| Page 3 of 3 < |
Drug Makers Delay Generics Hitting Market
Balto said the cost of filing is small, compared to what a drug company can earn by impeding competition.
Last year, in a speech to the generic industry trade group, FDA Chief Counsel Sheldon Bradshaw said he'd seen examples of citizen petitions that appear aimed at delaying generic drug approval. An FDA spokeswoman said the agency couldn't be more specific about its attempts to prevent such scenarios.
  Wendell Young, president of the United Food and Commerical Workers Union 1776, says his members should not be denied access generic drugs Wednesday, May 24, 2006 in the Union headquarters in Plymouth Meeting, Pa. The marketers of the world's second-largest selling drug appeared to dodge a major threat to their revenues two months ago by reaching a deal to keep a generic competitor at bay until at least 2011. (AP Photo/Rusty Kennedy) (Rusty Kennedy - AP) Updated Financial FeaturesSave & Share |
• 
Saving options
A survey conducted by Merrill Lynch assessed citizen petitions were filed on 15 drugs that had not yet faced generic competition from 2000 to 2003. Since then petitions have been filed on 41 such products.
Earlier this year, the FDA denied petitions filed over generic Flonase, opening the way for a cheaper version of the popular allergy medicine. The debut was a long time in coming: Flonase's patent expired two years ago.
The reason for the delay is unclear, but Flonase's manufacturer, GlaxoSmithKline PLC, filed a Citizen Petition the month the drug's patent expired. Glaxo eventually filed an additional petition.
Glaxo spokeswoman MaryAnne Rhyne said the petitions weren't a ploy to delay generic competition. She said the FDA had failed to clarify guidelines for approving generic nasal sprays, and Glaxo wanted to insure the product would meet safety standards.
Glaxo sued the FDA after it denied the petitions but the case was thrown out of court.
___
On the Net: