Docket Management
Docket: 01N-0078 - Assessment Attitudes Toward Direct-to-Consumer Promo of Prescription Drugs
Comment Number: EC -10

Accepted - Volume 1

Comment Record
Commentor Dr. Alan Goldhammer Date/Time 2001-05-18 13:56:43
Organization Pharmaceutical Research & Manufacturers of America
Category Association

Comments for FDA General
5. General Comments The following comments on the above noted Federal Register notice are submitted on behalf of the Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA represents the country's leading research-based pharmaceutical and biotechnology companies. Our member companies are devoted to inventing medicines that allow patients to lead longer, happier, healthier, and more productive lives; our members will invest over $30 billion in 2001 for the discovery and development of new medicines. The Food and Drug Administration (FDA) is proposing to conduct two surveys: one of physicians and a second of patients, to assess respective attitudes towards direct-to-consumer (DTC) advertising. PhRMA believes that these surveys, as presently constructed, will yield little useful information. PhRMA views the survey design as heavily weighted towards gathering information about attitudes and perceptions about DTC advertising when, in fact, the ultimate goal should be gauge DTC advertising’s impact on the public health. FDA must be cognizant of the fact that the landscape for health care is rapidly changing. In this information age, more and more patients are taking control of their health care decisions. As a result, many new sources of user accessible health care information are available. For example, some 50 consumer magazines focusing on health care hit the news stands every month. Just about every television station in the country has a physician dispensing medical news. Internet users can surf literally tens of thousands of sites dedicated to various health care topics including databases on clinical trials. According to a study by the Pew Internet and American Life Center, six out of every 10 Americans now have ready access to the Internet, and half of those who have online access look for health information at least once a month. And two out of every five say their research affects decisions they make about which doctors to see and what treatments to undergo. So while DTC advertising is one source of information for consumers, it is clearly not the only source of information. DTC advertising brings patients into doctors’ offices and allows physicians to treat people who might otherwise go undiagnosed and untreated. By telling people about the symptoms of such diseases and by assuring them that effective treatments are available, DTC advertising can improve public health and save lives. Patients can benefit from the valuable information DTC advertising provides on symptoms and new treatment options. For example: · The Centers for Disease Control (CDC) estimates that 45 million Americans over age 12 carry the virus that causes genital herpes. Yet, only about 4.5 million Americans are being treated. Recent surveys of DTC ads for genital herpes have provided some compelling results on the positive impact of DTC advertising. For example, 34% of physicians stated they had seen an increase in the number of newly diagnosed herpes patients. This seems to indicate that patients who may have been suffering in silence were prompted to seek treatment and talk to a healthcare professional about their disease. · For every one million men who went to physicians requesting a prescription for Viagra, doctors found: undiagnosed diabetes in an estimated 30,000; high blood pressure in 140,000; and heart disease in 50,000. Thus, FDA should consider the impact of DTC advertising on public health and refine these two surveys to reflect this. As an Agency dedicated toward improving and protecting the pubic health, the FDA must not rely on mere perceptions and attitudes but look towards understanding the contextual importance of informing the public of their options in health care decision-making.

EC -10