Ex-FDA Chief Calls for Fast 'Breakthrough' Path

Share this article:
Mark McClellan
Mark McClellan

Legislation to speed FDA approval of breakthrough drugs is being supported by both former FDA commissioner Mark McClellan, now a Brookings Institution senior fellow, and Friends of Cancer Research chairperson Ellen Sigal.

“When a new drug or drug combination shows extreme activity very early,” they wrote in The Hill's Congress Blog, “new approaches are needed that focus on the most efficient mechanisms to get a potential medical breakthrough to the relevant patients.”

McClellan and Sigal speak approvingly of bipartisan legislation introduced in the Senate to establish a breakthrough product designation that they say would (1) reduce the total development time and cost of the most promising breakthrough treatments, and (2) minimize the number of patients that would be given a control regimen or a currently available treatment that doesn't work very well.

Upon designation, the two explain, FDA and the drug sponsor would engage in intensive interactions to collaboratively construct and agree upon a drug development strategy.
Share this article:

Email Newsletters

More in Features

Read the complete April 2014 Digital Edition

Read the complete April 2014 Digital Edition

Click the above link to access the complete Digital Edition of the April 2014 issue of MM&M, with all text, charts and pictures.

Antidote: Are e-cigarettes safe?

Antidote: Are e-cigarettes safe?

The pros and cons of e-cigarettes

Combating concept churn

Combating concept churn

There's no cure. But the good news is that prophylaxis is possible.