lunes, 14 de enero de 2013

Orphan drugs: 30 años con padre...Ronald Regan.

Slide: F.Comas/Curso Postgrado Mercadeo Farmacéutico/ 
Facultad de Farmacia/Universidad Central de Venezuela (UCV)

30 years ago, the US Orphan Drug Act came into being, and with it, a door of possibilities opened up for patients with literally thousands of untreated diseases. The anniversary marks the beginning of a journey where medicines for rare diseases have gained a foothold in the portfolios of drug companies large and small, largely because of the Act’s rich array of incentives that finally made it worthwhile to invest real money.
Signed into law by President Ronald Reagan on January 4th, 1983, the ODA gave orphan status to drugs for diseases affecting less than 200,000 American citizens. The law granted seven-year patent exclusivity, tax credits equivalent to one half of the development cost (later modified to a fifteen-year carry-forward provision and a three-year carry-back that can be applied in any profitable year), direct grants, FDA fast-track approvals, and expanded access to patients under the Agency’s Investigational New Drug Program. The law was also later amended to waive FDA user fees established under PDUFA. (Más)

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