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Full-Text Articles in Law
It Is Time: Why The Fda Should Start Disclosing Drug Trial Data, Mustafa Ünlü
It Is Time: Why The Fda Should Start Disclosing Drug Trial Data, Mustafa Ünlü
Michigan Telecommunications & Technology Law Review
Although [drug] manufacturers bear the cost of research data generation, it is oftentimes a worthwhile investment that also confers significant commercial advantages. Consequently, they have argued that research data should be considered a trade secret and kept confidential. The FDA's longstanding position has been to accept this proposition. Even when Congress appeared to mandate disclosure or weaken the underlying rationale for secrecy, the FDA has continued to treat research data as confidential. A strong argument against a default posture of confidentiality is that research data disclosure would promote broad public interests by eliminating the societal costs brought about by keeping …
Agency Hygiene, Nicholas Bagley
Agency Hygiene, Nicholas Bagley
Articles
Prof. Bagley notes that reshaping captured agencies using the structural reforms suggested by Prof. Barkow may be politically infeasible and offers an alternative solution for eliminating interest-group capture. First, he suggests establishing a body within the Executive Branch that proactively investigates and documents capture dynamics. Second, he suggests creating legislative mechanisms that will encourage Congressional action on the body’s recommendations, and perhaps, more provocatively, requiring the Executive Branch to enact any such recommendations in the absence of Congress’s formal objection.
Disclosing 'Political' Oversight Of Agency Decision Making, Nina A. Mendelson
Disclosing 'Political' Oversight Of Agency Decision Making, Nina A. Mendelson
Articles
Scholars and courts have divided views on whether presidential supervision enhances the legitimacy of the administrative state. For some, that the President can supervise administrative agencies is key to seeing agency action as legitimate, because of the President's accountability to the electorate. Others, however, have argued that such supervision may simply taint, rather than legitimate, an agency action. The reality is that presidential supervision of agency rulemaking, at least, appears to be both significant and opaque. This Article presents evidence from multiple presidential administrations suggesting that regulatory review conducted by the White House's Office of Management and Budget is associated …