Drug Makers Use Safety Rule to Block Generics - NYTimes.com
▻http://www.nytimes.com/2013/04/16/business/drug-makers-use-safety-rule-to-block-generics.html?pagewanted=all
The issue has its roots in a 2007 law that allowed the Food and Drug Administration to require detailed safety programs for drugs with serious side effects or the potential for abuse. In many cases, those programs simply direct the company to educate doctors or patients about risks. But in other cases, they require that distribution be limited to approved pharmacists and health care providers.
...
Although the 2007 law said the programs should not be used to block development of generic drugs, brand-name companies said the language was vague and began restricting access to drug samples soon after it was passed.