A definite case of seen and unseen consequences. Developing a biopharmaceutical product requires the following: 1. A professional who discovers the possibilit

A definite case of seen and unseen consequences. Developing a biopharmaceutical product requires the following: 1. A professional who discovers the possibility of a new chemical entity, requires infrastructure: comprised of medical grade equipment (centrifuges, beakers, pipets, filters, microscopes, testing equipment, etc.), experts capable of understanding applications of drug, and many iterations of tests. There will be about 5,000 to 10,000 opportunities for these to address something like Hepatitis C. 2. The NCE is developed for dosage and scheduling. Again more testing. 3. The drug needs to be optimized for manufacturing: infrastructure requires additional experts and assessments 4. Preclinical testing is completed. Only 250 products out of that initial 5,000-10,000 NCE group make it here. 5. Only now is a submission made to the FDA. 6. Go through the process of FDA approval starting with human trials. Only around 10 of these from the 250 will be instigated. 7. FDA human trials, a three to four step process that only 21.5% entering the process will make it through. 8. Production of drug. 9. Sale of drug for seven years to recoup costs 10. Post-Surveillance of drug 11. In people with an asymetric heart ventricle that exhibits heart murmurs but only on Wednesdays, the approved drug causes uncontrollable urination. The drug company has to deal with trial lawyers who develop a lawsuit in the general area of $300 million. And this lawsuit can be brought against the company throughout the lifecycle of the drug and in some cases, the original patent holder can be held liable for the generically produced NCE's. 12. Drug finally goes to generic and the generic manufacturers in Brazil and India sell it for pennies, wiping out all profit margins for your product. 13. A third world nation tries and successfully invalidates a patent that you hold, wiping millions off of the revenue forecasts, thus eliminating the monies needed to test up and coming NCE's. Then someone on a forum The amazing part in all of this is that a drug gets made at all. The argument that it costs pennies to make, apply the same logic to a cars production. The modern car costs about $1,000 to manufacture, this includes materials and labor costs, the other monies include research, development, marketing, and all the other accouterments that make it possible; why are people not screaming for the costs to be lower, because they understand that there are costs and regulatory capture involved. [1] http://www.forbes.com/sites/matthewherper/2013/08/11/the-cost-of-inventing-a-new-drug-98-companies-ranked/ http://www.forbes.com/sites/matthewherper/2013/08/11/the-cos... [2] http://en.wikipedia.org/wiki/Drug_development http://en.wikipedia.org/wiki/Drug_development