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• • January 4, 1994 RE: FDA Research: Overview The following excerpts from hearings and articles may be helpful: The Atlanta Journal and Constitution, "Bring the FDA up to Snuff, but Leave State Authority Intact," 4/16/93. "Alarmingly, the watchful eye of the FDA is failing. Americans increasingly are exposed to health risks from inadequately inspected foods, medicines and medical devices." "A federal panel convened by HHS Secretary Louis Sullivan has concluded that the FDA needs more resources and expanded authority to fulfill its consumer- protection mission." Biomedical Market Newsletter, "FDA says its Problems are All Your Fault," 3/93. "Claiming that safety tests and approval applications for certain medical devices are so shoddy that they are 'not up to the level of fifth-grade science,' the FDA has gone on the offensive in a wide-ranging effort to improve the device review/approval process."

- 2 - • • ,"FDA Approval Delays of Several Years," 5/93. "Medical device manufacturers are now experiencing US FDA device review periods for 510(k) substantially equivalent devices of up to 912 days - two years longer than the statutorily required 90 day period." ,"Rep. Dingell says FDA Unable to Protect Pub- 1 c," 5/93. "An exhaustive but stinging, bipartisan report on FDA failures was released on May 12, 1993 by Rep. John D. Dingell, Chairman, Subcommittee on Oversight and Investigations, House Committee on Energy and Commerce." Dingell noted that the report "identifies continued organizational and structural weaknesses that make the FDA's Ctr for Devices and Radiological Health less than the sum of its parts - unable to either protect adequately the public from unsafe devices or to approve useful and safe devices in a resonable period of time." ,"New FDA Reforms Supported by Medical Device Manufacturers Assn.," 6/93. "The Medical Device Manufacturers Assn. (Wash., DC), a trade group for small and medium sized manufacturers, said it is pleased the FDA is finally trying to deal with the backlog of medical devices awaiting approval." "Although the reforms announced in late June 1993 'represent only a small start in addressing this critical situation, they indicate the FDA at least recognizes there is a problem. We believe Dr. Burlington is sincere in his efforts to clean up the CDRH, but believe CDRH must distinguish between a Pre- Market Approval (PMA) and a Pre-Market Notification 510(k)." ,"FDA Sliced and Diced in Explosive Expose's: Executive ctive Summary and Excerpts of Congressional Study Less Than the Sum of its Parts," 6/93. ~ O The Subcommitee on Oversight and Investigations of the Energy and Commerce committtee released a report on May ~ 12, 1993 which concluded that the FDA's Center for c0 C7~ con . Ca ~

3 • • Devices and Radiological Health needs "thorough reform and vigorous management..." "A series of subcommittee hearings and investigations have documented a number of instances in which the FDA approved devices that proved unsafe in use." The report discusses the "systemic defects within the FDA: Excessive delays in the review and approval process of device applications" as well as "low morale and productivity" and "organizational flaws." "The situation is intolerable, the backlog for pending device applications exceeds 1,100 (not counting the backlog of unfiled applications pending in CDRH's mailroom), compared to a dozen pending applications the same time the year before." "Industry complaints that the FDA cannot or will not offer an explanation for the increased device application approval review times appear to be justified.... ODE is now averaging 184 days to process and take some action on a 510(k) application. This period of time represents more than a 100% increase over ODE's original 90 day milestone for approvals." " backlogged, as of Apr. 30, 1993, reports the Medical Device Manufacturers Assn (Wash DC). Of the 4,850, over 1,300 are awaiting more information from manufactuers, over 3,500 are active and over 1,400 are over the 90-day review period." "The average time for processing a 510(k) has increased from 126 days for the year ending Sept. 30, 1992, to 174 days now. These statistics, supplied by the FDA, 'understate the problem,' claims MDMA. 'FDA numbers count only the days in the agency, and not the days spent by industry responding to questions.' ,"FDA Product Approval Backlog Hits 5,000, 8/93. "The US FDA has almost 5,000 510(k) applications Dermatoloqy Times, "ON CALL: Role of FDA Debated in Light of Congressional Hearings," 8/93. 2~ C While the possible expansion of the FDA's jurisdiction ~ is being discussed in Congress, "critics of the federal ~ ~ agency claim the agency doesn't use the power it has. c~ ~ . C1 . o O

A 4 S • The FDA has been castigated for not taking a more active role in the controversy over substances such as silicone, collagen, or the use of tretinoin for wrinkles. The FDA has been charged with not protecting consumers from these products." Food Chemical_ News, "EWG Finds Performance Disparity Among 12 FDA Pesticide Labs," 7/5/93. "The Food and Drug Administration's pesticide monitoring program understates 'the prevalence, levels, and multiplicity of pesticides in the diet,' in part because of 'a dramatic disparity in the quality of FDA labs,' according to a report on pesticides in children's foods released June 28 by the Environmental Working Group." Heritage Foundation Reports, "Regulatory Relief or Power Grab: Should Congress Expand FDA's Enforcement Authority," 6/11/93. "According to one source, 'FDA lacks the resources to implement all of the missions delegated to it by Congress "' (Hutt and Merrill, Food and Drug Law, pp. 1240). Modern Healthcare, "Life in the Slow Lane at the FDA," 2/1/93, p. 35. "Statistics show that the FDA is taking longer to review devices, and it's rejecting more of them under new amendments to the Food, Drug, and Cosmetic Act, which makes the agency responsible for evaluating the efficacy as well as the safety of medical devices." "In 1987, 5,265 medical devices were submitted for review under the agency's 510(k) process. The average review time was 69 days. By 1992, the number of 510(k) submissions had increased by 18.7% to 6,250. But review time had nearly doubled to an average of 125 days.... Meanwhile, device approval rates fell. Only 59% of the devices submitted to the FDA were approved in 1991, compared with 78% in 1987." "...vendors stalled... in the review process believe the NO) FDA's process is poorly organized, costly to the device (Z industry and threatens to put small companies at a ~, significant disadvantage." C~ va . CO . ~ ~

4 5 • • "The FDA's 'completely bogged down' process is hurting more than device makers, said Alan Magazine, president of the Health Industry Manufacturers Association." In its 1991 annual report, the FDA's Office of Device Evaluation attributed longer processing times to several factors, "including requirements of the Safe Medical Device Act of 1990, dealing with exemptions to the normal 510(k) process and the FDA's participation in congressional hearings and GAO program audits." "House Energy and Commerce subcommittee hearings last year suggested that there might be further delays, in device reviews. FDA officials acknowledged 'a change in direction' for the agency because of the interests of Commissioner David Kessler, M.D.., the new reporting requirements of the SMDA and other key objectives. This change in direction was said to be driven by "an increased emphasis on compliance, more attention paid to the manufacturing processes used to create new medical devices and stepped-up post-market surveillance of products to ensure their safety." "Vendors question the wisdom of diverting attention from product review to enforcement, arguing that it's as important to get new devices on the market as it is to crack down on problem devices." "The vendor group has lined up key congressmen to support its position. In August, for example, Rep. John Dingell (D-Mich.) wrote to Dr. Kessler, criticizing the apparent 'paralysis' of the FDA's device review process." Journal of Commerce, "FDA Hopes to End Foreign Inspection Backlog by Midyear," 3/11/93, p. 7A. "The Food and Drug Administration expects by midyear to eliminate what was a 12-month backlog of agency inspections required for foreign-based pharmaceutical plants to begin exporting products to the United States." ® ~ CV CT7 . CGD O t~:

a 6 • • Press Conference with Rep. John Dingel -- May 20, 1991 Dingell: "The Food and Drug Administration has been starved for resources for years. The handling of food and drug inside HHS and by the OMB during both the Reagan and the Bush administrations has been one of careful, selective starvation diet diligently applied. They are desperately short of money, they are desperately short of personnel, they are desperately short of laboratory facilities and the physical facilities in which they might conduct their business. Their training levels, their morale, their numbers of skilled and experienced staff are far below the levels which are needed for a properly functioning agency." On the subject of imports of foods from abroad: "... we're finding that substances which are not permitted on American agriculture production are being permitted and are coming in in amounts in excess..." On the subject of "other problems:" "... the inability of Food and Drug to deal with things like medical devices; the fact that Food and Drug cannot investigate an American food producer as often as the Department of Agriculture can regulate a packer of dog food or cat food.... And a major part of this stems from the totally inadequate budget that has been consistently and continually pushed, not only by this administration, but by the previous administration, the result of which has been a literal starvation of the Food and Drug Administration to the point where you're now seeing the inadequacies which were described by the Edwards Commission (sp) and by other entities -- including our own committee -- which have studied it." In response to the question "Are they [the FDA] up to this job?" "... they do not have resources to do any of their responsibilites adequately, nor do they have resources to do all of their responsibilities. The Food and Drug has shifted resources back and forth between different responsibilities, but in each instance, there has been a net loss in overall consumer protection because of the constant fire brigade approach that they have to do. Food and Drug sort of acts like the first bucket in a ~ fire brigade, and as a result, while they're putting out © one part of the fire in the building, the rest of it is ~, ~ going just a good bit hotter." ~ - C~ ~ C C.~

4 7 • • Washinaton News, "Kessler Promises Faster FDA Drug Approvals," 7/26/93. In response to David Kessler's promise to Congress to reverse a decade-long deterioration of the consumer protection agency, Senator John Glenn (D-Ohio), chairman of the Senate Committee on Governmental Affairs, "questioned how an agency whose staff and budget were cut throughout the 1980's could meet such a goal." "Noting the agency has averaged 29 months for new drug approvals despite a mandated 180-day deadline for reviewing applications, Glenn said, 'There either have to be more resources applied or something has to give."' "Glenn expressed concern over estimates that the FDA will need an additional $80 million to $150 million to carry out the mandates of 13 laws passed by Congress last year, while the Senate Appropriations Committee Wednesday approved significant cuts in the agency's fiscal 1992 budget. Because of legislative restrictions, the committee's action would make only $641.8 million actually available to the FDA, some $120 million less than the House-approved level." Glenn stated that "by chronically underfunding FDA throughout the last decade, while at the same time expanding its responsibilities tremendously, we have stretched this agency and its dedicated employees to the limit, if not beyond." The following excerpts from articles focus on FDA Commissioner David Kessler's agenda: Chicaao Tribune, "New FDA Commissioner: Change Not Just 'Idle talk'," 5/24/91 -- by Michael L. Millenson. "Kessler's goal is to reverse a decade-long decline in FDA clout that has left the once-proud agency 'overextended and underfunded,' in the words of a recent blue-ribbon panel report. FDA enforcement actions to protect the public, for example, dropped by nearly 50 percent since 1980." "The number of FDA employees, meanwhile, slid from 9,000 to 8,100 during a recent period in which Congress passed 23 laws broadening the agency's public health responsibilities." ~

. • • 8 Food Chemical News, "Kessler Decries Lack of Resources at Agency," 3/1/93. "Something has to be done to increase resources the Food and Drug Administration has available to do its job, FDA Comissioner Dr. David Kessler told an audience of food processors Feb. 23 at the National Food Processor Association's annual convention in Chicago." "'We are substantially behind in our field force from where we were in 1980,' Kessler said, noting the additional programs FDA is responsible for now." "When asked specifically whether the Center for Food Safety and Applied Nutrition is adequately staffed, Kessler stated flatly, 'No, We're kidding ourselves if we think that center has adequate resources... How do you take a project like the NLEA (Nutrition Labeling and Education Act) and not give CFSAN any more resources... If we don't put some resources into CFSAN, we're not going to be serving the public well.' Kessler cited import inspections as needing resources as well. Imports are an area 'where I lose sleep at night,' Kessler said. "We're not doing enough.' "Suggesting the possibility of user fees for import inspections, Kessler said, 'We're going to have to do something.' "He noted that the agency is going to have to address the issue of labeling foods derived from biotechnology. As a result of the reaction to the FDA's policy, the agency is going to have to play 'catch-up' in assuring the public of the safety of foods from biotechnology. 'We're not there yet,' he said. Pharmaceutical Business News, "One Goes - One Stays," 3/ 5/93. Concerning President Clinton's decision to retain Kessler as Commissioner: "Dr. Kessler had made it clear to the administration that more work was needed to reinvigorate the FDA, an agency that was seen as scandle-ridden and as an ineffective regulator when he took the helm in late 1990." O ~ . C~ c7a ~ O ~