After more than a decade of industry pleading for guidance on Orange Book patent listings, the U.S. FDA is finally planning on answering that request this year. If the guidance that’s produced reflects the FTC’s position that device patents can’t be listed for combination products, it could overturn years of accepted practice and possibly hinder the development of new, more advanced drug administration technologies.
A lot of development dollars are shed when the FDA withdraws approval or requests that a drug be withdrawn from the market because new potential risks have come to light. And it’s not just the brand company that feels the loss.