Tuesday, February 8, 2011

ePharma 2011: Updates and Insights from the FDA

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Updates and Insights from the FDA
Thomas Abrams, DDMAC, FDA

FDA is trying to protect public health. They have three objectives:
  • present drug promotions in not false and misleading,
  • ensure a balanced picture of drugs
  • aid in the communication of more useful information and the American public.
Three programs to meet objectives: comprehensive surveillance, voluntary compliance and a research program.

Risk information is critical prescriptions drugs have huge benefits, but also have just as many risk. FDA has heard the call for guidance in social media. Since they are committed to giving good guidance providing social media guidelines is taking longer than they originally planned. Since his is an complex issue, Abrams says they are committed to getting it right.

Current FDA resources are going to voluntary compliance. The goal is to have more companies is to self-regulate themselves. They want to prevent the misleading messages. Companies should be just as proud of the drugs they provide as well as of it in the market place. High quality promotion should be promotional, and healthcare professionals the information they provide about them (commercials). FDA reviews all submissions, and it has been an great source to keep them informed. There are 65 people in DDMAC, they receive 65,000+ submissions a year. FDA is increasing their wearning letters, as the FDA Enforcement Initiative was announced in August 2009. They’re now taking a risk-based approach to enforcement.
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