ASHINGTON — A majority of Americans opposes federal regulatory changes to speed up the development and approval of new medical treatments, a new STAT-Harvard poll finds — suggesting the public has serious doubts about legislation now moving through Congress.
The poll also shows strong public support for removing prescription drug advertisements from television. The spots directed at consumers have been criticized by the nation’s leading doctors group for promoting the overuse of expensive drugs.
The poll, by STAT and the Harvard T.H. Chan School of Public Health, comes as lawmakers from both parties are pushing to change government regulatory standards that they blame for slowing the approval process to get new products to patients.
The House passed its version of the legislation, the 21st Century Cures Act, in a lopsided bipartisan vote in July. And Republican Senator Lamar Alexander of Tennessee, who’s working on a set of companion bills in the Senate, says the package would be “the most important bill Congress considers this year.”
But nearly 6 out of 10 Americans said they oppose changing government safety and effectiveness standards to allow for faster approvals of new prescription drugs by the Food and Drug Administration, while 38 percent said they’re in favor of speedier FDA action, according to the poll. Half of the public similarly objects to regulatory changes to accelerate approvals of new medical devices, while 45 percent want the FDA to move faster on those products.
The poll sheds new light on how Americans balance their priorities between speed and safety in the approval of new medical treatments.
“There is a cautiousness about safety and efficacy here that people hadn’t realized before,” said Robert Blendon, a professor of health policy and political analysis at Harvard who oversaw the poll.
Views on changing prescription drug and medical device regulations
Based on a telephone poll of 1,006 US adults conducted April 27 – May 1, 2016
The questions in the poll explained both sides of the debate: supporters of faster action note that it can take years for new drugs and devices to get to market because of all the development, testing, and review requirements, but opponents worry that a faster process could lead to the approval of unsafe or less effective treatments.
“I don’t think they should speed it up any. They need to be tested,” said Florence Froats, a Democrat from upstate New York, who participated in the poll and agreed to a follow-up interview. She said she takes a lot of prescription medications: “They should all be reviewed, that’s for sure.”
Even people who want the FDA to move faster, and think red tape is largely to blame for the length of the process, want to make sure the agency doesn’t undermine safety.
“I think they can do both,” said Harry Walpole, a Republican from Shreveport, La. “They need to streamline the process but still be concerned with safety and not be too hasty.”
Read full STAT-Harvard poll results here
The pharmaceutical industry and other supporters say cutting the time it takes to bring new drugs to market would cut development costs and drug prices, but the poll found most people didn’t buy that argument: more than three-quarters of people said changing government standards to speed up drug approvals would not have much impact on prices, or cause them to rise.
The survey also found skepticism about a proposal championed by Republican Senator Ted Cruz of Texas, who returned to Capitol Hill Tuesday after dropping out of the presidential race. Cruz and another GOP senator, Mike Lee of Utah, want the FDA to approve prescription drugs or devices for unmet medical needs that have already been approved by other developed countries, including Canada, Israel, Japan, and members of the European Union such as the UK and Romania.
More than 6 out of 10 Americans — 62 percent — said the FDA should conduct its own reviews of the drugs and devices. Just 33 percent said the agency should approve them if they’ve been cleared by the other countries.
Cruz insists the proposal offers hope for people with rare diseases who want to try treatments that have been approved in developed countries with high quality standards.
“What’s more important to Senator Cruz than a misleading opinion poll are the 30 million Americans suffering from rare diseases every day,” Cruz spokesman Phil Novack said in an email.
The public is divided on whether the FDA should expand its mission to include restraining rising drug prices. That’s not part of its role now, but Democratic presidential candidate Bernie Sanders has suggested it should be.
According to the poll, 44 percent said the FDA should be allowed not to approve a new drug if it considers the price too high, while 49 percent said the agency should not have that authority.
The poll was conducted for STAT and Harvard by SSRS, which interviewed 1,006 randomly selected US adults by telephone from April 27 through May 1. The margin of error was plus or minus 3.6 percentage points.
The House sponsors of the 21st Century Cures bill declined to comment on the poll results. A spokeswoman for Alexander, Margaret Atkinson, said none of the Senate companion bills would change the FDA’s safety standards for drugs and devices.
“The slow and uncertain review processes at the FDA are standing in the way of terminal patients getting a drug that is their only chance, or blind patients getting a treatment that would give them sight, or a veteran getting an innovative prosthetic that allows him to chase his young child around the yard,” she said.
Senate Democrats say they have pushed for changes in the companion bills that they believe will make the measures safer than the House version. For example, they made sure that a bill to allow faster approvals of “breakthrough” medical devices doesn’t apply to products that are already on a faster track through a different process.
The poll found some partisan disagreements, with Republicans more likely than Democrats to favor speedier approvals of medical devices. The bigger differences, however, were between men and women. Men were more likely to support faster approvals, with 45 percent saying they wanted to change the standards for new drugs, compared to just 32 percent of women. The gap was even larger on medical devices.
Women may be more concerned about safety because they were twice as likely as men — 19 percent vs. 9 percent — to say they had experienced serious side effects from taking prescription drugs in the past five years. Among those who experienced a serious side effect, 86 percent said they had reported it to a doctor or the FDA.
The public doesn’t have a high level of confidence in the FDA’s oversight of prescription drugs, the poll found, with more than half of all Americans saying the agency does only a fair to poor job, while 4 out of 10 said it does a good or excellent job. They’re more upbeat about the agency’s regulation of medical devices, with nearly half saying it does a good or excellent job with those products.
The drug advertising issue has been in the news since last fall, when the American Medical Association proposed banning the advertising of prescription drugs and medical devices to consumers. Congress would have to approve such a ban, and that’s considered unlikely because it would turn into a debate over freedom of speech.
Views on TV prescription drug advertising
Based on a telephone poll of 1,006 US adults conducted April 27 – May 1, 2016
Blendon said the high number of people who are willing to ban the TV ads — 57 percent favored removing the ads, compared with 39 percent who are opposed — indicates that “there’s something about these ads that bother people a lot more than we would have thought.”
Froats, the New Yorker, said she was bothered by the number of TV ads. “I think that there is so much of it, and actually if you need medicine, your doctor should recommend it rather than you seeing something on TV and going to buy it,” she said.
The poll found that just 7 percent of Americans had considered taking a prescription drug they saw advertised on television in the past year, and most of these people felt the ads clearly explained the drug’s risk and potential side effects.
Not everyone has a problem with the heavy advertising by drug companies. “I know they are a private business and they’ve got to make money,” said Jeff Stayton, an independent from northern Indiana. “The ads are fine, they got all the side effects.”