Regulatory Exclusivity Revision: Working to Achieve Greater Innovation in Approved New Molecular Entities

Abstract Rewarding innovation is a part of the regulatory system for drugs, both in terms of patent protection and the granting of regulatory exclusivity. One particular area where there has been a significant amount of innovation is in the development of orphan drugs. However, there has been a persistent issue regarding the significant percentage of approved new drugs that are less innovative than their counterparts. Further, it appears that the level of innovation in approved drugs containing a new molecular entity (NME) has been on the decline. This issue is highlighted by the proliferation of "me-too" or "addition-to-class" drugs. Me-too or addition-to-class drugs include drugs such as Lipitor and Nexium. These are considered less ground-breaking than other NMEs, as they generally function similarly to products that are already on the market. To combat the proliferation of me-too drugs, this Note proposes increasing regulatory exclusivity as a way to incentivize drug companies to create more innovative NMEs. This Note suggests that increasing exclusivity periods for more innovative NMEs, in that they are a drug with an NME that either demonstrates a new way to treat a disease or is designated for priority review by the FDA, will result in a greater number of these drugs being produced.