The 1984 Hatch-Waxman Act created a streamlined path for generic drugs to reach the market after pioneer drug patents expire. The result has been the most vigorous and competitive generic drug market in the world, but the Hatch-Waxman Act does not apply to most biologics. Isolated from a variety of...

The failure to pass health care reform is not due to partisan politics, but because the Democrats are letting the legislation be written by organized labor and the pharmaceutical companies.

Establishing a pathway for biogeneric competition is an important but challenging task facing lawmakers today.

Drugpolicymaking seems to have left the patient out of the equation, while focusing only onthe political calculus of how angry politicians can take a bite out of the industry's hide.

The evolution of the European Union"s approach to regulating biosimilars is a potential model upon which we can design a process that facilitates access to biosimilars while providing assurances of safety.

The Obama budget does not address Social Security, Medicare or Medicaid, the real issues adding to the deficit.

The FDA has become a bureaucracy that "protects" people from the drugs that can save their lives.