While many of these delays are due to real manufacturing problems, “there are instances where I am certain that manufacture was stopped because they wanted to raise the price,” Brawley said.
This does not make any sense to me. It seems to fit into the standard template of blaming the big pharmaceutical companies. Generic drugs can be marketed once the original patent for the proprietary drug expires. A pharmaceutical company gets exclusive rights to a particular drug for a given period of time, and generally prices them high to cover the developmental costs. Once the patent expires, any company can produce a corresponding generic drug. These companies do not have the development costs to recoup for this drug, so all they have are the basic manufacturing costs. It should be possible to make just as much money producing the generic drug as the original company did when it had exclusive rights to the drug. If the drug is popular, it seems to me, there would be plenty of incentive for some drug company to produce the drug - all other things being equal. At least that's how it seems to me. I welcome any further illumination on this from FReepers who may have specific knowledge on the subject.
This situation began in 2010. Obamacare signed into law by President Barack Obama on March 23, 2010.
Big Pharma was against HillaryCare. But somehow jumped on board with the ObamaCare bandwagon, even to the point of running ADS to support it.
Blaming big Pharma is not the issue. This is a moral and ethical issue. Big Pharma cut a deal for their stockholders.
Obamacare gets it’s fascist medical plan.
It is that simple and that evil. Government and Medicine should NEVER be partners. People die when that happens.
Yeah I know Grants and all. But this is the GOV TELLING med what to do. Big difference.
The original company can make changes to the drug and keep exclusivity that way.
3.How long is exclusivity granted for?
It depends on what type of exclusivity is granted.
Orphan Drug (ODE) - 7 years
New Chemical (NCE)- 5 years
"Other" Exclusivity - 3 years for a "change" if criteria are met
Pediatric Exclusivity (PED) - 6 months added to existing Patents/Exclusivity
Patent Challenge – (PC) – 180 days (this exclusivity is for ANDAs only)
See 21 C.F.R. 314.108 New Drug Product Exclusivity.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079031.htm
see attached FR discussion from a couple weeks ago.
http://www.freerepublic.com/focus/f-news/2766456/posts
“This does not make any sense to me. It seems to fit into the standard template of blaming the big pharmaceutical companies. Generic drugs can be marketed once the original patent for the proprietary drug expires. A pharmaceutical company gets exclusive rights to a particular drug for a given period of time, and generally prices them high to cover the developmental costs. Once the patent expires, any company can produce a corresponding generic drug. “
That’s traditionally how the industry works. BUt there is a disturbing new trend, the “recapture” of some key generic drugs by manufacturers who, in return for some trivial testing and validation, are given a new patent on the drug, with exclusive manufacturing rights. Patients see the price of an old standard, like colchicine, skyrocket to new-drug heights.
If the FDA wanted to play fair with us, it would simply contract out any additional testing needed on old drugs, rather than granting monopolies like medieval royalty.