FDA approves 45 new drugs. 47 percent qualify for 50 percent Orphan Drug tax credit

In calendar year 2015, FDA’s Center for Drug Evaluation and Research (CDER) approved 45 novel drugs, approved as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biologics under Biologics License Applications (BLAs). This is a large number of approvals.

Of the 45 drugs, 21 (47%) were approved to treat “Orphan” diseases, and qualified for a 50 percent tax credit that can be applied to the costs of qualifying clinical trials. While the FDA makes the designation and approval of orphan indications public, the amount of money claimed for the tax credit is not transparent. And, while a 50 percent subsidy for the cost of clinical trials is an important subsidy, it does not provide the U.S. government with any leverage on pricing of uses of the products, in contrast to a grant or research contract, which provides for royalty free rights in patents and federal march-in rights when patent rights are abused.

15 drugs (33%) were approved to treat cancer, including 11 (73% of cancer drugs) that were approved for an “Orphan” indication. 11 of the 15 drugs also benefited from a priority review.

  • Twenty-four of the 2015 novel new drugs (53%) were designated Priority Review.
  • When more than half of products are given a priority, the head of the queue becomes crowded.

  • Twenty-seven of the 2015 novel new drugs (60%) were designated in one or more expedited categories of Fast Track, Breakthrough, Priority Review, and/or Accelerated Approval. Each of these designations helps expedite the speed of the development and/or approval process.

The FDA list of the approvals is here http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm430302.htm

An FDA blog about the approvals is here:

The FDA summary of the approvals is here:

Data on the 15 cancer drugs are available here.