To the Editor We share the concern expressed by Dr Hurria and colleagues1 in their Viewpoint regarding the underrepresentation of older adults in cancer trials submitted for registration with the US Food and Drug Administration (FDA). We disagree with the Institute of Medicine’s (IOM) recommendation to “amend patent law to provide patent extensions of up to six months for companies that conduct clinical trials”2 in this population. The Pediatric Research Equity Act, which provides 6 months of market exclusivity for manufacturers that study their products in children and which serves as the basis for this recommendation, has a more complex legacy than Hurria et al1 acknowledged.
Luo J, Kesselheim AS. Underrepresentation of Older Adults in Cancer Trials. JAMA. 2014;311(9):965-966. doi:10.1001/jama.2013.286454