Medical Device Daily Washington Editor

WASHINGTON – A recent poll shows that consumer confidence in the FDA's ability to ensure product safety continues to slide.

Results from a nationwide survey of 1,000 people, conducted by the political strategy and research firm Lake Snell Perry Mermin & Associates (Washington), seems to reflect waning consumer confidence in the agency's ability to ensure drug safety. The poll also touched on a lack of consumer understanding of FDA regulation of drugs vs. devices.

The study asked whether consumers were aware that the FDA had "lower safety standards" for implanted medical devices – such as pacemakers – than it has for prescription drugs. Though the pollsters did not explain what it meant by "lower safety standards," 86% of respondents answered "no" to this question.

Two-thirds of respondents favor an independent body conducting a top-to-bottom review of FDA practices and procedures, and nearly seven out of 10 said they support strengthening the agency's collection and reporting processes about drugs and devices that are found to be harmful after the product has been approved.

According to Celinda Lake, president of the polling firm, the results did not vary much by political party.

Opposition to cutting funding for FDA oversight is "overwhelming," she said, adding that the respondents said they were less likely to support candidates who voted to cut FDA funding.

"Even the most deficit-conscious were still less likely to vote for a candidate who voted to cut spending on FDA safety and inspection," she said.

In addition, nearly a majority of those surveyed – 48% – said they "strongly or somewhat strongly agreed" that industries regulated by the FDA had too much influence over the agency's decision. But an almost equal number – 45% – said they did not know.

"We were concerned that voters had other big issues on their minds – war, Medicare, the economy – and may not pay a lot of attention to this," Lake said. "But people want as well-funded and as vigilant an FDA as possible."

Lake said voters see their tax dollars as going to directly fund FDA programs, and they are willing to spend to ensure safety.

"The agency has many unfunded mandates with bioterrorism and drug safety," said Abbey Meyers, president of the National Organization for Rare Disorders (New York). "[The administration] has reduced money for factory inspections, which, given problems with flu vaccines, should be a priority. If you are going to give [FDA] more mandates, then you should increase the budget in proportion to the job that you want them to do."

Janell Duncan, legislative and regulatory counsel for the Consumers Union (Yonkers, New York), publisher of Consumer Reports magazine, said that public pressure is "resonating with FDA and Congress."

Diana Zuckerman, PhD, president of the National Research Center for Women & Families (Washington) said there is a change in the way Congress is talking about the FDA.

The talk "is on both sides of the aisle, and it is particularly noticeable because there are certainly a good number of Republicans that would be considered pro-industry and pro-private sector who have been very critical of FDA's regulation of industry," she said. "FDA is reeling from this kind of attention. Story after story has focused on the drug side, and people will begin talking about other issues as well."

Zuckerman said the FDA must support a system that makes all clinical trial information transparent for all those who need it. Companies use the "excuse" of trade secrets to keep FDA and public from seeing information they "don't particularly like" or shows a lack of research or long-term safety data, she charged.

"They are more secretive than the CIA," Meyers said of the FDA.

Zuckerman said some of the confusion also boils down to a question of authority. The FDA does not have power to force drug and device companies to conduct post-approval clinical studies, she argued, though review panels often request it as a condition of approval.

"Companies don't have to notify the patient when a product has been recalled," she said. "Even when they find out a medical device has been recalled because it is not safe, it is the doctors that are notified. Doctors are then supposed to notify patients, which they don't always do. Consumers have a hard time getting information they need to be safe."

FDA officials did not return calls seeking comment on the report.