Is the U.S. really slower than Europe in approving new drugs? FDA often hears claims that the U.S.

approves new drugs less quickly than other regulatory agencies, particularly the European Medicines Agency (EMA). This is not true; in many cases, FDA gets a drug on the market faster than does Europe. For example, FDA recently compared marketing approval of 57 novel drugs approved by both FDA and E.U. regulators from 2006 through 2010. The chart below shows that FDA approved the majority of these products before the EMA.

57 New Drugs Approved by FDA & EMA (2006-2010)
45 40 35 30 25 20 15 10 5 0

43 FDA EMA 14
New Drugs Approved First

2 out of 3 new applications were approved by FDA first

When a potential new drug represents a “therapeutic advance” (i.e., a new important medical use), FDA designates that drug with a priority review, so it can be evaluated faster than other drugs. Drugs that are not designated priority review are designated standard review. Twenty-seven of the 57 drugs approved by both FDA and EMA were FDA-designated priority review drugs. The chart below shows that FDA was first to approve more priority and standard review drugs than the EMA.

57 New Drugs Approved by FDA & EMA (2006-2010)
27 Priority Review Drugs Approved 30 Standard Review Drugs Approved

First Approvals:

3
FDA First EMA First

11 19
FDA First EMA First

24

FDA Approved Drugs First for:
88% of priority review drugs 58% of standard review drugs

. FDA approved more new drugs and approved them in less time than the EMA. to approve these new products. 53 days faster than EMA for standard review drugs 220 days faster than EMA for priority review drugs (more than twice as fast) Of any drug class. The chart below shows that of these 35 products considered by both agencies. FDA also took less time. cancer drugs are among those that need the fastest approvals and highest priority. FDA Approved More Cancer Drugs 35 new oncology drugs approved by either FDA or EMA 35 30 25 20 15 10 5 0 400 32 26 FDA EMA 350 300 250 200 150 100 50 0 373 FDA 261 EMA New Oncology Drugs Approved Average Number of Days to Approve New Oncology Drugs • FDA approved most of these products in 6-12 months • EMA approved most of these products in 11-14 months . on average. The chart below shows FDA had faster average approval times for both priority and standard review drugs. FDA analyzed 35 applications for new cancer drugs approved by FDA or EMA from FY 2003 through 2010.In addition to being first to approve most of the 57 drugs approved by both FDA and EMA. Average Timeline for FDA & EMA Drug Approvals (2006-2010) Average Number of Days to Approve a New Drug 500 400 403 300 200 183 100 0 Priority Review Standard Review 396 FDA EMA 449 FDA drug approval timeline average.

FDA Approved Cancer Drugs Faster than EMA 23 new cancer drugs were approved by both FDA & EMA 25 20 15 FDA 10 EMU 5 2 0 First to Approve First to Market 0 21 23 • Of 23 new cancer drugs approved by both FDA and EMA. enabled them onto the U.S. we recognize it is our public health duty to approve drugs as quickly and safely as possible. .S. market before they reached the European market • FDA is not in a “race” with other countries. The chart below shows that FDA was first to approve most of those 23 products and in each case. FDA approved 21 first All 23 came to the U.Twenty-three of the 35 cancer drugs were approved by both agencies. However. market sooner than EMA enabled its approved products to market.

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