Authorized generics

Authorized generics are prescription drugs produced by brand pharmaceutical companies and marketed under a private label, at generic prices. Authorized generics compete with generic products in that they are identical to their brand counterpart in both active and inactive ingredients;[1] whereas according to the U.S. Food and Drug Administration's Office of Generic Drugs, generic drugs are required to contain only the identical active ingredients as the brand.[2] Authorized generics compete with generics on price, quality and availability in the generic marketplace, and are marketed to consumers during and after what is commonly known as “the 180-day exclusivity period”. In June 2009 the FTC issued an Interim Report that found that drug prices are lower when authorized generics are marketed against a single generic drug than when they are not.[3] The report showed that with authorized generic competition during the 180-day marketing exclusivity period, retail drug prices are on average 4.2 percent lower than the pre-generic branded price, and wholesale drug prices are on average 6.5 percent lower than the pre-generic branded price.

Public studies

According to Roper Public Affairs & Media, 2005 public research underlines consumer demand to have authorized generic prescription drugs availalble, showing over 80 percent of Americans want the option of authorized generic prescription drugs.[4] Several independent organizations, including Pharmaceutical Research and Manufacturers of America,[5][6] Sonecon,[7] and GPhA[8] have commissioned their own studies on authorized generics, furthering the competitive debate.

References

  1. ^ Federal Trade Commission (March 29, 2006). "FTC Proposes Study of Competitive Impacts of Authorized Generic Drugs". http://www.ftc.gov/opa/2006/03/authgenerics.shtm. 
  2. ^ Food and Drug Administration. "Office of Generic Drugs". http://www.fda.gov/AboutFDA/CentersOffices/cder/ucm119100.htm. Retrieved March 16, 2011. 
  3. ^ Federal Trade Commission (June 2009). "Authorized Generics: An Interim Report". http://www.ftc.gov/os/2009/06/P062105authorizedgenericsreport.pdf. 
  4. ^ The Gale Group (August 29, 2005). "Prasco Laboratories: Over 80 percent of Americans Want the Option of Authorized Generic Prescription Drugs; Research Underlines Consumer Demand to Have Authorized Generic Prescription Drugs Available.". http://goliath.ecnext.com/coms2/summary_0199-4629969_ITM. 
  5. ^ The Gale Group (August 29, 2005). "Prasco Laboratories: Over 80 percent of Americans Want the Option of Authorized Generic Prescription Drugs; Research Underlines Consumer Demand to Have Authorized Generic Prescription Drugs Available.". http://www.phrma.org/news_room/press_releases/new_study_finds_that_authorized_generics_can_lead_to_lower_drug_prices,_increased_savings/. Retrieved March 16, 2011. 
  6. ^ IMS Consulting (Spring 2006). "Assessment of AuthorizedGenerics in the U.S.". Archived from the original on March 16, 2011. http://replay.waybackmachine.org/20090327070500/http://www.phrma.org/files/IMS%20Authorized%20Generics%20Report_6-22-06.pdf. 
  7. ^ Hassett, Kevin A.; Shapiro, Robert J. (May 2007). "The Impact of Authorized Generic Pharmaceuticalson the Introduction of Other Generic Pharmaceuticals". http://www.sonecon.com/docs/studies/050207_authorizedgenerics.pdf. 
  8. ^ The Generic Pharmaceutical Association (July 31, 2006). "Independent Analysis Reveals that Authorized Generics are Bad for Consumers, Lead to Higher Pharmaceutical Prices". http://www.gphaonline.org/AM/Template.cfm?Section=Press_Releases&CONTENTID=2707&TEMPLATE=/CM/ContentDisplay.cfm. 

External links