STREAMLINING DRUG APPROVAL
June 23, 2006
The real problem with drug development is not the loudly proclaimed issue of drug safety but the growing shortage of newer, more effective medicines that can treat or prevent the most costly and devastating diseases, say Robert Goldberg and Peter Pitts of the Center for Medicine in the Public Interest.
According to the Food and Drug Administration's Scott Gottlieb, the development process itself is not keeping up at a fast enough pace to match the progress on the discovery end. This effort to adopt these approaches to drug, device and diagnostic development and increase the number of products hitting the market to improve health was dubbed the Critical Path Initiative by the FDA.
- The use of biomarkers (a biological measure of response to a drug or disease progress) with links to health outcomes could shave years and billions of dollars off drug development.
- The new science produces medicines which are more personalized and better targeted to genetic profiles. Because biomarkers also screen out toxicities before medicines are marketed and identify who responds best, they are demonstrably safer and more effective.
- New computer models and imaging tools can predict not only the onset of illnesses such as Alzheimer's but also which drugs will work best for which patients.
The choice is this, say Goldberg and Pitts:
- Support the Critical Path and develop a new generation of safer, targeted medicines more quickly for the growing number of us who will be diagnosed with Alzheimer's, cancer and other diseases in the decades ahead.
- Or, slow down the current approach to drug development with paperwork and studies that discourage innovation and do nothing to make medicines safer and more effective.
Source: Robert Goldberg and Peter Pitts, "Streamlining drug approval," Washington Times, June 22, 2006.
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