Lawmakers push for speedy approvals of 'breakthrough' drugs

New legislative initiatives aimed at speeding U.S. drug approvals are all the rage in Congress these days. Pharmalot has the story of a new proposal from a bipartisan group of lawmakers calling for accelerated approval paths for "breakthrough" drugs. A breakthrough, they explain, would be a new treatment that has preliminary clinical evidence that it can do a better job at treating a serious or life-threatening ailment than existing meds. "Time and again we've seen regulators in Washington fail to keep up with the industries they are tasked to oversee," says Sen. Orrin Hatch (R-UT), a sponsor. "This bipartisan bill ensures that when it comes to treating patients suffering with cancer or other devastating illnesses, science and patient care will not be slowed down by government red tape." Story

 

Suggested Articles

Solid Bio fixed the manufacturing issue that led to a partial clinical hold on its DMD trial, but a full hold remains.

Commissioner Scott Gottlieb has laid out the reasons why he thinks the FDA needs a double-digit budget bump.

GW's cannabis-based epilepsy drug scored a favorable review from FDA staff ahead of an expert panel meeting.