When It Appears You've Lost . . . The Challenge Has Just Begun . . . Go For The Win!
Some years ago when I was working in the health care field one of my positions was president of a small pharmaceutical company. We had only one product. It was a pain pill. A narcotic which was a codeine derivative. The pill was to be taken for moderate to severe pain such as after a broken bone, a tooth extraction, root canal etc.
Our products was regulated by the United States Food and Drug Administration (FDA). Our product was formulated about 25 years prior to this time. In an effort to have more control over drugs the FDA had made new rules that we were to comply with. They did not tell us about these rules but rather published them into the Federal Register. These rules said drugs like ours were to complete a formal test process by a certain date. Since we did not know about the requirement we did not do it. If we had completed this process it would have taken us 2-4 years and our drug may not have been accepted. In other words: Out of Business!
The way the FDA works is when you haven't complied they show up at one of your distributors and take all of your product. If you don't like what they have done you have to sue them in Federal Court. Well they did it, they came into one of our main distributors and took all out product.
I got this news at about 3:00p.m.. Our office was in Newport Beach, California. The FDA is in Washington D.C. on the east coast which is three hours later. What should I do? I asked my secretary to book me a night flight for that night to Washington D.C.. I would be in Washington at 6:00a.m. the next morning. I told my secretary to call the FDA first thing in the morning and tell them I would be there at 9:00a.m. to meet them. If they were busy I said tell them I'll wait. If they are busy all day, tell them I'll wait till the next day. I need to see them.
When I arrived at the FDA I was surprised by the size of the building. It is shaped like the letter "E". The building was about 600 feet long and nine stories high! Upon entering the building I asked if this building was all the FDA? The receptionist said that this building was not only all the FDA but it wasn't all of it! She said the compliance division, which I needed to go to, was in another complex. I drove to the compliance division. Upon entering I told the receptionist who I was and the nature of my business and she said: "They are waiting for you".
I walked into the room by myself. There were about 8 people in the room. We all introduced ourselves. There next question was: "Are you an attorney?" I said: "no". They all shook their heads and said they couldn't remember meeting anyone representing a company that was not an attorney! To make a long story short they said we had not complied with federal law and they had no choice but to enforce the law and put us out of business!
After the meeting I went to the best law firm in Washington D.C. that specialized in FDA matters. They told me they could draw the matter out for a short time, but in the end we would loose.
At this point many would say that's it. You can't fight the government. Why not! We went to a second law firm and told them we did not think what the FDA did was right. We were required to keep track of every tablet we made. If it was given as samples that information all had to be submitted monthly. The FDA knew who we were, where we were and how to contact us, but they didn't. Our position was they should have made us aware of the requirements and helped us comply since our product had been on the market for over 25 years. It was a safe and effective drug. Twenty five years of use had proved it. The second law firm said nice thought, but we would loose ... It was the law.
Give up? Not on your life. We looked for a third attorney who would take the case and represent us on the premise that we were not treated fairly. The attorney said: "It's worth a try, no promises".
After several months and many motions back and forth the big day came. Los Angeles Federal Court. We sat at our table with our one attorney. The FDA sat at their table with many attorney's. The judge heard both sides and then said: "I am ready to make my ruling." You can imagine the thoughts going through my mind, had we wasted our time? Did we have a chance against the FDA? The judge stood up! He looked at the table of FDA attorney's and said: "You will Not put this company out of business! You did not treat them fairly. I am ordering you to help them comply. You are to return their product and while they are complying they can stay in business!
Wow! WE won! What had we done? First, another illustration.
The second week after I was promoted to president of a health care company with numerous long term care facilities we were called by the head of the Los Angeles City and County Health Department. He said the health department was closing our 69 bed mental facility in West Los Angeles! The reason was the facilities failure in numerous areas including nursing care, programming, physical plant care and a few others.
Wow! What to do! I called the head of the health department on the phone. "Could we meet?" He said why? I said I would like to meet him and review the problems. After a long pause he agreed. Driving to downtown Los Angeles I tried to think of how to handle what seemed like a hopeless situation. (Prior to going into any negotiation visualize yourself being successful.) Upon introducing myself the receptionist showed me into a room full of people. There must have been 15 people in the room. The head of the L.A. City and County health department then came in and introduced himself. He briefly went over all the problems and said: "Your company is not capable of solving all these problems". I said I had just been named president of the company a week ago. I then asked if he closed the facility what would he do with all the patients? He said he'd find places for them. I then said: "But if we could solve the problems wouldn't it be better for the patients and the City if the facility could stay open? I said I had full authority to hire whoever I wanted and spent whatever money I felt nesessary. I then asked him could he please give me a chance? He thought a moment and said here's the deal: no attorney's, the health department would be in and out of the facility many times during the 24 hours of every day. One mistake and it was over; the facility would be closed. I agreed. It was hard work! It took several months. We made it! After that the head of the health department gave me his personal phone number and said I could call him anytime I wanted!
Now what principals of negotiation were involved? First of all don't be intimated! When people say it's over, is it really? Believe in yourself. Don't be afraid. Be prepared. Do the unexpected. Look people in the eye. Your body posture needs to sell your abilities. Be tenacious. Be focused. If you can make the process lighthearted and have fun do it. Find some humor if you can. (During the meeting with the L.A. County Health Department I was wearing a Mickey Mouse watch. The health department head said our company was just ilke my watch: Mickey Mouse. I said I wish we were that successful! Brake down barriers. If you seem to be in a really hard spot ask the other party to try putting themselves in your spot and then ask them what they would do? Remember everyone else is a person just like you...your're equal. At the end of your negotiation ask for what you want! Many people forget this most important step. Follow through. Remember what you have learned.
Our products was regulated by the United States Food and Drug Administration (FDA). Our product was formulated about 25 years prior to this time. In an effort to have more control over drugs the FDA had made new rules that we were to comply with. They did not tell us about these rules but rather published them into the Federal Register. These rules said drugs like ours were to complete a formal test process by a certain date. Since we did not know about the requirement we did not do it. If we had completed this process it would have taken us 2-4 years and our drug may not have been accepted. In other words: Out of Business!
The way the FDA works is when you haven't complied they show up at one of your distributors and take all of your product. If you don't like what they have done you have to sue them in Federal Court. Well they did it, they came into one of our main distributors and took all out product.
I got this news at about 3:00p.m.. Our office was in Newport Beach, California. The FDA is in Washington D.C. on the east coast which is three hours later. What should I do? I asked my secretary to book me a night flight for that night to Washington D.C.. I would be in Washington at 6:00a.m. the next morning. I told my secretary to call the FDA first thing in the morning and tell them I would be there at 9:00a.m. to meet them. If they were busy I said tell them I'll wait. If they are busy all day, tell them I'll wait till the next day. I need to see them.
When I arrived at the FDA I was surprised by the size of the building. It is shaped like the letter "E". The building was about 600 feet long and nine stories high! Upon entering the building I asked if this building was all the FDA? The receptionist said that this building was not only all the FDA but it wasn't all of it! She said the compliance division, which I needed to go to, was in another complex. I drove to the compliance division. Upon entering I told the receptionist who I was and the nature of my business and she said: "They are waiting for you".
I walked into the room by myself. There were about 8 people in the room. We all introduced ourselves. There next question was: "Are you an attorney?" I said: "no". They all shook their heads and said they couldn't remember meeting anyone representing a company that was not an attorney! To make a long story short they said we had not complied with federal law and they had no choice but to enforce the law and put us out of business!
After the meeting I went to the best law firm in Washington D.C. that specialized in FDA matters. They told me they could draw the matter out for a short time, but in the end we would loose.
At this point many would say that's it. You can't fight the government. Why not! We went to a second law firm and told them we did not think what the FDA did was right. We were required to keep track of every tablet we made. If it was given as samples that information all had to be submitted monthly. The FDA knew who we were, where we were and how to contact us, but they didn't. Our position was they should have made us aware of the requirements and helped us comply since our product had been on the market for over 25 years. It was a safe and effective drug. Twenty five years of use had proved it. The second law firm said nice thought, but we would loose ... It was the law.
Give up? Not on your life. We looked for a third attorney who would take the case and represent us on the premise that we were not treated fairly. The attorney said: "It's worth a try, no promises".
After several months and many motions back and forth the big day came. Los Angeles Federal Court. We sat at our table with our one attorney. The FDA sat at their table with many attorney's. The judge heard both sides and then said: "I am ready to make my ruling." You can imagine the thoughts going through my mind, had we wasted our time? Did we have a chance against the FDA? The judge stood up! He looked at the table of FDA attorney's and said: "You will Not put this company out of business! You did not treat them fairly. I am ordering you to help them comply. You are to return their product and while they are complying they can stay in business!
Wow! WE won! What had we done? First, another illustration.
The second week after I was promoted to president of a health care company with numerous long term care facilities we were called by the head of the Los Angeles City and County Health Department. He said the health department was closing our 69 bed mental facility in West Los Angeles! The reason was the facilities failure in numerous areas including nursing care, programming, physical plant care and a few others.
Wow! What to do! I called the head of the health department on the phone. "Could we meet?" He said why? I said I would like to meet him and review the problems. After a long pause he agreed. Driving to downtown Los Angeles I tried to think of how to handle what seemed like a hopeless situation. (Prior to going into any negotiation visualize yourself being successful.) Upon introducing myself the receptionist showed me into a room full of people. There must have been 15 people in the room. The head of the L.A. City and County health department then came in and introduced himself. He briefly went over all the problems and said: "Your company is not capable of solving all these problems". I said I had just been named president of the company a week ago. I then asked if he closed the facility what would he do with all the patients? He said he'd find places for them. I then said: "But if we could solve the problems wouldn't it be better for the patients and the City if the facility could stay open? I said I had full authority to hire whoever I wanted and spent whatever money I felt nesessary. I then asked him could he please give me a chance? He thought a moment and said here's the deal: no attorney's, the health department would be in and out of the facility many times during the 24 hours of every day. One mistake and it was over; the facility would be closed. I agreed. It was hard work! It took several months. We made it! After that the head of the health department gave me his personal phone number and said I could call him anytime I wanted!
Now what principals of negotiation were involved? First of all don't be intimated! When people say it's over, is it really? Believe in yourself. Don't be afraid. Be prepared. Do the unexpected. Look people in the eye. Your body posture needs to sell your abilities. Be tenacious. Be focused. If you can make the process lighthearted and have fun do it. Find some humor if you can. (During the meeting with the L.A. County Health Department I was wearing a Mickey Mouse watch. The health department head said our company was just ilke my watch: Mickey Mouse. I said I wish we were that successful! Brake down barriers. If you seem to be in a really hard spot ask the other party to try putting themselves in your spot and then ask them what they would do? Remember everyone else is a person just like you...your're equal. At the end of your negotiation ask for what you want! Many people forget this most important step. Follow through. Remember what you have learned.
posted by Paul Edgren at 10:26 PM
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