FDA and Post-Market Safety

Question 1

What did the FDA AA do? What did it mandate?

Answer 1

Gave new authorities for FDA regarding post-market drug safety

• enforce post-market studies
• safety-labeling changes
• REMS
• Can impose civil penalties for violations

It mandated FDA to establish a post-market risk identification and analysis system

Question 2

What are the types of REMs?

Answer 2

Med guides and package inserts
Communication plan –> companies provide this to health care providers and professional societies
Elements to assure safe use (ETASU)
Implementation system –> monitor and evaluate REMs being followed
Assessment timetable –> 18 months, 3 years, and in 7th year assement of REMs

Question 3

What does the assessment include?

Answer 3

Includes:

• ADRs
• non-enrolled or uncompliant prescribers

Question 4

FDA MedWatch is?

Answer 4

Voluntary program for ADRs