American Enterprise Institute (AEI) scholar Scott Gottlieb, MD a former senior adviser to the Center for Medicare and Medicaid Services (CMS) warns that a new ruling by CMS will force people to get open-heart surgeries that might have been avoidable.

This is an all too familiar story, the FDA impeding useful innovations in the US entrepreneurs here are forced to test promising medical devices in costly animal studies for years before they can advance their products into clinical trials. In response, American device makers are moving their business overseas.

The FDA must continue to pressure Chinese authorities to test what is on the market and remove any substandard products found.

Efforts to limit the commercial use of data on physician prescribing could have broad implications for regulatory programs that promote drug safety. At issue are a series of laws pursued by state legislators that would restrict access to information on the prescriptions written by individual doctors.

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.

Requirements to test new drugs against older medicines would add a major hurdle to the development and approval of new medicines. Equally important, the proposed mandates are unnecessary.

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.

Many scientists worry that an overaggressive Food and Drug Administration could strangle a revolutionary technology still in its infancy.

Cutting funding to organizations that oversee food safety and drug approval would have a counterproductive impact.

The FDA should be required to disclose its reasons for rejecting a drug, and Congress should reaffirm the provisions of the FDA Modernization Act.