Legal challenges

Pharmaceutical Benefits Advisory Committee rejections, and the lack of available appeal mechanisms, have been increasingly challenged in recent years. One route available is to pursue a legal challenge to the Federal Court of Australia for a review of the decision. Most recently, in March 2000, the Federal Court rejected a pharmaceutical company s application to overturn the recommendation of the PBAC not to list a product on the scheme. 

If the approach shown by the Connecticut court continues to predominate, a carefully written state assault weapons ban is likely to withstand all legal challenges. 

Through a series of legal challenges and allowable extensions, Eli Lilly staved off a generic version of its blockbuster antidepressant Prozac for five years, until August 2001. 

Over 30 months elapsed between the time AGS and Lindow notified EPA and the tests were conducted. The EPA review process for the notifications and EUP applications consumed about six months, and the applicants spent four to six months developing additional data requested by EPA. The remaining 18 to 20 months were consumed by efforts to resolve legal challenges mounted against both EPA and the applicants in an effort to prevent the field trials. Table I... 

Individual small scale field test proposals have been reviewed. The Agency s regulatory decisions have withstood legal challenge and two field trials have been conducted. 

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