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THE FOOD &DRUG LETTERJ An Independent Bi-bti'eekly, Founded 1976 WAsx;NcToN Bus-Nss INFORMATION, INc. 1117 North 19th Strret, Arlington, VA 2'?09-1795 Editorial: (703) 2-17-3-;2-4 * Circulation: 2-17-3-13-1. Fax: 247-3421 July 29, 1994 Dear Reader, • One of the continuing mysteries of FDA is the means by which the agency fills influential positions at or near the tops of center and headquarters staffs. To some, FDA managers are like pigeons, encountered only in the adult state. But just as there really are baby pigeons, there really are baby bureaucrats. This issue, we explain the programs and processes designed to spot and season talented staffers whose careers and abilities significantlv affect your company and products. For many years, Gerald Meyer was the man to see at FDA's Drug Center -- not because he could work miracles with a flagging submission or inject momentum into sagging review, but because he knew the place inside and out. A few months ago, Meyer retired from the government. Now in private industry, he has given F&DL an exclusive, in-depth interview on his insights into how FDA works, what works well at FDA and what does not. In this issue, we present Meyer Speaks, Part I. WHEN FDA FILLS A JOB VIEWED AS SIGNIFICANT, reactions inside the agency and out often.include puzzlement. Why was the vacancy not filled from the ranks? What does this person know about our industry/products/regulatory issues? What creden- tials and experience -- never mind ulterior motives -- are behind the appointment? And where in the world does the agency get these people, anyway? Cynics inside FDA and out trace the roots of some agency hiring to political logrolling, bureaucratic back-scratching and that relatively new bugbear of the meritocracy, political correctness. Officials at centers where a new boss seems nothing like the old boss gripe that they now report to a neophyte insensitive to quirks and nuances they spent decades perfecting. Companies that operate under the center's scrutiny mutter in the same vein. FDA hirings follow protocols that vary to suit particular jobs. The six regional director's positions always are filled from within, on the assumption that only an insider could handle the assignment. Wider recruitment efforts -- using search committees, advertising, inquiries to trade and professional bodies -- attend the hiring of center direc- tors, who can be hired from anywhere. • Sometimes a center directorship is filled via executive prerogative reserved to the HHS secretary, who has authority to reassign members of the senior executive service at will. The elite of government managers, this cadre occupies the highest slots of the civil service, perched above grade 15 with a separate pay and person- nel arrangement. That was the mechanism brought into play when Bruce Burlington was tapped to head the Devices Center. He moved to devices from the Drugs Center Copyright ~ 1994 by Washington Business Information, Inc. - Founding Member, Newsletter Publishers Association - ISSN 0362-6466 Available through DlOGENES searchable electronic database (301/881-2100) The Food & Drug Letteris protected by copyright. It is illegal under Federal law (17 USC 101 et seq.) to make regular cover-to-cover copies or faxes of F&DL without our permission - even for internal use. Violators risk criminal penalties and $100,000 damages per offense. Permission is granted for subscribers registered with Copyright Clearance Center to reproduce parts or all of F&DL, for internal reference or personal use only, for 54 50 per page per copy. Send payments to CCC, 222 Rosewood Drive, Danvers, MA 01923 (fax 508/750-4744). 0362-6466/94/00+54.50

THE FOOD & DRUG LETlER - 2 - July 29, 1994 • at the order of HHS in a move symbolizing the dire straits of his new home. "We had in Bruce a capable candidate, and we had in the Devices Center an organization in turmoil," said a topsider. "We wanted someone in that position very quickly, and the secretary had the latitude to make it happen." Of course, some hirings are blatantly political, occasioned by a change in administration or commissioner that replaces one generation of deputies with the next. And, as in any organization, internal politicking for plum positions at FDA can reach fever pitch. But at the next several echelons down the FDA food chain, there is method behind the seeming madness of managerial appointments. In place since the 1970s, the Mid-Level Developmental Program aims to attract, keep and advance the careers of agency staffers deemed to have great promise, to the benefit not only of the individuals involved but the agency itself. All FDAers working at civil service grades 11 through 13 are eligible; however, although many call, few are chosen. Every other year, six to eight applicants are selected to participate in the 12-month sequence of training and cross-training. Like a medical school curricu- lum, the program rotates enrollees through a variety of disciplines with the goal of producing managers able to shift venues within FDA without losing their balance. The emphasis is on cross-fertilization and cross-familiarization, not only to fine-tune staffers' skills but to diminish barriers between divisions of FDA. "The program was established to help these managers develop their skills in management or science while increasing the understanding and awareness of various parts of the agency wi.th one another," said Linda Sudyam. Biennial Search Winnows 300 Applicants To A Handful • Sudyam, interim deputy commissioner for operations, chairs the management de- velopment committee that oversees the process. Twice a year, that panel -- members include representatives from each center and one from the field -- reviews the de- velopment program and other activities for their effectiveness in improving FDA management. The panel also makes the final choices for the program. The number of applications varies from 100 to 300 per cycle. The next cycle will begin in autumn 1994, with desk-to-desk distribution of an announcement to every FDAer in grades 11 through 13. Interested parties will fill out application forms that cover 20-odd pages and require assent from three supervisory levels, usually including center directors or director of regional affairs. In the winter, qualification review boards - - a standard government hiring mechanism -- rank applicants. Criteria include past performance, willingness to take new assignments and creativity in unexpected situa- tions. Another factor is the extent to which individual career goals intersect the agency's assessment of its management needs. Review boards will cull applications to a core of 20 or 30 semi-finalists. In the spring, Sudyam and cohort will examine those filings, perhaps interviewing all applicants, perhaps only some. Then final cuts will be made. The "fellows ," as those chosen for the program are known, will spend from June of one year to June of the next rotating through assignments of their own devising. First they get a week-long orientation, then work with the agency's Office of Human Resources to structure a year's worth of experiences around FDA. They keep their civil service grades and salaries, and their pre-fellowship jobs are held. In theory, a fellow could pick a dozen assignments -- one for each month the program

THE FOOD & DRUG LETTER - 3 - July 29, 1994 • lasts. However, the usual arrangement is three to five rotations, selected by in- dividual interest and agency need. Some take on analytical or research projects that they set up, some move into line assignments. The game of musical chairs is abetted by the temporary openings created by the fellowships. Headquarter staffers often move out of the Parklawn Building into such field jobs as acting district directorships or investigations branch directorships, while staffers whose careers so far have been in the field usually rotate through agency headquarters, whether in centers or some element of the commissioner's office. "The experience is akin to medical school," Sudyam told us. "Fel- lows get to pick what they want to do. Someone from the field comes to the commissioner's office. The idea is to see how different managers operate, to get exposure to new aspects of the agency, and to improve the fellows' opportunities for promotion." • After each rotation, the supervisor who managed the fellow delivers an assess- ment, and the fellow summarizes the experience in a report. Then it is on to the next project or assignment. Fellows' reports are kept in personnel files and are available to future applicants and managers. Given the program's age and biennial nature, as well as falterings that kept it from operating consistently until 1980, "graduates" number about 50, but many have moved into important agency positions. Former fellows include Drug Center compliance chief Stephanie Gray, acting As- sociate Commissioner for Management Kathleen Beck, regional affairs office Deputy Director for Resource Management Susan Soderberg, San Francisco Regional Director Ronald Johnson, and Devices Center acting Compliance Director Lillian Gill. Minority Recruitment Programs Are Underway Besides the mid-level development program, FDA participates in an HHS-wide recruitment and retention apparatus for grades 13 and 14, as well as the Federal Executive Institute in Charlottesville, Va. , where four to six members of the agen- cy's senior executive service (i.e. , above grade 15) can attend four-week training sessions on general management techniques. Neither non-whites nor women proliferate among agency managers. While 18% of FDA's entire work force is African-American, of 80 senior executive service jobs, only three are held by blacks. Overall, the agency's work force is 4% Hispanic, but with the recent retirement of the sole Latino senior manager FDA has no hispan- ics in ranking positions. Among 80 top managers, 11 are white females with one black female -- less than 20%, compared to 40% among private-sector executives. FDA is trying to bring more minorities and women into positions of prominence. An executive training program exists for women in grades 11 and 12. A minority-oriented program being created will attempt to en- courage more persons of color to seek and obtain management jobs -- an effort that has engendered controversy such as greeted the naming of Gill, a black female, as acting device compliance chief. • itics t d FD ointment as an example of lambasted her a ~ pp , cr ou A an Both inside the triumph of political correctness over managerial logic. That is nonsense, according to Devices Center chief Burlington, describing Gill as an example of the p ~ ~ new order of FDA management hiring. "The question is: does she have the right training to head device compliance? The answer is 'yes,'" he told F&DL. An ex- C+~ development program fellow, Gill embodies the principle of learning to manage by A= -3 Copyright 9 1994 Washington Business Information, Inc. CP 4h

a • THE FOOD & DRUG LETTER - 4 - July 29, 1994 wandering across the boundaries separating centers. "We think it is around the greater agency for talent," Burlington said. useful to look "More and more it is not a question of promoting up the line. In- stead, people are seen as having gained value because they have moved around," he explained. "This experience makes a more rounded manager and is consistent with a lot of trends in the pharmaceutical industry, where companies perceive value in a breadth of experience. When you manage, you do not simply manage down; you have to manage up and across. • • Burlington, who has worked not only in biologics and devices, but drugs, dur- ing his tenure at FDA, pointed to his own experience. "Having worked in several settings gives me a better array of tools with which to deal with problems," he said. "The issues I work with now involve other centers, and my having knowledge of the ways in which they see and deal with problems improves our interactions." Cross-center resumes may not become mandatory at the agency, but they will be encouraged, Burlington predicted. "I would be amazed if we do not see this ap- proach more and more," he said. "It is now a normal career development pathway." The rise of the variegated manager is associated with another trend in and out of FDA: the emphasis on general management expertise as opposed to expertise in a given discipline. "At times people have said, 'What I need out of an office direc- tor is the quintessential area expert," Burlington told us. "For example, if you were talking about a review office, you would want the best clinical trialist." --But now the perspective has tilted away from deep, narrow spe- cialization and toward the skilled generalist adroit not at a given discipline but at the discipline of managing people and programs. "At the office director and division director level the fundamental issue is management," Burlington said. "Competence in that regard takes priority over sci- entific experience and track record. We are looking for a strong manager who also can make a personal contribution, but mainly we want a strong manager." It may be logical for Gill's critics to assume that she is a "two-fer" in the PC category, satisfying the statistical need at FDA to hire more female and minor- ity managers. However, Burlington attacks this logic as fallacious and corrosive. "I find that conclusion extremely troublesome," he told us. "It undermines the strength Ms. Gill brings to her position. If there were no Equal Opportunity Office program at all I still would be asking her to do this. She :.s simply a ter- rific manager. I hope that when the device compliance director's job is put up for formal competition to be filled permanently, she decides to apply." IF VARIETY IS THE SPICE OF REGULATORY LIFE, Gerald Meyer has had experiences enough to fill every jar on the rack. In 30-plus years of government work -- 20 at FDA, Meyer has planned and executed budgets, written legislation, helped to tug bills through Congress, overseen FDA stewardship of drug reviews and approvals, ad- vised other nations on how to structure their bureaucracies and even sandwiched in a brief tenure at mid-life as an entrepreneur in private industry. Meyer has been acting Drug Center director, its long-time deputy chief, as- sociate commissioner for management and operations, and director of legislative affairs. Earlier in his career, he punched the clock at the HHS comptroller's office, the House Appropriations Committee and the National Cancer Institute. In 1977-79, he briefly took himself out of the civil service to work as president of

THE FOOD & DRUG LETTER - 5 - July 29, 1994 • a Whittaker subsidiary active in toxicology. At 58, Meyer again has left the fed- eral fold, retired not to pasture but to a job as regulatory affairs director for Digital Equipment and a consultancy with Charter Venture Capital. F&DL asked him to comment on FDA's present and future from a perspective ren- dered unique by time and tempering. Meyer praised as sound the general management structure of FDA drug review and oversight, but also listed ways in which it could be improved. He urged more money for work space and support staff and systems, less competition between the field and center staff and a greater effort to remove the punitive tone from interactions with industry. Instead of hunting for opportunities to catch and punish companies, FDA should be improving efforts to communicate with industry, he said. The former agency insider faults the current commissioner for subordi- nating day-to-day management at the agency to a position well below the publicity-mongering for which David Kessler has become well-known. • Besides encouraging positive contacts with industry, Meyer suggests that the Drug Center reward staffers for making decisions rather than the opposite. Part of this effort should focus on distinguishing scientific ability from managerial skill when promoting or appointing middle and upper managers. Meyer faults the agency and Drug Center for too often assuming that the former implies the latter. About public relations, Meyer voices grave warnings about the failure to in- still in staffers who must deal with the sometimes grating presence of industry representatives a greater sense of politesse, as well as more self-control. And, according;to Meyer's harshest remarks, management ranks at the Drug Center still include too many bosses short on temper and shorter on interpersonal skills, wheth- er in dealing with agency staffers or callers from industry. User Fee Requirements Will Set Agency Tone On the issues front, Meyer maintains that in the coming years, FDA's biggest challenge will be to comply with the drug user fee law while incorporating staff cuts, budget reductions and increased spending in many sectors. And FDA must do so while maintaining the sharply increased review speed stip- ulated under user fees. This implies a far greater reliance on computerization at FDA and among companies, the former Drug Center deputy chief noted. He takes comfort in the availability of automated data systems sufficient to the task of handling a new drug application and yet cheap enough to fit into any firm's budget. Manufacturers should be more aggressive about insisting on better quality assurance, Meyer says. A symptom of consistent failure to do so is 483-itis, the chronic inflammation of the post-inspection report often accompanied by severe headaches in the executive suite. • Meyer's prescriptions for improvements in the Drug Center include more and more regular meetings between headquarters staff and the field. "If I were di- rector, I would probably have at least a biweekly meeting with someone from the field of the stature of [departing Philadelphia Regional Director] Richard Davis, as well as investigators," Meyer said in describing his wish list. "The fact is that the pre-approval inspection means headquarters shares re- sponsibility for review and approval with the field. That relationship is good, but it should be better. Both partners should have more respect for one another's Copyright "r 1994 Washington Business Information, Inc.

i a J . THE FOOD & DRUG LETIER - b- July 29, 1994 roles in that process." Despite nods toward more cooperation between headquarters and field, competition between these arms of FDA persists, often ensnaring compan- ies in a game that arises when one branch is aiming as much to embarrass the other as to find genuine problems with a filing or inspections. "We mouth the right words, but from the industry perspective there still is a lot of `Gotcha!' going on," Meyer said. As an example, he described a situation in which an inspector examining assay specifications decides they should be more rigorous. Today many field staffers would attempt to impose that change on the spot. Instead, Meyer said, they should check with the center. "The inspector may believe specifications can be tightened then and there, but the right way is to call the reviewing chemist and talk to him about it," Meyer said. "Inspectors should not be attempting to negotiate with the firm. The inspector may be right about the specifi- cations, but he has to understand his role and that of the chemist." • The same principle applies to a reviewer tempted to take it upon himself to judge the validity of a supplemental application for a change of site or equipment simply by looking at the description on paper. "It would be foolish to think that you could make an informed judgment that way," Meyer said. "The people in the field can see the actual situation and decide what should happen." Meyer recommends that FDA move to encourage more dialogue between the field and industry. "There is no question that companies have a thirst for answers to their questions," he said. "I would like to see FDA take a more aggressive ap- proach to:outreach, even if every session has to be held in Washington in order for the agency to be able to afford the program." More Detailed and Frequent Comdunication Urged At FDA Such outreach efforts would be more effective if FDA analyzed material like the entries made by inspectors on Form 483s. "They should be looking at the con- tinuing problems companies are having, using 483 citations to see the spread," Meyer said. Another step would be to circulate lists compiled by the field of the most frequent citations resulting from inspections. "Companies need to learn about new or evolving requirements in time to implement changes before the next round of inspections," Meyer added. "There are efforts in that direction, but they should be increased. If responsible firms know what is expected of them, they will bust their tails to do that, and the end result will be higher quality." • On the other hand, firms that find themselves in hot water for lack of stan- dard operating procedures, confirmatory raw materials analysis and other everyday aspects of quality control deserve what they are getting, he said. "This stuff has been around for years, and if someorle is still being written up for not having it, the quality assurance guy should be fired and somebody higher up should have his rear end kicked for not firing him sooner," Meyer said. If such chronic lapses are eliminated to a significant degree, the "Gotcha!" ~ game stops being so much fun, and inspections will evolve into a form of audit, he ~ ~ predicted. "It will be a matter of FDA seeing how good you are at doing the job, ~ and you finding out about ways to improve that job," he said. Meyer reserves his ~ strongest words -- positive and negative -- for FDA managers. ~ "I would like to see a system in which FDA delegates approval authority and ~ gives increased pay and status to division directors who demonstrate good science ~t ~

i THE.FOOD 6r DRUG L.ETTER - 7 - July 29, 1994 $5,000 REWARD FOR INFORMATION ON ILLEGAL PHOTOCOPYING Washington Business Information, Inc., offers a 55,000 reward to persons providing conclusive evidence of illegal photocopying of this publication. This offer follows reports of continued violations of our copyright, particularly in some law firms and corporations. Anyone knowing of illegal photocopying who contacts WBII will be guaranteed confidentiality. It is illegal under Federal copyright law (17 USC 101 et seq.) to make regular cover-to-cover copies or faxes of this newsletter without our permission. Not for routing. Not for'intemal purposes.' Not for FYI memos. To re2rt if(gqal cqAyina, call Karen Harrington at 703247•3436. Confidentiality assured. For additional subscriptions and information, please phone 703/247-3434. and leadership and also show good interpersonal skills with industry," he told us. "The burden should be on the division director to use his office rather than passing decisions through for the next guy to review." Declining to name the worst offenders, Meyer acknowledged that certain division directors are notorious for intransigence, arrogance and downright rudeness. "You do not have to be a great statesman and diplomat, but to you do have to be honest and accessible," he said. Deputy director for review management Murray Lumpkin and cardiorenal drug chemistry chief Robert Walters were his examples. "Lumpkin is an example of a manager taking responsibility and doing something with it," he said. "Walters has zero backlog, and that is be- cause zero backlog is his goal. If he has to, he rolls up his sleeves, screens out the silly stuff and gets to the answer right away." • • Meyer's portrait of the destructive FDA manager is one whose backlog never changes no'matter how many resources are thrown at it. "These people usually lack cqnfidence and competence, but are supremely arrogant," he said. "They are on a power trip." Another type he sees combines abuse of power and fear of making wrong decisions. "They keep whining that they need more information. That is a lot of B.S.," Meyer told us. "What they need to do is make a decision." Meyer traces the stalled career of drug evaluation I chief Robert Temple to his tendency to avoid confronting problematic managers under his command, and in- stead allowing them to create fiefdoms where mismanagement rules. "That cost Bob the job of center director," Meyer told us. "He blindly defended certain parties until the agency had to decide, 'Bob, you cannot deal with problem employees."' Industry also is complicit. "The people at companies can be peck- ish," Meyer said. "We are talking about human beings here. But if you behave badly at a company you are only representing that company. At FDA, you are doing so on behalf of the United States of America." There is no easy way for FDA to find out about managers legendary by rumor. Manufacturers with filings moving beneath such individuals' purview understandably are reluctant to blow the whistle. It is easier to move around a rock than try to bore a hole in it, especially when the trip may not recur for years, if ever. But Meyer still would like to see FDA work harder on improving the way its most public representatives answer the sometimes harsh queries that come to them from industry. "There is no way to overstate how much it hurts the agency when someone makes a thoughtless comment, such as one attributed to someone I promoted," Meyer said, noting that the FDAer told a caller, "The only reason I am answering your inquiry about your overdue application is as a personal favor to Dr, Lumpkin." Word got Copyright m 1994 Washington Business Information, Inc.

i r • • lincerely, Issue No. 174 The Editors ~ ~ P.S. -- More observations from former Drug Center Deputy Director Gerald Meyer ~ will appear in the Aug. 12 F&DL. ~ ~ PUBLISHED 24 TIMES A YEAR; SUBSCRIPTION 5845 IN U.S. & CANADA, ADDITIONAL COPIES MAILED IN SAME ENVELOPE S420 A YEAR EACH ~ Affiliates: Washington Drug Letter, Europe Drug & Device Report, Devices & Diagnostics Letter, Regulatory Watchdog Service ~ Publisher: David Swit • Editorial Director: Sean Oberle • Editor: Michael Dolan .~ THE FOOD & DRUG LF.TTER - 8- July 2S, 1?94 __ out about that remark in no time; Meyer said he heard about it from six different company reps. "If someone at the agency is that tired or that angry or that over- worked, he should swallow hard and say, 'I cannot talk right now, let me call you back tomorrow,'" Meyer told us. But more often the staffer rises to the bait. "Invariably, these situations turn into disasters on both sides," Meyer said. "The person making the call is getting chewed on because the application is not making progress. He needs to be able to tell his boss the status. On the other hand, the person at FDA has to be able to say honestly that the reviewer did not finish last week, and that is why things are not moving forward." "I would get people in small groups or speak to them individually and tell them, 'If you are irritated or pressed or tired, you should be especially conscious about how you respond to dumb or confrontational or thoughtless remarks. Your knee-jerk reaction may be perfectly justified, but it probably reflects adversely on FDA," Meyer said. "You do not need to force people to go to meetings where they pay some jerk $5,000 to tell them how to win friends and influence people." A much harder nut to crack is that created by the collision of user fees and reductions in agency resources. The combined effect of demands by the user fee law and deficit-driven cuts in FDA access to people and money should be of concern to everyone in drug review, Meyer said. At the same time, FDA faces administrative constraints. "The government is cutting grade 14 and 15 positions and limiting senior executive service slots. They are not processing pay adjustments. They are making bonuses so hard to get that people do not spend the time writing reams of material to get them approved." These factors impose a drag on efforts at recruitment and retention of such important staff types as reviewers and medical officers. Gaps in the work force in turn sap the agency's ability to meet user fee goals. The entire situation is further worsened by caps on government salaries, in Meyer's estimation. "FDA should offer competitive salaries. If the agency could offer those salaries, it could get plenty of good people and not have to spend a lot of time doing so." As Meyer sees it, in the best world, FDA would be an independent agency, out from under the HHS rubric and able to make hiring and policy decisions without hav- ing to buck them up the line. "But we are not going to see that happen." Meyer says the other elements are in place for drug review to flourish: a ca- pable review staff, increased efforts at cooperation by industry and FDA, stronger efforts by manufacturers to deliver high quality applications the first time. "But you have these tough user fee goals and those administrative constraints making the jump to the next level insurmountable. A lot of it is silly stuff, but it is not as if you can simply unravel it and get to the job," he told F&DL.