Business Insight presented by Arlington Dermatology What is happening to generic drugs? The concept of generic drugs and their development is very simple: when the 10- year long or 20-year long patents expire for the original medicine, the generic drug companies can bring their equivalents to the market. This means that the original drug was already paid for 10-20 years, pharmaceutical companies, recovered their costs of development and now, generic companies may bring new, matching drugs to fill the market with much cheaper product. The clinical trials still must be conducted for generic drugs, but they are much shorter and much more robust, because they must prove only their bioequivalence, which means that their new generic drug is no worse than the brand drug. Usually, this is done on a much smaller sample size, both, generic and brand drugs, head-to-head, with much shorter period of time needed. We have conducted those generic trials for many years. There were a few generic companies that brought several of the new generics to development every year. Our patients enjoyed those studies as usually they did not have a placebo component, so everybody got treated from day one. And then, out of the skies, these studies disappeared. What happened? Do we not need generics anymore? On the contrary, due to a very high cost of pharmaceutical products, we need the generic industry more than ever. But some other trends developed and cut a lot of the support for generics. First, brand pharmaceutical companies fight to prolong their patents life. There are many ways of doing that. Some involve modification of ingredients, alteration of formulation, and more. This way, they can say that the NEW brand drug is not quite the same as before and they request more time to collect on it. Secondly, as generic drugs are cheaper, many companies just pulled out of that business because they do not make enough profits. This is very sad because we DO need cheaper medications. Any attempts of the government getting involved with some subsidizing gets kills as 'social medicine. The outcome of these silly disputes is the fact that we continue paying more and more. Currently, practically all generic medications are manufactured outside of the country, with India being a leading market for generics. This is not safe and not practical for the American patients. India is far away, and it is a totally different economic market. Supply chain disturbances can cut delivery of life- saving drugs any day. Another pandemic and we will be in trouble again. While FDA makes the most effort to visit and inspect manufacturing plants outside of the US, it is frequently found that there are violations in the processes that often are a result of totally different business functioning in India and the US. A couple of months ago, one of the large pharmaceutical companies did not receive an approval for their new drug not because of the drug development and safety, but because of the manufacturing errors. With generics, where production must be cost effective, the issue is even more critical. The problem should be re-considered and re-thought. I am not quite promoting social medicine here, but I do believe that the involvement of our government in generic drug production can benefit us all. Michael Bukhalo, MD Arlington Dermatology 5301 Keystone Court Rolling Meadows, IL 60008 Tel. 847 392 5440 | www.arlingtondermatology.net Business Insight presented by Arlington Dermatology What is happening to generic drugs ? The concept of generic drugs and their development is very simple : when the 10- year long or 20 - year long patents expire for the original medicine , the generic drug companies can bring their equivalents to the market . This means that the original drug was already paid for 10-20 years , pharmaceutical companies , recovered their costs of development and now , generic companies may bring new , matching drugs to fill the market with much cheaper product . The clinical trials still must be conducted for generic drugs , but they are much shorter and much more robust , because they must prove only their bioequivalence , which means that their new generic drug is no worse than the brand drug . Usually , this is done on a much smaller sample size , both , generic and brand drugs , head - to - head , with much shorter period of time needed . We have conducted those generic trials for many years . There were a few generic companies that brought several of the new generics to development every year . Our patients enjoyed those studies as usually they did not have a placebo component , so everybody got treated from day one . And then , out of the skies , these studies disappeared . What happened ? Do we not need generics anymore ? On the contrary , due to a very high cost of pharmaceutical products , we need the generic industry more than ever . But some other trends developed and cut a lot of the support for generics . First , brand pharmaceutical companies fight to prolong their patents life . There are many ways of doing that . Some involve modification of ingredients , alteration of formulation , and more . This way , they can say that the NEW brand drug is not quite the same as before and they request more time to collect on it . Secondly , as generic drugs are cheaper , many companies just pulled out of that business because they do not make enough profits . This is very sad because we DO need cheaper medications . Any attempts of the government getting involved with some subsidizing gets kills as ' social medicine . The outcome of these silly disputes is the fact that we continue paying more and more . Currently , practically all generic medications are manufactured outside of the country , with India being a leading market for generics . This is not safe and not practical for the American patients . India is far away , and it is a totally different economic market . Supply chain disturbances can cut delivery of life- saving drugs any day . Another pandemic and we will be in trouble again . While FDA makes the most effort to visit and inspect manufacturing plants outside of the US , it is frequently found that there are violations in the processes that often are a result of totally different business functioning in India and the US . A couple of months ago , one of the large pharmaceutical companies did not receive an approval for their new drug not because of the drug development and safety , but because of the manufacturing errors . With generics , where production must be cost effective , the issue is even more critical . The problem should be re - considered and re - thought . I am not quite promoting social medicine here , but I do believe that the involvement of our government in generic drug production can benefit us all . Michael Bukhalo , MD Arlington Dermatology 5301 Keystone Court Rolling Meadows , IL 60008 Tel . 847 392 5440 | www.arlingtondermatology.net