Food & Drug Bulletin

Dear Reader:

Sometimes I hear comments questioning the need for legal counsel in matters relating to FDA product clearance and enforcement activities. One rationale for these comments is that regulatory affairs personnel can provide needed service. Another is that help can be obtained directly from FDA personnel. Clearly, regulatory affairs and FDA personnel represent valuable assets, but they are not substitutes for the advice and protection provided by legal counsel.

The FDA exists to enforce federal laws. Interactions with the FDA are either disclosable to the public under the Freedom of Information Act or as part of discovery in litigation. These interactions are used often as evidence by plaintiffs in products liability, breach of contract, and other types of litigation. Additionally, related communications, unless covered by work product or attorney-client privilege, are subject to embarrassing or harmful disclosure.

Legal counsel provides advice about whether FDA is correctly interpreting and applying the law, and assists clients in understanding what is required by law and options that are available. Of equal or greater importance is the fact that attorney client-communications are usually protected from disclosure.

In sum, knowledgeable use of legal counsel ranges from prevention to protection and can help to ensure that FDA adheres to fair play and equal justice. As such, legal counsel should play an integral part in every FDA-regulated business.

Sincerely,

Larry R. Pilot

Articles In This Issue

FDA Forced to Re-Think Its Policies On Certain Advertising Restrictions

FDA Releases 180-Day Generic Drug Exclusivity Proposed Rule

National Uniformity Bill Re-Introduced to Preempt Food Labeling Law

FDA Issue MDR Exemption Document for Y2K Problems

FDA Dietary Supplement Policy Undergoes Increased Scrutiny

Public Citizen Health Research Group V. FDA: FOIA Suit for IND Material

Congress Closely Monitors Prescription Drug Sales Over the Internet

FDA Issues Final Guidance on Prescription Drug Advertising

M&C Expands Legal Services

Click here to access/download the Food & Drug Bulletin (September 1999) in Adobe Acrobat (PDF) format.

If you do not have the free Acrobat reader, go to www.adobe.com.

For more information, please contact: