Tuesday, March 26, 2013

3/26/13 - FDA Seeks End of Road for Compounded Biologics

If the FDA gets the authority it wants, it could be the end of the road for compounded versions of some biologics and high-risk drugs.
In the aftermath of a deadly meningitis outbreak linked to drugs from the New England Compounding Center and ongoing quality problems with other compounders, the agency is working with lawmakers on legislation that would set stricter standards for compounding pharmacies and increase the agency's oversight.
One measure FDA Commissioner Margaret Hamburg is calling for is a ban on the compounding of complex and high-risk drugs and biologics.
Such products should only be made by an FDA-registered drug manufacturer under an approved new drug application, she said. In the past, seemingly minor changes in the manufacturing or packaging of a biologic have led to safety issues.
It's a move Genentech Inc., a unit of Basel, Switzerland-based Roche AG, would welcome, given ongoing concerns about compounded versions of its Avastin (bevacizumab), used off-label as a cheaper alternative to Genentech's Lucentis (ranibizumab in treating wet age-related macular degeneration (AMD) and other eye diseases.
Approved to treat certain forms of cancer, Avastin is manufactured, formulated and packaged specifically for administration by intravenous infusion in cancer patients, Genentech spokesman Terry Hurley told BioWorld Today.

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