Encouraging New Uses for Old Drugs
Author Affiliations Article Information
- 1Washington University in St Louis School of Law, St Louis, Missouri
- 2Leonard D. Schaeffer Health Policy Studies, Brookings Institution, Washington, DC
- 3Schaeffer Center for Health Policy and Economics, University of Southern California, Los Angeles
- 4Public Policy, Pharmacy, and Economics, University of Southern California, Los Angeles
JAMA. Published online December 4, 2017. doi:10.1001/jama.2017.17535
US Food and Drug Administration (FDA) approval of a new drug typically coincides with a period of patent protection, during which the manufacturer will often apply for additional indications to expand the market for the product. For example, the tyrosine kinase inhibitor imatinib (Gleevec; Novartis) was originally approved to treat Philadelphia chromosome–positive chronic myelogenous leukemia, but has since been approved for treatment of other cancers. Many noncancer drugs also follow this pattern, including botulinum toxin A (Botox; Allergan), which was originally approved for the treatment of strabismus and blepharospasm and subsequently approved for treatment of cervical dystonia, cosmetic uses, and chronic migraine.
This pattern of additional testing and approvals is common for more expensive on-patent drugs, but new indications are rarely sought for less-expensive generic drugs, for which it is more difficult to profit from the research. This creates a policy conundrum: follow-on innovation for low-cost generic products offers a rare opportunity to simultaneously improve health outcomes and likely reduce health care expenditures, but how could such research be encouraged?
The Problem
When drugs are patent protected, companies have incentives to conduct clinical trials and validate their products for both core indications and additional uses. If the drug proves safe and effective for the new use, the patent holder can recoup the costs of the additional trials by marketing the drug at a monopoly price. However, after generic products for the original indication enter the market, prescriptions for the new indication can be filled with a generic product, dampening incentives for innovator companies to study those new indications, in what has been referred to as the “problem of new uses.”1
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