Article preview from "The Pink Sheet" - October 28, 2008
Find out why the FDA appears to be setting new policy on when drugs should be available for compassionate use...
Article preview from "The Pink Sheet" - October 28, 2008
FDA Action On Off-Label Tysabri May Signal Policy Shift On Compassionate Use
FDA appears to be setting new policy on when drugs should be available for compassionate use
The agency intervened in a battle being waged by the family of Frederick Baron, a prominent Dallas trial lawyer, to get access to Biogen Idec's Tysabri (natalizumab) for treatment of his multiple myeloma. The drug is approved for multiple sclerosis and Crohn's disease under a risk management program that prohibits off-label use.
Biogen had turned down Baron's request for Tysabri because of its link to progressive multifocal leukoencephalopathy (PML), a rare and often fatal brain inflammation.
Baron, a major fundraiser for the Democratic party who headed up fundraising for Sen. John Edwards during his presidential campaign, was able to draw on his political connections. Several high-profile individuals, including President Bill Clinton, Sen. John Kerry, D-Mass., Sen. John Harkin, D-Iowa, Sen. Ted Kennedy, D-Mass., and FDA Commissioner Andrew von Eschenbach, pleaded with Biogen to allow Baron to receive the drug.
In an open letter to Biogen CEO James Mullen, Baron's son, Andrew, said doctors treating his father at the Mayo Clinic concluded that Tysabri offered the last chance to try to save his life. He also noted that von Eschenbach had granted special approval for use of the drug for this purpose.
While Biogen did not relent, Baron was able to get the drug with FDA's help. In an Oct. 16 posting on his Web site, Andrew Baron reported that "the Mayo Clinic working with the FDA found a legal basis" for his father to receive Tysabri.
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