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

While biopharmaceutical companies may be thought of as mission oriented, they are almost certainly the poster children for adaptation. They need to focus on finding the most pressing relevant issues to help their patients.

The FDA's restrictive approach toward new drugs, supported by Senator Ted Kennedy, comes at the expense of many patients and possibly Kennedy, too.

The FDA's restrictive approach toward new drugs, supported by Senator Ted Kennedy,comes at the expense of many patients and possiblyKennedy, too.

The new Obama drug initiative is of a piece with the administration's abiding faith in the virtue of government investment as a trump to private entrepreneurism. At the core of this religion is a faith that that the political allocation of capital leads to better, or at least more "equitable" outcomes.

Worldwide attention by regulatory authorities on the contribution of genetic factors to drug response has increased. This is reflected by a developing regulatory framework that facilitates PGx integration into drug development such as Voluntary Exploratory Data Submissions in the USA and Japan, as well as the more recent, formal biomarker qualification by the regulators.

Styrene's recent listing as "reasonably anticipated to be a human carcinogen" means something very different from how it is being framed by advocacy groups and the media—and this knowledge gap threatens to wreck legislative havoc across the country.

Patients would be better off if states were able to tailor the benefits that Medicaid covers—targeting resources to sicker people and giving healthy adults cheaper, basic coverage.