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Bill to Speed Approvals for Drugs Cut Back


By SABRINA TAVERNISE
APRIL 30, 2015

http://www.nytimes.com/2015/05/01/health/bill-to-speed-approvals-for-drugs-is-cut-back.html?_r=0

Legislation that would have accelerated the pace of federal drug approvals in a way that critics said threatened to erode patient safety was formally released this week, in a scaled-back version with many of the most controversial provisions left out.

The legislation, called 21st Century Cures, has been in the works for months. Its lead sponsor, Fred Upton, Republican of Michigan, said it would speed the pace of drug cures by removing unnecessary hurdles from the regulatory process.

Critics, including top officials at the Food and Drug Administration, had expressed concern that the changes would risk patient safety; for example, by potentially permitting shorter clinical trials and letting drug companies use alternative measures of health as evidence of a drug's effectiveness and safety.

The draft, at about 200 pages it is half its former size, seemed to allay fears among some experts that it would fundamentally rewire the way drugs are approved. Earlier proposals to give drug companies broad powers to promote their products for uses other than the approved ones and to market brand-name drugs for a longer time without generic competition were not included.

The F.D.A. has defended its record for drug approval speed, saying that in 2014, it approved the most new drugs in almost 20 years, and that it moves faster than its counterparts in other wealthy countries. Experts note that pathways exist for expedited approval, and that the F.D.A. is held to relatively strict timelines under other rules set by Congress. Instead, they say, the bottleneck for new drugs is often a matter of the years of research it takes to find them.