NACDS urges Congress to refrain from adopting e-pedigree mandate
ALEXANDRIA, Va. New federal legislation to require that pharmacies and drug wholesalers establish electronic pedigrees for every drug they sell or distribute would throw both industries into turmoil and add “extraordinary” costs to their operations, the head of the National Association of Chain Drug Stores warned Thursday.
The Safeguarding America’s Pharmaceuticals Act of 2008 was introduced Thursday by Reps. Steve Buyer, (R-Ind., and Jim Matheson, D-Utah. If passed and signed into law, the bill would mandate electronic pedigree requirements to assist in the tracking and tracing of prescription drugs in the domestic supply chain.
NACDS president and chief executive officer Steve Anderson responded quickly to the proposal. “While instances of drug counterfeiting may occur,” he said, a federal e-pedigree mandate is the wrong approach.
“Despite the perception that e-pedigree and track and trace mandates are quick solutions, their adoption and implementation would be extremely complex and costly for retail pharmacies and others in the supply chain, and without the desired benefit,” Anderson asserted. “These systems are many years away from full development, have not been fully tested and lack uniform standards and patient privacy safeguards.”
There are alternatives to assure a safer drug supply as the industry gears up for e-pedigrees, Anderson added. Among them: adopting tougher uniform federal licensing standards for drug distribution and using the Food and Drug Administration to certify that manufacturers, distributors and pharmacies follow secure supply-chain guidelines.
“These steps would go a long way in improving safety and further protecting the supply chain by building on effective systems currently in place,” Anderson said.
Combination of Celebrex and Lipitor may prove effective in fighting prostate cancer
WASHINGTON A new combination between the drugs Celebrex, which lowers cholesterol, and Lipitor, an anti-inflammatory drug, can be used in controlling prostate cancer before it becomes deadly, according to published reports.
The study first cultured prostate tumors in mice, and then gave the mice either Lipitor or Celebrex, or a combination of the two. All proved to be successful in halting cancer growth. The study also found that putting a combination of Lipitor and Celebrex in lower doses was most effective. Scientists have yet to find why these two combinations have such a positive effect on fighting prostate cancer.
Prostate cancer is the second-leading cancer killer in men, and the presence of the two drugs may help stop the progression of the cancer before it gets worse, according to the study.
Even though this discovery has gone only through preliminary trials, many are excited by the positive implications it may have for prostate cancer. According to K. Scott Coffield, a professor of surgery at Texas A&M Health Science Center College of Medicine and a urologist-oncologist at Scott & White, “They need to come up with the molecular mechanics and then take it back to clinical trials. It’s early but it’s interesting and that’s wonderful.”
The research will be presented at the American Association for Cancer Research’s annual meeting in San Diego.
Snabes tapped as BioSante Pharmaceuticals vice president of clinical development
LINCOLNSHIRE, Ill. BioSante Pharmaceuticals announced Michael Snabes as the company’s new vice president of clinical development, according to published reports.
Snabes will be responsible for the development of LibiGel, which is a testosterone gel for the treatment of female sexual dysfunction. Snabes has a history with BioSante as he served as medical consultant of BioSante since November 2005, where he focused on clinical and regulatory matters, according to published reports.
He is a board certified reproductive endocrinologist, and has a Ph.D. in physiology and reproductive endocrinology. According to published reports, he also played major role in the submission of BioSante’s New Drug Application Elestrin, which now has been approved fully by the Food and Drug Administration.
“We are very pleased that Michael has agreed to accept this position with BioSante,” said Stephen Simes, president and chief executive officer of BioSante. “Michael has been an important part of our clinical team for more than two years and his full-time involvement will help us to implement fully and accelerate our development of LibiGel in the treatment of FSD, specifically hypoactive sexual desire disorder in menopausal women.”