By Glenn Petrie, Ph.D.
Senior Scientific Advisor
ABC Laboratories
www.abclabs.com
Dr. Francis Collins, Director of NIH, has stated that it
takes “around 14 years and $2 billion or more “to develop a new drug. Based on
statements like these, Congress has come to the conclusion that the drug
approval process is too onerous and lengthy and is the primary impediment to
the discovery and approval of new drugs. In response they have passed the 21st
Century Cures Act with nearly unanimous, bipartisan approval. But is this a
fallacious assumption? Some argue that the FDA review and approval process is
the fastest and most streamlined in the world and that accelerating the
approval process may impact patient safety.
In an editorial in the New England Journal of Medicine, Dr.
Jerry Arvon states ”The bill would also encourage the FDA to rely more on
biomarkers and other surrogate measures rather than actual clinical end points
in assessing the efficacy of both drugs and devices.” While surrogates have
previously been utilized as endpoints by the FDA to support accelerated
approvals, this was only for drugs intended to treat life threatening
illnesses. Dr. Arvon goes on to state
that biomarkers “may not always predict the drug’s capacity to improve patient
outcomes “. The literature has many examples of cancer drugs approved utilizing
these criteria that not only do not extend life, but have side effects.
While the argument regarding expedited drug
approval continues, one aspect of the new law has unanimous support; an
additional $8.75 billion in funding for NIH over the next 5 years. According to a study published in Health Affairs, federal funding of basic
research played a major role in the origin of transformative drugs approved
between 1984 and 2009.
