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European Biopharmaceutical Review

Acting Up

On January 4, 1983, President Reagan signed the Orphan Drug Act (ODA) into law with the goal of providing financial and marketing incentives so that private pharmaceutical companies would develop more therapeutics for rare diseases. The benefits offered by the ODA include seven years of marketing exclusivity upon approval, tax credits worth 50% of the cost of human clinical trials and federal research grants to fund the development of orphan drugs.

Today, critics question whether the ODA is being used appropriately by firms. Most of this discussion is centred around the ‘orphan subset’ – a subset of a relatively common disease that a narrowly-targeted therapy might be developed for to qualify as an orphan drug and reap the ODA’s protections and benefits. In February 2017, Senator Chuck Grassley opened an inquiry into potential abuses of ODA by drug sponsor; this inquiry is likely to investigate the practice of ‘salami-slicing’ and how this may contribute to high prices of orphan drugs.

Salami-Slicing


This practice is defined as “artificially subdividing diseases to create subgroups of patients that fall under the orphan drug prevalence threshold”.

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Matthew Weinberg is Chief Executive Officer at The Weinberg Group. He guides all strategic issues with management client efforts, emphasising the provision of tactical and operational assistance to technically-oriented entities in areas including R&D, regulatory affairs and quality assurance. Matthew’s assignments have involved development of new products, testimony of the management and economics of scientific enterprises, contract issues and product advancement.

Emily Krulewitz is a Consultant at The Weinberg Group. Her work involves issues related to the development and regulation of therapeutics, medical devices, tobacco products and foods. Emily has experience in the preparation, coordination and compilation of regulatory submissions as well as responding to various legislative challenges through the development of technical reports. She received a bachelor’s degree in chemistry and integrated arts from Northwestern University, US, and a master’s degree in biotechnology from Johns Hopkins University, US.

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Matthew Weinberg
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Emily Krulewitz
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