US House of Representatives to vote on bipartisan reform to US medicine regulation
21st Century Cures Act would boost funding to NIH and US FDA
A new proposed bipartisan 21st Century Cures Act, a bill that could accelerate the US Food & Drug Administration (FDA) approval of new drugs, could receive the House of Representatives vote by early July. The House energy and commerce committee unanimously approved the bill in May.
If passed, it would also boost funding to the National Institutes of Health (NIH) by about US$10bn over five years, and an extra US$550m to the FDA over the same period.
But health advocates are concerned that it could encourage the FDA to move away from controlled trials when determining if a drug is safe enough to enter the market. The 21st Century Cures Act suggests ‘clinical experience’, which includes observational study, patient anecdotes, and other such methods, be given more consideration, something that had previously only been used as supplemental evidence for determining drug safety.
The bill currently has 138 House supporters – most of which boast the pharmaceuticals/health industry as one of their top 20 contributors in the 2014 election cycle.
In general, both name brand and generic drug companies, which are often at odds, want the bill to go through. Many pharmaceutical companies and trade groups have lobbied on the initiative, including pharmaceutical firm Johnson & Johnson.
