Do We Need These New Medicines?

US Food and Drug Administration approved many medications like Blincyto and Harvoni for rare diseases in 2014

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) One year, 41 approvals. The US Food and Drug Administration (FDA) approved more medications in 2014 than it has in 18 years. Why so many new medications?

Many of those approvals were first-of-their-kind treatments for rare diseases, noted FDA Commissioner Margaret A. Hamburg, MD, on the FDA's blog, FDA Voice.

"What really matters is that many of these new products offer significant clinical value to the care of thousands of patients with serious and life-threatening diseases," Dr. Hamburg wrote.

"That’s certainly the case for patients with rare diseases that affect 200,000 or fewer Americans. So far this year we’ve reached a milestone with a record 15 approvals for rare diseases. The previous high was 13 drugs in 2012. These results are all the more significant because patients with rare diseases often have few or no drugs available to treat their conditions."

In total, the FDA' Center for Drug Evaluation and Research (CDER) approved 41 medications in 2014 — the most since the agency's record-holding 53 approvals in 1996, reports ABC News. In 2013, the FDA approved 27 medications.

With so many novel treatments in 2014, the FDA had to work to quickly get these treatments to the patients who needed them, Dr. Hamburg wrote.

The agency did so with expanded fast-track programs and accelerated approvals for treatments that could vastly improve the lives of patients who don't have many treatment options for their conditions.

For instance, Dr. Hamburg noted, Harvoni (ledipasvir and sofosbuvir) was the first treatment for chronic hepatitis C virus genotype 1 infection that did not also require interferon or ribavirin — it was a complete treatment for the disease. The FDA prioritized Harvoni's review process because officials saw it as a breakthrough therapy.

"In this holiday season of joy and reflection, we have much to be grateful for in the work that CDER does every day on behalf of patients," Dr. Hamburg wrote.

Review Date: 
January 2, 2015
Last Updated:
January 5, 2015