Table 3 Financial, legislative, and scientific strategies for advancing generic agents

From: Drug repurposing for Alzheimer’s disease and other neurodegenerative disorders

Legislative strategies

Provision of period of exclusivity for generic repurposed agents

Tax incentives for scientific development of new uses devoted to neurodegenerative disorders

Legislation to require public and private insurers to reimburse the new use of generics with established efficacy and safety for a neurodegenerative disorder

Regulatory strategies

Waiver of Prescription Drug User Fee Act (PDUFA) fees

Establishment of rapid communication channels with regulatory agencies

Rapid review and expert input by regulatory authorities during the development process

Financial strategies

Innovation surcharge

Social impact investing

Mega-fund creation

Crowdsourcing

Motivational prizes

Advocacy collaboration

Philanthropy or venture philanthropy

Scientific strategies

New formulations (patch, sublingual, etc)

New dosing approaches

Novel combination therapies

Prodrug identification and development

Medicinal chemistry approaches to create new molecular entities that may have the benefits observed in trials of generic agents

  1. A variety of strategies spanning legislative, regulatory and scientific approaches can assist in advancing repurposed agents. Innovative financial tools may help to fund trials of repurposed agents where intellectual property protection is limited and conventional funding streams are unavailable.
  2. There are hurdles to advancing repurposed agents as treatments for neurodegenerative disorders.
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