A Boston Globe article, Lobbyists focus on safety in debate over generic drugs, describes the positions taken by the biotech industry and generic industry over proposals to create a regulatory pathway for generic versions of biotech drugs. In essence:
- Biotech manufacturers want generic players to conduct extensive clinical trials before gaining regulatory approval. According to their association, “Unlike a pharmaceutical product, where you can simply demonstrate that you have the same chemical formula and you don’t need the clinical data, a follow-on biologic is a very, very different process.” Obviously this will drive up the cost of entry dramatically and delay the introduction of new products.
- Generic manufacturers admit there is something to the argument, but they want legislation to explicitly authorize biotech generics.
Generic versions of chemically based drugs have helped keep drug spending under control, and there’s an implicit assumption that the only way to control biotech prices is with biogenerics. However, there is another way, as I’ve discussed in A better idea than biogenerics:
- Allow biotech drugs to be approved and marketed as they are now, without price regulation
- After patent expiration or after a certain number of years on the market, regulate price. The price could be based on cost of goods, a percent of the previous selling price, or some other mechanism
Biotech and generic company lobbyists aren’t going to be interested, but lobbyists for taxpayers should be!