FDA Asked To Improve Approval Processes For Orphan Drugs

Lawmakers appealed to FDA Commissioner Margaret Hamburg to improve consistency of approval processes for orphan drugs, in a letter spearheaded by Senator Edward Markey.

“We write in recognition of the Food and Drug Administration (FDA’s) efforts to ensure public access to safe, innovative and novel therapeutics, particularly for rare diseases and where there are unmet medical needs, and to ask that you continue to commit to ensuring that potential new medicines are guided and reviewed consistently across the agency,” the letter stated, which was signed by 38 members of Congress. The lawmakers said that many families continue to struggle with limited options for rare diseases and development of new, more effective medical treatments often comes too slow. “Innovation of new and safe drugs is especially urgent for rare diseases, for which either no approved therapeutics or no cures currently exist,” the letter stated.




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