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minded liberals. See, for example, Gina Kolata,

drug approval guarantees a repeat of the far dead -

"Odd Alliance Would Speed New Drugs," New

lier tragedies of delayed access to AIDS, cardio-

York Times, November 26, 1988, p. 9; "Opening Up

vascular, and other life-saving medications.

the FDA," Wall Street Journal, November 15, 1991,

p. A10; Jon David Aloisi-Nalley, "Activists Go

302. Grabowski and Vernon, 1983, pp. 44­46.

Face-to-Face with Bureaucratic Foes," Guardian,

303. Dale Gieringer, "The Safety and Efficacy of

February 15, 1989, p. 9; Jon David Aloisi-Nalley,

New Drug Approval," Cato Journal 5, no. 1

"We Want Expanded, Faster and Better Drug

(Spring­Summer 1985): 189­96.

Trials," Guardian, November 2, 1988, p. 5; Jon

David Aloisi-Nalley, "Target: FDA's Drug

304. Washburn, p. 17.

Policies," Guardian, September 14, 1988, p. 3;

Susan Okie, "AIDS Coalition Targets FDA for

305. An FDA regulator discusses such issues in

Demonstration," Washington Post, October 11,

Denise Grady, "Calculating Safety in Risky World

1988, p. A17.

of Drugs," New York Times, March 6, 2001, p. D1.

297. Lichtenberg, 1999, pp. 13­14.

306. Nicholas Wade, "Swift Approval for a New

Kind of Cancer Drug," New York Times, May 11,

298. Mary Olson of Yale University's School of

2001, p. A1.

Public Health finds that prior to the 1992

Prescription Drug User Fee Act user fee reforms,

307. The Polling Company, "A National Survey of

the mean new drug review times averaged 30

Emergency Room Physicians Regarding the Food

months. Six years later, mean review times

and Drug Administration," Competitive Enter-

declined to less than 12 months (although mean

prise Institute, October 1999, p. 12.

review times have increased somewhat since

then). In the early 1980s, only 2­3 percent of new

308. Siegel and Roberts, "Reforming FDA Policy,"

drugs were introduced in the U.S. market because

pp. 71, 73.

drugmakers typically completed other countries'

approval processes first. But by 1998, more than

309. Gina Kolata, "Bioterror Drugs Stall Over

60 percent of new drugs appeared first on the U.S.

Rules and Logistics," New York Times, November

market. See Mary K. Olson, "How Have User Fees

13, 2001, p. D4. See also Christina Markus, "FDA

Fights Flexibility," Legal Times, November 5, 2001,

Affected the FDA?" Regulation 25, no. 1 (2002): 22.

pp. 28, 29.

See also U.S. General Accounting Office, "Food

and Drug Administration: Effect of Users Fees on

310. U.S. Food and Drug Administration, "FDA

Drug Approval Times, Withdrawals, and Other

Amends Its Regulations to Provide for Approval of

Agency Activities," GAO-02-958, September 2002,

Certain New Pharmaceutical Products Based on

p. 3 (noting that the approval time for drugs con-

Animal Efficacy Data," FDA News, May 30, 2002,

taining active ingredients that have never been

www.fda.gov/bbs/topics/NEWS/2002NEW

marketed in the United States in any form has

00811.html.

increased since 1998 from about 13 months to 20

months).

311. "Critics Say Drugs OK'd Too Quickly, Too

Slowly," Washington Times, August 21, 2001, p.

299. Jennifer Washburn, "Undue Influence,"

B12.

American Prospect, August 13, 2001, pp. 16­17.

312. Berndt, pp. 106­07. The average drug trial

300. Calfee, 2000, p. 15.

also includes more patients. Henry Grabowski

estimates that today's drug trials average 5,500

301. Rezulin was found to cause liver damage.

patients, compared to 2,000 patients in the 1980s.

See, for example, "F.D.A. Increases Efforts to

See Otesa Middleton, "Rising Drug Prices Blamed

Avert Drug-Induced Liver Damage," New York

on Larger Studies, Ads," Dow Jones Newswires,

Times, August 14, 2001, p. D5. Writer Donna

December 11, 2002.

George Storey complains that "we consumers

have no guarantee that a similar tragedy will not

313. Kolassa, p. 18.

happen again." See Donna George Storey, "An

FDA-Approved Killer," Washington Post, May 20,

314. Tanner, pp. 182­83.

2000, p. A23. Indeed, there have been serious

problems with statins, which reduce cholesterol.

315. Sam Kazman, "Saying Yes to Drugs," Journal

Ron Winslow, "Experts Worry That Side-Effect

of Regulation and Social Costs, June 1992, pp. 35­36.

Fear Could Set Back Cholesterol Battle," Wall

Street Journal, August 22, 2001, p. B1; Philip Hilts,

316. Cowell.

"Drug's Problems Raise Questions on Warnings,"

New York Times, August 21, 2001, p. 1. But slowing

317. Lenard et al., pp. 18­24.

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