This editorial in July 27 2011 Wall Street Journal really has a good approach to simplifying the whole drug approval process.
We do want any new drug to be safe. However I'm not sure that the Government needs to get involved in a drug's effectiveness.
If it isn't effective, doctors won't prescribe it! Hospitals won't use it, and government medical insurance shouldn't pay for it to be prescribed.
I would add two more conditions onto a revision of the law as proposed by Michele Boldrin and S.Joshua Swamidass in this article:
1.A patent on the new drug might be pending--but should not be approved until the drug is proven effective.
2. The drug company must maintain an on-line database that shows the number of patients using the drug and the reported side effects and "improvements" reported. That provides the public all of the information necessary to make decisions on whether or not to use the new drug. Of course patient privacy must be protected. Also the site has to be open to the public, and presented in a way that non-doctors could understand.
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