Criticism Of FDA Citizen Petitions Is Often Misguided

Law360, New York (November 20, 2017, 3:07 PM EST) -- In the late 1970's, the U.S. Food and Drug Administration (FDA) established the citizen petition process to implement the First Amendment right to "petition government" in the context of FDA-regulated products and activities. The citizen petition process allows any interested person or organization to formally ask the FDA to take (or refrain from taking) regulatory action on virtually any topic. For nearly 40 years, citizen petitions have been used by a wide variety of stakeholders to initiate important public dialogues about health, safety and public policy.

In recent years, however, the citizen petition process has come under sustained attack by critics,...

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