“Although fast-track processing of drugs facilitates earlier access of drugs that are urgently needed by society, it also may undermine safety. From 1988 to 2010, some of the fast-track products have gone unpredicted and withdrawn which is mentioned in Table 2. Increased cardiovascular events from selective cox-2 inhibitors valdecoxib and rofecoxib, rapacuronium-induced bronchospasm, alosetron-induced ischemic colitis, hepatotoxicity from cerivastatin, and troglitazone were grievous. Lack of efficacy is also exemplified from some fast-track products such as drotrecogin alfa, mibefradil, moxalactam, and cefonicid.[3]”
“There are critics that FDA is liberal and approve the molecules in an accelerated way based on trivial information submitted by marketing authorities. The critic is evidenced by the annual report of FDA approval of 35 new chemical entities in 2011; the review was completed in an average of 8.2 months will make us frown surprisingly. Despite the critics, FDA approved 41 novel compounds in 2014 (15 fast-track products) and 45 novel compounds (14 fast-track products) in 2015.[4]”
Expedited drug review process: Fast, but flawed
Krishnan Vengadaraga Chary
Department of Pharmacology, Saveetha Medical College, India
J Pharmacol Pharmacother. 2016
\expedited drug review process: fast, but flawed 2016.pdf
Accelerating cost of care:
New drugs fast-tracked by FDA
Discoveries in genetics and cell signaling have been validated by significant research and introduction of precision analysis technologies. These discoveries have presented the opportunity to pursue new drugs to treat diseases by modifying cell signaling in an attempt to change cellular behavior. By modifying the physiology at the cell level, it is hoped that disease progression and symptoms can be controlled.
Unfortunately, the threshold for FDA approval is very low. Typical drug approvals, due to being “fast-tracked,” lack data for long-term safety or efficacy. Additionally, approvals may only require a modest improvement in patient survival of only a few weeks. Many of these drugs do not replace existing chemotherapeutic drugs. Rather, they provide another choice, expensive choice, to the patient, and is family, desperate to extend life a few months or weeks longer. Regardless of the source of the trend, the fast-tracked approvals of expensive drugs have resulted in an exponential increase in infrastructure and cost of care. With very limited expectations for improving outcomes, it is projected that more and more patients will abandon conventional care for chronic diseases and cancers.
The diagram below represents the new categories of sciences for the genetics of cell signaling. Each category presents the opportunity to introduce several new drugs, each targeting a specific gene, to either inhibit or promote its expression. With each new class of science, in addition to a swarm of new drugs, an immense growth in infrastructure will occur. From basic research to delivery to advocacy, every conceivable category of immense medical establishment will see significant growth with a corresponding incremental cost of care.