Regulatory Focus™ > News Articles > Too Fast, or Too Slow? Public Disagrees Over Pace of FDA's New Drug Approvals

Too Fast, or Too Slow? Public Disagrees Over Pace of FDA's New Drug Approvals

Posted 25 February 2015 | By Alexander Gaffney, RAC 

According to a new survey, the US Food and Drug Administration (FDA) is in a lose-lose situation when it comes to regulating healthcare products.

FDA's Lose-Lose Proposition

The poll, sponsored by research advocacy group Research!America and conducted with help from Zogby Analytics, polled approximately 1,000 adults about their views on America's role in public health research and development.

The research indicates, for example, that Americans are broadly in favor of new initiatives to discover and develop new treatments and cures for diseases. Sixty-seven percent of respondents said it was "very" or "somewhat" important that Congress act on those initiatives within the "first 100 days of the [most recent] legislative session."

That level of support bodes well for the Senate and House, which have both launched initiatives meant to overhaul the manner in which FDA approves new drugs and medical devices.

But the study also shows the difficulty faced by FDA on a daily basis. Poll respondents were faced with an either/or question: Should FDA err on the side of expeditious drug approvals to ensure faster access to needy patients, or err on the side of slower approvals to ensure the safety of approved drugs?

ResearchAmerica - Pace of Drug Approvals

Thirty-eight percent of respondents said they would rather FDA approve drugs "more quickly in order to get new treatments to patients, even if it means there may be risks," while 25% of respondents said they wanted FDA to "act more slowly in order to reduce risk, even if it means patients may wait for treatments." Another 19% of respondents said they weren't sure how FDA should approach regulatory approvals, while 18% said they agreed with neither statement.

In other words, if FDA approved a drug quickly, the approval would likely be met with disapproval by 25% of respondents. If it approved the drug after extensive deliberation, it would be met with disapproval by at least 38% of respondents.

Clinical Trials Get Public Approval, But Vaccines Struggle

The poll also touched on other topics of interest to regulators. A majority of respondents said they would be interested in finding out more about taking part in clinical trials, would take part in a trial if asked by a trusted friend, see clinical trial participation as a valuable contribution to public health and would recommend that their friends and family take part in a clinical trial.

ResearchAmerica - Interest in Clinical Trials

When asked about their personal assessment of vaccine safety, 17% of respondents said they were "very confident" in the "current system in the US for evaluating the safety of vaccines and recommendations for when they should be given." Another 39% said they were "somewhat confident," while 33% said they were either "not too confident" or "not at all confident."

Around half of respondents said they would be willing to share personal health information to help advance medical research (55%) and better track disease and disability (46%). Another 46% said they supported the use of animals to help advance medical research, compared to 27% who said they did not.

 

Research!America Study


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