A new bill introduced last week in the US Senate by Senator Orin Hatch (R, UT) is known as the Dormant Therapies Act of 2014. The primary objective of this bill would be to offer a drug developer 15 years of data exclusivity for development of a medicine that meets an unmet medical need. In other words, if any drug could be shown to be effective and safe as a treatment for a previously unmet medical need, generic drug makers would be excluded from using the data generated by a brand-name drug maker to obtain regulatory approval and sell their own, similar, generic versions of the drug for a total of 15 years.
This is a rather controversial proposal, and if you are interested in the pros and cons of the proposal, we refer you to the Pharmalot blog site of The Wall Street Journal, where Ed Silverman discusses these in greater detail. Suffice it to say here that:
- Innovator drug companies currently may gain 5 years of data exclusivity for a new prescription small molecule pharmaceutical and 12 years of data exclusivity for a biologic prescription medication. An extension to 15 years is therefore significant for any molecule that meets an unmet medical need.
- Similar legislation was also introduced in the House of Representatives in 2011 by Rep. Leonard Lance (R, NJ) as part of the “Modernizing our Drug & Diagnostics Evaluation and Regulatory Network Cures Act” (also known as the MODDERN Cures Act).
A key question in the 114th Congress that will convene in early 2015, with a Republican majority in both houses, will be whether the proposals laid out in the MODDERN Cures Act and the Dormant Therapies Act are brought forward into the developing legislation to be proposed under the ongoing and evolving 21st Century Cures Initiative, being spearheaded by Rep. Fred Upton (R, MI) and Rep. Diana DeGette (D, CO).