First Amendment Clinic

First Amendment Clinic Cases

Seife v. FDA

Cornell’s First Amendment Clinic represents plaintiff and veteran investigative journalist Charles Seife as co-counsel with Yale Law School’s Media Freedom and Information Access Clinic and Vinson & Elkins LLP in a case involving the Freedom of Information Act Exemption 4 where Seife is seeking access to safety and efficacy clinical trial data contained in documents known as “Clinical Study Reports” for that were used by the FDA in the controversial approval of a drug to treat Duchenne Muscular Dystrophy marketed as Exondys 51. Specifically, this case presents a novel legal question in the Second Circuit: Whether information that defendants claim constitutes “confidential commercial information” (or CCI) can be released upon a showing that there is a significant public interest in release of the information. Here, there are several public interests. First, there is an interest in “shed[ding] light on the FDA’s performance of its statutory duties under Exemption 4, particularly given the substantial concerns that exist of possible scientific misconduct and agency malfeasance” that arose in the approval process. See Seife Reply Br. at 2. Second, “the withheld data also hold the key to public health questions about the effectiveness of the drug and potentially fatal side effects from using it, . . . so disclosure will valuably inform doctor-patient decision-making about a drug whose list price can exceed $1,000,000 per patient per year.” See Seife Opening Br. at 3-4. Secondarily, the case presents other questions about the rigor of evidence drug companies must put forward to establish the information they seek to withhold is likely to cause substantial competitive harm to the drug manufacturer and whether in light of all the information that has been made public about the drug in question here, that standard is met.

 

Related Documents:

Seife Combined Cross Motion in Opposition to the Defendants’ Motions for Summary Judgment and Cross Motion for Summary Judgment (PDF)

Seife Reply Brief In Further Support of (1) Seife’s Motion for Summary Judgment and (2) Seife’s Motion to Strike (PDF)

Declaration of Charles Seife (PDF)

Reply Declaration of Charles Seife (PDF)

Declaration of Dr. Peter Lurie (PDF)

Reply Declaration of Dr. Peter Lurie (PDF)

Declaration of Dr. Diana Zuckerman (PDF)

Declaration of Cortelyou C. Kenney (PDF)