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would permit various operating units of the agency to maintain their established recordkeeping systems, but information on drugs, chemicals, and formulas would be indexed into the central system. The central system would be computerized. The so-called central retrieval index would be computerized.

CURRENT INFORMATION SYSTEM

Mr. FARNUM. What method do you have at this time of providing information, other than just the old paper method from the field? Dr. GODDARD. We are using part-time computers which the Department has. It runs to about one shift.

Mr. CARDWELL. I think it is getting up to that.

Mr. SPARER. We have several in our medical program. We have an adverse reaction reporting system which is underway. We have a Project Rapid, which abstracts information or takes information out of the IND's and the NDA's and makes them available to the scientists. We have much of the data on our regulatory programs in machine processing form. It prints out and tells us what is happening in the field establshments,

Mr. CARDWELL. On the other hand, I think the Food and Drug Administration has a real uphill battle ahead of it to develop new techniques and to make greater use of technological advances in information handling.

It is a tremendously difficult job for them. The task of dealing with a new drug application-all these things hold implications for the use of computers at every level.

Mr. FARNUM. The computer can do only so much. There are many other things which have to be done. In your systems analysis section are you tackling in full force your paper processing?

Dr. GODDARD. I have asked that considerable attention be devoted to what was being done to the paper processing system which exists

now.

Mr. DUNCAN. Do not the drug companies themselves computerize a lot of their information as they develop these new drugs? What I am thinking about is, would it not be possible for them to send you a bunch of punch cards rather than 20 volumes.

Dr. GODDARD. That might be. I cannot say without reservation that that would be the case.

Mr. RANKIN. We have one experiment which is just underway in which I believe an 80-volume submission measured by the conventional method was turned in as 80 volumes plus punch cards which the company had developed. From this experiment we hope to determine whether it is possible to go to machine records that companies normally handle.

Mr. FARNUM. With the data being provided by the manufacturer? Mr. RANKIN. Yes. The manufacturer would furnish a duplicate set of cards when he punched his own for transmission to the Food and Drug Administration.

Mr. SPARER. On your question on the paper processing systems, we have had a team of paper processing experts, if you will, management analysts, in the Bureau of Medicine almost continually during the past year, reviewing their paper processing techniques and trying to tegrate this into the overall data system program.

Mr. FOGARTY. Mr. Farnum is the expert on this committee on computers and methods and systems. I am not even going to try to understand some of the complications involved. I will let Mr. Farnum take care of it.

QUACKERY

Speaking about Krebiozen reminds me that you did not mention anything in your summary statement about "quackery." They tell me that is a billion-dollar business.

Dr. GODDARD. Yes, the use of devices and other methods.

Mr. DUNCAN. Hardware.

Mr. FOGARTY. Yes, but not limited to hardware.

Dr. GODDARD. This strikes at the educational program that we are attempting to develop to get the consumers more aware of the harmful effects that may result from quackery, what may happen when they deprive themselves of proper medical attention. This approach is only one, I should underline. We are continuing with our enforcement activities in the field of quackery.

COOPERATION OF FDA AND AMA

Mr. FOGARTY. Did not the FDA and the AMA get together a couple of years ago on this problem?

Dr. GODDARD. There was a meeting, as I recall.

Mr. RANKIN. We cosponsored two national quackery conferences. Mr. FOGARTY. We still have a lot of quack doctors in the field, especially in the field of mental illness. We have them up my way,

too.

Dr. GODDARD. When you say "quack doctors," you are using a general term.

Mr. FOGARTY. And there are some in the Southwest, too.

Dr. GODDARD. There are many people posing as doctors, if this is the term of reference you are employing

Mr. FOGARTY. Some have been convicted. It takes as much as 4 or 5 years to catch up with some of these characters. I have not heard much in the last couple of years. What are the famous ones?

Dr. GODDARD. I do not know of any of the famous ones. look into it.

I will

Mr. FOGARTY. I have heard of them in Pennsylvania, in Detroit, Fort Worth. Who was the one in Detroit?

Mr. RANKIN. That was Dr. Koch.

Mr. FOGARTY. I think he also operated in Pennsylvania. Hoxsey was in Texas.

Mr. CARDWELL. He operated out of Texas and ended up in Pittsburgh and the Midwest.

Mr. FOGARTY. I am thinking of people like Hoxsey.

Off the record.)

FDA STATEMENT ON ABBOTT LABORATORIES DRUG RECALL

Mr. FOGARTY. I have an article on the Abbott Laboratory, "FDA's Methods Questionable, House Unit Says."

[From the Washington Post]

ABBOTT LABORATORIES PROBED-FDA'S METHODS "QUESTIONABLE," House UNIT SAYS

(By Morton Mintz, Washington Post staff writer)

On the morning of September 1, 1964, Inspector Jerome Bressler, of the Food and Drug Administration, got a phone call from the agency's Chicago district office.

"Bail out," he was told. "Get out before noon."

The call was made while Bressler and two colleagues were in the third day of an inspection at the huge plant of Abbott Laboratories in North Chicago, Ill.

Up to that point, the Bressler team had observed 25 questionable manufacturing practices and listed 14 specific recommendations for improvement. But they bailed out. The time: 11:56 a.m.

The bail-out order originated in Washington with Allen E. Rayfield, Head of FDA's Bureau of Regulatory Compliance.

He phoned Clifford G. Shane, chief inspector in Chicago, and said, "I want them out by noon," Shane testified.

Rayfield gave no explanation, Shane told the House Intergovernmental Relations Subcommittee. He "hung up and that's the end of the conversation."

Rayfield's testimony was that he thought he had given his reasons: The team had been in the plant long enough, had discovered nothing new, and was making production personnel nervous, increasing the possibility of error. He also believed Abbott needed more time to initiate new control procedures, he testified.

The inspectors and Rayfield who began his FDA career as a seafood inspector 30 years ago, were among the agency witnesses heard by the subcommittee during five executive sessions held from July through September.

The 673-page transcript of the hearings, which used the Abbott matter to provide a case history of FDA's performance, now has been made public.

Representative L. H. Fountain, Democrat, of North Carolina, chairman of the subcommittee, said yesterday that "the hearings clearly demonstrated some highly questionable actions and procedures on the part of FDA in administering the 'good manufacturing practices' provisions of the Drug Amendments of 1962." He said he expects the full House Government Operations Committee to make recommendations intended "to strengthen generally this important phase of FDA's drug safety activities."

The transcript shows that the day before Rayfield ordered the inspectors out he conferred here with Elmer O. Krueger, director of quality control for Abbott.

But Rayfield denied under oath that the drug company executive had asked for a halt to the investigation.

Subcommittee investigators, however, produced a memorandum from Abbott's files in which Krueger said that at the August 31 meeting he had asked Rayfield to "give serious consideration to my request" that the inspection be delayed on the ground that this would better serve the public interest. The memorandum added that Rayfield "indicated that he would."

Questioned by Representative Fountain about "this conflict," Rayfield insisted he had no recollection of Krueger's requests, although the executive "may well have" made it.

"I do not know any other explanation I can make, sir," he said.

The circumstances of the bail-out order figured in a charge by Fountain that "much conflicting testimony" and "lapses of memory"-most of them Rayfield's prevented the subcommittee from getting all the facts from FDA witnesses. The provisions of the law with which the legislators were concerned classify drugs not produced in accord with current good manufacturing practices as adulterated and provide criminal penalties. They do not take a manufacturer's intent into account.

FDA Commissioner George P. Larrick, in an open session preceding the closed hearings, restated to the subcommittee the position he took in a 1960 speech. "Drug manufacturers who do not have adequate scientific control facilities," he said, "are toying with the health of the American public."

At the same session the subcommittee inserted in the record another speech, made here a year ago, in which an Assistant Commissioner, Winton B. Rankin, said there had been 243 recalls of drug lots in the 21⁄2 years ended June 30, 1964many more than in any comparable period in the past.

Rankin attributed the 243 recalls "in part to a breakdown in control in a significant number of pharmaceutical manufacturing plants."

In the closed hearings that followed, the subcommittee investigated how FDA, in 1964 and 1965, handled a series of recalls of injectable solutions. In the case of Abbott Laboratories, the quantitites of the commonly used solutions involved in the recalls were among the largest in the agency's 59-year history. Although reports of one death and numerous adverse reactions were received, the subcommittee said, it found no clear-cut evidence that these were attributable to the mixups.

In a statement yesterday, Abbott said that "contrary to" a summary prepared by the subcommittee "no serious medical difficulties were reported to Abbott *** nor to our knowledge *** to the FDA."

Abbott officials were interviewed in Chicago by subcommittee investigators but did not testify. The subcommittee staff said the company was aware of the hearings and would have been granted an opportunity to testify had it requested it.

Defending the FDA's role in the Abbott case, Acting Commissioner Rankin said, "We believe the public interest has been fully protected throughout."

The first phase began on April 30, 1964, when Abbott notified FDA that it was recalling 11,430 bottles of intravenous solutions after 500 incorrect labels accidentally went into a labeling machine. A total of 11,215 were recovered and destroyed including 483 out of 500 that had been accidentally mislabeled. Patients had received 151.

Involved in the mislabeling were dextrose (sugar) and sodium chloride (salt) solutions. FDA medical personnel saw a hazard, especially to diabetics.

In this and later recalls, Abbott said yesterday, the possibility of harm was "extremely remote." Among seven independent medical experts it had consulted on this question, Abbott said, six agreed and one did not express an opinion.

CHANGES PUT INTO EFFECT

FDA sent inspectors to the Abbott plant. They found 27 objectionable practices, many relating to labeling in manufacturing processes. Within about 2 weeks, FDA said, its “major recommendations" had been effected. On July 1, 1964, the case was placed in permanent abeyance.

The second phase began on August 13, 1964, when Abbott learned that a second batch of solutions-made before the recommendations had been effectedhad label mixups.

Abbott employees recovered 10,461 out of the 11,256 bottles involved. They also launched a check of each of the 7 million bottles of all Abbott injectable solutions in distribution channels throughout the Nation. This check was audited by FDA inspectors who looked at 900,000 bottles.

The results were in on August 28: 69 bottles in 54 different manufacturing lots were found mislabeled. On that date, a second plant inspection, the one which lead to the "bail out" instruction to FDA inspectors, was started.

In a very few instances, the subcommittee said, FDA inspectors found that Abbott personnel had violated company orders by saying they had checked bottles when they had not.

USERS WARNED BY TELEGRAM

Six days earlier, at a meeting here between FDA and Abbott officials, the company agreed to send telegrams-400,000 of them-to all potential users. The telegrams warned against use of any bottle with a cap and label giving conflicting information.

In his statement yesterday, FDA's Rankin noted that the wires cost Abbott $385,000. The cost to the firm of the 1964 phases as a whole was indicated by Rayfield's testimony to be about $1 million.

Last year, the firm earned $22.5 million after taxes on sales of $212.6 million. The warning telegrams, Rayfield testified, were considered adequate action by Dr. Arthur Ruskin, deputy director of FDA's Division of New Drugs.

But Dr. Ruskin said otherwise in a memo that the subcommittee found in FDA files. The memo was dated August 25, 1964, 3 days after the meeting between FDA and Abbott officials.

Because of the large number of mixups, he wrote, and because of "the impossibility of determining if bottle contents may not be labeled properly by either bottle cap or bottle label, we recommend that all Abbott injectables be removed from the market ***."

Dr. Ruskin cited eight afflictions, including heart, kidney, and liver disease, in which a mixup "might prove fatal."

The subcommittee wanted to know why this recommendation--which Rayfield estimated would have cost Abbott $5 million-had been dropped in favor of a less costly, less drastic action.

Rayfield testified that the memo had been prepared for the files and had not been shown to anyone with regulatory responsibility.

The memo, typed on yellow paper, was in fact not addressed to anyone.

STILL ANOTHER MEMO FOUND

Subcommittee investigators found another memo in FDA files that bore the same date as Dr. Ruskin's. This one was written by Julius Hauser, then assistant to Dr. Joseph F. Sadusk, the medical director.

Hauser, wrote that the 45 batches known as of August 25, 1964, to have label mixups "are more than sufficient to establish that all parenteral (injectable) drugs produced by the firm by the same methods and using the same facilities and controls are adulterated within the meaning of" the 1962 amendments to the drug law.

Hauser, who, like Dr. Ruskin, was not called to testify, recommended removal from the market of all questioned Abbott injectable solutions "as promptly as possible."

"I have no explanation" for the Hauser-Ruskin memos, Rayfield testified. He added that the adequacy of the telegram warnings was concurred in by Commissioner Larrick and Dr. Sadusk.

Larrick has been widely reported to be planning to retire (and his Deputy, John L. Harvey, has confirmed that he does plan to retire). Dr. Sadusk's decisions in the drug-safety area have been sharply criticized by Fountain in earlier hearings.

NEEDS OUTWEIGHED RISKS

In the Abbott statement yesterday, the firm said that recall of all of its injectables would have created a "health hazard vastly greater than the remote risks of a few mislabeled bottles," because of "the need of the majority of hospitals***for Abbott's huge production."

Also explored by the Fountain subcommittee with the role played by Deputy Commissioner Harvey, one of whose brothers is an Abbott sales executive.

"I have not consulted with him," Rayfield testified in his initial subcommittee appearance. "I have deliberately avoided him on this matter."

He went on to say that although he had kept FDA's second-raking official "on board" (informed of developments), Harvey, who also plans to retire, had told him:

"Allen, I am not going to get involved in the decision making process. I have a brother connected with Abbott."

But in a second round of questioning Rayfield was confronted with a memo prepared by James Nakada, the FDA headquarters employee with primary responsibility for monitoring the Abbott recalls.

The memo told of a meeting at FDA on September 1, 1964-the day Rayfield phoned the out-by-noon order to Chicago.

Nakada wrote that Rayfield discussed the situation with Harvey who had, recommended a tough choice be given Abbott:

Either "recall all lots where mixups were found," which Abbott was reluctant to do, or else "issue a complete information letter" to everyone who might have stocks of the drugs in question.

Nakada testified that he attended the meeting.

Representative Fountain then asked Rayfield why-having told the subcommittee earlier that the Deputy Commissioner was not making decisions in the Abbott matter he went to Harvey for a decision.

Rayfield rummaged among possibilities, then suggested one-for which he had no documentation-that it was not Harvey who made the decision, but Commissioner Larrick.

On the day the inspectors left, Abbott elected to recall every batch in which there was mislabeling. The firm retrieved 131,510 bottles.

Fourteen days later, the situation apparently changed. The subcommitte found still another memo, this one dated September 15, in which Krueger, th Abbott executive, said he had met with Rayfield (no one else was present) and reached an agreement.

With certain exceptions, Kreuger wrote, he had been given authority to decide whether to recall additional lots of injectable solutions if discrepancies were discovered between bottle label and bottle cap information.

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