More on Biotech Generics and the Democratic Congress

I noted yesterday the article on TheHill.com reporting the new Dem Congress intentions to legislate a pathway for biotech generics. I was skeptical of how they would approach the difficult trade offs involved, and the article didn't give many details. Seems there is still work to be done:

Hatch, Republican of Utah , said yesterday that the issue is too important to try to pass before the Senate recess, expected at the end of next week .

``There's no question we can't do much in this Congress," he said. ``I look forward to working with [Waxman], if we can do a balanced approach -- because nothing else is going to pass."

One of the problems is going to be deciding whether or not to put biotech generics through clinical trials of their own. If they're not required to undergo trials, I'm curious to see how they deal with the reality that slightly different drugs will have different effects. Some good, some bad. Who is liable when they're bad, considering there were no trials? This article suggests the burden may be put on the prescribing doctors:

The FDA says it needs similar authorization before it gives copies of biotech drugs speedy reviews. Deputy Commissioner Janet Woodcock says the process would have to be different from the way traditional generic drugs are reviewed. That's because science hasn't advanced far enough for the agency to establish that the biotech copies are identical to the originals - only to say they are similar.

That's why the FDA calls imitations of biotech drugs "follow-ons," not generics. Likewise, the agency wouldn't allow pharmacists to freely substitute follow-on biotech drugs for originals, as they can do with traditional medicines. A doctor would have to specifically request the follow-on, unless the generic drug makers prove through studies that the original and its imitation are the same.

No doubt a lack of pharmacist discretion will mean less generics being used. If you couple that with how direct to consumer marketing campaigns increase prescription rates, it seems biotech companies would be able to defend their market share from generics much better than traditional pharma's can. I would be disappointed but not surprised to see marketing regulations in the bill.