FDA Failures

Nineteen eighty-nine was not a banner year for the U.S. Food and Drug Administration (FDA). In December, Frank Young quit as head of the agency. A successor has yet to be nominated. Young's Deputy Commissioner, Jim Benson, is the interim director of the agency.

The leadership change followed a major scandal at the FDA's generic drug division. A series of criminal cases revealed that several generic manufacturers routinely bribed FDA personnel to speed approval of their products. Most recently, the FDA's program for testing medical devices has been battered by a pair of Congressional reports about the program's ineffectiveness and by news accounts of dangerous products slipping through the agency's safety net into the marketplace.

For example, former Washington Post reporter Morton Mintz recently wrote about a particularly egregious medical device case. Mintz reported on allegations raised at trial in a case involving G.D. Searle and Company and its Copper-7 (Cu-7) intrauterine contraceptive device .

The Cu-7 was approved by the FDA in 1974, after Searle conducted an international trial of the device involving thousands of women. The introduction of the Cu-7 coincided with the removal of A.H. Robins' notorious Dalkon Shield from U.S. markets, and the Searle product quickly became the nation's top-selling IUD.

Like its ill-fated counterpart, however, the Cu-7 quickly developed problems. Searle was ultimately forced to remove it from the market in 1986 because of mounting product liability actions. The suits have been filed by women who blame the Cu-7 for pelvic infections and other complications, often affecting their ability to bear children. The women who actually brought suit, however, represent only a fraction of those who had to have the device removed for medical reasons; 26 percent of users � over two million women � were forced to do so within three years of it being implanted.

Despite these developments, the FDA did not reconsider its original approval. This is not very comforting, for, as Mintz points out, the agency's original approval process is not stringent. It is essentially an honor system, and manufacturers who fail to provide the FDA with complete information on known ill-health effects associated with their products are a common problem.

Searle is a case in point. A trial lawyer handling a Cu-7 case in Los Angeles has uncovered evidence that the company underreported pelvic infections linked to the device when it initially presented its Cu-7 trial data to the FDA. Full disclosure may well have kept the Cu-7 off the market altogether.

The FDA says it is "looking at" the alleged underreporting.

Phillips in Flames

The massive explosion and Fire that leveled the Phillips

Petroleum Company's chemical facility in Pasadena, Texas in October 1989, killing 22 and injuring 124, was a "foreseeable consequence" of known problems with the plant's operations, according to a preliminary investiga-

tion by the Oil, Chemical, and Atomic Workers International (OCAW).

OCAW investigators found three primary causes of the tragedy: an inadequate safety policy governing the maintenance of the plant's reactor systems (It is believed that a valve left open during a maintenance procedure allowed the vapor release which triggered the explosion.); the use of poorly trained subcontractor maintenance crews to work on reactor systems as a cheaper substitute for the regular Phillips workforce; and an inherently flawed reactor design. Each of these factors should have been addressed before the explosion, union officials contend. OCAW vice-president Robert Wages told a Congressional committee that earlier accidents and near-accidents at the plant should have established that conditions were hazardous. He faulted Phillips' management and the Occupational Safety and Health Administration (OSHA) for failing to take appropriate action.

"Other factors that appear to have set the stage for the catastrophic accident and contributed to its tragic out-come," Wages added, "include pressures to keep production rates up, a relentless effort to reduce labor costs by reducing the proportion of Phillips employees on the plant workforce, a flawed alarm and evacuation program and inadequate enforcement of OSHA regulations coupled with a lack of appropriate regulations."

Over the last several years, OSHA cited the Phillips facility repeatedly for serious safety violations. It had not, however, performed a comprehensive inspection of the site since 1975. Union officials said that the accident and the enforcement history of the plant should spur Congress to enact "right-to-act" legislation for petrochemical workers, granting them the authority to serve as surrogate OSHA inspectors who can require companies to correct workplace hazards.

Laxness at Eli Lilly

A Food and Drug Administration (FDA) inspection of

Eli Lilly and Co.'s Indianapolis capsule and tablet plant found "objectionable conditions in nearly every area" of the plant. The inspections, conducted between April 17 and August 25, 1989, uncovered practices that were not in compliance with FDA rules for Current Good Manufacturing Practices (CGMP), including "failure to have writ-ten standard operation procedures for many tasks and record-keeping problems."

As a result of the findings, Lilly recalled 18 batches of 10 prescription drugs from wholesalers and temporarily stopped distribution of all products from the plant.

The FDA inspection discovered that a number of manufacturing procedures used for these products were not in accordance with those outlined in Lilly's original new drugs applications. No new products will be re-leased until revised procedures are in place. In a news release, Lilly promised that "overall capsule and tablet manufacturing systems and procedures in the Indianapolis facility will improve as a result of the FDA's observations." ^

� Garth Bray