The institute will have no responsibility for clinical research. Funding will come from contributions by the pharmaceutical industry. The consumers will benefit, too. If there is less costly testing involved and more efficient processes, ultimately there will be cost savings that ought to be passed on to the consumer. It will also create faster tracking of products through the regulatory process.
Consumer groups are concerned about moving the public process to the private sector.
This takes a research function from inside the FDA to outside the FDA, and that is somewhat distressing. Officials stress that the FDA won't be giving up control over the regulatory process. Nothing has changed with giving up some of the functions to the outside.