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- 02/08/2017

Is it right to make FDA approvals easier?

Pharma Horizon

During the last meeting with pharmaceutical executives, President Trump has promised to ease and make quicker drug’s approval from FDA.

But is this right?

President Trump hasn’t yet name to head FDA  new  but the most accredited name for the job so far is Jim O’Neill, who  said in an August 2014 speech at a biotech conference: “Let’s prove efficacy after they’ve been legalized,”. His suggestion to approve drugs with no tests of their effectiveness, will lead patients would become part of a continuing experiment and be prescribed medicines their doctors know little about.

A recent FDA report cited 22 specific cases of drugs that passed Phase II clinical trials, but failed in Phase III, underlining why O’Neill’s arguments could be dangerous.

Some experts have taken as example the Genentech’s Tarceva approved by FDA in 2004 and then only in December 2015, Genentech released the results of the study showing it did work for only for  patients with a rare gene mutation.  So 12 years after been approved, FDA hat to remove Tarceva’s approval, except for a small amount of patients. During this lapse of time the $7,800-a-month cancer drug caused rashes and rarely worked.

Tarceva is not the only example of drug been  prescribed that may not work for most patients.
Vinay Prasad from the Oregon Health and Science University warned :“As you lower the regulatory standards you open the flood gates to more of these ineffective drugs.” He also pointed to a study that found the average gain in survival for the 71 cancer drugs approved from 2002 to 2014 was just 2.1 months. 

Read further on Los Angeles Time 




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