Biologics are medications engineered from living human or animal cells using biotechnology. Drugs included in this category are new treatments for cancer, rheumatoid arthritis, inflammatory bowel disease, and multiple sclerosis. While competition from generics have significantly lowered prices of conventional drugs (the HIV/AIDS meds are the classic example of this) there is not yet legislation surrounding production of generic biologics. Currently these name-brand biologics can cost patients tens of thousands a year. About 43% of Medicare Part B is spent on the top 6 biologics.
Currently conventional drugs (stuff like aspirin, Prilosec, etc.) pharmaceutical companies get 5 years of data exclusivity. This means for 5 years after FDA approval of a new drug, competitors cannot use the companies' clinical trials safety and efficacy data, to apply for approval of generic versions. Essentially, this amounts to a monopoy for that period of time and can delay competing generics from entering the market. This can lead to higher prices for a longer time period.
The health reform bills propose by the Senate HELP and House Energy and Commerce contain proposals that would lengthen this data exclusivity period for biolgics to 12 years as opposed to the 5 for conventional drugs. Pharma's argument is that biologics cost more in research and development and therefore need a longer period data exclusivity. According to research this isn't really true. Studies that show the R&D costs for biologics ($1.2 billion in 2006) and conventional drugs ($1.38 billion in 2006) are not different, and the development time differs little as well (97.7 months vs. 90.3 months on average, respectively).
What Can I Do?
Go to http://affordablemedsnow.org/ and send an email or even better call your congresspeople and let them know that you care about this and that you support the proposal by Representatives Henry Waxman and Charles Schumer (H1427/S726) that would maintain the 5 years data exclusivity for biologics.
Bryan Eustis is a genius
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