The FDA’s County Watchdog : Game Warden of the Bio-Tech Forest Monitors Safety : WALTER SCHNEGGENBURGER : Q
As supervisor of the U.S. Food and Drug Administration office in Santa Ana, Walter Schneggenburger watches over the county’s fast-growing biotechnology industry.
With an undergraduate degree in science from Canisius College, a Jesuit school in Buffalo, N.Y., Schneggenburger joined the FDA 24 years ago.
After working as an FDA investigator in Buffalo, Los Angeles and Long Island, he opened the agency’s first office in Orange County in 1976. The county was previously covered by investigators working out of Los Angeles.
The FDA enforces the Food, Drug and Cosmetic Act, which prohibits the distribution of impure foods, drugs or cosmetics in the United States or misleading labeling of such products. While the FDA central office in Washington approves new drugs and medical devices for marketing, local FDA offices such as Santa Ana’s check the validity of test data that the Washington office uses in making its decisions.
Also, locally stationed FDA investigators inspect the premises of manufacturing companies that sell food, cosmetic and medical products across state lines to make sure that they are operating in compliance with federal health and safety laws. They also investigate complaints they receive from company employees and consumers.
At 56, Schneggenburger has seen the FDA’s role become more complex, reflecting the greater sophistication of the industries it regulates. He monitors the proliferation of new companies in the county that manufacture varied high-tech products, ranging from artificial heart valves to lithotripters that pulverize kidney stones.
In an interview with Times staff writer Leslie Berkman, he discussed how his office struggles to keep up with the county’s explosion of new medical technology. Q. What is the jurisdiction of the FDA office in Santa Ana?
A We used to cover the whole county. But now we cover an area between San Juan Capistrano and the 91 (Riverside) Freeway. The northern part of the county is handled by our Los Angeles office and the southern part by our San Diego office. There was just so much work that we couldn’t handle it all. And we keep losing staff.
Q. Why are you losing staff members?
A. Well, they get promoted and move on.
Q. Can’t you hire more people?
A. It’s easier said than done. How do you get people to move into an area that has the highest housing costs in the country? And our salaries can’t compare with private industry.
Q. What is the average salary you pay your inspectors?
A The salaries range between $15,000 and $43,000. We pay the lowest starting salary of anyone we talk to, whether state or county government agencies or private industry. I mean, that’s ridiculous.
Q. Where do you recruit?
A. Industry pays twice to three times as much as we do. So what happens is we get them out of college and train them, and then they go to industry. I hate to say that. But that’s the way it is.
Q. How many people do you have on your staff now?
A Right now we’ve got nine investigators plus a secretary.
Q. What is the educational background of FDA inspectors?
A They must have a background in science. They have to have at least 30 (college) credits in science for the job. They are going to go out and inspect food, drug and cosmetic and medical-device firms, and you hope they will know some physics, some chemistry, some biology so they can evaluate what the firms are telling them. I mean, it is up to us to decide whether what these people are telling us is actually true or just a big scam.
Q. How many firms does your office police?
A About 621. We could build that inventory up probably a lot higher, but we just don’t have the time. Sometimes companies come and go before we can get to them. Usually we hear about them because there is a problem.
Q. Do you make routine inspections of manufacturers?
A. By law, medical device firms have to be inspected every two years. But we can’t get to it a lot of times. Problems come up, and you have to worry about emergencies, so you don’t get to do the routine work.
Q. What have been the biggest cases your office has investigated?
A Well, there was the plastic bubble that was supposed to let you lose weight miraculously. One of them stuck in a woman’s intestine, and she died. Then there was the Jalisco cheese poisoning epidemic of 1985, and we are still working on complaints about medicated patches worn on the skin that are being marketed as weight-loss products.
Q. How many complaints do you receive each day from the public?
A About one a day. Most of our time is spent on routine inspections. Maybe 15% on follow-ups of complaints from the public. It depends, of course. When we had the Jalisco cheese problem (bacteria contamination connected to cheeses made by Jalisco Mexican Products Inc. of Artesia killed 40 people, mostly infants), everybody was working on that, making sure that all the cheese was removed from the stores and destroyed. And when we had complaints about glass in baby food, I had two to four people on it. When a real problem is emerging and is reported in the newspapers, the number of complaints increases because of greater public awareness.
Q. Is your work influenced by the large number of medical-device companies in the county? A. Most of our work is in devices. They are not garden-variety devices. They are exotic devices right on the threshold of science. Lithotripters that are used to crush kidney stones, interocular lenses for cataract surgery patients and heart valves. You can’t get more exotic than that.
Q. What do you look for when you inspect medical-device firms?
A Well, you have to determine, do these people actually know what they are doing. Do they have records so that if there is a problem, they can trace it back to the raw material and/or procedures used?
Q. How do you know whether they are using the proper materials for each device?
A. Sometimes we have to do research that the company should have been doing. We don’t have a big library here, but we’ve found things occasionally that they (the company) should have found. It’s bad when you go into a firm and you feel you know more about their product than they do.
Q. Does the FDA assist fledgling research and development firms trying to get medical products approved by the FDA for marketing?
A. Our office turns them over to the FDA’s small manufacturing assistance group. The group has a local office in San Francisco to help them through the maze of federal regulations.
Q. How many consumer scams do you find?
A. They don’t come along that often. Most thinking people can recognize them. But there are some fast talkers out there.
Q. What would be an example of a self-evident scam?
A Well, these patches (for weight reduction.) You put them on, and there is no skin-penetrating effect going on there. There are legitimate skin-penetrating drugs out on the market, but it takes years for them to come up with a delivery system. Then these guys came on the market and had all sorts of disclaimers saying you have to use it with adequate diet and exercise. Well, if you do that, you don’t need a patch to lose weight.
Q. Do you think your office wastes a lot of time protecting the consumer from obvious scams?
A. I don’t feel it’s wasted time. It’s just that the public should be better educated so as not to pay attention to these things. AIDS is another problem area. Everyone is on the market with an AIDS cure. Medicine just doesn’t work that fast.
Q. Does your office play a role in clinical testing of new drugs?
A We check the records of clinical researchers in our geographical area to see if the data they have sent to (the FDA in) Washington corresponds to what they actually collected from their patients. The decision about whether a drug ultimately will be approved is made in Washington from clinical information collected throughout the country.
Q. Do the doctors conducting clinical tests ever try to pull the wool over your eyes?
A One of our investigators working a case found that a lot of the raw data indicated that drugs under testing were administered on Saturdays and Sundays. Do you know doctors that have office hours on Saturdays and Sundays?
Q. Not too many.
A. You got it. Sometimes when you dig out an old calendar and start looking, you find that a patient wasn’t around in that time period or had some disqualifying disease. You get suspicious. And sometimes you find that a doctor conducting tests has false credentials. You see, what a lot of people don’t know is the AMA (American Medical Assn.) keeps a record of everyone who ever went to any medical school anywhere in the United States, whether they graduated or not.
Q. What happens when you discover discrepancies in the clinical testing records?
A A clinical trial may be thrown out, and then the drug firm that paid for it gets a little peeved because they wasted their money. So they don’t go back to that clinical researcher again.
Q. How does the expansion of the biotechnology industry in the county affect you?
A. You could ride down in the Irvine Spectrum, just up and down the roads, and stop at every building, and you’d find something new in this field.
Q. Since you are short on staff, how do you select the companies you are going to inspect first?
A. You look for companies whose products have the biggest impact on the consumer. You ask yourself if there are going to be deaths or serious illnesses involved if they make an error.
Q. What recourse do you have when you find something wrong?
A. There are three things we can do: We can seize the product, we can prosecute the firm’s owners for past misdeeds or get an injunction to prevent them from doing something in the future.
Q. Can you fine a violator?
A. Well, part of the prosecution is a fine and/or a jail sentence.
Q. Do you think the laws punish violators enough?
A Well, they are getting stronger by case law. The U.S. Supreme Court said in deciding the 1975 case of U.S. vs. Park that even though a person is the president of a company and has many people below him, he is still ultimately responsible for that firm. So a person can’t be president and say, “Well, I didn’t know what was going on out at the shipping dock.”
Q. Are the violators prosecuted under criminal or civil law?
A What happens is, usually it starts as a civil case, but it may turn into a criminal case as things go along. And sometimes an FDA action is accompanied by private lawsuits. For instance, a recall of a heart valve may trigger a rash of lawsuits by patients and surviving relatives.
Q. Some observers say that when the FDA pressures companies to recall faulty artificial heart valves from the market, it stirs up private lawsuits that put the valve industry at great financial risk. Do you feel responsible for discouraging the manufacture of artificial heart valves?
A. If people are dying because of a break in a valve, I feel responsible. It is not up to me to manufacture things and put them on the market. It is up to me to see that things on the market are made well, so that someone isn’t going to get hurt by them. If we find that heart valves aren’t doing what they’re supposed to do, are we supposed to let them continue making them? I’m going to say no. People may die with them (defective valves). They are also dying without them, but at least we have nothing to do with that. We are not going to make people suffer unduly and be given false hope.
Q. Have you seen the industries that you police change during your career?
A When I started, most of these things were in a science fiction book. We were looking at canneries and bottling plants. That’s where it was. And it’s very exotic now, such as computer-controlled diagnostic equipment for blood tests. Our work has gotten much more technical in nature. Now instead of just looking for rodent droppings and insects, we have to know genetic engineering and advanced physics. It is harder to find violations.
Q. Do you have to go back to school for extra training?
A That and have an inquiring mind. We have classes in computers and in how to look for shortcomings in biomedical research. We also have classes in product sterilization and how to package food properly. Still other classes are devised to help us keep up with changing technology. You end up being a very well-rounded individual.
Q. Does industry in the county tend to be more sophisticated than in other parts of the country?
A. Yes. This particular area doesn’t have many food-processing plants. It is a very high-tech area out here. There are about 38 new firms starting up every month or so. And we just can’t keep up with it all.
Q. Why are you moving your office from Santa Ana to Irvine?
A. Our lease is up here, and most of our work is down there. So if we go down there it is going to cut travel time.
Q. What keeps you going?
A. I feel I am helping people.
Q. Do you get much gratification? Perhaps most people don’t know you are here or what you are doing.
A. It’s all right. That doesn’t bother me. I know what I’m doing. I’m worried about protecting people. And that’s what all the investigators in this office are worried about. Sure, we could go somewhere else, almost every one of us, but I don’t think you get the same satisfaction that you get working here.
