Japanese pharmaceutical company tries to ban generic versions of Prograf drug to extend its monopoly
Saturday, February 11, 2012 by: Ethan A. Huff, staff writer
A group of consumers has filed a class-action lawsuit against Japanese pharmaceutical company Astellas Pharma for presenting what they say is a "sham" petition to the U.S. Food and Drug Administration (FDA) to extend the market exclusivity period for its transplant drug Prograf. According to Courthouse News Service, the lawsuit alleges that Astellas filed its petition not out of a concern for public health, but rather to simply extend its monopoly on the overpriced drug, which reportedly rakes in nearly $1 billion a year for Astellas.
Astellas "filed a baseless citizen petition with the FDA with the sole intent of foreclosing market entry by generic competitors, that improperly extended its monopoly and kept Prograf prices at supra-competitive levels," says the complaint. And this petition served as a placeholder for Astellas to continue marketing the drug at inflated prices, as the FDA reportedly took almost two years to provide a proper response.
During this time, Astellas raked in millions more than it would have if the market's exclusivity period would have run its natural course and expired. As a result, plaintiffs in the case, which also include insurance companies that were bilked by artificially-high prices for the drug, are seeking legal remedy for Astellas' alleged criminal behavior.
This is precisely how most drug companies work, though. Not content with simply playing by the same rules as everyone else, they rely on exclusive patents that allow them to make obscene profits on monopoly drugs that cost pennies on the dollar to produce. And as appears to be the case with Astellas, they are more than willing to milk the legal system as much as possible in order to maintain monopoly control over their drugs for as long as possible.
In an attempt to deflect the lawsuits filed against the company, Astellas petitioned for their dismissal citing supposed First Amendment rights. But in her ruling on the case, U.S. District Judge Rya Zobel explained that "[w]hen petitioning conduct is a mere sham to cover what is actually nothing more than an attempt to interfere directly with the business relationship of a competitor, such conduct is not immune."
Prograf is a drug given to transplant patients to prevent rejection of vital organs. It works by deliberately lowering immune function, and its many negative side effects include decreased urination, back pain, bloody urine, chronic fatigue, muscle problems, neurological damage, diabetes, severe allergies, and even death.
Saturday, February 11, 2012 by: Ethan A. Huff, staff writer
A group of consumers has filed a class-action lawsuit against Japanese pharmaceutical company Astellas Pharma for presenting what they say is a "sham" petition to the U.S. Food and Drug Administration (FDA) to extend the market exclusivity period for its transplant drug Prograf. According to Courthouse News Service, the lawsuit alleges that Astellas filed its petition not out of a concern for public health, but rather to simply extend its monopoly on the overpriced drug, which reportedly rakes in nearly $1 billion a year for Astellas.
Astellas "filed a baseless citizen petition with the FDA with the sole intent of foreclosing market entry by generic competitors, that improperly extended its monopoly and kept Prograf prices at supra-competitive levels," says the complaint. And this petition served as a placeholder for Astellas to continue marketing the drug at inflated prices, as the FDA reportedly took almost two years to provide a proper response.
During this time, Astellas raked in millions more than it would have if the market's exclusivity period would have run its natural course and expired. As a result, plaintiffs in the case, which also include insurance companies that were bilked by artificially-high prices for the drug, are seeking legal remedy for Astellas' alleged criminal behavior.
This is precisely how most drug companies work, though. Not content with simply playing by the same rules as everyone else, they rely on exclusive patents that allow them to make obscene profits on monopoly drugs that cost pennies on the dollar to produce. And as appears to be the case with Astellas, they are more than willing to milk the legal system as much as possible in order to maintain monopoly control over their drugs for as long as possible.
In an attempt to deflect the lawsuits filed against the company, Astellas petitioned for their dismissal citing supposed First Amendment rights. But in her ruling on the case, U.S. District Judge Rya Zobel explained that "[w]hen petitioning conduct is a mere sham to cover what is actually nothing more than an attempt to interfere directly with the business relationship of a competitor, such conduct is not immune."
Prograf is a drug given to transplant patients to prevent rejection of vital organs. It works by deliberately lowering immune function, and its many negative side effects include decreased urination, back pain, bloody urine, chronic fatigue, muscle problems, neurological damage, diabetes, severe allergies, and even death.