Qui Tam

Senator Requests Clarification of Recent Memo to FDA Employees

By Nolan and Auerbach

U.S. Sen. Chuck Grassley wrote a letter on March 24, 2009 to FDA’s acting commissioner asking for clarification of a recent memo to FDA employees, warning agency employees of their obligations to keep certain information confidential.

In the letter, addressed to Frank M. Torti, MD, MPH, Grassley writes: “While I appreciate the fact that some information, including certain business trade secrets, needs to be protected from unauthorized disclosures, I have serious concerns that your memorandum goes beyond legitimate privacy concerns and appears to run contrary to many statutes protecting executive branch communications with members of Congress.

Specifically, your memorandum notes that certain information acquired from businesses and industry is protected as confidential and may only be disclosed in limited circumstances. Your memorandum cited the Food, Drug, and Cosmetic Act, the Freedom of Information Act (FOIA), the Trade Secrets Act, and the Privacy Act, as well as FDA regulations as the controlling authority for determining when a document or information may be disclosed. You added that FDA employees who violate these provisions may face disciplinary sanctions and criminal liability.”

Grassley’s concern is that FDA employees should have the right to talk to Congress and to provide Congress with information free and clear of FDA agency influence. Further, these employees have the right to be free from fear of retaliation or reprisal, he writes.

For the letter in its entirety, go to http://www.iowapolitics.com/index.iml?Article=153174. For more information about qui tam law and health care fraud, including pharmaceutical fraud, contact Nolan and Auerbach, PA.

Full post as published by Pharma 101 - Pharmaceutical Fraud on March 25, 2009 (boomark / email).