Two thoughts for your consideration.
1) Opt-out. Allow anyone to opt-out of the FDA. That is, allow terminal patients/early adopters/test pilots to voluntarily buy products from companies before the FDA certifies them as safe and effective. For example, people might decide that they will use drugs that have cleared Phase I trials and proven safe, and use their own judgment for whether the drug is effective. Essentially this is a rollback of cases like Cowan vs. United States, a 1998 case in which the FDA sued to prevent a terminal AIDS patient from using a drug that they had not yet approved:
http://goo.gl/li7jl
2) Multiple regulators. The purpose of sites like Metacritic or Rotten Tomatoes is that any one reviewer is flawed, but an aggregate will usually be better. But for most drugs and devices, only a very small number of people within the FDA plus perhaps a 15 person expert panel are involved. FDA does not have the internal expertise to evaluate all fields of medicine, so frequently gets outside experts from Harvard Medical School, the Mayo Clinic, and the like to serve on its panels. Here is an example where the chair is from Mayo:
http://goo.gl/8lxEQ
The multiple regulators concept would allow any of these institutions to certify drugs and devices, just as we allow multiple medical schools to certify MDs. As another analogy, a company rejected by one regulator can get a second opinion from another, just as academics can submit to multiple journals if the first one rejects a paper. Indeed, much FDA review is already subcontracted out to expert panels from these institutions anyway. In return for doing approvals, Harvard Med or Mayo would get the user fees authorized under PDUFA/MDUFA that would otherwise go to FDA. People could wait for a drug to be approved by the FDA, or they could take a drug which had Harvard Medical School's stamp of approval.
These two proposals - opt-out and multiple regulators - are relatively simple to implement yet will cause huge changes in the system.
Right now we have a crude version of both in that a wealthy patient can opt-out of the FDA by flying to Europe, and a company can to some extent have multiple regulators by going for the EU's CE Mark first rather than the FDA. Indeed, within the medical devices space they now say "Europe first" just like internet startups today say "mobile first".
But it would be better if a patient could opt-out without flying to another country, and a company could get a second opinion from a different regulator without launching outside the US.