The following is an English translation of El Nacional's interview with AEI fellow Roger Noriega, who told the Venezuelan newpaper that its government is deeply involved in the drug trade but he has "never heard of a witness who is in a better position to bear witness to the criminal activities of dozens of officials in the highest levels of that government."

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.

The crisis in financing is having a chilling effect on biomedical innovation. As discussed in my last column, the main problem in our industry is that the sheer cost of drug development has become almost prohibitively expensive, effectively pricing almost everyone but the largest companies out of the market.

Drug makers aren't chasing blockbusters like Lipitor anymore, or uncovering compounds the same way.

Successfully translating scientific discoveries requires a sense of urgency, which some disease foundations seem to have, and many big pharmas appear to need. Patients waiting expectantly for medical research to produce important new cures are finding bad news almost everywhere they turn.

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 is restricting the speech of private drug firms. This may violate the First Amendment rights of drugs companies.