Device Advertising and the First Amendment: Your Rights

Within recent years the effect of the First Amendment on FDA-controlled speech has drastically changed. Courts have stated standards for what FDA can do in controlling speech in advertisements. The difficult question is predicting the practical impact of these court decisions. FDA still has enormous authority to control speech and labeling. This presentation discusses the balance between FDA control of indications versus court restrictions on FDA control of speech.

Device Advertising and the First Amendment: Your Rights was presented by Robert J. Klepinski, of Fredrikson & Byron and aired 2007-08-23. This audio conference will be replayed on Wednesday, December 17, 2008 by popular demand. For more details or to register for this conference please visit our site www.fxconferences.com

Indications: The Next Battleground in FDA Advertising Enforcement

Recent Supreme Court decisions have provided new protection to commercial speech, challenging the manner in which FDA regulates industry. In response, FDA takes great care to not mention advertising and has shifted its enforcement focus to indications.

The Food, Drug, and Cosmetic Act (FDCA) does not give FDA broad control over advertising, yet it does give FDA explicit control over the approval/clearance process and the resulting indications. FDA is tightening up on statements in ads by closely interpreting indications. This makes it even more critical to plan and write accurate PMA and 510(k) scopes to prevent FDA enforcement.

This audio conference discusses the best way to work within the new reality of FDA advertising enforcement.

Indications: The Next Battleground in FDA Advertising Enforcement was presented by Robert J. Klepinski, of Fredrikson & Byron and aired 2007-01-18. For more details or to purchase a download of this event, please visit our site www.fxconferences.com

Good Reprint Practices: What the FDA Says Now

After years of arguing about the legality of distributing medical journal articles concerning unapproved uses for approved drugs and devices, the FDA has finally released a draft guidance recognizing such distribution as a normal activity. The guidance on Good Reprint Practices outlines the type of articles suitable for dissemination to healthcare professionals, the types of articles which should not be disseminated, and acceptable methods of distribution. However, in some ways this new guidance may be even more rigorous than past programs. It could even be argued that some of the provisions are unconstitutional.

In this audio conference, our speaker will discuss the scope of the draft guidance on Good Reprint Practices and provide expert advice on implementing a program to ensure compliance for drug and device companies.

Good Reprint Practices: What the FDA Says Now is presented by Robert J. Klepinski, FDA Compliance Attorney, of Fredrikson & Byron. For more details, please visit our site www.fxconferences.com