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Avastin for Age Related Macular Degeneration Could Save More than $1B
Genentech's Avastin off-label use for macular degeneration, rather than the company's similar eye drug Lucentis, could have saved Medicare more than $1 billion over two years, an HHS inspector general found in an audit. Also, Medicare beneficiaries would have saved $275 million. Currently, Lucentis is the single-biggest expense in the pharma budget of Medicare Part B, which covers injectables and biologics, the Wall Street Journal reports.
The price difference between the two drugs—$2,000 versus about $50—prompted a call on Medicare to ask Congress for more power over pricing, at least with expensive biologics like Lucentis. A potential complication is that for this use, Avastin must be repackaged into small doses; a manipulation that opens Avastin to contamination.
Editor's Note: Pharmacies involved in this activity must be USP Chapter <797> compliant.
http://online.wsj.com/article/SB10001424053111903648204576554880739392912.html?mod=rss_Health
Par Pharmaceutical Engaged in Illegal Drug-Switching Scheme, U.S. Says
Par Pharmaceutical Cos. has engaged in an illegal drug-switching scheme to increase sales, the U.S. said in a lawsuit in which two Mylan Inc. units are also accused by a whistleblower of wrongdoing. The lawsuit claims that Woodcliff, New Jersey-based Par conspired with its pharmacy customers to switch prescriptions of generic Zantac from tablets to higher-priced capsules to skirt Medicaid price limits. To increase sales, defendants marketed their higher-priced dosage forms to pharmacies by falsely portraying their drugs as equivalent to popular, lower-priced generics, allowing the drugstores to get higher reimbursements from Medicaid programs and "evade the government's price limits," according to the complaint.
http://www.bloomberg.com/news/2011-09-06/mylan-units-implicated-in-u-s-lawuit-against-par-alleging-drug-switching.html
Investors Sue to Reduce Johnson & Johnson's CEO $150M Salary
A J&J shareholder lawsuit demands CEO William Weldon give up a large part of the compensation he has received since 2006 and could force J&J to explain why it pays Weldon more than any other pharmaceutical company CEO even though the company has languished during his reign. Weldon has received $150 million in compensation since 2006 and he earns more than the next four highest-paid drug company CEOs combined. The "lavish and excessive" package came despite J&J's stock, revenues, and operating cash flow staying flat, its R&D declined and its liabilities increased. Also, there have been 26 product recalls from all areas of the company (16 of those were Tylenol-related), including the recall of 93,000 artificial hips after they were implanted in patients.
J&J paid kickbacks to the government of Saddam Hussein and operated a bribery scheme in Greece; yet during this period, Weldon's pay doubled from $14.3 million in 2005 to $28.7 million in 2010. J&J has yet to file a response, but it defended Weldon's pay in an April disclosure to the SEC.
http://www.bnet.com/blog/drug-business/investors-take-aim-at-j-js-150m-ceo/9574?utm_source=twitterfeed&utm_medium=twitter
Quality Problems More Likely in Offshore Drug Plants
Drugs produced in offshore manufacturing plants—even those run by U.S. manufacturers—pose a greater quality risk than those prepared in the mainland U.S., a new study suggests. The results show how difficult it is to transfer world-class quality control to an offshore plant, even under the best of conditions.
The study utilized inspection data that the U.S. FDA compiled on Puerto Rican and mainland U.S. pharmaceutical manufacturing plants. These plants produced both over-the-counter and prescription drugs. Facilities in more distant, less developed countries may face even greater obstacles to quality control. The results should serve as a caution to pharmaceutical executives who want to cut costs by producing drugs offshore.
http://www.eurekalert.org/pub_releases/2011-09/osu-qpm090611.php
Patent Case in India May Threaten Cheap Drug Supply
The supply of generic drugs for the developing world could be badly threatened if Swiss firm Novartis wins a challenge to India's patent law. The situation involves an appeal by Novartis seeking patent protection for a newer version of its leukemia drug Glivec–a case watched closely by global pharmaceutical firms.
Novartis is contesting the Indian patent office's rejection of a patent application for the updated version of Glivec saying it is better absorbed by the body. The Medecins Sans Frontieres (MSF) organization calls the improvement a "minor modification." The drugmaker's challenge goes to the heart of India's patent act, which says a patent cannot be granted for an old drug unless changes make it significantly more therapeutically effective.
In India, generic versions of Glivec sell for 8,000 rupees ($174) for a month's treatment compared with 120,000 rupees for the brand-name version, MSF said. Since, 1995, India allows patents for new inventions for an updated drug if they demonstrate greater therapeutic efficacy. The base compound for Glivec was discovered in 1993. However, India rejects applications for minor changes to existing drugs, which critics say are aimed at extending the life of original patent monopolies from their original 20 years—a practice known as "evergreening."
The cost difference between generic and brand name drugs is crucial for poor people around the world, MSF said, noting generics from India have pushed down prices for older anti-AIDS drugs by 99 percent.
http://news.yahoo.com/india-patent-case-threatens-cheap-drug-supply-msf-143709896.html
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