Finally, with the help of my Congressman, FDA told me what they should have told me almost six years ago, when I asked for the names of contractors providing Risk Evaluation and Mitigation Strategy (REMS) program services to the agency. As a FDA bureaucrat could easily have informed me, federal law provides that the American people (you know, the ones "our" government is "for") cannot know who that government does business with. And get this, it's because "public disclosure of this type of information may cause substantial competitive harm to the owner of that information"!
And here I thought federal law protected competition among businesses as advantageous to the American people. Silly me.
Here is the full text of the letter from Andrew Tantillo, Acting Associate Commissioner for Legislative Affairs at U.S. FDA:
"Dear Representative Smith:
Thank you for your email of April 15, 2021 on behalf of your constituent, Dr. Howard Berryman
Edwards, regarding information about who manufacturers contract with to administer the Risk
Evaluation and Mitigation Strategy (REMS) program.
Information related to the vendors that manufacturers contract with to administer REMS
programs, if made known to the Food and Drug Administration (FDA or the Agency), is
generally included in the REMS Supporting Document Submissions filed with FDA. There are
several vendors that FDA is aware of that provide or have provided REMS services. Under
federal law, FDA may not be permitted to publicly release the names of the contractors that are
used for each of the individual REMS programs because non-public business relationships
constitute confidential commercial or financial information within the meaning of 18 U.S.C. §
1905, 21 U.S.C. § 331(j), and 5 U.S.C. § 552(b)(4) that is exempt from public disclosure under
those statutory provisions and/or relevant FDA regulations. U.S. Courts have recognized that
public disclosure of this type of information may cause substantial competitive harm to the
owner of that information. If a business relationship has been made public in a lawful manner,
such as in public REMS materials, FDA will publicly disclose in other Agency records for that
drug application the existence and identity of that contractor.
We encourage your constituent to contact the Center for Drug Evaluation and Research’s
(CDER) Division of Drug Information (DDI) with specific questions about drugs regulated by