Is It True that the FDA Approves Fewer Drugs Now?

There has been much discussion on mainstream and alternative medicine websites, including our own, regarding the rate that the FDA approves new medications for market. Considering the importance of access to helpful medicines, it is no wonder this has became such a controversial and debated topic. We have read the criticisms of the FDA on many sites from many sources, but what is the other side of the story? Below is information directly from the FDA. What do you think? Do you trust the source of the information? Do you think the FDA is important to protect the American people or do they get in the way of free market development of medicines and restrict the freedom of the people? For your information and review.

TFH Admin

Is it true FDA is approving fewer new drugs lately?

FDA sometimes hears concerns from the public that the Agency is not approving enough new drugs. Actually, the number of new drugs FDA approves each year has remained relatively steady over time. For instance, In 2010 FDA’s Center for Drug Evaluation and Research (CDER) approved 21 novel new drugs known as New Molecular Entities (NMEs). The chart below shows that this number is similar to NME approvals over the past five years.



In fact, 21 NME approvals in one year is about in line for yearly approvals for the past decade. The chart below shows a ten year period from 2001 through 2010, in which FDA averaged about 23 NME approvals per year (22.9).



While 21 approvals in 2010 is typical of previous years, an increase in approvals would be the ideal scenario. A good part of the reason for this flat approval rate over time is that drug companies are not filing as many applications with FDA for new drug approval as they have in the past. The chart below shows that over the past five years, applications filed with FDA for NMEs have not been increasing. If applications do not increase, the likelihood of approvals increasing is reduced.



The trend towards fewer filings for NMEs extends beyond the past five years. The chart below shows that except for 2002, in which 22 applications were filed with FDA for new NMEs, the 23 applications for NMEs in 2010 is the lowest number in over 15 years.



FDA has been taking action for some time to help drive new drug development and increase applications for novel new products. In 2004, noting a slowdown, FDA launched its Critical Path Initiative, FDA's national strategy to help advance pharmaceutical innovation. Our long-term efforts are showing positive signs and FDA will continue to support the scientific community to advance new drug development. For more information on FDA’s Critical Path Initiative visit: http://www.fda.gov/ScienceResearch/S...ve/default.htm