Drug & Device News

E-Prescription Program to Start Next Year

The Department of Health and Human Services (HHS) plans to implement a program to encourage prescribers of medication to use electronic prescribing systems by offering e-prescribers incentive payments. The program will begin in 2009 with a “carrot”: a 2% incentive payment to e-prescribers. In 2011, that payment will go down to 1%, and in 2013 to '%. In 2012 the “stick” will kick in ' eligible prescribers who do not use e-prescription methods will receive a reduction in payments under Medicare.

According to the Institute of Medicine (IOM), more than 1.5 million Americans are injured each year by drug errors. HHS estimates that the new system, which will produce electronic records of patients' drug use, will save Medicare up to $156 million over the five-year course of the program by helping patients avoid adverse drug events.

No Guilty Plea Without Guilt

A federal judge has refused to accept the Department-of-Justice-brokered guilty plea of Chi Yang, the founder of a Dublin-based biotech company that has been charged with fraud. The company, SynPep, synthesizes peptides ' linear chains of amino acids ' for laboratory customers, including the National Institute of Health, Walter Reed Army Medical Center, Lawrence Livermore National Laboratory and Merck & Co. Inc. The company was charged with giving customers false measurements so that they would think the peptides they were receiving were the ones they ordered, rather than the less pure ones they were actually given. Yang agreed to plead guilty to making a false statement rather than to fraud, but the agree-upon sentence would remain harsh: Yang would accept a sentence of a year and a day, plus 12 months of home confinement, his company would shut down, and both he and the company would pay fines and/or restitution in the hundreds of thousands of dollars. However, when Yang entered his plea, Justice Sandra Armstrong demurred, stating, “It is not my practice to accept guilty pleas from people who are not guilty.” Problematic for the court was Yang's answer to the question of what role he had played in falsifying the purity measurements of the peptides. His answer: “I didn't do it. I didn't even know that peptide ship[ed] out, but the peptide was altered ' by the employees.” Judge Armstrong said, “I have to listen to what you say you did and what you didn't do. And then I have to decide on my own whether or not that makes you guilty of the crime. If it doesn't make you guilty of the crime, then I'm not going to take the guilty plea.” Yang's further assertions that he was indeed guilty proved unpersuasive to the court. A trial is scheduled for Nov. 3.

Hormone Replacement Drug Labels Enjoy Benefit of the Doubt

The 168 New Jersey plaintiffs alleging hormone replacement therapy (HRT) drugs caused them to contract breast cancer were delivered a blow on July 11 when the judge assigned to the lawsuits threw out the first two cases to come before the bench. Superior Court Judge Jamie Happas ruled in those cases that New Jersey's Products Liability Act's presumption of adequate labeling applied, and that the first two plaintiffs had failed to overcome that presumption with regard to the three suspect drugs they took to treat their menopausal symptoms: Premarin, Prempro and Provera. Wrote Happas, “The ultimate decision of the FDA to provide or not provide certain information in a prescription drug label can not be criticized unless a plaintiff has provided evidence of the pharmaceutical company's deliberate concealment or non-disclosure of after-acquired knowledge of harmful effects or if the pharmaceutical company was found to have manipulated the post-market regulatory process.” The dismissals came in what were supposed to be the first two HRT cases tried in New Jersey, Bailey v. Wyeth Inc., L-9999-06, scheduled for Sept. 15, and DeBoard v. Wyeth Inc., set for Oct. 27.

MS Drug Users Develop Rare Brain Infection

The manufacturers of multiple sclerosis (MS) drug Tysabri have announced that, once again, their product is implicated in the development of a rare brain infection in users. Tysabri, distributed jointly by Biogen Idec and Elan Corp., was taken off the market a few years ago after some patients taking it developed progressive multifocal leukoencephalopothy (PML), a brain infection that usually occurs only in people with weak immune systems. The consumers who got PML prior to the 2005 market withdrawal of Tysabri were taking other MS drugs besides Tysabri, and it is known that some other MS drugs weaken the immune system. When Tysabri went back on the market in 2006, people were advised not to combine it with other MS drugs. The two new cases of PML in Tysabri users occurred in patients who were not on other MS drugs but had previously used different MS medications.

E-Prescription Program to Start Next Year

The Department of Health and Human Services (HHS) plans to implement a program to encourage prescribers of medication to use electronic prescribing systems by offering e-prescribers incentive payments. The program will begin in 2009 with a “carrot”: a 2% incentive payment to e-prescribers. In 2011, that payment will go down to 1%, and in 2013 to '%. In 2012 the “stick” will kick in ' eligible prescribers who do not use e-prescription methods will receive a reduction in payments under Medicare.

According to the Institute of Medicine (IOM), more than 1.5 million Americans are injured each year by drug errors. HHS estimates that the new system, which will produce electronic records of patients' drug use, will save Medicare up to $156 million over the five-year course of the program by helping patients avoid adverse drug events.

No Guilty Plea Without Guilt

A federal judge has refused to accept the Department-of-Justice-brokered guilty plea of Chi Yang, the founder of a Dublin-based biotech company that has been charged with fraud. The company, SynPep, synthesizes peptides ' linear chains of amino acids ' for laboratory customers, including the National Institute of Health, Walter Reed Army Medical Center, Lawrence Livermore National Laboratory and Merck & Co. Inc. The company was charged with giving customers false measurements so that they would think the peptides they were receiving were the ones they ordered, rather than the less pure ones they were actually given. Yang agreed to plead guilty to making a false statement rather than to fraud, but the agree-upon sentence would remain harsh: Yang would accept a sentence of a year and a day, plus 12 months of home confinement, his company would shut down, and both he and the company would pay fines and/or restitution in the hundreds of thousands of dollars. However, when Yang entered his plea, Justice Sandra Armstrong demurred, stating, “It is not my practice to accept guilty pleas from people who are not guilty.” Problematic for the court was Yang's answer to the question of what role he had played in falsifying the purity measurements of the peptides. His answer: “I didn't do it. I didn't even know that peptide ship[ed] out, but the peptide was altered ' by the employees.” Judge Armstrong said, “I have to listen to what you say you did and what you didn't do. And then I have to decide on my own whether or not that makes you guilty of the crime. If it doesn't make you guilty of the crime, then I'm not going to take the guilty plea.” Yang's further assertions that he was indeed guilty proved unpersuasive to the court. A trial is scheduled for Nov. 3.

Hormone Replacement Drug Labels Enjoy Benefit of the Doubt

The 168 New Jersey plaintiffs alleging hormone replacement therapy (HRT) drugs caused them to contract breast cancer were delivered a blow on July 11 when the judge assigned to the lawsuits threw out the first two cases to come before the bench. Superior Court Judge Jamie Happas ruled in those cases that New Jersey's Products Liability Act's presumption of adequate labeling applied, and that the first two plaintiffs had failed to overcome that presumption with regard to the three suspect drugs they took to treat their menopausal symptoms: Premarin, Prempro and Provera. Wrote Happas, “The ultimate decision of the FDA to provide or not provide certain information in a prescription drug label can not be criticized unless a plaintiff has provided evidence of the pharmaceutical company's deliberate concealment or non-disclosure of after-acquired knowledge of harmful effects or if the pharmaceutical company was found to have manipulated the post-market regulatory process.” The dismissals came in what were supposed to be the first two HRT cases tried in New Jersey, Bailey v. Wyeth Inc., L-9999-06, scheduled for Sept. 15, and DeBoard v. Wyeth Inc., set for Oct. 27.

MS Drug Users Develop Rare Brain Infection

The manufacturers of multiple sclerosis (MS) drug Tysabri have announced that, once again, their product is implicated in the development of a rare brain infection in users. Tysabri, distributed jointly by Biogen Idec and Elan Corp., was taken off the market a few years ago after some patients taking it developed progressive multifocal leukoencephalopothy (PML), a brain infection that usually occurs only in people with weak immune systems. The consumers who got PML prior to the 2005 market withdrawal of Tysabri were taking other MS drugs besides Tysabri, and it is known that some other MS drugs weaken the immune system. When Tysabri went back on the market in 2006, people were advised not to combine it with other MS drugs. The two new cases of PML in Tysabri users occurred in patients who were not on other MS drugs but had previously used different MS medications.