Pro Pharma Talks

1. What is off-label drug use?      a. Off-label drug use is when doctors prescribe medications for unapproved uses      b. FDA cannot control how doctors prescribe      c. 20% of Rx in US are fore off-label uses 2. Why use a drug for off-label purposes?      a. Tried all other options without success      b. Literature to support drug’s use, even if limited      c. Different dosage form      d. Dosage for which there is evidence that a higher dose may be effective      e. Drug is generic so there is no financial benefit for a manufacturer to obtain approvals 3. What are the risks?      a. Balance between effectiveness and risk is tilted toward risk      b. Investigational studies with close monitoring of safety 4. Approvals      a. Experi