From what I’ve been reading so far, the bipartisan Senatorial agreement on biogenerics sounds fairly reasonable. Apparently the bill would:
- Guarantee 4 years of exclusivity for the innovator firm, even if the patent is at or near expiration at launch. Seems reasonable
- Require a clinical trial, but allow FDA to waive that requirement. I like the second part
- Allow FDA to approve a drug as interchangeable –not just similar. That’s extremely important to the market’s development
- Provide one year of exclusivity to the first generic product. That’s ok, I suppose, but it means more time before prices drop significantly
The devil is in the details, so I’ll be interested to learn more. It’s also far from clear that this bill will ultimately be enacted. However, it’s better than what I expected to emerge.
I’m still in favor of my proposal for price regulation post-patent expiry. It’s more economically efficient and safer. Maybe someone will take up the idea if this current effort fails.June 25, 2007