In a speech given by the former Commissioner of the U.S. Food and Drug Administration, Dr Margaret Hamburg finally, answers to the people criticizing her decisions during her term. She also mentioned how the agency had made “great leaps in evidence-based medicine” over the last five decades. She also fears that these standards might be under an attack.
Stressing on how important clinical trials are, Dr Hamburg made comments upon the new bill. It is known as 21st Century Cures. She mentioned that rushing drugs into the market, which aren’t tested adequately may induce a lot of damage. The bill, pushed by The House of Representatives aims to put FDA approve drugs on a ‘fast-track’ basis. These fast speeds of approval shall be particularly made for “breakthrough therapies”.
Should the new bill be implemented, drugmakers would only have to conduct long term safety and efficacy studies till the product is on the market, rather than before,
Breakthrough therapies are a designation, particularly provided when early data of a product show “substantial improvement” over existing therapies. In 2014, the FDA has approved the highest number of drugs ever in a year. The last year has also witnessed the approval of more drugs than it had ever approved in two decades.
However, despite what statistics might say, critics argue about her decisions. According to the them, FDA rules and regulations are the major obstacle towards developing new drugs or treatment methods. In her defense, Dr Margaret mentioned in her speech that innovation doesn’t matter if “products don’t work”.
Dr Hamburg was quick to mention that the FDA has a faster rate of providing the approval stamp than any other developed nation. It approved more drugs last year than it ever had in two decades. Criticizing those who had argued that FDA regulations get into the way of new innovative treatments, she argued that “innovations don’t matter if product doesn’t work.”