Kate Ackley wrote a great story about the most recent attempt to create a regulatory approval process for generic biotechnology medications on the Hill. Rep. Anna Eshoo (D- Calif.) and Joe Barton (R-Texas) has introduced the Pathway for Biosimilars Act, and it is a pretty good piece of work although there are two interesting aspects about it.
First it creates a really long period of data exclusivity, which means that the FDA cannot use any of the filed data from the original patented biotechnology drug to compare to the data about the generic version of the drug. The 14 years of data exclusivity is what the patent holder pharmaceutical companies wanted, the generic pharmaceutical companies want less, much, much less.
In the name of protecting R&D investments on the part of the patent holders, the generic demand are probably on the lower end, but the patent demand is probably a bit on the high end. I am guessing somewhere in the middle, just based off my knowledge of politics, but my guess has nothing to do with the actual scientific requirements.
The second interesting aspect is what lobbyists call the “Botox carve-out”. The Botox carve-out makes an exception to the generic biologics approval process, so that biologics based on biological agents and toxins will not be approved. In essence this will make the patents for Botox last forever, as it is based on the botulin bacteria. I am not sure if Eshoo and Barton feels that they owe this to Allergan, the company who owns Botox, since the Allergan political action committee donated $5,000 to each of them last year. That was a cheap everlasting patent, but it will hamper some painkillers and other medication that are in the pipeline based on toxins.
The lobbyists paid for by the patent owning companies say this is due to national security concerns. This is a straw man. If you were a terrorist, would you really apply for a FDA approval?