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vienna · 06-27-11, 06:58 PM

Sometimes the FDA does actually act on behalf of the patient and not the mega-pharma corps; earlier this year, the FDA declined to enforce exclusivity for a brand-name drug over pharmacy compounded, generic versions. The issue was price. When the drug, progestin, was compounded by a pharmacy, the cost to the patient was around $15.00 USD per injection. A pharma-corporation, KV, who did not invent or patent the drug, bought exclusive rights to the brand-name version for $200 million USD. To recoup, they increased the price of the brand-name drug (Makena) to $1,500 USD per injection. The FDA then refused to enforce KV's exclusivity claims and allowed continued pharmacy-compounding of the drug. KV responded by lowering their price to a mere $590 USD per injection. AFIK, the non-enforcement of exclusivity continues. It should also be noted that the drug, progestin (or brand-name Makena) is a pregnancy assisting drug to treat pregnancy complications and the course of treatment would require many injections...

http://www.stltoday.com/business/loc...4ecd8c732.html

http://www.ipbrief.net/2011/06/01/a-...sivity-policy/

Sometime the actions of mega-pharm corps can be a bitter pill to swallow...

06-27-11, 06:58 PM	#2
vienna Navy Seal Join Date: Jun 2005 Location: Anywhere but the here & now... Posts: 7,731 Downloads: 85 Uploads: 0	Sometimes the FDA does actually act on behalf of the patient and not the mega-pharma corps; earlier this year, the FDA declined to enforce exclusivity for a brand-name drug over pharmacy compounded, generic versions. The issue was price. When the drug, progestin, was compounded by a pharmacy, the cost to the patient was around $15.00 USD per injection. A pharma-corporation, KV, who did not invent or patent the drug, bought exclusive rights to the brand-name version for $200 million USD. To recoup, they increased the price of the brand-name drug (Makena) to $1,500 USD per injection. The FDA then refused to enforce KV's exclusivity claims and allowed continued pharmacy-compounding of the drug. KV responded by lowering their price to a mere $590 USD per injection. AFIK, the non-enforcement of exclusivity continues. It should also be noted that the drug, progestin (or brand-name Makena) is a pregnancy assisting drug to treat pregnancy complications and the course of treatment would require many injections... http://www.stltoday.com/business/loc...4ecd8c732.html http://www.ipbrief.net/2011/06/01/a-...sivity-policy/ Sometime the actions of mega-pharm corps can be a bitter pill to swallow... Last edited by vienna; 06-28-11 at 01:23 PM.