Public's View of FDA Shows Agency Needs to Improve

Public opinion about the effectiveness of the US Food and Drug Administration in overseeing drug safety shows ground for improvement. A recent poll that was conducted by Harris Interactive and Health Day finds that although the reputation of FDA has improved, the agency is still receiving low marks for its role in regulatory oversight and monitoring drug safety. The survey was conducted online in the United States in mid-April 2009 among a cross-section of 2495 adults.

In 2008, the public gave FDA its lowest rating in five years for ensuring the safety and efficacy of new prescription drugs. Fifty-eight percent of respondents gave FDA a negative rating and 35% a positive rating. In the 2009 survey, the numbers improved slightly although a majority of respondents still provided FDA with a low grade. Fifty-two percent of respondents gave FDA negative ratings on ensuring the safety of drugs, and 54% gave FDA negative marks for getting new drugs to the market more quickly. On the plus side, positive ratings for managing prescription drug recalls or withdrawals increased from 39% in 2008 to 53% in 2009.

“Perceptions of drug safety have gone up and down,” says Humphrey Taylor, chairman of the Harris Poll, in a Harris Interactive Apr. 30, 2009, press release. “As stories break about drug problems, and Vioxx comes to mind, those numbers change. We seem to have recovered from the low figures of last year.

Rating FDA

The survey asked respondents to evaluate FDA’s performance in specific functions relating to drug safety. These functions were: managing prescription drug recalls or withdrawals when safety concerns arise, ensuring the safety and efficacy of new prescription drugs, monitoring the safety of prescription drugs after they are approved and prescribed, ensuring that prescription drugs come to market more quickly, and ensuring the safety of prescription drugs that are manufactured outside the US. The survey showed the following:

• Managing prescription drug recalls or withdrawals: 11% said FDA’s performance was “excellent,” 43% said it was “good,” 28% said it was “fair,” and 12% said it was “poor”

• Ensuring the safety and efficacy of new prescription drugs: 8% said FDA did an “excellent” job, 39% said FDA did a “good” job, 33% said it was “fair,” and 16% said it was poor.

• Monitoring the safety of prescription drugs after approval and once they have been prescribed: 8% said FDA did an excellent job, 39% said the agency did a “good” job, but 46% said FDA did only a “fair” or “poor” job

•Ensuring that prescription drugs come to market more quickly: 48% said FDA did an “excellent” or “good” job, but 54% said the agency did a “fair” or “poor” job

•Ensuring the safety of prescription drugs that are manufactured outside the US: only 35% said that FDA did an “excellent” or “good” job, 30% said FDA did a “fair” job, and 22% said it did a “poor” job.

Although these results show a need for further improvement by FDA in the eyes of the public, the agency has improved its reputation in overseeing certain functions. For example, 52% of respondents gave FDA a negative rating for ensuring the safety of prescription drugs that are manufactured outside the US in 2009, but this response was better than the results from 2008, when 62% of respondents gave FDA low marks. FDA’s effectiveness in the view of the public also slightly improved from last year in other areas as outlined below:

• Ensuring the safety and efficacy of new prescription drugs: Positive ratings: 2009, 47% of respondents; 2008, 35%; negative ratings: 2009, 47% of respondents, 58% in 2008.

• Ensuring that prescription drugs come to the market more quickly: Positive ratings: 2009, 37% of respondents; 2008, 30%; negative ratings: 2009, 54% of respondents, 60% in 2008.

The survey asked respondents for additional input on the pace of drug approvals. The survey asked if FDA approves prescription drugs too quickly (i.e., before they are safe), too slowly (i.e., a drug could have been approved sooner for patients’ benefits), or at the right speed (i.e., optimal approval time for drug safety).

Thirty-five percent of respondents said FDA acted “too slowly” in approving drugs, 19% said FDA moved “too quickly,” and 18% said FDA acted at “the right speed.” More than a quarter, or 28%, said they were not sure.

Other concerns

A concern for FDA and for the pharmaceutical industry as a whole is the level of public confidence in the safety of drugs. Only about one-quarter of respondents said that they were “very confident” in the safety of over-the-counter (OTC) drugs and prescription drugs, both brand name and generic. Sixty-one of respondents said that there only “somewhat confident” in the safety of OTC drugs, and 62% said that they were “somewhat” confident in the safety of prescription products.

In identifying priorities for FDA, 37% of respondents said that ensuring the safety and efficacy of new prescription drugs should be a top priority for the agency. Twenty-five percent said that monitoring the safety of prescription drugs after they are approved and prescribed should be a top priority. Interestingly, more respondents (59%) said that food safety should be a top priority at FDA.