How Business Is Done
One of the big costs in American health care is prescription drugs. It is not unheard of for a month's supply of a needed drug to total $100 or even more. For those without health insurance that covers drugs, that's a big hit on the budget. It's an even bigger hit on federal and state budgets that have to cover that cost under Medicare and Medicaid policies. We all pay for the high costs of needed medicine, one way or the other. That's why an article in today's Washington Post sent my blood pressure up.
A procedure designed to alert the Food and Drug Administration to scientific and safety issues is getting a hard look from members of Congress, who say they are concerned that it may be getting subverted by the brand-name drug industry.
Some at the FDA, as well as leaders in the generic drug industry, complain that "citizen petitions" -- requests for agency action that any individual, group or company can file -- are being misused by brand-name drugmakers to stave off generic competition.
The simple act of filing a petition, they say, triggers another round of time-consuming and often redundant reviews of the generics by the FDA, which can take months or years. In the process, consumers continue to pay millions of dollars more for the brand-name drugs.
Statistics collected by the staff of Sen. Debbie Stabenow (D-Mich.), who has introduced legislation with Sen. Trent Lott (R-Miss.) that would rein in industry-filed citizen petitions, show that 20 of the 21 brand-name petitions settled by the FDA since 2003 were ultimately rejected.
...In a letter sent last week to FDA Acting Commissioner Andrew von Eschenbach, Stabenow and Lott estimated that the delay in approving a generic version of the antidepressant Wellbutrin XL is costing consumers $37 million a month. [Emphasis added]
Here's how the scam works. The maker of a brand name pharmaceutical waits until the FDA approval of a generic competitor is just around the corner. Then the brand name maker files one of these "citizen petition" with the FDA, which is then bound to re-run many of the tests, thereby delaying the approval of the generic competitor. Twenty out of twenty-one times, the generic is approved, but only after several more months of agency examination. In the mean time, the brand name maker rakes in the money on its much more expensive drug during that time.
The cost to consumers, insurance companies, and the government has to be billions a year, if the makers of Wellbutrin XL gets over $37 million a month on that drug alone. And all of this is perfectly legal under the current system.
If you want to see how big PHARMA is huffing and puffing about this threatened congressional inquiry, go read the article. It will make you sick.
A procedure designed to alert the Food and Drug Administration to scientific and safety issues is getting a hard look from members of Congress, who say they are concerned that it may be getting subverted by the brand-name drug industry.
Some at the FDA, as well as leaders in the generic drug industry, complain that "citizen petitions" -- requests for agency action that any individual, group or company can file -- are being misused by brand-name drugmakers to stave off generic competition.
The simple act of filing a petition, they say, triggers another round of time-consuming and often redundant reviews of the generics by the FDA, which can take months or years. In the process, consumers continue to pay millions of dollars more for the brand-name drugs.
Statistics collected by the staff of Sen. Debbie Stabenow (D-Mich.), who has introduced legislation with Sen. Trent Lott (R-Miss.) that would rein in industry-filed citizen petitions, show that 20 of the 21 brand-name petitions settled by the FDA since 2003 were ultimately rejected.
...In a letter sent last week to FDA Acting Commissioner Andrew von Eschenbach, Stabenow and Lott estimated that the delay in approving a generic version of the antidepressant Wellbutrin XL is costing consumers $37 million a month. [Emphasis added]
Here's how the scam works. The maker of a brand name pharmaceutical waits until the FDA approval of a generic competitor is just around the corner. Then the brand name maker files one of these "citizen petition" with the FDA, which is then bound to re-run many of the tests, thereby delaying the approval of the generic competitor. Twenty out of twenty-one times, the generic is approved, but only after several more months of agency examination. In the mean time, the brand name maker rakes in the money on its much more expensive drug during that time.
The cost to consumers, insurance companies, and the government has to be billions a year, if the makers of Wellbutrin XL gets over $37 million a month on that drug alone. And all of this is perfectly legal under the current system.
If you want to see how big PHARMA is huffing and puffing about this threatened congressional inquiry, go read the article. It will make you sick.
posted by Diane at 4:14 AM
2 Comments:
Why do repugs even bother spouting the words, "Free Market"? I can't repeat myself enough, they hate competition and do everything possible to drown it.
PeasantParty
Thanks for the post. Amazing...
yearly Kos is on all week at 4:00 and it's a big part of why they hunted him.
I'd suggest this post, and other key ones, be uberlinked at a variety of sites. As people traffic the different sites from seeing Kos they can come across items like your thread.
-Mr.M
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