Follow on biologics (generic biologics) will be a safe scientific fact of life in the near future. But that's not fast enough for Congressional Democrats who want to use the biotech industry as a source of income redistribution and a cash cow for expanding SCHIP. So it has turned to Bill Haddad, an individual who is the godfather of the Hatch-Waxman act and whose company Biogenerics, stands to profit from the creation of FDA approval of generic biotech medicines to write the legislation for followon biologics. In its current form it is sweetheart deal for generics firm: No testing requirements, no postmarket studies, just show up with the files from the innovator company and your own brew. As for the $70 billion in savings, which just coincidentally equals the amount needed to fund the SCHIP expansion, Dems have turned to the PBM trade group -- which will profit from early termination of biotech patent -- to come up with projections of how much cash will be saved by swiitching patienets to knockoffs.
Only one problem, the standards in the bill are nearly a half century old. The same members of Congress bawling about how FDA can't protest the public against unsafe drugs would expose people to biotech products produced in ways that have caused seizures, paralysis, and incurable blood disorders in thousands of patients over the years. The other problem is that the biotech drugs they want to copy are not even off patent. They want to make that problem disappear by just legislating the right of some companies to contest their patent claims out of existentence. Why the disregard of IP and public health? To reward political cronies and appease constituencies who want to expand Medicaid as a way of advancing national health care.
Only one problem, the standards in the bill are nearly a half century old. The same members of Congress bawling about how FDA can't protest the public against unsafe drugs would expose people to biotech products produced in ways that have caused seizures, paralysis, and incurable blood disorders in thousands of patients over the years. The other problem is that the biotech drugs they want to copy are not even off patent. They want to make that problem disappear by just legislating the right of some companies to contest their patent claims out of existentence. Why the disregard of IP and public health? To reward political cronies and appease constituencies who want to expand Medicaid as a way of advancing national health care.
