Reply #7: In addition to the 20 year patent protection, this gives firms a 12 year period...

[slipslidingaway]

in which the data used to make the biologic does not have to be shared with anyone. They run concurrently, but can essentially sit on the data for 12 years. This provision was passed by in the House and Senate bills, a few senators voted against the amendment...Harkin, Sanders and Brown.

The Biotech Index (BTK) went up 16% in one day as these amendments were approved back in July.

:shrug:

Links in thread below...

"Sen. Tom Harkin: Keep in mind what we’re talking about here. We’re not talking about patents. Everybody gets a 20 year patent… What we’re talking about here is data, data exclusivity… How do you get that data? You get it through FDA supervised trials… Where do they do those clinical trials? Academic health centers. Who supports academic health centers? Our taxpayers… When should that data be released so that another company out there, some other entrepreneurs, can look at the data and say… I’ll bet if we changed this and did this, we might come up with a new formulation that might actually help something else. They’re still going to have to go through their clinical trials… At least they’ll be able to look at the data. If you don’t do that that means that the company can sit on that data for 12 years. Then they let the data out. Clinical trials will take another 7 years or more, so you’re going to have at least a whole 20 year run in there… before anyone can ever surface with anything even comparable to what that drug or that biologic is..."


http://www.democraticunderground.com/discuss/duboard.php?az=show_mesg&forum=389&topic_id=6848443&mesg_id=6848443

"The question before Waxman's committee last summer was this: How many years of monopoly protection should be afforded to biotechnology drugs, known as biologics, before cheaper alternatives are allowed on the market? These miraculous drugs — which differ from traditional, chemical-based pharmaceuticals because they are derived from living matter — are widely regarded as the future of the pharmaceutical industry and, indeed, of medicine itself. While only 20% of drugs on the market today are biologics, it is expected that, with 633 biotechnology medicines in development last year for more than 100 diseases, half the new drugs approved in 2015 will be. Biologics average more than 20 times the cost of traditional drugs: treating breast cancer with a year's worth of the biologic Herceptin can cost $48,000; Remicade, for rheumatoid arthritis, can cost $20,000 annually. For other, rarer diseases, the price of biologic treatments can be as high as $200,000 a year..."


More here...

FDL - Are You Or Someone You Know Paying $50,000 A Year For Drugs?
http://www.democraticunderground.com/discuss/duboard.php?az=show_mesg&forum=389&topic_id=6866481&mesg_id=6866481

"...But young medical and public health students across the country feel their hands are being tied as healers of the future, and they are coming out in protest. Eric Butter, a biostatistics major at UNC, led one of many such protests around the country last week.

“It is a really important issue that might not affect us now, but 10 years down the road it will be huge,” Butter said..."


and here...

Senate HELP amendment on "data exclusivity"
http://www.democraticunderground.com/discuss/duboard.php?az=show_mesg&forum=389&topic_id=6164248&mesg_id=6165037