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President Obama Signs 21st Century Cures Act
In a ceremony on the White House campus, President Barack Obama has signed into law legislation that makes new investments in cancer research and the fight against drug abuse, according to STAT News.
The 21st Century Cures Act invests $1.8 billion for a cancer research “moonshot” that is strongly supported by Vice President Joe Biden. Biden’s son Beau died of brain cancer in 2015.
The bill also authorizes giving states $1 billion over two years to prevent and treat the abuse of opioids and other addictive drugs, such as heroin, and streamlines the approval process for medications and medical devices at the FDA.
Overall, the measure calls for $6.3 billion in new spending during the coming decade.
But not everyone is cheering. For example, Michael Hiltzik, a Pulitzer Prize-winning financial columnist for the Los Angeles Times, wrote:
“The 21st Century Cures Act is a huge deregulatory giveaway to the pharmaceutical and medical device industry, papered over by new funding for those research initiatives. The punchline is that the regulatory rollback is real, but the funding may not be—it’s subject over the next decade to annual appropriations by Congress that might never come.”
“This continues a trend of eroding standards at the Food and Drug Administration since the 1990s,” added Michael Carome of the advocacy group Public Citizen.
The bill opens a path for the FDA to approve new indications for existing drugs without demanding thorough clinical testing. Instead, the agency can rely on “real-world evidence,” which includes observations, adverse-event claims, and other data not subject to rigorous analysis. “That’s a much lower level of evidence,” Carome said.
He points to the case of Essure, a device implanted in women’s fallopian tubes as an alternative to permanent surgical sterilization. Currently marketed by Bayer, Essure was given expedited approval by the FDA in 2002 based on “two nonrandomized, nonblinded, prospective studies that lacked a [control] group and enrolled a total of 926 women,” according to a report last year in the New England Journal of Medicine. Post-marketing experience has pointed to potential serious adverse events and a lack of firm evidence that the device is safer than tubal ligations. The FDA hasn’t taken Essure off the market, but it has convened a study panel and has required a warning of health risks on the label.
Sources: STAT News; December 13, 2016; and Los Angeles Times; December 5, 2016.