I hate to be the one to throw some facts in here but to get FDA approval, the company is spending hundreds of millions of dollars in additional research, including an international study involving 1,700 women, Divis said. The FDA last month signed off and gave Makena orphan drug status. That designation ensures Ther-Rx will be the sole source of the drug for seven years."
Looking up: http://en.wikipedia.org/wiki/Orphan_drug
"The Orphan Drug Act (ODA) of January 1983, passed in the United States, with lobbying from the National Organization for Rare Disorders,[1] is meant to encourage pharmaceutical companies to develop drugs for diseases that have a small market. Under the law, companies that develop such a drug (a drug for a disorder affecting fewer than 200,000 people in the United States) may sell it without competition for seven years,[2] and may get clinical trial tax incentives."
So the company spent a ton of money getting this drug FDA-approved and gets to make a profit off it during a 7 year window. At the end of the 7 year window the drug is cheaply available to everyone.
If you look past the rhetoric, this seems like a win-win. Look at the information in the article: Aetna covers the drug for 1,000 women a year. Is any company going to spend hundreds of millions on FDA approval to sell maybe $100k of drugs a year?
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I hate to be the one to throw some facts in here but to get FDA approval, the company is spending hundreds of millions of dollars in additional research, including an international study involving 1,700 women, Divis said. The FDA last month signed off and gave Makena orphan drug status. That designation ensures Ther-Rx will be the sole source of the drug for seven years."
Looking up: http://en.wikipedia.org/wiki/Orphan_drug
March 14, 2011 - 2:12pm"The Orphan Drug Act (ODA) of January 1983, passed in the United States, with lobbying from the National Organization for Rare Disorders,[1] is meant to encourage pharmaceutical companies to develop drugs for diseases that have a small market. Under the law, companies that develop such a drug (a drug for a disorder affecting fewer than 200,000 people in the United States) may sell it without competition for seven years,[2] and may get clinical trial tax incentives."
So the company spent a ton of money getting this drug FDA-approved and gets to make a profit off it during a 7 year window. At the end of the 7 year window the drug is cheaply available to everyone.
If you look past the rhetoric, this seems like a win-win. Look at the information in the article: Aetna covers the drug for 1,000 women a year. Is any company going to spend hundreds of millions on FDA approval to sell maybe $100k of drugs a year?
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