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.

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.

Congress enacted and renewed the Prescription Drug User Fee Acts (PDUFA) in 1992. The authors model and quantify the impact of PDUFA-I and -II on drug approval times.

We need to design regulatory approaches to ensure that molecular diagnostic tests are reliable while not overburdening those seeking to develop these important new technologies.

The current Senate deliberation over aid to Colombia aimed at fighting narcotics reminds us that there are two debates over how the government ought to deal with dangerous drugs. The first is about their illegality and the second is about their control. People who wish to legalize drugs and those...

The best way to lessen drug-related crime is to reduce demand through increased drug testing and supervision of probationers and parolees.

How severe is the crisis in the pharmaceutical industry?

With the fates of the Food and Drug Administration and the pharmaceutical industry more intertwined than ever, our health depends on regulatory innovation as much as on scientific progress.