Pitfalls of FDA’s Breakthrough Drug Program

Posted in News on 4.17.2018
While the FDA’s expedited review programs are often touted as a way of speedily getting life-saving or life-altering drugs into the hands of patients in need, some experts, among them Alosa Health founder Jerry Avorn, are skeptical about the FDA’s breakthrough drug therapy (BTD) program.

Firstly, Avorn and colleagues note that the BTD program results in huge gains for the pharmaceutical industry by eliminating years’ worth of research and development costs. This means that there is a clear profit motive associated with submitting a request for the BTD designation.

Secondly, drugs undergoing expedited review are able to win approval based on less supporting data than would be required through the standard review process, leaving their value and value relative to other therapies “untested and uncertain”. The process is faster, but at the expense of rigorous evaluation of evidence.

Add in the media’s tendency to refer universally to drugs undergoing expedited review as “innovative” and “game changers” (labels that are often applied prematurely, well before there is sufficient supporting evidence), and it is easy to see how the BTD program leaves the door open to misunderstanding and misinterpretation concerning drugs’ perceived safety and value.

Interested in learning more? Read the full article from Endpoints News here.