The U.S. Food and Drug Administration’s (FDA) ongoing efforts to assert its authority to regulate U.S.-based companies that offer unlicensed stem cell therapies (Regenerative Sciences or Celltex, for example) has prompted a mixed response from the regenerative medicine community. On the one hand, getting an unlicensed treatment has many potential downsides, so the FDA’s crackdown may help to protect patients from, say, growing bone in their eyelids. On the other hand, some researchers have questioned whether it makes sense to regulate stem cells as drugs, and a common complaint is that the FDA’s approval process is too burdensome and stifles medical innovation.
Criticisms of this type go back a long way, but how does the U.S. public view the FDA’s activities? After all, it’s consumers who bear the risks of untested therapies, so their policy preferences are highly relevant to any proposed reform of the FDA’s drug approval process. I wasn’t able to find any empirical work that addressed this topic in a stem cell context, so instead I’ll summarize what polling evidence there is on U.S. public perceptions of the FDA and its role in regulating prescription drugs. This should provide some insight into Americans’ likely preferences for the regulation of stem cell therapies.
The Kaiser Family Foundation’s Health Poll Search provides access to an extensive database of survey items relating to healthcare. Most FDA-related questions ask respondents to express a general opinion about the agency, such as whether they view it favorably or unfavorably or how they rate its performance. The graph below shows the percentage of positive evaluations (“favorable,” “excellent,” or “good”) of the FDA for 13 questions asked in U.S. national surveys over the last couple of decades.
While a large majority of Americans evaluated the FDA positively in the 1990s and early 2000s, approval ratings for the agency’s performance have been dropping since then. Admittedly, this trend mirrors the decline in Americans’ general trust in government and their ratings of most federal agencies, but the FDA does tend to fall on the lower end of the spectrum. But is the FDA’s less-than-stellar public reputation a function of frustration with the length of time it takes to approve new drugs, or is it driven by perceived regulatory failures? The answer, it seems, is: a little bit of both.
On the one hand, it’s clear that ensuring the safety of prescription drugs is top of mind for most Americans. In a 2007 Zogby poll, for example, 47% of respondents thought that “[e]nsuring the safety and effectiveness of new drugs” should be one of the FDA’s highest priorities, with only 16% feeling the same way about “[e]nsuring that new drugs come more quickly to the market.” Similarly, in a 2010 Research Enterprise Poll, 59% of respondents ranked “[p]rotecting the safety of the American public” as the FDA’s number 1 priority, while “[g]etting new medicines and medical products to the American public” was ranked last by 42% of respondents. In several Kaiser Foundation surveys, moreover, large pluralities believed that there is “not as much [regulation] as there should be” in “[m]aking sure prescription drugs are safe for people to use” (36% in 2000, 50% in 2005, and 44% in 2008), with no more than 12% believing that there was too much regulation.
On the other hand, Americans generally think that the FDA is too slow to approve new prescription drugs, with pluralities of 35%, 41%, and 52% rating the agency as taking too long, depending on how the question is asked. In a 2010 poll, respondents were asked to choose between these two scenarios:
“Some people say: the FDA should move more quickly in order to get new treatments to patients, even if it means there may be risks. Other people say: the FDA should act more slowly in order to reduce risk, even if it means patients may wait for treatments.”
52% chose the first option.
Overall, then, Americans appear to have a nuanced view of the FDA’s drug approval process. They tend to view ensuring the safety of prescription drugs as a much higher priority than encouraging pharmaceutical innovation, and large pluralities believe the sector needs more regulation. At the same time, they think the FDA takes too long to approve new drugs. In short, Americans want safe and effective treatments approved without undue delay.
In a recent poll on the Knoepfler Lab Stem Cell Blog, 34% of respondents selected a reduction in clinical trial timelines as their top priority for FDA reform in the stem cell domain. Based on the survey evidence I’ve laid out in this post, it seems likely that this would also be the most popular choice if the question were put to the U.S. public as a whole.
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