21st Century Cures Drug Bill Triggers a DC Dust-Up Over Relaxed Development Regs

Fierce Biotech, July 10, 2015. Lawmakers in the House easily passed the 21st Century Cures Act today, a big step toward once again shaking up the legal framework built to guide drug development in the U.S. while significantly boosting the amount of funding that flows to the NIH. Consumer advocates, though, see the new development regulations as a recipe for unleashing drugs and devices that would later prove dangerous and unhelpful.

Read More »

House Passes ‘Cures’ Bill to Hasten Drugs to Market

Medscape, July 10, 2015. The House of Representatives overwhelmingly passed a bipartisan bill designed to speed up the development and approval of new drugs and medical devices. “The bill greatly benefits the pharmaceutical industry [and] medical device manufacturers,” said Diana Zuckerman.

Read More »

This Bill Promises to Speed Up Drug Approval So Much That It’s Making People Uncomfortable

The Washington Post, July 8, 2015. The bill slated to land on the House floor on Thursday seems unassailable on its face – the 21st Century Cures legislation promises to modernize medicine and speed the development of lifesaving treatments. But a vocal chorus of physicians and pharmaceutical industry watchdogs warn that the bill is full of stealth provisions that could actually put sick people in harm’s way, by speeding the development of treatments that are neither safe nor effective.

Read More »

Speeding Up the Drug-approval Process Could Have a Downside

The Wall Street Journal, May 30, 2015. Would a congressional bill designed to jump-start medical innovation end up lowering standards for approving new uses of existing medicines? Consumer advocates are raising this concern about the 21st Century Cures legislation, which passed the House Energy and Commerce Committee unanimously last week and, in part, is designed to reform the approval process for drugs.

Read More »