Senate bill would provide stricter oversight on repackaging

A group of senators on the U.S. Senate Health, Education, Labor and Pensions (HELP) committee released a Avastin bevacizumab -- subject to stricter regulatory controls by FDA. The bill defines compounding manufacturers as entities that compound sterile products without, or in advance of, a prescription and sell those products across state lines, as well as entities that pool sterile products or repackage sterile, single-use, preservative-free vials. Under the bill, FDA also would be able to specify categories of drugs that cannot be safely compounded, including drugs with complex formulations and biologics. Additionally, the bill would prevent compounding manufacturers from compounding versions of FDA-approved drugs that are marketed, except in cases of a drug shortage.

Avastin is repackaged and used off label as a cheaper alternative to Lucentis ranibizumab, which is approved to treat wet age-related macular degeneration (AMD). The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) markets both VEGF inhibitors in the U.S. Roche markets Avastin elsewhere, and Novartis AG (NYSE:NVS; SIX:NOVN) markets Lucentis elsewhere. ...