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The FDA Push for More Generics

  • March 21, 2018
  • RPh on the Go

generic pillsThe high cost of prescriptions has been the bane of American society for a long time. We have watched so many people struggle to afford their medicines, make decisions over healthcare, and eat too often. For the pharmacist, it can be heartbreaking to watch our patients struggle to make ends meet and take care of themselves. The FDA has taken great strides to push for easier access to generics and we will soon see the snowball effect of their efforts.

At It’s Worst

2012 was the year in which we could see just how awful the situation became. Applications for generic approvals were backlogged to the point where almost 3,000 applications were waiting. The system of approving those applications was certainly not functioning at its best and created a serious problem in the prescription market.

Change Began in The Obama Administration

With the evident problem emerging into the light in 2012, it became apparent that a change had to happen. It took a long time to start the repairing of the system and it was Dr. Robert Califf who began tackling the issue with his induction as commissioner of the FDA in 2016. With nearly 2,800 applications backlogged and more arriving, his work was cut out for him and he proved to be a driving force in reducing the numbers. Prior to his induction, approvals for the year averaged in the 400s. With Dr. Califf working tirelessly at the helm, there were over 600 approvals in 2016. Dr. Califf left his position in January 2017 and his seat sat empty until May. One would assume that it would translate into another slump, but his successor proved all of us wrong.

It Continues to Improve

May 2017 found Dr. Scott Gottlieb inducted as our current commissioner of the FDA and he is carrying on the profound efforts his predecessor brought to the table and has expanded on them. Not only did he keep that momentum going, he exceeded expectations by ensuring that over 700 applications were approved! This isn’t just limited to generics either, it includes medical aids and various therapies that we have been waiting on for a very long time. The current backlog now sits at just a few hundred applications and we can imagine that we will see even more approvals this year with lightning speed.

Ease at The Pharmacy

With these generics being approved quicker it means we will see them on shelves sooner and assisting our patients in far better ways. The 2016 election year showed how much the American peoples wanted to see more affordability in healthcare. No matter where you stand politically, we can honestly say that this is the one thing that is going well and in our favor. What we now hope to see is that there are continuous efforts to make the approval process more efficient while remaining safe and secure for all of us. In the meantime, pharmacists should keep patients well informed about generic options and whether generics are on the way. Helping them find ways to take care of themselves further nurtures the relationship you have with them.

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