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Friends Study on FDA vs. EMA Cancer Drug Approvals Release and Congressional Hearing

Friends Study on FDA vs. EMA Cancer Drug Approvals Release and Congressional Hearing

On June 16, 2011, Friends of Cancer Research (Friends) held a Capitol Hill briefing titled “Science and Progress at the Food and Drug Administration (FDA): Exploring the Future of Innovation and Global Competitiveness.” The briefing was held in conjunction with the release of a study in the peer-reviewed medical journal Health Affairs conducted by Friends that compares approval rates for cancer drugs by the FDA versus the European regulatory arm, the European Medical Association (EMA).

The full pdf of the Health Affairs Article is Available HERE

The study found that between 2003-2010 FDA approved 32 new anti-cancer drugs while EMA approved only 26. FDA not only approved more new cancer drugs than did the EMA, it approved these drugs more quickly: of 23 drugs approved by both agencies, the median time from marketing submission to FDA approval was 182 days vs. EMA approval of 350 days. A Reuters exclusive broke the story about the study, and was later covered by over 30 major news outlets including; The New York Times, The Wall Street Journal, CNBC, Fox News, The Chicago Tribune, The Boston Globe, and a featured op-ed in Roll Call (full coverage report at the bottom of this email).

Moderated by Kate Rawson of The RPM Report, the briefing featured a panel including Dr. Janet Woodcock, Director, CDER, FDA; Dr. John Marshall, Clinical Director of Oncology, Georgetown-Lombardi Comprehensive Cancer Center; Jonathan Leff, Managing Director, Warburg Pincus; and Dr. Ellen Sigal, Chair, Friends of Cancer Research.

Friends Chair Ellen Sigal introduced Congresswoman Diana DeGette (CO) who delivered the keynote address praising the study and discussing the ways in which the FDA is a crucial instrument in getting drugs to consumers.  Rep. DeGette specifically discussed the recent wave of drug shortages in the oncology community and told the audience about the development of a new system that would warn about an impending drug shortage.  The Congresswoman concluded by saying that if the FDA can act as a “communication hub” for disseminating information about market responses to drug shortages, they can have a significant impact on drug approval track record.

Dr. Woodcock made the point that while this is important news, “We are not in a contest or a race with the European Union or any of our regulatory partners around the world,” she said. Dr. Sigal agreed and said that the study was great news for patients here in the United States, there must be further support public and federal support for the agency in order for this trend to be able to continue.

The briefing reached beyond the study to dig deeper into the drug approval process.  Panelists were unanimously pleased with the study results but acknowledged that the road to drug approval can be arduous and talked about areas of improvement, particularly in clinical trials. They discussed patient participation in clinical trials as a crucial factor in the continuing development of the drug approval process as well as expanding the use of molecular profiling within groups of patients across the country.

During the briefing, the panel also fielded questions about public and private investment in drug approvals, a shift from development of blockbuster drugs to more personalized medicine, and whether speed or safety should be the top priority.

While some challenges still face the FDA, Dr. Woodcock expressed that she was pleased with the study and hopes the information will begin to dispel the “urban myth” that patients diagnosed with cancer in the U.S. are at a disadvantage over their European counterparts.  “FDA review of cancer drugs is efficient. It’s rapid,” Woodcock said.  “The real problems are in the scientific development programs and scientific uncertainty.”