Business Insight presented by Arlington Dermatology Where do our medications come from? I just posted the most difficult question ever. The process of obtaining any medication in the US is very complex. First of all, there are thousands of new drugs developed in the US. Almost 100% of clinical trials for new medications are global, which means that their sponsors, pharmaceutical companies, conduct their clinical trials in multiple countries at the same time. The process of approval of these drugs will differ due to various regulatory authorities, FDA in our country. Some countries, like Japan, will deny approvals based on projected cost of the drug if it does not meet the standard of superiority comparing to the existing treatments. Social medicine and the cost of medication play a big role unless it is a novel compound, making it better than any other available treatment. Secondly, we have thousands of medications available in the form of generic. India is the number 1 manufacturer of generic drugs. However, India buys many components of their production from China. So, for instance, ibuprofen, is made in India based on 90% supply from China. Exported to the USA as a final product, we assume it is from India. Our regulatory agency, FDA, has agreements with the countries that conduct clinical trials and manufacture our drugs to allow for inspections related to good clinical manufacturing process and good clinical practice. However, we do not really know what percentage of the production of generic drugs is inspected. We assume that our partners are honest and provide the quality we would desire. There are many other countries we depend on: Germany, Canada, Mexico, United Kingdom, and more. Manufacturing of biologic drugs is probably the most expensive and requires superb technology. Germany is probably a leader in that area. Drugs not approved in the US by FDA cannot be brought to our country. If they make it here for some reason, they are being used off label. This means that, if you experience some side effects from them, there is not much you can do if you live in the US. Pharmacies and medical offices may not purchase such drugs. Many medications have exclusive rights to be manufactures only and only by the pharmaceutical company. If there are some compounding institutions selling 'substitutes, they do it illegally and again, you are on your own if you experience any problems. There were some examples of 'substitute Botox' distributed several years ago. They ended pretty badly for some users and doctors who used them paid a price. There is a big dilemma that was born recently. If there are some extra tariffs planned on pharmaceutical products from outside of the US, this means that the price of drugs will go up. It is already higher in our country than everywhere in the world and obviously, we will pay that higher price. The question will be coming to a discussion: is it possible to bring all these drugs to be produced in the US? Please, feel free to comment to us and look forward to the second part of this discussion next week. 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 Where do our medications come from ? I just posted the most difficult question ever . The process of obtaining any medication in the US is very complex . First of all , there are thousands of new drugs developed in the US . Almost 100 % of clinical trials for new medications are global , which means that their sponsors , pharmaceutical companies , conduct their clinical trials in multiple countries at the same time . The process of approval of these drugs will differ due to various regulatory authorities , FDA in our country . Some countries , like Japan , will deny approvals based on projected cost of the drug if it does not meet the standard of superiority comparing to the existing treatments . Social medicine and the cost of medication play a big role unless it is a novel compound , making it better than any other available treatment . Secondly , we have thousands of medications available in the form of generic . India is the number 1 manufacturer of generic drugs . However , India buys many components of their production from China . So , for instance , ibuprofen , is made in India based on 90 % supply from China . Exported to the USA as a final product , we assume it is from India . Our regulatory agency , FDA , has agreements with the countries that conduct clinical trials and manufacture our drugs to allow for inspections related to good clinical manufacturing process and good clinical practice . However , we do not really know what percentage of the production of generic drugs is inspected . We assume that our partners are honest and provide the quality we would desire . There are many other countries we depend on : Germany , Canada , Mexico , United Kingdom , and more . Manufacturing of biologic drugs is probably the most expensive and requires superb technology . Germany is probably a leader in that area . Drugs not approved in the US by FDA cannot be brought to our country . If they make it here for some reason , they are being used off label . This means that , if you experience some side effects from them , there is not much you can do if you live in the US . Pharmacies and medical offices may not purchase such drugs . Many medications have exclusive rights to be manufactures only and only by the pharmaceutical company . If there are some compounding institutions selling ' substitutes , they do it illegally and again , you are on your own if you experience any problems . There were some examples of ' substitute Botox ' distributed several years ago . They ended pretty badly for some users and doctors who used them paid a price . There is a big dilemma that was born recently . If there are some extra tariffs planned on pharmaceutical products from outside of the US , this means that the price of drugs will go up . It is already higher in our country than everywhere in the world and obviously , we will pay that higher price . The question will be coming to a discussion : is it possible to bring all these drugs to be produced in the US ? Please , feel free to comment to us and look forward to the second part of this discussion next week . Michael Bukhalo , MD Arlington Dermatology 5301 Keystone Court Rolling Meadows , IL 60008 Tel . 847 392 5440 | www.arlingtondermatology.net