Here’s an exciting new development, something I’ve been expecting—and hoping for—for a while.
Instead of the standardized medical care that has been the goal of most policy wonks, it is finally dawning on some people that each patient is unique and needs a course of treatment customized to their particular situation. This realization has come to have a name—personalized medicine—and conferences are being organized around the concept.
The push for personalized medicine should grow in 2009 as even more medical and pharmaceutical professionals begin to understand that drugs affect patients differently based on their genetic makeup.
“We expect personalized medicine to gain momentum and garner much attention,” Lerner quotes Keith Bradbury of Medco Health Solutions, a prescription management service, as saying. “This year will likely bring stronger evidence to help demonstrate the value of genetic testing when prescribing certain drugs.”
Big Impact on Biologics
The expansion of personalized medicine into the drug development process, through which drugs are tailored to specific genetic makeups, will likely have an even greater impact on biologics—biological drug treatments—than on chemical pharmaceuticals.
In fact it opens up a whole new era for such treatments, so it is timely that there is a big dispute in the industry right now over what is known as “follow-on biologics.”
Follow-on biologics, or FOBs, are the biologic equivalent of generic drugs, and there is a dispute raging over how long the original innovator should have patent rights and “data exclusivity” before copycat manufacturers can jump on a new development.
Effect on Innovation
This is a burning issue in Congress, with a slew of bills introduced in the last session to allow exclusive rights to the new biologics for anywhere from zero to 14 years. This has resulted in much discussion among scholars about how long—and whether—a minimal exclusivity period would encourage competition.
Analysts say biologics are extremely difficult to develop and test, and if the innovators can’t benefit from the investment, they will create fewer of them. The analysts also correctly point out there is plenty of competition already in developing new biologics.
How Congress answers these questions will be a matter of life or death for many thousands of Americans. My conclusion is the last thing we want to do is discourage new developments at the very time when customized, personalized medicine is finally becoming accepted.
Greg Scandlen ([email protected]) is director of Consumers for Health Care Choices at The Heartland Institute.
For more information …
“Major Gains in Personalized Medicine Are Expected in 2009; More Rx Approvals Are Seen for Genetic Tests,” Drug Benefit News: http://www.aishealth.com/Bnow/hbd020409.html