Second, it calls on FDA to develop a plan by the year 2000 to clear the legendary backlog of products awaiting approval. Congress here makes itself a hostage to an endless series of demands for additional resources the FDA will say it needs to do this. Third, it codifies many policies that are already in place, giving the impression of a lengthy list of improvements. Companies are currently prohibited from distributing such critical information. The bill contains other minor improvements, such as loosened restrictions on health claims for food products and expanded use of third party, including academic institutions, to review medical devices.
Many critical reforms recommended by blue-ribbon panels are absent.
The private firm will need FDA approval to sell it. Obviously, the FDA has a conflict of interest for this approval. The FDA Reform Bill passed by Congress includes requirements to speed the review of new vaccines and drugs and to reauthorize the Prescription Drug User Fee Act. It should stick to regulation and leave discovery to industry. The taxpayer has essentially funded a private company's Research and Development.