Monday, August 18, 2008

Specialty drug developments

The AMA News reports that "Legislation creating an approval process for generic biopharmaceuticals could save billions of dollars in the next decade, but a crowded congressional agenda and a lack of consensus among lawmakers may prevent passage of a bill this year." The generic and brand name manufacturers are fighting over the patent exclusivity period. I was surprised to read that the AMA is agnostic on the legislation:
The American Medical Association has not taken a position on the bills. It is concerned about any measure's effect on patient safety, incentives for innovation and physicians' independence. Legislation should not compel doctors to treat biogenerics as interchangeable with brand-name biologics and should balance the need for market exclusivity with competition, according to the AMA.
How can we ever expect the price of these specialty drus to come down without generic alternatives? But of course no one expected the price of gasoline to come back down.

In more heartening news, Medco is teaming up with the Food and Drug Administration to "study
pharmacogenomics, or "personalized medicine'' - the way genes can
alter the effectiveness of drugs. At the 2007 OPM AHIP FEHBP conference, Medco CEO David Snow explained how genetic tests can help doctors identify the appropriate dosage at an individual patient level for certain widely prescribed medicines like the blood thinner warfarin (brand name Coumadin).

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