https://www.nytimes.com/1977/03/14/archives/demoralized-fda-struggles-to-cope-some-top-jobs-remain-unfilled-at.html
DEMORALIZED F.D.A. STRUGGLES TO COPE
March 14, 1977, Page 1Buy Reprints
WASHINGTON, March 13 — In just a decade the Food and Drug Administration has evolved from amorphous obscurity deep within the capital bureaucracy into both the world's paramount regulator of consumer goods and the Federal Government's most criticized, demoralized and fractionalized agency.
With the agency's ban on saccharin, it is again at a storm center of complaints from consumer groups that the action was too long delayed and from diet food interests that the step was capricious and without scientific justification.
Second article of a series.
But the agency, a bureaucratic waif that is responsible for overseeing a staggering $200 billion worth of products yearly, is not only whipsawed by the public controversy, it is so demoralized that a number of its top positions long go unfilled, so burdened that it cannot keep up with the explosion of consumer goods and so battered by lawsuits and outside pressures that its power to make its decisions stick is sometimes undermined.
Ambitious Safety Effort
Its bureaucratic problems have been so vexing that in just the last three years the agency has been the target of more than 100 Congressional investigations, 50 highly critical reports by the General Accounting Office and a series of internal inquiries despairing of ever setting the place right.
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Moreover, it is plagued by the inherent difficulties raised by the speed with which industry develops new products and the countervailing speed with which analytical science develops new methods for detecting potential danger in substances on the market.
Even critics who are frustrated with the agency's performance say that no other government has attempted such an ambitious effort to insure the safety of food and drugs for its people. This raises questions about the limits of what can be expected from any such agency as the F.D.A., especially when the public's expectations are so diverse.
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Additionally, the agency has increasingly become a scapegoat of forces on both the right and left: the former charging that the agency is overregulating to the point of subverting personal freedom, the latter that it is failing its legislative mandate to protect the public from adulterated foods and nostrums far more harmful than snake oil.
The litany of complaints by special interest groups is led by the pharmaceutical industry and the medical profession, which charge that the agency obstructs progress by failing to give speedy approval to the miracles of modern science that could save lives and prevent suffering.
Consumer advocates counter that the scientific oversight of the agency is sloppy and inadequate, thus exposing the public to scores of unneeded and dangerous drugs and chemicals that contribute to all manner of ailments and diseases, including cancer, the most feared of all.
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Present and former F.D.A. officials express a weariness in discussing the depth of the agency's problems and their frustrations in trying to solve them.
“The Congressional hearings in the last couple of years just about destroyed the agency,” an agency official said privately. “The staff has been torn by dissension and strife, the morale is bad, there's no direction and stagnation has set in.”
Another Federal official who has been intimately connected with the agency for years and is a member of a review team exploring the agency's deficiencies and its future expressed his opinion somewhat differently:
On Monday, Wednesday and Friday I think there's no hope for F.D.A.; on Tuesday, Thursday and Saturday I think it's possible to turn it around.”
Ralph Nader was among those persons familiar with the agency who has been both a highly vocal critic willing to be identified.
“What the F.D.A. needs is guts,” said the consumer advocate, noting decisions in which agency officials have made decisions, then reversed themselves. His point was that the agency, which lacks a strong constituency to give it support, is whipsawed by lobbying groups and is sometimes undermined by pressure from the White House and Congress.
In some widely publicized cases involving the agency's efforts at regulation, subsequent investigations disclosed that the first effect of an F.D.A. order either to ban or to restrict use of a product was a march to the White House or Capitol Hill by agents of the manufacturer seeking to use political influence to have the injunction removed.
Indeed, after his departure as Commissioner of the agency in 1969, Dr. Herbert E. Ley said that “what the F.D.A. is doing and what the public thinks it's doing are as different as night and day.” He complained further that during his 18‐month tenure he had been under “constant, tremendous, sometimes unmerciful pressure” from drug industry officials.
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But the $10 billion a year market in prescription and over‐the‐counter drugs made by 2,500 companies is less than half the agency's regulatory responsibilities. It has the legislative authority to oversee the products of 50,000 food companies that market $130 billion worth of goods. Add to the list cosmetics, medical devices such as eyeglasses, veterinary medicines fed to livestock and such other diverse products as microwave ovens and aerosol sprays.
As problems arise the agency becomes embroiled in thousands of cases, some of which develop into national controversies, and at times it seems that the agency lurches from crisis to crisis.
After the detection of botulism in Bon Vivant vichysoisse in 1971, it was discovered that the company's New Jersey processing plant that had produced the tainted batch had not been inspected by the agency in more than four years.
Cranberries tainted with a dangerous weed killer, fish contaminated with mercury, artificial sweeteners that may cause cancer, oral contraceptives that may contribute to strokes, alleged cancer cures of no proven worth that draw emotional but uninformed support from a gullible public—these represent only a few of the agency's crises.
Successive Administrations, starting with President Kennedy's, have reacted to the controversies by throwing increasing amounts of funds and personnel at the criticism.
Since the so‐called Kefauver‐Harris amendments, which set the regulatory tone of the modern F.D.A., were enacted in 1962, the agency's annual budget has increased more than tenfold from $23 million to $242 million, while its staff has tripled from 2,400 to 7,200.
Yet criticism of the agency has seemed to be directly proportional to Federal appropriations.
A year ago the Ford Administration was on the verge of releasing an economic‐report containing scathing criticism of the agency's utility and effectiveness. The comments were later deleted for unexplained reasons.
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During the agency's 15‐year period of both expansion and trouble, its commissioners have tended to leave the agency with sighs of relief.
“Two to three years is the limit you can run such an agency,” said one former Commissioner, Dr. James L. Goddard. “By that time everyone is mad at you.”
Key administrative positions at the agency have sometimes gone unfilled for years and as a result various departments have been allowed to drift and founder through lack of leadership and authority.
Nine months elapsed between the announcement last July by Dr. Alexander M. Schmidt that he intended to leave, and the naming earlier this month of his successor as Commissioner, Dr. Donald Kennedy.
The position has been held in relatively low esteem by academicians, physicians and management specialists, and the salary of $50,000 a year is relatively modest when compared with similarly demanding positions in medicine and industry.
There has been no director of the agency's important Bureau of Food since the departure of Dr. Virgil O. Wodicka tow and a half years ago.
Complaints About Staff
The directorship of the Bureau of Medical Devices and Diagnostic Products remained vacant almost as long, 28 months, until the appointment last June of David Link. Agency sources said almost 40 persons had been offered the position.
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The agency now has 70 professional vacancies, including 20 physicians, 14 toxicologists, 7 pharmacologists and 5 lawyers.
Groups of dissident employees have trooped to Capitol Hill to testify against their superiors, plunging the agency into name‐calling internal squabbles that remain unresolved.
“One of the most frustrating, embarrassing and degrading experiences I've ever had in my medical career,” was the way Dr. Gerald Solomons of the University of Iowa described to a Senate committee his service as an F.D.A. consultant two and a half years ago. He and 10 colleagues said they were harassed, transferred and even overruled when they pro duced negative findings after evaluating new drugs.
The internal complaints have also concerned lower level employees, with some agency officials privately describing members of the F.D.A.'s professional staff as “retreads” and “has beens.” In testimony a year ago dealing with low morale at the agency, Dr. J. Richard Crout, director of the Bureau of Drugs, said this about the chaos in which he had found the agency:
“There was an enormous documents room . . . where some people said fights went on and there was absenteeism. There was open drunkenness by several employees, which went on for months. There was intimidation internally. I tell you that in my first year at F.D.A., even lasting longer than that, 1972‐73, going to certain kinds of meetings was an extraordinarily peculiar kind of exercise.
“People—I'm talking about division directors and their staffs—would engage in a kind of behavior that invited insubordination. People tittering in corners, throwing spitballs—I'm describing physicians. People who would, let me say, slouch down in a chair, not respond to questions, moan and groan with sweeping gestures, a kind of behavior I have not seen in any other institution as a grown man.”
Leading the Congressional investigations of the agency's difficulties have been Senator Edward M. Kennedy, Democrat of Massachusetts, who heads the Subcommittee on Health of the Labor and Public Welfare Committee, and Senator Gaylord Nelson, Democrat of Wisconsin, who directs the Subcommittee on Administrative Practice and Procedure of the Senate Judiciary Committee.
In summing up hearings of the two subcommittees, Senator Kennedy said last summer: “During the past two years these subcommittees have received testimony from 30 F.D.A. employees about the practices and internal management of the agency.
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“These accounts included serious allegations of undue industry influence, improper transfers, details or removals, alteration of files and forced withdrawal of memoranda, bias toward drug approvals, improper manipulative use of advisory committees, disappearance of critical agency action memoranda into what the F.D.A. Commissioner termed ‘a mysterious bottomless pit,’ and incredibly slowmoving ineffective enforcement and compliance programs with years elapsing between the discovery of a problem and the initiation of a solution, and inappropriate use of medical officer recommendations.”
In reaction to these hearings and others previously held by House committees, a special new investigating panel was set up in February 1975 by Caspar W. Weinberger, who was then Secretary of Health, Education and Welfare. He gave the committee 18 months to try to interpret the charges and suggest remedies.
But bickering has broken out within the investigating group, formally called the H.E.W. Review Panel on New Drug Regulation. Key personnel, including the original chairman, have resigned; the reporting deadline has passed, and an extension has been granted until the end of the month. The panel will file two comprehensive reports totaling over 1,000 pages in April and May dealing with F.D.A. staff problems and scientific judgments.
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