HOT news:FDA NEWS RELEASE FDA obtains waiver from European Commission to facilitate export for U.S. pharmaceutical manufacturers The U.S. Food and Drug Administration announced today that the U.S. is now a “listed” countrydisclaimer icon with the European Commission (EC) so that U.S. companies need not obtain an export certificate from the FDA before shipping certain pharmaceutical products to Europe. Without the waiver, all U.S. companies shipping active pharmaceutical ingredients (APIs) to Europe after July 1, 2013 would have had to first submit documentation from the FDA that the product was manufactured in accordance with Europe’s good manufacturing practices. To avoid that burden for companies, the FDA filed a formal “listing request” with the EC in January 2013 that the FDA’s good manufacturing practices be considered at least equivalent to those in Europe. The EC has now approved that request following a comprehensive audit of the FDA’s regulatory and inspectional oversight of APIs. The audit took place from May 13 - 20, 2013. “Working with the EC, the FDA has helped U.S. pharmaceutical companies avoid duplicative administrative efforts which impede trade and delay the manufacture of needed medicines,” said FDA Commissioner Margaret A. Hamburg, M.D. “At the same time, the FDA applauds Europe for taking steps to protect its pharmaceutical supply chain and will continue to collaborate with its regulatory counterparts around the world to help keep our own supply chain safe.” Europe’s requirement for the import of APIs falls under its Falsified Medicines Directive, enacted in 2011 in response to the challenges posed in keeping the pharmaceutical supply chain safe at a time when products are increasingly sourced from around the world. Protecting consumers around the globe from falsified medicines is an enormous and complex undertaking that requires international cooperation. Over the past several years, the FDA has been transforming from a domestically-focused agency to a proactive, global public health agency in order to carry out our mission more effectively in a world where trade, and product safety and quality, have no borders. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. Ask:What is the difference between Brands and Generics? Why do people prefer Generics? Answer : Generics are usually priced up to 80 percent less than equivalent brand-name versions. Why? Because brand-name drugs invest large amounts of money to advertise and persuade you to buy their product, Because generic manufacturers spend less on advertising and product development and because generic versions of the same quality rx medication create competition and competition can drive prices down. Ask:Do your generics look exactly the same as brands? Answer: Since there is no single standard on how generics should look like, every manufacturer can have different appearance of the same pills. Our generics are manufactured abroad, so they might look different than the ones manufactured in the US. However appearance is not important. What really matters is that our generics have exactly the same chemical composition and ingredients as the brands and as US generics. We only cooperate with big reputable manufacturers, who are approved and licensed by their national FDA. So we do guarantee that what you receive is the correct product, and it will work the same as the brand. Ask: Why do some patients need compounded drugs? Answer : Pharmacy compounding can serve an important public health need if a patient cannot be treated with an FDA-approved medication. Some examples of the need for compounding include: If a patient has an allergy and needs a medication to be made without a certain dye. If an elderly patient or a child can’t swallow a pill and needs a medicine in a liquid form that is not otherwise available.