Herb Kohl is riled up. But first some background: You may recall that Genentech caused a furor recently by restricting distribution of its Avastin cancer med, which is widely used to treat wet macular degeneration, even though the drug was never approved for that purpose. The biotech wants to halt sales to compounding pharmacies, citing FDA concerns about contamination when an Avastin vial is split into different doses.

Opthalmologists complain the move will hurt patients, because the alternative treatment is Genentech’s newer Lucentis, which is approved for the eye disease, but costs 40 times as much, or about $2,000. The decision renewed criticism that Genentech is trying to steer business toward Lucentis at the expense of patients, especially since the biotech won’t study Avastin for the eye disease (although the NIH is doing so).

Kohl, a Democrat from Wisconsin who chairs the Special Senate Committee on Aging, is concerned because the limits on Avastin distribution may wind up costing Medicare anywhere from $1 billion to $3 billion, since the agency is a big Avastin purchaser. So he’s working on legislation that would give CMS the authority to waive co-payments for patients participating in government-funded clinical trials and comparative-effectiveness studies.

Meanwhile, he’s turning up the heat on Genentech. He recently sent a letter (look here) to Susan Desmond-Hellman, Genentech’s president of product development, asking her to provide documentation concerning Genentech’s decision, as well as info to explain discrepancies concerning her knowledge of talks to provide the NIH trial with Avastin. Kohl also wants to know why Genentech sent letters to Avastin patients warning them about off-label use and its possible side effects.

At the same time, Kohl is asking the FDA to clarify a few things. In the latest of two letters to FDA commish Andy von Eschenbach, he wants a straight answer about whether the agency objects to Genentech selling Avastin to compounders, since Genentech claims the FDA has objections, while interviews with FDA officials by Kohl staffers suggests otherwise. And he wants more info about FDA inspections that resulted in Avastin lots being destroyed.