The US Food and Drug Administration's drug approval standards have been defended by Dr. Margaret Hamburg, who has served as Commissioner of the FDA since May 2009. Hamburg defended the standards in her final speech after six years as commissioner against critics seeking weaker regulatory standards.

"The great leaps forward in evidence-based medicine of last 50 years have come in large part as a result of high standards for product approval that Congress put in place after series of disasters involving unsafe and ineffective medical products", said Hamburg, 59, said on Friday at a National Press Club lunch in Washington, DC.

A provision in a draft House of Representatives bill identified as 21st Century Cures, is going to enable the FDA to approve drugs that designated as 'breakthrough therapies'. Designation, 'Breakthrough therapy' is presently provided when early data shows a product may confer substantial improvement over an existing therapy.

Particularly, the products are reviewed quickly and companies given more intensive FDA drug development guidance. But they have not received approval based on the preliminary data alone. About 96 breakthrough therapy requests have been received by the FDA and it has approved 31.

According to Ms Hamburg, the FDA usually gives approval to new drugs faster as compared any other developed nation. According to experts, the FDA has given approval to the most new drugs in 20 years in 2014.

Ms Hamburg disagrees with critics who say that the FDA regulation is the main problem to the development of innovative new treatments. She also said that the FDA backs 'responsible' communication of scientific information. An approach that undercuts the incentive for studies to be done is not backed.