Disclosure of Clinical Trial Data: Why Exemption 4 of the Freedom of Information Act Should Be Restored

Clinical trial data generated during the FDA drug approval process can be very valuable. While patients and doctors desperately need this information to make informed choices about medical treatment, drug sponsors strive to keep this resource secret to ensure their ability to profit from their own research. In the wake of the controversy over antidepressant use in children, both the public and Congress have called for the disclosure of all clinical trial data. However, rather than taking an all-or-nothing approach that could harm the development of new drugs, this iBrief argues that Congress should address the issue of trial data disclosure by restoring the proper balance to Exemption 4 of the Freedom of Information Act

Disclosure of Clinical Trial Data: Why Exemption 4 of the Freedom of Information Act Should Be Restored

Clinical trial data generated during the FDA drug approval process can be very valuable. While patients and doctors desperately need this information to make informed choices about medical treatment, drug sponsors strive to keep this resource secret to ensure their ability to profit from their own research. In the wake of the controversy over antidepressant use in children, both the public and Congress have called for the disclosure of all clinical trial data. However, rather than taking an all-or-nothing approach that could harm the development of new drugs, this iBrief argues that Congress should address the issue of trial data disclosure by restoring the proper balance to Exemption 4 of the Freedom of Information Act

No Man’s Land

This poem is inspired by a set of letters between Jes Jerry Jessen and his sister Helen during his time as a soldier during World War I

The Obsolescence of San Antonio v. Rodriguez in the Wake of the Federal Government’s Quest To Leave No Child Behind

Since the mid-1950s, a sea change in public education has taken place. Public education—a policy concern traditionally reserved to the states—has become a core concern of the federal government. This Note surveys three of the federal government’s most significant appropriations of power: the enactment of the Elementary and Secondary Education Act (ESEA) in 1965; the creation of the Department of Education in 1980; and the passage of the No Child Left Behind Act of 2001 (NCLB), the most recent, and easily most expansive, iteration of the ESEA. This Note also considers the manner in which the Supreme Court has facilitated federal control over education, despite the Court’s refusal to recognize a formal right to education. Finally, this Note argues that the federal government’s incursion into the realm of public education has established an implicit right to education that has rendered San Antonio v. Rodriguez, the Supreme Court’s 1973 decision that denied the existence of a fundamental right to education, obsolete