The cost of 'Cures': FDA bill's rare disease provisions to cost $869 million

Dive Brief:

  • According to a report from the Congressional Budget Office (CBO), giving six months of exclusive marketing rights to a company that develops an orphan drug for a rare disease will cost $869 million between 2016 and 2025.
  • One of the main goals of the 21st Century Cures Act is to incentivize drug makers to develop more new drugs. A longer period of exclusivity for certain drugs is one incentive that is being used.
  • Opponents of this provision suggest that drugmakers are winning incentives at taxpayers' expense, because longer periods of exclusivity translate into a longer wait for a generic or biosimilar option to be introduced. 

Dive Insight:

The broad goal of the 21st Century Cures Act, which was introduced by Reps. Fred Upton (R-MI) (pictured above) and Diana DeGette (D-CO) from the House Energy and Commerce Committee, is to “accelerate the discovery, development and delivery of life saving and life improving therapies and transform the quest for faster cures.”

In other words, the goal is to get more drugs approved for patients. Speaking at the 21st Century Cures Roundtable held on May 6, 2014, Margaret Anderson, Executive Director of FasterCures, famously said, "“There are 7,000 known diseases. We have treatments for only 500 of them. We have work to do."

One way to get more drugs developed is to offer incentives, at the same time that some regulatory reforms are put in place to expedite the approval process. While this makes sense, there is a cost and the CBO has set out to quantify them. According to a report in the WSJ, Jerry Avorn, a Harvard Medical School professor of medicine and vocal opponent of the extended marketing exclusivity extension, called the provision "a lavish giveaway to the pharmaceutical industry."

While both sides have a point, closing the gap between 7,000 diseases and 500 available treatments will undoubtedly require some compromises on both sides.

Filed Under: Regulatory / Compliance