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...

Follow-on biologics are not like ordinary generics, and therefore require Congress to exercise a deft regulatory hand.

Several recent books have criticized the pharmaceutical industry for developing too many "follow-on" or "me-too" drugs--a name given to drugs that work the same way as pioneering drugs that create a new class of treatments. Do follow-on drugs raise costs while diverting R&D funds from true innovation, and should the...

With the signing of a Strategic Arms Reduction Treaty with Russian president Dmitri Medvedev on April 8 and the convening of the Nuclear Security Summit on April 12-13 2010, President Barack Obama pressed ahead to fulfill his vision of nuclear disarmament. Yet the administration's bilateral approach has put the arms-control...

This timely book brings together a remarkable group of authors who examine the federal role in education policy and reform during the past fifty years.

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.

As Washington considers slashing $500 billion from the defense budget over the next decade, the lessons of Libya should give pause to anyone whose plans will reduce the U.S. military's ability to control the air.