Administration (FDA) regulations and guidelines currently regulate drug advertisements, pharmaceutical ads most often fail to provide the public with adequate information about potentially dangerous drug side effects. RxHealthValue is a new, independent group, representing more than 30 consumer groups, private employers, purchasers, health care providers, labor unions and academics. Last month, this organization recommended that the FDA ‘‘develop standards for full disclosure of drug risks and benefits information for all prescription drugs advertised directly to consumers.’’ The group also called for specifying that ‘‘fair balance’’ means that full disclosure of risks and side effects is given equal print or air time as the description of benefits in the same communication. I would also like to insert in the RECORD a May 3, 2000 USA Today article providing further evidence of the need for adequate information about drug risks. According to the article, less than 1% of physicians have seen a drug label in the last year. And ‘‘in many cases, patients never even see the package insert, and when they do, the tiny typeface and medical jargon often leave them more confused than ever.’’ These inserts are jampacked with important warnings and most often go unnoticed. The article reports that drug labels are complex and fail to provide patients and doctors with critical information. Consequently, many patients and doctors fail to read drug labels, leading to inappropriate prescribing, illness and even death. The article also cites the recent withdrawals of Rezulin, Posicor, Duract and the anticipated removal of Propulsid as evidence that both patients and physicians are unaware of critical drug information. The FDA noted that after altering Rezulin’s label to recommend monthly liver function tests, less than 10% of patients had the tests. And 85% of the 270 Propulsidrelated adverse side-effects reported to the FDA (including 70 deaths) occurred in patients with risk factors already listed on the drug’s label. Similarly, all but one of the 12 cases of adverse events (including four deaths) occurred among patients who took the drug for longer than the recommended ten days. Adding importance to the need to provide accurate, balanced advertising is the fact that the news media often misses the facts. According to a study featured in this month’s issue of the New England Journal of Medicine (NEJM), newspaper and television medical reporting is often inadequate or incomplete. The NEJM found that the media often lacks or omits critical information about drug risks, overstates the benefits, cites medical experts without mentioning their affiliation with the drug industry, and fails to provide adequate information about drugs in general. The analysis of 207 recent news stories revealed more than half as completely silent about drug risks or side effects. It is clear both patients and medical professionals need comprehensive drug warning information. In the event that any drug company claims that changes in tax treatment will directly decrease their investment in research and/or lead to higher drug prices for consumers, I would refer to a recent study that proves how preferential their tax treatment really is today. The nonpartisan Congressional Research Service (CRS) analyzed the tax treatment of the pharmaceutical industry and found taxpayer financed credits contribute powerfully to lowering the average effective tax rate for drug companies—by nearly 40% relative to other major industries between 1990 to 1996. There should be a responsibility attached to such preferential tax treatment and accurate, balanced advertising on matters affecting people’s lives should be an easy obligation to meet. The need for this bill is clear. In an environment where the Institute of Medicine (IOM) reported between 48,000 to 98,000 people die every year due to medical errors—with medication errors accounting for one out of 131 outpatient deaths and one out of 854 inpatient deaths—providing medical professionals and consumers balanced information about drug risks and side effects is critical. By denying tax deductions for unbalanced prescription drug ads, we can change pharmaceutical company behavior to ensure that their advertising includes clear, life-saving information that will better inform the American public, reduce health care expenditures and save lives. I look forward to working with my colleagues to make this a reality.