Paul Fehlner pfehlner at revisiontx.com
Sat Apr 18 11:34:21 PDT 2020


For COVID-19, speed is critical, in particular, the speed of collecting data that supports review of truly effective medicines, and if approved, labeling with clear use instructions. Ideally, this process would provide for transparency and access. However, as with a patented drug or new vaccine, repurposing a generic drug requires a sponsor to file a new drug application, something clinicians, health authorities, and generic drug companies do not typically do, and which results in data exclusivity. We propose creating an impartial entity to manage this process for repurposed generic drugs, with the aim to have evidence-based decisions for approval or rejection, clear instructions for use, and global availability at generic prices if approved. Preliminary discussions with key stakeholders are promising, but ceding this effort to entities that prioritize property interests. We seek investment to prove this concept towards full-scale implementation as soon as possible.

 A single entity that aggregates data from clinical studies around the world and submits that data through processes familiar to health authorities like FDA and EMA would secure evidence-based approvals as quickly as possible without burdening clinicians, health authorities, or generic manufacturers. Such an entity created to serve the public benefit can be trusted to do this unencumbered by existing commercial pressures. It could also commit to full transparency and sharing of data and regulatory dossiers consistent with the calls for pooling resources for COVID-19 treatment.

 We are drug companies organized for public medical benefit.  As such we are positioned to advance an organized effort to speed evaluation of repurposed generic drugs for COVID-19.  We propose to:

·       Aggregate data from multiple clinical and real-world evidence studies of repurposed generic medicines in COVID-19 through an open access platform. While traditional controlled studies are the gold standard, the urgency of COVID-19 demands flexibility. Data aggregated from small studies and real-world use may collectively produce evidence adequate for decision.

·       Seek formal regulatory review for evidence-based approval or rejection of a repurposed generic medicine for use in treating COVID-19 to protect patients’ interest in safety and efficacy and preserve integrity of the health system.

·       Enable all manufacturers globally to sell an approved repurposed medicine labeled for use in treating COVID-19 at a reasonable price, for example close to the generic price.

·       Ensure that regulatory exclusivities associated with new drug approvals of repurposed medicines for COVID-19 benefit the public and not individual companies.

·       Contribute data, regulatory dossiers, and IP rights to international COVID-19 technology pools, like that proposed by the President of Costa Rica and endorsed by the WHO.

 In the fight against COVID-19, we must elevate patients and societal benefit by ensuring that the public gets the full value of heroic efforts already in motion.


Audacity Therapeutics, PBC

Paoli PA 19301

www.audacitytherapeutics.com <http://www.audacitytherapeutics.com/>	
reVision Therapeutics, Inc.

Ridgewood NJ 07450

www.revisiontx.com <http://www.revisiontx.com/>


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