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STEEPLE (Economic (Biopharma restructure -Old product franchises decline…

- - - - violating anti trust laws
      - pay for delay agreements
        
        Congress - illegal?
        
        Increased from 0 cases in 2004 to 66 within 5 years
      - Patent extensions
        
        New formulations
        
        New uses
- - - - Drug companies misusing the system for their benefit
    - - Loophole - manufacturer can voluntarily restrict access even when not required by the FDA to delay generic competition
        
        restrict availability of testing samples
        
        shared safety systems
    - - In response FDA is aiming to
        
        Boost Competition
        
        Enforcement Actions
        
        Leglisation
        
        Speed up competition review
        
        Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act