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...

Congress must wean the FDA from its misapplied "first, do no harm" principle, which causes far more harm than it prevents.

AARP's reports on drug prices invariably conclude that prices are increasing faster than inflation, but after factoring in generic-drug prices, drug costs for the elderly are actually decreasing.

Washington must continue to guarantee drugmakers a certain period of exclusivity, but it should also increase the transparency of the patent system and close legal loopholes used by both drugmakers and their generic competitors.

Washington must continue to guarantee drugmakers a certain period of exclusivity, increase the transparency of the patent system, and close legal loopholes used by drugmakers and generic competitors.

As Congress considers legislation that would allow imitative biological products, known as "biosimilars," to rely on the safety and efficacy data of original innovators, it must ensure that any provisions passed will foster, not stifle, discovery.

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

Congress should act in protecting patents for follow-on biologics, relying on a few basic principles that do not suppress research and developmentin this vital sector.