Government

FDA's Hayes: goal approach to regulation FDA commissioner believes

regulations should be made

only if necessary, that

industry will comply if

agency sets realistic goals

David J. Hanson C&EN, Washington

The Food & Drug Administration performs one of the most important and keenly felt tasks of any federal agency—assuring Americans a safe food supply and effective and safe medication. The extent and impor­tance of the agency's duties have in­creased manyfold since the first food safety law passed in 1906 and Harvey W. Wiley was the first FDA commis­sioner. Today, FDA through a variety of laws and amendments monitors food additives, food colors, medi­cal devices, biologies, and more. Throughout its existence, FDA gen­erally has been an efficient and highly regarded organization.

Arthur Hull Hayes Jr., 48, became the 17th FDA commissioner April 13, 1981. He came to government from a clinical position at a time of consid­erable flux in federal policies prompted by the Reagan Adminis­tration. Fiscal restraint, regulatory reform, and reduced government are all policies likely to influence FDA operations. In a recent interview with C&EN, Hayes talked about the im­pact of some of these things, as well as his own philosophy on the role of FDA.

No stranger to the vagaries of ex­perimental drug work, Hayes worked for some time as a clinical pharma­cologist, and saw the system from that side. He believes there definitely is need for change, but he also thinks regulations should be made only if absolutely necessary. He is trying a voluntary, cooperative approach to some problems, and thinks that by setting realistic goals, industry will comply.

"I want to approach the issues from a standpoint of goal orientation rather than saying what regulations we should have or have not," he says.

We have been working very hard over the past

few months reviewing all of food safety

"What are the [FDA's] goals? What are we trying to accomplish? What is the best way to do it given the level of science and technology out there?"

One issue Hayes feels strongly about, and which illustrates his ap­proach to solving problems, is the fight over sodium in food. As director of the hypertension clinic at Hershey Medical Center before coming to FDA, Hayes had long been concerned about the relationship between sodi­um intake and hypertension. Coinci-dentally, Congress also was raising the issue last year just as Hayes be­came FDA commissioner, with a bill, H.R. 4031, that would have required the salt content of foods to be labeled. Hayes, though, went to the food companies, faced them with the threat that if they did not do some­thing about sodium labeling volun­tarily, there would soon be a law to force them tô. The companies chose to do their own labeling.

"I think sodium and hypertension, our first big test of the voluntary ap­proach, has been a huge success," Hayes says. "We're going to have 50 to 60% of sodium labeled within a year. The law would not even have started and [we're getting] things the law would not even have covered."

The whole matter of regulating chemicals for food safety is expected

to reach a peak this year because se­rious efforts are under way to amend the food safety laws. Although some chemicals in foods are not regu­lated—those "generally recognized as safe"—others, including new color additives, animal drugs, pesticide residues in food, and naturally oc­curring contaminants, are covered by a number of laws and amendments. A bill (S. 1442) introduced last year by Sen. Orrin Hatch (R.-Utah), chair­man of the Committee on Labor & Human Resources, seeks changes to the laws, redefining what will be considered safe and giving more flexibility to FDA and the food in­dustry. Hearings on the bill, originally scheduled for last November, have been reset for late this month. Laws that would be affected by the bill in­clude the Federal Food, Drug & Cos­metic Act, the Poultry Producers In­spection Act, the Egg Producers In­spection Act, and the Federal Meat Inspection Act.

One delay has been the lack of a clear Administration position on these proposals. Hayes says that there is a Cabinet-level council, chaired by Health & Human Services Secretary Richard S. Schweiker, that has been charged with reviewing food safety to develop an Administration stance, and he notes that he is part of a

Jan. 18, 1982 C&EN 45

Government

working group doing much of the de­tail work. "We have been working very hard and very long over the past few months reviewing all of food safety—looking at the Hatch bill and what it addresses, looking at concerns and suggestions we have had for years emanating both out of the FDA Bu­reau of Foods as well as the commis­sioner's office. And we are in the process of making recommendations to the Cabinet council," Hayes says. The working group's final presenta­tion is set for this month, and then recommendations will be taken to the President.

"The recommendations will in­volve the Delaney amendment, a definition of food safety and food categories, withdrawal of products, and all the things that are impor­tant," Hayes says. He warns that what is called the food safety laws are really not so simple, and that they are indeed in need of change. "The food safety law is really not that at all. It really is a series of laws. Some of them old, some of them relatively new. Some of them very general, some of them vague. Some allow discretion, some, like the Delaney amendment, allow no discretion at all. Get cancer in one species—that's it."

To change the laws, Hayes insists that both what the public expects from the laws and what science and technology realistically can achieve have to be considered. "What we are trying," he says, "is to think through, again goal oriented, what we are

We are trying to think

where science & technology

will take us in the future

trying to do, what is important, where science and technology have taken us, and where they will take us in the fu­ture. We would like to see any food safety law or amendment to the cur­rent law not only be timely and ap­propriate and guarantee the safety of the food supply right now, but also five years and 10 years from now. You can't go changing the laws every year."

One of the most important reasons for changing the laws, Hayes believes, lies in the advances of science and technology since the laws were writ­ten. "When some of these laws were written . . . scientists could tell you, for a particular chemical, that they could find one part per thousand. That means that zero, when you're talking about zero risk, is one part per thousand and one.

"Now, for some of these chemicals, 20 years after, 15 years after, we can find one part per billion or one part per trillion. That's nine or 12 magni­tudes greater. Now, if you can find one part per trillion, what is the new definition of zero risk? One part per trillion and one."

These advances have brought up a philosophical issue which must be faced. Can government regulators make decisions to meet the needs and expectations of the public the same way today as they did 20 years ago? Hayes believes a change is needed. "I think one has to step back, scientifi­cally and sociologically, and say do we really believe that the risk of zero being one part per thousand is the same as one part per trillion? What are the expectations of the American public? What they want is a safe food supply."

So FDA is faced with having to take a middle road between the extremes of allowing people sometimes to get sick from their food, and not allowing a single molecule of contaminant in food. Clearly, Hayes says, the public won't accept the first choice, and science cannot assure the second. So you have to choose. The choices, Hayes says, come to, "What can you guarantee [the public] in terms of methodology and analytical capabil­ities? Also, to what extent will you alter the food supply or its cost by demanding [certain criteria]? And I don't mean cost just in terms of money, but in terms of choice, cost in terms of taste or color."

So this is where Hayes sees the proper role for government, both in its legislation and implementation of policies. Hayes thinks it is important that people know their food is going to be safe, yet they cannot be ex­

pected to sort out the science behind what is safe and what is not. "They're not scientists, they don't want to be scientists," he says. So it is the proper place for government to bring to­gether the technology and expecta­tion of the public in a realistic way to help people, and "assure them of the things they cannot do for themselves, that they cannot decide for them­selves, or analyze."

"In a broad sweep, the legitimate concern of the food safety laws is to attempt to pull together, in 1982 and beyond, the government's legitimate role of doing for people that which they can't," he continues. "I think that it is fair to say that all parties agree that food safety legislation, the science, and public expectations are flexible enough so that you can make decisions that are consonant with all these factors, but at the same time not so loose that anything can happen and nobody has control and suddenly the people do not have any confidence in what is going on. Or any confidence in the food supply as they know it and want it to continue."

Food safety, of course, is not the only matter Hayes' agency is working on. With his experience in clinical investigations from the other side of the fence, Hayes is convinced that there is much that can be done to improve the FDA drug approval process, too. But the main efforts so far have been several studies, both inside and outside of FDA, on just what to do. One study at FDA is looking at the process for new drug applications (NDAs) and at investi­gational new drug policies (INDs). The hope is that the time required for FDA review and approval of these steps can be reduced so that both the companies that are developing and testing the drugs and the consumers who would eventually use them can benefit sooner.

Another change FDA is looking at is to give more of the early-on re­sponsibility for examining drug test data to local institutional review boards. These panels, made up of scientists from hospitals and medical schools, screen early data. Allowing these peer review committees to ap­prove more advanced stages of testing could speed final approval.

These changes in the system and others also are being examined by a Congressional committee set up by Rep. James H. Scheuer (D.-N.Y.) and Rep. Albert Gore Jr. (D.-Tenn.). Their report, which Hayes says he will have to consider carefully, will not be issued until February.

One action that caught the public

46 C&ENJan. 18, 1982

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eye was the FDA approval of the drug timolol for use in preventing death and further heart attacks among people who have survived an initial heart attack. Approval of the drug for this use was based only on foreign data—a study from Norway. Asked if this was the start of a policy of giving more weight to foreign studies, Hayes says that that is an option still being studied.

"Our policy has been that we think it is preferable, and we usually expect to see at least one domestic study" on a drug application, "And there are very good reasons for that. To say that foreign data are ipso facto the same as domestic data is not true. We don't have the same ability with for­eign investigators to know about them, to examine their facilities, to look at the raw data and case reports. We're also talking about other countries, different sensitivities, laws, regulations, privacy statutes, and the like. Secondly, there are differences in medical practice and diagnostic criteria. I'm not suggesting we have to take a hard line on foreign data or that it is automatically suspect until proven otherwise. What we are trying to do is to work out a policy that we feel protects Americans but at the same time does not deny those that are developing the drugs, and ulti­mately of course the patients, the use of the drug because of the demand for domestic studies that really are not necessary."

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HEALTH PRODUCTS CIRCLE 41 ON READER SERVICE CARD

Government

market new drugs are asking for other changes in addition to speeding up the review process. To help them re­cover their development costs, Con­gress is considering the Patent Res­toration Act which would add up to seven years to a firm's patent to compensate for time the company lost in trying to get the drug through the government approval maze. The Senate has passed such a bill, S. 255. A similar bill, H.R. 1937, is in the House. Hayes agrees with the idea.

"I have taken the position, and it is consonant with Secretary Schweik-er's, that innovative research by creative development firms is im­portant. They are the suppliers of new drugs to this country. And in other countries where other systems have been tried, they have not worked. So drug companies must have a reasonable return on their money investment because the state of science and [meeting] the expec­tations in drug development are ter­ribly expensive. Otherwise, as with any other company, they will dry up and blow away.

"There is no question time is lost because of our drug development and approval process. But, whether it takes five years or 10 years, and it varies from drug to drug, nobody ex­pects to get rid of premarketing ap­proval. Patients, physicians, every­body expects that when a drug goes on the market it is safe and effective. Nobody wants another thalidomide, nobody wants another elixir of sulfa-nilamide." (Sulfanilamide elixir was a medicine that killed more than 100 people in 1937 and led to passage of the 1938 Food, Drug & Cosmetic Act on which most food and drug laws are based today.)

"The question is," says Hayes, "how are the drug companies going to get a return on that investment if there is, by public demand and sci­entific ability, time lost in the neces­sary development? That time will never be zero. It seems to me patent restoration is obvious."

If a cloud hangs over future policies at FDA, it is the Reagan Adminis­tration's plans for budget cuts in the next couple of years. Late last year, for instance, a story began spreading that FDA was going to close its drug-testing labs because of an impending 20% budget cut. Consumer groups immediately howled that FDA was shirking its duties to monitor drugs and that more reliance would have to be put on the industry's own data, which were held to be unreliable. Hayes says the budget situation has the potential for being serious, but so

Time Is lost because

of our drug development

and approval process

far, anyway, the cuts have not been as bad as imagined.

"As it turns out, though our budget is not as big as originally requested by the Secretary, we are not going to have to take the substantial cuts to the degree we thought we were going to. I can't tell you where I'm going to take budget cuts for next year until I know what the cuts will be. Besides, there are a couple of other things that are changing concomitantly that will influence the decision. One of these is changes in the drug approval process. That obviously will alter resources. If, indeed, food safety amendments are pressed, that gives the agency more flexibility. It means I'm going to have to have certain sorts of people at the very highest levels who can fill those functions.

"A last factor is that in the very near future, I'm going to announce three new bureau directors—for vet­erinary medicine, medical devices, and drugs. I think they ought to have the right to look at what they are doing, what their goals are, and tell me how they want to use a given amount of money. I can assure you this: Given any level of budget cut, our priorities will be such that those areas that are most important, either mandated or of our own initiative in terms of assuring a safe food sup­ply—that drugs and biologies are safe and effective and that radiation-emitting products we are responsible for are safe and appropriately la­beled—that those will be done." G

48 O&ENJan. 18,1982

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