The LA Times reflects on the tenth anniversary of the phenomenal scientific accomplishment of sequencing the human genome. I do hope that the personalized medicine will bring down health care costs over time. A leading genetic scientist, J. Craig Venter, observes in the journal Nature
"Where will genomics be ten years from now? As sequencing capacity increases globally and the data quality improves, we will move beyond the current goal of one genome per person to sequencing multiple genomes per person from sources including sperm and egg cells, blastocysts, stem cells, pre-tumour cells and cancer cells. This will enable us to select healthy cells for reproduction and tissue transplants, or to better understand ageing and tumour development. Equally important for medical progress is the sequencing of the genomes of the millions of microbacteria that dwell within all of us. The genome revolution is only just beginning."
Reuters reports that U.S. prescription drug sales in 2009 climbed by 5% in 2009 to just over $300 billion. The AP reports that "Sales of high-priced specialty drugs made up more than 20 percent of sales, up from 7.5 percent in 2008. Specialty drugs include injectable, biotech medications used to treat chronic conditions like cancer and psoriasis." The Patient Protection and Affordable Care Act created a regulatory pathway for approval of "generic" versions of specialty or "large molecule" drugs (or "biosimilars") which after a 12 year exclusivity period for the manufacturer. The European Union which created this regulatory pathway in 2004 has approved several biosimilar drugs according to the Biotechnology Industry Organization.
Congress created a regulatory pathway for approval of generic versions of small molecule drugs in 1984. Reuters notes that "The shift toward [small molecule] generics is likely to accelerate by 2012, when several major products, including the world's two biggest-selling medicines - the cholesterol fighter Lipitor and the blood clot preventer Plavix - face competition from cheap generics."