To FDA, both practices should be illegal!
"Are generic drugs being delayed to market?" PBS NewsHour 6/28/2014
Excerpts
SUMMARY: Are generic drugs being delayed to market by so-called "pay for delay" deals between drug companies? The deals happen after generic drug companies challenge the patents on brand-name drugs. The settlements include a date that the generic drug can enter the market, and in some cases, a payment from brand company to the generic company.
MEGAN THOMPSON (NewsHour): In 2004, Karen Winkler was diagnosed with multiple sclerosis, a debilitating disease affecting the nervous system. The 46-year-old mother of three, who lives in Clarkston, Michigan, struggles every day with numbness, pain and extreme fatigue.
KAREN WINKLER: It’s so overwhelming. You wake up tired. And as the day progresses, it just gets worse and worse. And it’s where you could fall asleep standing up.
MEGAN THOMPSON: In 2005, Winkler’s doctor prescribed a brand-name medication called Provigil. It was one of the only drugs for fatigue on the market that had minimal side effects. It was made by a company called Cephalon, which earned $475 million dollars on Provigil that year. Winkler’s doctor put her on a half pill, every day.
KAREN WINKLER: It was perfect, you know. I had three young kids and I could still do- pretty much do everything that I did. And, you know, if I had 10 things on the to-do list, you know, I could either get the 10 things done or at least eight or nine of them.
MEGAN THOMPSON: Better yet, Winkler says her doctor told her Provigil was expected to go generic soon – possibly within a year. And that could have saved Winkler more than a thousand dollars a year. The potential savings were especially important because her disease made it impossible to go back to work as she’d planned. And around that same time, her husband’s pay was cut and the family had to dip into savings and a 401(k).
KAREN WINKLER: Then it didn’t go generic. And it was a whole different story.
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MEGAN THOMPSON: Why hadn’t Provigil gone generic? And why was the price of it rising so sharply? As Winkler discovered through online research, the company manufacturing the drug, Cephalon, was using two common but little known business strategies that critics say end up costing consumers. First, there’s something that opponents call, “pay for delay.”
MEGAN THOMPSON: Here’s how “pay for delay” works. According to the Federal Trade Commission, when generic manufacturers challenge a patent, the brand-name manufacturer sometimes pays to keep the generic version off the market.
MEGAN THOMPSON: In the case of Karen’s drug, the company that makes Provigil paid a total of $200 million to four generic companies. That deal guaranteed no generic would come to market for another six years.
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MEGAN THOMPSON: But because of what critics describe as those “pay for delay” deals, Provigil didn’t go generic. So Karen Winkler and other consumers paid the price. And it turns out she paid even more because of that second controversial business strategy that Cephalon used then and other drug manufacturers continue to use today — something opponents call “evergreening.” The idea is to get consumers off the drug they’re taking and on to another brand drug the same company is making.
MEGAN THOMPSON: In Winkler’s case — off Provigil whose patent was about to expire. — and onto Nuvigil, whose patent had several years to run. Companies sometimes do this by jacking up prices on the first drug. That’s what happened to Winkler when, seeking relief from the rising price of Provigil, her doctor offered her Nuvigil.
KAREN WINKLER: So, I thought, “Great. You know, here’s a solution.” Came home and I started taking the pills for two or three days and got a pounding, pounding headache from it. And, to the point that it was almost like having a migraine.
MEGAN THOMPSON: That’s when Winkler went online and figured out what was going on.
KAREN WINKLER: And what they were trying to do was to get patients off of Provigil, because they knew it was going to be going generic shortly, to start taking this Nuvigil that had this new, extended patent period. And then obviously once Provigil went generic, everybody on Nuvigil would not be going to a generic drug. They would be still on the Nuvigil.
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