A bipartisan coalition of lawmakers is rushing to finalize a new healthcare law that would overhaul the Food and Drug Administration (FDA). The bill, called the 21st Century Cures Act, is also a huge win for lobbyists: 1,455 lobbyists, working on behalf of 400 different healthcare companies, medical device makers and research institutions weighed in on the 900 pages of regulatory tweaks and research grants. Originally conceived as a bill to boost research ... pro-industry groups have used the bill as a vehicle to achieve their long standing legislative agenda. It effectively makes it easier for drug companies and medical device manufacturers to get FDA approval for their products without demonstrating that consumer safety has been taken into account. Consumer advocates are particularly concerned with several provisions that make it much easier for pharmaceutical companies to bypass stringent testing requirements to market and sell drugs for multiple uses. Currently, if a company wanted to sell a drug to treat more than one ailment, it must conduct randomized scientific trials showing the product does indeed work for each separate illness it's marketed for. The 21st Century Cures Act lowers that threshold. The bill also frees pharmaceutical companies to work with insurance companies to promote off-label uses for their drugs and creates a new category of ... medical devices which qualify for expedited regulatory approval. The lawmakers who introduced the measure are bankrolled by the healthcare industry.
Latest
Latest News
Each news summary is created according to strict standards. Here's how we do it.
Each summary is created using a consistent editorial procedure. The target length is approximately 16 lines of 11-point Arial text in a 650-pixel-wide column. Up to 25% of a summary may be set in bold to emphasize the most important ideas. Summaries are composed of verbatim excerpts presented in the same sequence as they appear in the original news source, with very minor editorial additions. Where material has been omitted between excerpts, the omission is indicated with ellipses (...). Any words added by an editor for clarity or context appear in [brackets]. Our original news editor was Fred Burks. Tod Fletcher edited most summaries from 2007 through 2014, and Mark Bailey has served as news editor since 2014.