Morgan Lewis on Life Sciences
July/August 2004

In this Issue:

• FDA Issues Draft Guidances on Advertising and Promotion:
  The Food and Drug Administration released three new draft guidance documents regarding direct–to–consumer (DTC) advertisements of drugs, biologics, and medical devices. The draft guidances describe FDA’s requirements for DTC broadcast advertisements for restricted devices, propose alternatives to the “brief summary” requirement for DTC print advertisements for drugs and biologics, and provide guidance on and attempt to stimulate the use of “disease awareness"; communications.
• What Industry Needs to Know About FDA's Plan to Combat Obesity:
  As part of its plan to combat the nation’s growing obesity epidemic, FDA recently released a report prepared by the Agency’s Obesity Working Group (OWG). Among other things, the report includes recommendations to FDA for steps that can be taken to improve food labeling and suggests that the Agency should urge restaurants to voluntarily provide calorie and nutrient information. In addition, the report supports FDA’s plans regarding the development of obesity therapeutics.
• Compliance Function Moves into the Corporate Spotlight:
  The U.S. Sentencing Commission, an independent agency within the federal judiciary, was established in 1985 and has as its mission the development of a national sentencing policy for the federal courts. The sentencing guidelines issued by the Commission structure the courts’ sentencing discretion with a goal that offenders who commit similar offenses receive similar sentences.
• Speeches & Articles
• Quick Hits

For the full story, please view the PDF.