January 12, 2016 Articles

It's the Hard-Knock Life: The Rough-and-Tumble over Orphan Drug Pricing

Constituencies that disagree with regulations issued by HHS are likely to have more opportunities to challenge their validity.

By Mark P. Goodman, Maura K. Monaghan, Kristin D. Kiehn, Jacob W. Stahl, and Kaitlin T. Farrell

The Department of Health and Human Services (HHS) has encountered hurdles in implementing the voluminous Patient Protection and Affordable Care Act (PPACA), including the challenge of accomplishing its health care policy objectives where those objectives are not clearly expressed in, or even appear to conflict with, the PPACA’s statutory text. HHS has been sued by impacted constituencies regarding its interpretation of the PPACA on a number of occasions and will likely face more lawsuits in the future.

At the same time, the issue of the affordability of drugs, particularly drugs for serious, life-threatening conditions, is receiving intense public attention. Turing Pharmaceuticals, and its chief executive officer Martin Shkreli, came under fire for raising the price of Daraprim, a drug used to treat parasitic infections in HIV patients, from $13.50 per pill to nearly $750 per pill, an increase of 5,000 percent. After initially defending the price hike as necessary to keep the company in business, Shkreli backed down, promising to lower the price and provide the medication for free to the uninsured. The Senate Special Committee on Aging has just issued requests for documents about drug pricing to four different pharmaceutical companies, and the House Investigations Committee is reportedly considering whether to launch its own probe.

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