FDA drug approvals reached 18-year high in 2014
Jan-03-2015

The Food and Drug Administration approved 41 first-of-a-kind drugs in 2014, including a record number of medicines for rare diseases, pushing the agency's annual tally of drug approvals to its highest level in 18 years.

FDA drug approvals are considered a barometer of industry innovation and the federal government's efficiency in reviewing new therapies. Last year's total was the most since the all-time high of 53 drugs approved in 1996.

The 2014 approval list includes 15 drugs for so-called orphan diseases, which are rare conditions and disorders that affect fewer than 200,000 people in the U.S. Last year's tally, which included drugs for rare cancer and metabolic disorders, exceeded the 13 orphan drugs approved in 2012.

The record-setting number reflects the drug industry's ongoing shift toward specialty drugs for niche conditions, which often come with extra patent protections, streamlined approvals and higher price tags.

For example, last month the FDA granted accelerated approval to Amgen's Blincyto, a biotech therapy to treat a rare form of leukemia. Shortly thereafter, Amgen announced it would price the immune-system boosting cancer drug at $178,000 per year. Earlier in the year the agency approved Myalept for an ultra-rare metabolic disorder that affects roughly one in a million people in the U.S. The drug from Aegerion Pharmaceuticals costs about $325,000 per year.

While the uptick in innovative medicines is good news for patients, it is sure to reinvigorate debate over the price of new drugs as insurers and public payers increasingly push back against higher costs.

America's Health Insurance Plans, the chief lobbying group from insurers, spent much of the last year speaking out against the costs for innovative new drugs, for both orphan conditions and more common diseases. AHIP and other groups took particular issue with the price of Harvoni, a new hepatitis pill which costs $94,500 for a 12-week supply.

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