The FDA’s reputation with the general public is under assault

Most U.S. adults say the FDA's decisions are influenced to some extent or a great extent by politics rather than medical science.

ROCHESTER, N.Y. –A new Wall Street Journal Online/Harris Interactive Health-Care Poll reveals that the majority of U.S. adults think the U.S. Food and Drug Administration’s (FDA) most important function is to ensure the safety and efficacy of new prescription drugs. However, over the past two years, the public has become increasingly skeptical about the agency’s ability to meet that mission, with seven in 10 adults giving the FDA a negative rating. A vast majority of adults are concerned about the agency’s ability to make independent decisions that will ensure public access to safe and effective drugs. In addition, large majorities across party lines say the FDA’s decisions are influenced by politics rather than medical science. All of this suggests the FDA is facing an uphill battle in the court of public opinion.

These are some of the results of a Harris Interactive^® online survey of 2,371 U.S. adults conducted between May 12 and 16, 2006 for The Wall Street Journal Online’s Health Industry Edition.

According to the poll, most adults say they are concerned about the FDA’s ability to make independent decisions that will ensure that patients have access to safe and effective medicines (80%), and their ability to effectively communicate safety concerns about prescription drugs to doctors and the public (76%).

FDA job approval and importance of their functions

A majority of adults have a negative view of the job the FDA is doing on:

• Ensuring that truly innovative prescription drugs come to market more quickly (70%), with 21 percent of adults saying it is the most important function for the FDA to focus on.
  
  In 2004, the numbers were reversed: then, 56% felt the FDA did a good or excellent job, while 37% felt the agency did a fair or poor job in this regard.

• Decisions concerning which brand name prescription drugs can be marketed as generics (63%), with seven percent of adults saying it is the most important function for the FDA to focus on.
• Decisions about which drugs can be marketed over-the-counter without a prescription (62%), with five percent of adults saying it is the most important function for the FDA to focus on.
• Ensuring the safety as well as the efficacy of new prescription drugs (58%), with 58 percent of adults saying it is the most important function for the FDA to focus on.

Access to prescription drugs

For large majorities of adults, it is important that people like them have access to the following:

• Complete information about the safety issues associated with prescription drugs (94%)
• Affordable prescription drugs even if they aren’t the newest ones available (93%)
• New, experimental drugs whose efficacy and safety aren’t proven, but that may offer a new treatment choice for patients who otherwise are out of options (72%)
• New and better drugs, no matter what they might cost (71%)

In the name of political science

The poll also found that 82% of adults feel the FDA's decisions are influenced by politics rather than medical science. People feel this way regardless of their party affiliation, even though Republicans (77%) are slightly less apt than Democrats (87%) and Independents (88%) to feel that FDA decisions are influenced by politics rather than medical science.

Perceptions of FDA advisory committees

The FDA uses consultants on its advisory committees to evaluate the safety and efficacy of prescription drugs before they are approved and after they are on the market, and these committee members must disclose if they have consulting agreements with any drug companies or own drug company stock. Owing to this fact, fully two thirds (66%) of adults think the members of these committees should not be allowed to have consulting agreements with prescription drug companies, and about three quarters of adults (74%) think they should not be allowed to hold or purchase stock for prescription drug companies.

Downloadable PDFs of Wall Street Journal Online/Harris Interactive Health-Care Polls are posted at http://www.harrisinteractive.com/news/newsletters_wsj.asp.

Methodology

Harris Interactive^® conducted this online survey within the United States between May 12 and 16, 2006 among a national cross section of 2,371 adults, ages 18 years and over. Figures for age, gender, race/ethnicity, education, income and region were weighted where necessary to align with population proportions. Propensity score weighting was also used to adjust for respondents' propensity to be online.

All surveys are subject to several sources of error. These include: sampling error (because only a sample of a population is interviewed); measurement error due to question wording and/or question order, deliberately or unintentionally inaccurate responses, nonresponse (including refusals), interviewer effects (when live interviewers are used) and weighting.

With one exception (sampling error) the magnitude of the errors that result cannot be estimated. There is, therefore, no way to calculate a finite "margin of error" for any survey and the use of these words should be avoided.

With pure probability samples, with 100 percent response rates, it is possible to calculate the probability that the sampling error (but not other sources of error) is not greater than some number. With pure probability samples of 2,371 adults, one could say with a ninety-five percent probability that the results have a sampling error of +/- 3 percentage points. However that does not take other sources of error into account. This online survey is not based on a probability sample and therefore no theoretical sampling error can be calculated.

These statements conform to the principles of disclosure of the National Council on Public Polls.

About the Survey

The Wall Street Journal Online/Harris Interactive Health-Care Poll is an exclusive poll that is published in the award-winning Health Industry Edition of The Wall Street Journal Online at www.wsj.com/health.

About The Wall Street Journal Online

The Wall Street Journal Online at WSJ.com, published by Dow Jones & Company (NYSE: DJ; www.dowjones.com), is the largest paid subscription news site on the Web. Launched in 1996, the Online Journal continues to attract quality subscribers that are at the top of their industries, with 761,000 subscribers world-wide as of Q1, 2006.

The Online Journal provides in-depth business news and financial information 24 hours a day, seven days a week, with insight and analysis, including breaking business and technology news and analysis from around the world. It draws on the Dow Jones network of nearly 1,900 business and financial news staff-the largest network of business and financial journalists in the world. The Online Journal also features exclusive content, including interactive graphics on business and world news, and online-only columns about the automotive industry, technology, personal finance and more.

The Online Journal offers three industry-specific verticals: the award-winning Health, Media & Marketing and now Law. Health offers authoritative analysis, breaking news and commentary from top industry journalists. Media & Marketing is designed for professionals in the advertising, marketing, entertainment and media industries. Law is designed to provide law firms and attorneys timely information on events and trends important to the legal market. Subscribers to all also get access to the full content of the Online Journal.

In 2005, the Online Journal was awarded a Codie Award for Best Online News Service for the second consecutive year, and its Health Industry Edition was awarded Best Online Science or Technology Service for the third consecutive year. In 2004, the Online Journal received an EPpy Award for Best Internet Business Service over 1 million monthly visitors.

The Wall Street Journal Online network includes CareerJournal.com, OpinionJournal.com, StartupJournal.com, RealEstateJournal.com and CollegeJournal.com.

About Harris Interactive^®

Harris Interactive, the 13^th largest and fastest-growing market research firm in the world, provides clients with research-driven insights and strategic advice to help them make more confident decisions, leading to measurable and enduring improvements in performance.

Widely known for The Harris Poll^® and for pioneering online market research methods, Harris Interactive serves clients worldwide through its United States (www.harrisinteractive.com), Europe (www.harrisinteractive.com/europe), and Asia offices and is supported by its a wholly-owned subsidiary Novatris (www.novatris.com) in Paris and an independent global network of affiliate market research companies. Harris Interactive is headquartered in Rochester, New York, and Europe operations are based in London.