1. DRUG SAFETY RESEARCH June 16, 2006

2. ISSUES Pharmaceutical Industry Depends on Block Buster Model (currently ~80 BBs). Block Buster Model requires fast and broad market penetration immediately following the drug’s approval. Broad market reach can be achieved mainly by Direct to Consumer Advertisement (DTCA).

3. CONSEQUENCES Drugs are used by millions of people based on clinical trial results (very limited data). Increasing number of drugs are being pulled out of the market due to their unacceptable side-effects, causing big financial losses for businesses.

4. CURRENT DRUG SAFETY RESEARCH Impact of DTCA on drug safety –Does DTCA lead to unsafe use of drugs increasing adverse drug effects? –Study benefit/risk relationship for DTCA for select drugs? An alternative to the current drug safety approval process –Under what conditions staged market approval of all drugs is economically viable