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In Defense Of “Me-Too” Drugs: Is Primary Care Losing Out To Rare Disease R&D?

This article was originally published in RPM Report

Executive Summary

Regulatory and financial incentives have sparked major investment in orphan drug development. One-third of the new molecular entities and novel biologics approved by FDA in the past five years have been orphan drugs. But now some stakeholders are questioning whether the focus on orphans is orphaning another market: primary care conditions that are still not adequately treated. Are incentives needed?


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