Authorized Generic Drug Study (P062105)

The Federal Trade Commission released its final report in August 2011, entitled Authorized Generic Drugs: Short-Term Effects and Long-Term Impact. This was preceded by an interim report, released in 2009, and entitled Authorized Generics: An Interim Report.

Comments in Response to 71 Fed. Reg. 16,779 (April 4, 2006)

  1. AARP (June 5, 2006)
  2. Actavis Group (June 5, 2006)
  3. American Antitrust Institute, Consumer Federation of America, Families USA, and US Pirg (June 6, 2006)
  4. Consumers Union (June 4, 2006)
  5. Eli Lilly and Company (June 5, 2006)
  6. Generic Pharmaceutical Association (“GPhA”) (June 27, 2006)
  7. Gilberts LLP (June 5, 2006) 
  8. IMS Health Incorporated (June 5, 2006)
  9. Ohio Public Employees Retirement System (April 25, 2006)
  10. Pharmaceutical Research and Manufacturers of America - PhRMA (June 5, 2006)
  11. Prasco, LLC (June 5, 2006)
  12. Prescription Access Litigation Project (June 5, 2006)
  13. Ronald Davis -on behalf of unnamed client (June 4, 2006)

Comments in Response to 72 Fed. Reg. 25,304 (May 4, 2007)

  1. Generic Pharmaceutical Association (8/31/2007) #529613-00005
  2. Gilbert's LLP (6/4/2007) #529613-00004
  3. Pharmaceutical Research and Manufacturers of America - PhRMA (6/4/2007) #529613-00003

Additional Comments

  1. Pharmaceutical Research and Manufacturers of America – PhRMA (October 28, 2009)

Proposed Special Orders

Brand-Name Drug Company Special Order
Generic Drug Company Special Order
Authorized Generic Drug Company Special Order

Illustrative Examples of Excel Spreadsheets for Providing Responses to Questions

The following PDF versions of filled-in Excel spreadsheets illustrate how companies should enter their responses to the applicable questions. These examples are for illustrative purposes only; information provided to companies may differ depending upon data availability.  

Example:  The FTC provides spreadsheet to Brand-Name Drug Company
Example:  Brand-Name Drug Company provides response to the FTC

Example:  The FTC provides spreadsheet to Generic Drug Company
Example:  Generic Drug Company provides response to the FTC

Example:  The FTC provides spreadsheet to Authorized Generic Drug Company
Example:  Authorized Generic Drug Company provides response to the FTC

 


Last Modified: Tuesday, November 15, 2011