Clues may be in the Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers; Availability (available at FederalRegister.gov).
The pharmaceutical industry lobbied to restrict Americans access to prescription drugs by the internet from other countries, most notably Canada, is it now working to limit the competition they face from off-patent generic medication?
How could they do this? Bureaucratic red tape and regulatory fees.
In the Summery of the Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers; Availability this sounds promising: "The Generic Drug User Fee Amendments of 2012 (GDUFA) is designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry." However with laws and regulation what is intended, or proclaimed as intended, is not always what we get.
I dug a little deeper and the fees seem high to me and certainly are vague, although I have no experience in the pharmaceutical industry. Just look at this chart:
A $174 million facility fee? What is a facility? Just the factories where the drugs are produced or are distribution centers also included? Is this fee spread among producers or will each one have to pay this fee? Foreign producers pay more, which makes sense, but how much more? So much more that they won't even enter into the U.S. market?
I gathered this from a 20 page FAQ about the legislation. If the questions and answers run to 20 pages imagine what is buried deep in that piece of political handicraft? The act (Public Law 112-144
112th Congress) has already been signed into law and it's now about how to enforce it.
My best guess is that the pharmaceutical industry will be happy with both the law and its regulation, that it is some sort of reward for going along with Obamacare.