August 12,1997 — The FDA issues its first draft of Guidance for Industry: Consumer-Directed Broadcast Advertisements.

Previously, advertising of drugs had been restricted by the FDA requirement that all prescription drug ads disclose a brief summary including all the warnings, precautions, contraindications, and adverse events known for the drug. This had effectively limited advertising to print media.

The new guidance eliminated the requirement for the summary, and substituted an "adequate provision" clause: instead of having to tell consumers about all the risks, pharmaceutical companies had to make adequate provision for them to find out for themselves, for example by providing a phone line.

1997 —Congress passes the FDA Modernization Act (FDAMA), and the Best Pharmaceuticals for Children Act (BPCA). This amendment gives 6-month patent extensions to drug makers who conduct pediatric clinical trials of existing drugs and get them approved for use in children, through 2007.

November, 1997Article: A Double-blind, Randomized, Placebo-Controlled Trial of Fluoxetine in Children and Adolescents With Depression. In a study of 96 youth ages 7 to 17 with major depressive disorder, Graham Emslie et al find that 27 out of 48 (56%) of those receiving fluoxetine and 16 out of 48 (33%) receiving placebo are rated "much"or "very much" improved. He concludes that "Fluoxetine was superior to placebo in the acute phase treatment of major depressive disorder in child and adolescent outpatients."

Data from this NIMH-funded trial was used by Eli Lilly to gain an additional 6-month patent exclusivity for Prozac (FDA, 2001). See FDA Medical Review Sept 14, 2000.

December, 1997 —Acute phase of Study 329 is completed.