Pay-for-Delay Drug Settlements Draw Fire
September 2nd, 2010 | No Comments | Source: BurrillReportSo-called pay-for-delay settlements involving generic and branded drug makers are becoming more common and costing consumers $3.5 billion each year, according to FTC Chairman John Liebowitz, who testified before Congress that he wanted to eliminate such agreements altogether.
These deals allow branded drug makers to sell their expensive products without generic competition for a period longer than the duration of the patents they hold on their drugs.
In the first 9 months of fiscal 2010, drug makers entered into 21 patent litigation settlements. That’s more than the entire previous year.
“That’s almost an epidemic,” Leibowitz told BurrillReport. “Every single FTC Commissioner, going back through the Bush and Clinton administrations, has supported stopping these unconscionable agreements.”
The FTC supports legislation designed to halt pay-for-delay settlements. At the moment, this legislation is tucked into a Senate spending bill.
Both branded and generic drug companies would prefer to leave things just as they are. “The FTC’s testimony fails to present the whole story regarding patent settlements,” according to a statement released by the Generic Pharmaceutical Association. “Over the past 10 years, patent settlements have enabled dozens of first-time generics to come to market many months before patents on the counterpart brand drugs expired.”
The Pharmaceutical Research and Manufacturers of America, which represents branded drug makers, agreed. “A blanket ban could decrease the value of patents, remove an important option for a patent-holder’s defense of intellectual property, and reduce the incentives for future innovation of new medicines,” it said.
A Senate panel has already recommended banning pay-for-delay deals, but narrowly. Pennsylvania Democrat Arlen Specter introduced an amendment to remove the ban from the spending bill, but that amendment did not pass. The ban must pass the full Senate and House before becoming law.





The 5-year agreement also calls for Pfizer to contribute $22.5 million to the University. Proprietary information will be shared for drugs that are currently on the market and those that failed during testing. The deal is believed to be the first of its kind in the industry.
Teva, an Israeli company many have never heard of, is the 800 pound gorilla of generic drug makers. Last year, Teva products were used to fill 630 million prescriptions, or one out of every 6 prescriptions in the US. That’s more than Pfizer, Novartis and Merck combined.
The jury set damages at $47 million. This amount is tripled under the Racketeer Influenced and Corrupt Organizations Act, meaning that Pfizer must pay damages equaling $141 million.
To reach these conclusions, Graham Jackson and colleagues reviewed more than 50 studies of Internet drug purchasing behavior that had been published between 1995 and 2009.
Last June, he bet health reform would happen and decided to cozy-up to the Democrats.
The recommendation follows release of data from the so-called Jupiter trial, which was sponsored by AZ. In Jupiter, Crestor reduced the risk of heart attacks in apparently healthy adults with no prior history of cardiac disease and normal cholesterol levels.
The $1.9 billion buy would be the second consumer-focused company purchased by the Paris-based drug giant in less than a year. The other one was France’s Laboratoire Oenobiol, which makes health and beauty supplements and nutritional products.
Even before the acquisition of Chattem and with little presence in the US consumer products market, Sanofi managed to generate about $2 billion per year in world-wide OTC sales.
In a
The proof comes in the form of a study published in the
The scientists detected no change in the preexisting trend in the number of Plavix prescriptions written after DTC advertising was introduced.
In that trial, Vytorin reduced LDL cholesterol levels much more than simvastatin alone but surprisingly, atherosclerotic plaques
China’s remarkable economic growth is driving the decision, according to Chief Executive Daniel Vasella.
They were motivated the poor side-effect profile of previously available drugs, and encouraged by relentless and
To reach these conclusions, David Gunnell and colleagues at the University of Bristol reviewed the records of 80,660 men and women aged 18-95 years that had received a smoking cessation product (Chantix, Zyban or nicotine replacement therapy) between September 2006 and May 2008.
Chantix also did not appear to increase the risk of depression or suicidal thoughts, confirming
Five years ago, Parke-Davis forked over $430 million to settle a similar suit involving Neurontin.
White’s group identified 24 articles and correspondences with editors that had either been produced with support from grants that Parke-Davis or by Parke-Davis ghostwriters.




