Kessler Resignation Sparks Concern About Future Of FDA

BIDDING ADIEU: David Kessler, who headed FDA for more than six years, says he is pleased with his record. When David Kessler, the commissioner of the federal Food and Drug Administration (FDA), announced his resignation in late November, many people were surprised. The controversial FDA head was in the middle of waging war against the United States tobacco industry when he decided to step down after more than six years in the job. His supporters, including public health advocates, contend that he has made FDA a more effective agency in protecting consumer safety and health. Detractors, such as those in the tobacco and medical device industries, argue that Kessler has favored too much government regulation, delaying drug and medical device development. Many in Congress agree with them and have launched efforts to reform FDA. While FDA officials claim that Kessler's departure will not affect the agency's plans to go ahead with proposed restrictions on teenagers' access to tobacco and with curbs on tobacco advertising, most groups agree that the future direction of FDA is up in the air. The new commissioner's policies will determine if the agency follows Kessler's regulatory zeal, for example, or whether it will take a less active, visible role. Writing in Newsweek (Dec. 9, 1996, page 28), Kessler summed up his term: "The things we have done at FDA can and will affect the public's health-and that means we've fought the good fight." Kessler, who cited a desire to return to private life in his resignation statement, listed his agency's accomplishments: "from food labels to tobacco rules, from mammography standards to world-record times for drug approvals, from heightened food safety to crack-downs on fraud." He has said that he will stay until a successor is appointed. He declined to be interviewed for this article. Many consumer advocates and industry representatives praise Kessler's achievements as commissioner. They note that he was tough on inaccurate food labeling and drug advertising. He also improved the adverse drug reaction reporting system, tightened mammography guidelines, and started the approval process for the first U.S. abortion pill. What's more, he helped speed "priority" AIDS and cancer drugs through the approval process and to the market (S. Benowitz, The Scientist, April 29, 1996, page 1). PLAYING POLITICS: Attorney William Vodra notes that under Kessler, FDA advanced causes via politics rather than science. Kessler will be remembered for "restoring credibility to an agency that was rocked by scandals, when morale and public confidence in the agency was down," says attorney William Vodra, a partner at Washington, D.C.-based law firm Arnold and Porter and a former FDA associate chief counsel. Vodra notes that the agency was considered a paper tiger when Kessler took over in 1990. He quickly changed that image, and companies "thought twice about challenging the agency," Vodra states. INCREASED BURDEN: Stanford’s Henry Miller contends that Kessler overregulated drugs and medical devices, hampering patient access and product development. Critics contend that among other things Kessler tried to overregulate drugs and medical devices and introduced unrealistic requirements for approval. "FDA has raised the regulatory burden on drug companies by continually introducing new requirements and policies, regardless of their potential to hinder the delivery of new and innovative therapies to patients who need them," contends Henry I. Miller, a senior research fellow at the Hoover Institution and a consulting professor in the Institute for International Studies at Stanford University. Kessler's tenure has been a whirlwind of activity. He arrived at FDA in 1990, chosen to clean up an agency still reeling from a scandal that included FDA employees who took gratuities from generic drug companies. Kessler came with law and medical degrees from the University of Chicago and Harvard, respectively. He had taught food and drug law at Columbia University's law school, had been medical director of the Hospital of the Albert Einstein College of Medicine in the Bronx, and had served on Sen. Orrin Hatch's (R-Utah) Labor and Human Resources Committee. Kessler immediately restructured the top management at FDA. He appointed four new deputy commissioners and a senior adviser and structured the agency into several new divisions. He subsequently created an Office of Criminal Investigation to improve the agency's enforcement capabilities. One of his first actions was to campaign against false food labeling, particularly against those products misleadingly labeled as fresh or low-fat. This culminated in 1994 in the Nutrition Labeling and Education Act, which required nutrition labeling for products regulated by FDA. Kessler's regime has had its share of ups and downs. In 1992, for example, he pressured manufacturers to agree to a voluntary moratorium on the sale and use of silicone breast implants. However, medical device companies and women's groups balked at the lack of scientific data, and the moratorium was subsequently overruled in 1994 by the Clinton administration, which permitted implants for reconstructive surgery on breast cancer patients. Also in 1994, the agency began its attack on tobacco. In 1995, Kessler outlined the agency's controversial plans to combat smoking, restricting minors' access to vending machines and cutting tobacco advertising. Kessler successfully negotiated the 1992 Prescription Drug User Fee Act (PDUFA), which expires this year. Under the act, industry pays "user fees" to FDA to hire more reviewers and quicken the drug approval process. KUDOS FOR MODERNIZATION: Kessler nudged the FDA approval process into "the modern world," says BIO’s Carl Feldbaum. Carl Feldbaum, president of the Washington, D.C.-based Biotechnology Industry Organization (BIO), argues that an updated PDUFA will be instrumental in continuing FDA reform. "Industry paid FDA $88 million [through PDUFA] last year to hire reviewers to speed the drug-review process," he notes. FDA is negotiating with BIO and the Pharmaceutical Research and Manufacturers of America (the pharmaceutical industry's trade group, known as PhRMA) to reauthorize PDUFA, "which we hope will reduce not only [drug] review time, but also drug-development time," says Feldbaum. It will force better communication among companies and the agency." Kessler's tenure has been marked by battles with the Republican Congress, which has been pressing for legislative reform of the agency. The proposals call for less authority and bureaucracy at FDA and for greater involvement of the private sector. Reform bills were introduced last spring in both the House and Senate (K.Y. Kreeger, The Scientist, May 13, 1996, page 1), though none has been passed into law as of yet. The bills call for privatization of a wide range of the agency's medical device and drug-review work. Under privatization, reviews would be conducted by a third party and paid for by the drug industry. The bills also call for lowering standards for drug approval and blood safety. While Kessler and the agency have resisted many of these changes, the supporters argue that they would speed life-saving drugs to the market. Many consumer groups and companies, however, give Kessler credit for updating FDA. "He inherited an agency averse to change, particularly in regard to regulation of biologics," says BIO's Feldbaum. He continues that Kessler "recognized the need for administrative reform of the way biologics are reviewed [using outside experts]. He nudged the FDA approval process closer to the modern world." Likewise, AIDS groups, which have clashed with FDA over access to new drugs, applaud Kessler's efforts in speeding up approval of potentially life-extending AIDS medicines. "Historically, FDA hasn't had enough money to effectively conduct drug and product reviews," notes Spencer Cox, director of antivirals projects for the New York-based Treatment Action Group, an AIDS activist organization. "With the user fee act, Kessler worked hard with industry to come up with a solution at least partially acceptable for everyone. Congress wasn't going to appropriate more money for FDA. This was the only way to speed review times, and it's been a very successful program." A MIXED BAG: HIMA’s James Benson thinks the commissioner "tackled tough issues" but overemphasized enforcement. Others see Kessler's tenure as a mixed success. James S. Benson, senior vice president for technical and regulatory affairs at the Health Industry Manufacturers Association (HIMA) in Washington, D.C., thinks the commissioner will be remembered as "someone who tackled tough issues [such as silicone breast implants and tobacco], and increased the public's awareness of the FDA." Yet he contends that Kessler overemphasized the enforcement aspect of his job. For example, he acted too quickly in restricting access to silicone breast implants in 1992, says Benson, who served as acting FDA commissioner in 1989 prior to Kessler's appointment. However, he believes that Kessler put politics ahead of science and reacted to the threat of liability before adequate medical research had been done. Subsequent research showed Kessler's actions were premature-and unwarranted. In 1993, the council on Scientific Affairs of the American Medical Association (AMA) issued a report urging AMA to support women's right to have silicone implants (AMA, Council on Scientific Affairs, JAMA, 270:2606, 1993). Photo: Chad Evans Wyatt BATTLE-WEARY FDA: Fending off reform attempts has hampered the agency’s effectivenes, maintains Sidney Wolfe. "FDA has been so busy fending off congressional reform attempts that it hasn't had adequate time and resources to study drugs already on the market," maintains Sidney Wolfe, director of Washington, D.C.-based Public Citizen's Health Research Group. While Wolfe believes that Kessler may have been the most effective FDA commissioner to date, he complains that the agency doesn't have as much power as it should. FDA cannot level civil monetary penalties, for example. Kessler has no shortage of critics. "People will say that he achieved his goals-restoring public confidence in the FDA-over broken products and bodies," says Vodra. He contends, for example, that "politics, not science" drove the agency's decision to remove silicone breast implants from the market. Vodra argues that Kessler succumbed to pressure from the Plaintiffs Product Liability Bar and in turn, "destroyed access to a product for women, created a multibillion-dollar case in the courts, and hurt the breast implant and medical device industry." Despite Kessler's accomplishments, the constant battles with Congress over reform were weighing down the agency, contends Peter Teeley, vice president of government relations at Amgen Inc., a biotechnology company in Thousand Oaks, Calif. "He was losing effectiveness. It was time for him to go." WASTED EFFORTS: Labels will continue to protect the cigarette industry from FDA attack, says Elizabeth Whelan. Elizabeth M. Whelan, president of the American Council on Science and Health (ACSH), a consumer advocacy organization based in New York, believes some of Kessler's efforts were in vain. "We admire his aggressiveness in attacking cigarettes, but he encouraged a breast implant moratorium that wasn't warranted scientifically." Whelan maintains that the agency's efforts to curb cigarette access and advertising are wasted because the warning labels on packages protect the industry from liability claims from smokers. Some claim that Kessler's policies added bureaucratic delays and slowed FDA's effectiveness. The Hoover Institution's Miller, who held several positions at FDA from 1979 to 1994, including director of the office of biotechnology, believes that Kessler's decision in 1995 to have drug companies increase reporting of the adverse side effects of their products was "near catastrophic." One study (C.L. Meinert, Controlled Clinical Trials, in press) found that "the regulation increased costs of clinical trials per patients 62-fold, as well as increasing paperwork 63-fold, with no commensurate benefit to patients. This contributed to doubling drug-development time, raising the cost for bringing a new drug to market to about $500 million," says Miller. He states this and other criticisms in his book Policy Controversy in Biotechnology: An Insider's View, scheduled to be published this year by R.G. Landes Co. of Austin, Texas. CONGRESSIONAL ACTION: Congress cut the approval time for therapeutics despite Kessler’s strict regulatory policies, claims Rep. Thomas Bliley, Jr. Other criticisms come from within Congress. In a recent speech to the American Enterprise Institute, House Commerce Committee chairman Rep. Thomas J. Bliley, Jr. (R-Va.), maintained that the committee would continue to push for FDA reform. He noted that in spite of Kessler's strict regulatory policies, the committee's efforts had much to do with the fact that in 1994, "the median approval time for important new therapeutic drugs was cut by two-thirds." He added that the agency approved "almost as many new breakthrough drugs-new chemicals never released here-in the first six months of 1996 as in all of 1994." At the 40th annual Food, Drug and Law Institute meeting in Washington, D.C., last month, Kessler defended his agency's record. He showed data indicating that FDA has increased drug approval times. He cited, for example, the fact that FDA approved 121 drugs in FY96, and 46 were breakthroughs, which was 18 more than 1995. FDA took a median of 15 months to evaluate the drugs, three months faster than in 1995, and twice as fast as in 1990. Of the 27 drugs for life-threatening diseases, FDA spent only a median time of 7.8 months in review. Kessler acknowledged that FDA needs to improve in evaluating medical devices, noting that only eight breakthrough devices made it through the approval process within a year for FY96. HARD ACT TO FOLLOW: CPSI’s Michael Jacobson believes it will be difficult to find a health advocate to head up FDA. Many wonder what direction the post-Kessler FDA will take and who the new commissioner will be. Michael Jacobson, director and cofounder of the Center for Science in the Public Interest (CSPI), a food and nutrition watchdog group in Washington, D.C., predicts that "it will be difficult to replace him with a health advocate, especially when the Senate confirms the presidential nominee." He's concerned that the new commissioner won't be as supportive as Kessler of government regulation of the food and tobacco industries or as strong an opponent of congressional reform. Like consumer groups, industry representatives hope that the agency will continue to work to reduce new drug and medical device development and approval times. Lisa Raines, vice president of government relations for Cambridge, Mass.-based Genzyme Corp., states, "There are whole new categories of biotechnology products being developed, and a key will be to continue to protect the public health while still getting products to patients and not compromising safety and efficacy testing of new drugs." Raines notes that accelerated approval programs, designed to give patients access to promising drugs prior to final approval, are limited because insurance companies won't pay for experimental products. "The new commissioner should focus on providing limited approval to products early in the process, which would give meaningful patient access" while company research and testing continue, she says. The drug-development process can take as long as 15 years from the time a promising compound is discovered to the time a drug reaches the bedside, she notes, and "the current health care system cannot [continue to] afford long development times and expensive drugs." Washington attorney Vodra suggests that the next commissioner faces several contentious reform issues beyond privatization. "[Another] issue is off-label uses and dissemination of information, which involves promoting information to physicians and other health care providers about a drug's potential use other than that specified on the label." SPEEDY SUGGESTION: Louis Lasagna proposes that regulators and drug firms discuss questions early in the new drug application process. A bill sponsored last year by Sens. Bill Frist (R-Tenn.) and Connie Mack (R-Fla.) would allow companies to market off-label uses of a drug to physicians. The same bill, which never left committee, provided for companies to send peer-reviewed articles to doctors touting off-label uses. The bill will be reintroduced in a modified version in the 105th Congress. Supporters note that half of all cancer treatment prescriptions are off-label. Critics worry about inadequate research and incomplete reporting of only positive results. Louis Lasagna, director of the Tufts University Center for the Study of Drug Development in Boston, suggests that the issue of faster drug development and approval might be resolved if "both the regulators and the drug companies sit down early in the NDA [new drug application] discussion process to answer questions to smooth the process." He also favors a faster and more effective ombudsman system for companies to appeal disputes over drug approval. No matter who is appointed commissioner, Vodra thinks that "many people are overreacting" to Kessler's departure. "Kessler isn't the FDA," he comments. "It has a long, rich history. It will go on without him."

Kessler Resignation Sparks Concern About Future Of FDA

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