Some lawmakers on Capitol Hill are pushing a new measure that would limit the drug industry's use of citizen petitions to delay generic competition. Twenty of the last 21 petitions sent to the FDA in the last three years were rejected, but critics maintain the forced delay in marketing a generic competitor gained drug makers hundreds of millions of dollars. The Washington Post uses Biovail as an example. The drug maker's petition has forced a generic competitor to Wellbutrin XL into regulatory limbo, helping maintain its market for the brand-name therapy.
- here's the article from The Washington Post on petition reform