Tuesday, January 13, 2015

Is the FDA driving the development of drugs instead of science?

Yes according to Joseph V. Gulfo, MD, MBA, in a recent post at The Hill.  According to the article, 41 new drugs were approved in 2014 and 40% of them were orphan drugs.  The Orphan Drug act is a big part of this - pushing exclusivity and driving profits. Gulfo sees this as a problem - because they see drug approvals but the public continues to fewer drug approvals that drive health.  Instead those being approved and their high costs are seeing profits that lean on blockbuster drug levels.

So to conclude his article, Gulfo points out what the Orphan Drug Act has taken away from - science and medicine are no longer driving development for health.  Instead it's the policies of that the FDA set forward for drug approvals.  Do you agree?

Dr. Gulfo will be joining us at Partnerships in Clinical Trials on Thursday, April 23 for the presentation Picking up the Pieces of Clinical Trial Failure: How I Battled the FDA and Won.  For more information on this session and the rest of the program, download the agenda.  If you'd like to join us, as a reader of this blog, when you register to join us and mention code XP2000BL, you can save $100 off current rates - lowest rates of the year expire Friday, January 16.

No comments: