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Here is another good news/bad news column about the 112th Congress.
In an attempt to protect poor, uninsured and underinsured Americans from unsafe drugs, we are making sure that some go without drugs completely. It is time the law was changed.
Adding a new mandatory "comparative effectiveness" test to the approval process for new drugs in the reauthorization of the Food and Drug Administration (FDA) Prescription Drug User Fee Act constitutes a needless waste of time and money.
Will more regulations and a more centralized food safety bureaucracy make us safer? What kind of regulations and implementation mechanisms would best serve the public's desire for ensuring food safety?
The FDA's efforts to resolve scientific differences and to take final actions are causing it to miss review goals that it commits to as part of the PDUFA.
Think the contraception decision was bad? Wait until bureaucrats start telling your insurer which cancer screenings to cover.
So the Democrats' drug-safety concerns were about enriching the plaintiffs' bar?
The FDA should be required to disclose its reasons for rejecting a drug, and Congress should reaffirm the provisions of the FDA Modernization Act.







