Subscribe to the Daily Dispatch via email
(Links to outside sources were active as of the date of this dispatch; however, not all news sources maintain links to current stories indefinitely. Some links also may require registration.)
New Drugs Released at Slowest Rate in a DecadeNew drugs to treat and cure sick patients are coming into the market in the United States at the slowest rate in a decade, despite billions invested by pharmaceutical companies on research and a costly expansion by the federal agency that reviews new medicines, according to The Washington Post.
The decline in the number of new drugs is most pronounced in the category considered by the Food and Drug Administration to have the greatest promise for patients -- those listed as breakthrough "priority" drugs and "new molecular entities" that are different from any others on the market.
The slowdown is troubling to many because it is largely unexpected. The drug industry now invests three times as much money in research as it did a decade ago, and the FDA has already undergone a major revamping to become more efficient and prompt -- an expansion funded largely by user fees from the drug makers. Yet the number of industry applications for innovative new drugs is down significantly, and the average time needed by the FDA to review applications is moving up.
The net result of both trends is a steep drop in the number of new drugs coming to the market to help cure and treat illnesses, and growing disappointment among many patients and their families and advocates.
In her book, Dependent on D.C., Charlotte Twight, an economics professor at Boise State University, writes that the FDA has used its regulatory power in recent years to delay and restrict access to lifesaving drugs. "In each case, the core issue has been the FDA's arbitrary use of bureaucratic power to override the patient's freedom to make a personal choice in light of current information about the dangers and benefits of a particular medical treatment," Twight says, adding that the FDA's institutional structure leaves officials more likely to be punished for introducing a new treatment too soon, rather than too late.
President Bush's proposals to drill for oil in an Alaskan wilderness, boost energy exploration in the Rockies, and consider changes to some major environmental laws are back in play, following the Republicans' resounding success in the Nov. 5 congressional elections, The Washington Post reports.
Nothing illustrates the shift in environmental politics more vividly than the leadership changes about to occur on two key Senate committees. The environment committee's chairmanship is switching from James M. Jeffords (I-Vt.), a hero to many environmentalists, to James M. Inhofe (R-Okla.), one of their least-liked lawmakers.
The Energy and Natural Resources Committee, meanwhile, will be headed by Sen. Pete V. Domenici (R-N.M.), who supports drilling for oil and gas in the Arctic National Wildlife Refuge. The question of whether to drill in ANWR holds almost iconic status for conservatives and conservationists alike, and Democrats no longer have the Senate or White House control that helped them hold off the proposal for years.
Jerry Taylor, director of natural resources studies, believes that Republican control of the House and Senate will have little impact on environmental policy: "There's little reason to think that a wholesale assault on environmental regulations is in the offing," Taylor says. "First, the United States Senate is a 60-vote institution given the omnipresent threat of a filibuster. Second, the Republicans lack an environmental agenda and thus have nothing in the policy cupboard to put on the political table. Third and most importantly, the American public is, by and large, reasonably comfortable with the environmental code as it currently exists."
Democrats plan to take one last shot at blocking one of President Bush's judicial nominees while they still control the Senate, hoping to defeat the promotion of a former aide to retiring Sen. Strom Thurmond (R-S.C.), according to the Associated Press.
The Senate set aside most of today to debate the appeals court nomination of U.S. District Judge Dennis Shedd. While under its current Democratic control, the chamber has only debated an appeals court nomination.
Democratic senators and liberal groups have criticized Shedd's ruling as a trial judge, saying he has been insensitive in civil rights and employment discrimination cases.
In "How Constitutional Corruption Has Led to Ideological Litmus Tests for Judicial Nominees," Cato Vice President for Legal Affairs Roger Pilon writes, "The battle between politics and law takes place at many points in the American system of government, but in recent years it has become especially intense over judicial nominations. That is because judges today set national policy far more than they used to--and far more than the Constitution contemplates. Because the original constitutional design has been corrupted, especially as it relates to the constraints the Constitution places on politics, we have come to ideological litmus tests for judges."
Jonathan Block, editor, jblock@cato.org