Actually, I think the biggest issue isn’t politics, it is the way the FDA is funded. Basically, in the words of The Boston Globe, "… in 1992, Congress put the fox in the chicken coop. It passed the Prescription Drug User Fee Act, which authorizes drug companies to pay “user fees” to the FDA for each brand-name drug considered for approval. Nearly all of the money generated by these fees has been earmarked to speed up the approval process. In effect, the user fee act put the FDA on the payroll of the industry it regulates. Last year, the fees came to about $300 million, which the companies recoup many times over by getting their drugs to market faster.
Unfortunately, Congress got very used to the FDA being largely self-funded, therefore they have given little money to the FDA to ensure public safety. This applies not only to drugs, but also to our food. Last year, there were several prominent outbreaks of eColi in spinach and other vegetables that are supposed to be managed by the Food and Drug Administration.
The Washington Post opines that its time to break the FDA from its user fee habit.
Insulin users are not immune to these problems, either. Did you know that the FDA requires no batch testing of insulin made via rDNA technology? The U.S. Patent and Trade Office filing for Humulin shows that potency of insulin made via synthetic processes can vary by up to 20%. It can be managed, but do you really want a for-profit business to police itself? There are only 3 companies selling insulin, so your choices are pretty limited. While I don’t believe there is a conspiracy theory, I do believe that regulators should be working for public interest, not the needs of the drug industry, but thats not the way it now works.