OK, a couple of things. That lawsuit against Hamburg lists her as one of seven defendants. Johnson & Johnson are the deep pockets, and proving RICO against Hamburg is highly unlikely to be successful. Remember, anyone can sue anyone, write all sorts of allegations in a complaint, but then they have to prove it in court. The mere existence of a civil suit does not establish fault against any of the named defendants.
Gottleib has proven himself to be a level headed Commissioner, with some decent plans for the agency. While it is theoretically possible a change in Commissioners could alter policy, there are still not only 3 years for standards to be established, but also 3 more years for lots of legitimate medical data to reach public attention (or at least professional attention). The more positive medical data generated, the harder it will be for any future Commissioner to radically alter the direction currently being taken.
Congress and the Clinton administration established that BP would pay user fees to get faster drug approval. This has allowed the feds to decrease FDA funding, now relying on a quarter to half of the ~$4.5 billion dollar budget to be funded from outside the government (depends who's numbers get used, but to me $2.5 Billion coming from the Federal budget leaves an awful big chunk funded by the industry itself).
It's unlikely that will ever change as no one wants to add those expenses back onto the Federal budget. BP isn't bribing the FDA, but sure are legally funding it, so we, the public don't see more Federal money being spent. Think about the size of BP, and in food, and how can such a tiny line item in a budget be so small relative to the tasks assigned. Maybe with more inspectors and researchers, less questionable stuff would get passed.
On the subject of passing drugs, the Right to Try Act was passed by the Senate and the House, along with allowing those user fees to keep on going, and I believe already signed by Trump. The right to try thing is sorta interesting.
T
he “right to try” bill, introduced by Senator Ron Johnson, Republican of Wisconsin, aims to establish a new pathway for terminally ill patients to gain access to experimental drugs that have not been approved by the F.D.A....
These patients are often extremely ill and unable to participate in clinical trials, or have no other treatment options....
In some cases, drug makers fear they could be sued by patients who say they have been injured by unapproved drug products.
The bill would establish national standards and rules to help channel drugs still under development to terminally ill patients.
It would also shield pharmaceutical companies and doctors from some of the legal risks of providing drugs that have not been approved by the agency.
Senate Passes F.D.A. Funding and ‘Right to Try’ Drug Bills
So now folks are defended in the use of experimental treatment outside of a clinical trial.I personally think it's overall a good thing, but I am concerned about establishing a precedent for pushing through more drugs than necessary for the extremely ill.
Last but not least, the FDA sends out hundreds of warning letters every year to BP alone. BP's response is to either ignore it, argue it without changing anything, and several cases of turning around to the FDA and saying "sue us" which the FDA really doesn't do.
IMO, until the public and Federal government decide the FDA is important to establish drug approvals and monitoring, as well as assuring the food supply chain remains safe for public consumption, hires enough people to do that, and refuses to allow industry to fund the very approval process they want accelerated, the better off we'd be and there would be less sentiment that there is "rampant corruption" in the agency.