Speeding up new drug approvals: No good deed ¦
Few industries evoke an emotional response greater than the pharmaceutical industry. This cannot be surprising, since drug companies are typically viewed by the public as either providing miraculous life-altering therapies, or greedy instruments of Satan. There is little middle ground.
So, it is rather surprising that a new law, called the 21st Century Cures Act, has been overwhelmingly approved by the House, 344-77 on July 10th.
The new law, also known as H.R. 6, gives more latitude to the FDA in tailoring its safety and efficacy requirements for the approval of breakthrough medicines. Such drugs (as well as breakthrough medical devices) that are given this designation will no
