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What Is the Role of the FDA/USP in Pharmaceutical Sciences?

 JeromeSkelly
 

 

Dr. Jerome Skelly
AAPS Past President
 

1) If you had to explain the role of the FDA/USP in pharmaceutical sciences to a 4th grade science class, what would you say? 

2) What is the overall goal of the FDA/USP? 

3) What is the relationship between the FDA and USP? How do the two organizations work together? 

4) What are some of the landmark achievements by the FDA/USP to this date? 

5) What does the typical day of a FDA/USP scientist look like? 

6) What’s the most exciting part of a FDA/USP scientist’s job? What’s the most challenging? 

7) What personal achievement at work are you most proud of? 

8) What type of educational background is required for a FDA/USP scientist? (e.g. BS, MS, Ph.D., Pharm.D., etc.) 

9) How would you direct someone into working for the FDA/USP (i.e., what should they study, what internships should they seek, what is the entry level position called, any tips to help get their foot in the door)? 

10) Is there anything you wish you would have known about your field prior to choosing it as your career? 

Q 1) If you had to explain the role of the FDA/USP in pharmaceutical sciences to a 4th grade science class, what would you say? 

A) “These are two organizations. One is the Federal government, i.e., the FDA. The other is an independent organization, the USP, but the U.S. law authorizes it.

The USP is in responsible for drug chemistry, purity, strength, formulation and the kinds of tests that are done to ensure a drug is a quality product in the U.S. marketplace. It sets the U.S. standard, and since the U.S. is ahead of the rest of the world, its quality standards become guidelines for many other countries as well. Physicians originally set up the USP standards in 1820. They were primarily published and revised by physicians every ten years from that period until about the 1880’s. That is when it really became a pharmacy publication with pharmacists, chemists, and physicians involved in the revision process.

The FDA on the other hand was first established in 1906 with the passage of the first Food and Drug Act. Harvey Widely, one of the original crusaders campaigning for this federal law, was put in charge and set the first standards. The law was enacted after a number of episodes in which meat from diseased animals had been harvested and sold to the public. There were many other issues with pesticides, and other chemicals. In 1938, one pharmaceutical firm added diethylene glycol to a pediatric drug dosage form without ever testing it, killing a number of children. Following that episode, the law was changed so that toxicity testing had to be conducted and submitted to the FDA for approval, before the product could be sold.

In 1962, congress enacted a new law that said not only did it not have to be toxic but the drug also had to be efficacious, i.e. it had to work. Since then the FDA’s primary drug responsibility is supervising the development of new drugs. They monitor very carefully the type of experiments conducted to ensure the safety of the human subjects that will be undergoing the tests. They insist on very good laboratory and production practices and have a series of regulations in this area.

The FDA and the USP overlap as far as the chemistry, strength, etc. of drugs are concerned. Once the product’s usage in the marketplace is established, the USP primarily takes over and follows that product until it is no longer produced. These two organizations ensure that the medications in this country works as indicated, when taken according to its labeling and that it’s a quality product for its lifetime.”

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Q 2) What is the overall goal of the FDA/USP? 

A) “They both have the same goal-to ensure the quality of products in the U.S. marketplace so that a physician and a patient can rely on them to treat a given indication. The USP is primarily concerned with the dosage form. The FDA, in addition to dosage forms, is also concerned about the drug development process--how it is manufactured, the purity of the conditions under which it is manufactured, and the protection of the human subjects during the drug testing phase.”

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Q 3) What is the relationship between the FDA and USP? How do the two organizations work together? 

A) “In the last twenty years, both organizations have worked well together. They have a joint panel where they have professionals from both units working together to solve problems where there is overlap, and there tends to be overlap in the new drug development process.”

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Q 4) What are some of the landmark achievements by the FDA/USP to this date? 

A) “The greatest achievement is the reliability of products in the U.S. marketplace. You can go to other parts of the world where you can’t be sure of the quality of product you are taking. In the United States, you can be absolutely certain that the medication your physician prescribed, and that is given to you, is a pure medication, which will work as indicated.”

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Q 5) What does the typical day of a FDA/USP scientist look like? 

A) “There are so many types of scientists in the FDA that it is very difficult to answer that question directly. Let me, however, describe to you the primary scientist in the FDA—the reviewer.

That person --a chemist, pharmocologist, pharmacokineticist, physician, dentist, pharmacist, or even a nurse -- is reviewing data submitted by the pharmaceutical industry. They make sure the data meets the regulations, that the product is of high quality and reproducible and that it will be a stable product for the time it is going to be in the marketplace. In addition to the reviewers, they have some research scientists whose primary focus is to develop tests for new products.

The FDA also employs scientists as inspectors. These scientists inspect pharmaceutical plants to make sure that they are complying with the good laboratory and manufacturing procedures that are prescribed. They also have some administrative scientists who work with the lawyers to keep up with the publications, regulations, and guidelines for use by the industry and the academic communities.

The USP is a little different. While they are also involved in the testing and reviewing of data sent to them, they are primarily organizers of data and developers of drug tests. For instance, when the FDA gets a new drug application, it’s usually a substance intended to treat a particular disease entity. It is developed by one company. When the USP gets involved, they are trying to set a test for a drug product that a number of companies are going to be manufacturing. They work in the development of testing across companies, whereas the FDA is mainly concerned with one company.”

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Q 6) What’s the most exciting part of a FDA/USP scientist’s job? What’s the most challenging? 

A) “The most exciting part is the assurance that you have good quality products in the marketplace, particularly when it is a breakthrough drug. For instance, when the first anti-viral drug was approved it became apparent to the FDA--because this was all done in double blind studies with placebo control--that the people being treated were doing much better than the people on placebo. The FDA called in the company, broke the code, and said they were going to go ahead and approve the drug right away because it was a major breakthrough. When something like that happens, it is a very exciting day for people in the FDA.

The most challenging is the nature of the competitive market, when you have two or three pharmaceutical firms trying to get a drug to the market for the same indication. They may be working on different forms of the same chemical entity, or they maybe working on different chemical entities to solve the same problem. In this type of situation, it can be very challenging for the FDA to make sure they are fair to all parties. All parties are suspicious that the FDA is favoring one of the groups over another; it is just a normal occurrence.

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Q 7) What personal achievement at work are you most proud of? 

A) “There were really two. My first assignment in the agency had to do with “Maple Syrup Urine Disease”. Some babies are not able to metabolize what we call branch-chain amino acids, which are part of mother’s milk or any part of a normal diet. It results in the secretion of urine that smells like maple syrup. If these amino acids are not removed from the milk, these amino acids build up in the blood stream, eventually causing the baby to die. These children may live for a month, but will die from this disease--there is no way you are going to be able to do anything for them. This doctor in Alabama found a baby like that, and wanted to get the correct amino acids. However, nobody in the FDA, back in the late 60’s, knew what to do. I tried to help him. While the baby unfortunately died, we managed to set up a procedure using poison control centers so as to prevent that problem from occurring again. Today, the program has grown into a professional society and I feel great having had a hand in it.

The other thing I really feel strongly about is the issue of changing the formulation of an approved drug that is being sold in the marketplace. They contain certain inactive ingredients which are necessary for the formation of a solid tablet. Every once in awhile there is an oil embargo, or a strike and you can’t get the type of ingredient you need. So you have to make a change in the formulation. But, when you make a change in the formulation, you can change the bioavailability of the drug. When I started back in this science in the 1960’s, we knew from published research that even different batches of the same product, made by the same company, sometimes did not give you the same therapeutic effect. In order to tackle this problem, I used a dissolution test, which had already been developed, and correlated that data with in vivo and blood level data. This enable the FDA to assure that every batch would be equivalently bioavailable. With that discovery, the problem went away! This is now the basis of the generic drug program that we have in this country. Nobody has ever established that a product approved by the FDA as being equivalent and meeting both USP and FDA requirements, has ever been inequivalent in the body. I am absolutely delighted with that major accomplishment.”

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Q 8) What type of educational background is required for a FDA/USP scientist? (e.g. BS, MS, Ph.D., Pharm.D., etc.) 

A) “If one is interested in the inspectional service, a B.S. in chemistry, or a Pharm.D. is fine. If one is interested in the regulatory affairs department, the same degrees are very good. In order to do research either in industry, or performing critical review in a particular area in the FDA, like pharmacology or toxicology, then one should really get a Ph.D. Many people who get a Ph.D., for instance in organic chemistry, never think of working in the drug industry, but all of a sudden here they are working in a drug firm trying to synthesize new compounds or new analogs of a drug substance that is known to be effective. Physicians, dentists and nurses, as well as engineers, are also employed.

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Q 9) How would you direct someone into working for the FDA/USP (i.e., what should they study, what internships should they seek, what is the entry level position called, any tips to help get their foot in the door)? 

A) There are a couple of things. While this is not well known outside of the pharmacy field, there is something called the Public Health Service Commission Corp. A student, while still in school, can take a summer job with a temporary commission of a lieutenant in the Navy and come in and work for the FDA, Environmental Health Agency or NIH. This gives students an amazing opportunity—getting an inside glimpse of how these agencies function, while still in school. The other thing one can do is to apply through the Civil Service Commission to the FDA.

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Q 10) Is there anything you wish you would have known about your field prior to choosing it as your career? 

A) I wish I would have known that pharmacokenetics was coming along as a field of science--I would have gotten a pharmacy degree. Basically, when you are going into science, one needs to use the scientific method and be aware of all the developing issues, at all times. Nothing remains static in science, everything changes. When I first came into the industry, physicians dosed everybody the same. Now we are using pharmacokenetic and pharmacodynamic approaches to dose human subjects and individualize drug therapy. Patients are receiving much better treatment now then they did forty years ago—we have accomplished tremendous advances in medicine and pharmacy. I am absolutely delighted to be a part of it.

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