From Medscape
June 27, 2011 — Complaints that the US Food and Drug Administration (FDA) approves too few new drugs and takes too long to approve them have been contested by researchers from the Friends of Cancer Research advocacy group, on the grounds that (at least for oncology drugs), the FDA's track record is better than that of the European Medicines Agency (EMA). The report, by Samantha A. Roberts, PhD, and colleagues, was published online June 16 in Health Affairs.
During the time period studied, 35 new cancer drugs were approved by one or both of the regulatory agencies. The FDA approved 32 anticancer drugs and the EMA approved 26. All of the drugs that were approved by both agencies were available to patients in the United States first, which partly reflects the fact that pharmaceutical companies usually seek FDA approval before applying to the EMA.
The median time from marketing submission to marketing approval was 182 days for the FDA and 350 days for the EMA. Only 3 of the 32 anticancer drugs approved by the FDA took more than a year to receive approval.
The longer time to approval by the EMA is partly because the European Union requires 2 steps before a drug can be marketed. It must receive approval from the EMA Committee for Medicinal Products for Human Use, and then the European Commission must adopt that opinion.
User fees from the Prescription Drug User Fee Act of 1992 have helped provide the FDA with resources to shorten drug review times. That act is up for reauthorization in 2012. In discussing the upcoming reauthorization, Roberts et al write: "Increasing the speed of drug review times might not be as high a priority as achieving other objectives in advance regulatory science." In particular, they note, "the vast trove of data at the FDA must be transformed into a harmonized format and organized in a common database so that it can be queried by topic and analyzed to address key questions."
Dr. Roberts, who is a science policy analyst at the Friends of Cancer Research in Washington, DC, told Medscape Medical News that the researchers are emphatically not arguing that funds should be shifted from drug approval.
"We think the overall funding of the agency needs to increase (particularly federal funding) and that these additional funds need to be used for the regulatory science initiatives. It is important to note that this study only examines the review period at the very end of the long process of new drug development. Advancement of the regulatory science initiatives may help alleviate some of the challenges encountered at other stages of development and review, which have a large impact on the success of new medicines. These initiatives are aimed at things like developing new clinical trial designs that can incorporate biomarkers, so that the trials are more efficient, facilitating codevelopment of a drug with a corresponding diagnostic, and using informatics for real-time monitoring of accumulating safety and efficacy data of products that have already been approved," Dr. Roberts said.
She added: "We published these data to say that this is one aspect of oncology drug development that is going relatively well, at least for this snapshot in time, but funding for actual reviews would need to be at least maintained for this to continue. To really improve oncology drug development, what we now need is focus on and investment in making the clinical trial process itself smarter and more efficient."
Daniel Carpenter, PhD, who reviewed the study for Medscape Medical News, said that this study "brings data to a question that has been dominated by anecdote and hyperbole." Dr. Carpenter is the Freed Professor of Government and director of the Center for American Political Studies in the Faculty of Arts and Sciences at Harvard University in Cambridge, Massachusetts, and the author of a book on pharmaceutical regulation in the United States, entitled Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA (Princeton University Press, 2010).
Dr. Carpenter said that he agrees "with the authors that increasing the speed of drug review times is not as high a priority for future policy changes. There should be greater focus on the postmarketing study of drugs, and greater focus on reducing, where possible, the cost and time of drug development before FDA review. These are not simple questions with facile answers — the drug trials conducted during the [Investigative New Drug] stage are critical to public health, and they provide a public good of vast proportions, as their lessons are used downstream in prescribing decisions, the composition of formularies for hospitals and insurers, and very often in other firms' and scientists' drug development decisions. Yet I think that Roberts and colleagues are correct to suggest that less focus should be on approval times and more focus should be on what happens before the FDA review and on what happens after the FDA review."
Dr. Roberts and Dr. Carpenter have disclosed no relevant financial relationships.
Health Aff (Millwood). Published online June 16 2011.
.
Journalist
Janis Kelly
Janis Kelly is a freelance writer for Medscape. She has been a medical journalist since 1976, with extensive work in rheumatology, immunology, neurology, sports medicine, AIDS and infectious diseases, oncology, and respiratory medicine.
No comments:
Post a Comment