QDIS Blog

The end of the year is always a time for reviewing what the year has held and making resolutions and predictions for 2007. With that in mind, I’d like to present my predictions of what may happen in the pharmaceutical and biotech industries in the year.

1. Biogeneric Regulations: The process for developing biogeneric regulations will get started in the US. This will likely be prompted by an act in Congress. I don’t expect for draft regulations for comment though to come out until sometime in early 2008. I think this is too bad and I personally would like to see regulations in place for comment before the end of 2007.
2. Mergers and Acquisitions: Mergers and big deals will continue in 2007 at full steam. Many of these will involve big pharma acquiring small biotech in order to fill their pipeline. Unfortunately, I don’t think the opportunities will pan out. The problem is that the principals involved in the small biotech that make it a success will not join the big pharma company. They will take their profits and most likley start another small biotech. The big pharma will not get the benefit that they tout to their investors for these purchases and will continue to pay too much for them on th fear that someone else will buy this small biotech instead.
3. Early Stage Deals: More deals will involve earlier and earlier stage products. Big pharma will be more willing to pay big prices for potential drug candidates at earlier stages of development in order to try and fill their pipelines.
4. DTC Advertising: Direct-to-Consumer (DTC) advertising will come under increasing attack and regulations will be enacted to prevent DTC ads in the first year of launching a new drug. Some companies have already said they will do this but I think it will become a matter of law.
5. The FDA: The FDA will be given additional powers to regulate drug post approval. This may include the ability to fine companies if they do not perform agreed upon studies within a certain timeframe.
6. The FDA; The FDA budget will be increase but only by a small amount: not enough to reflect what they actually have to accomplish.
7. Outsourcing: Although outsourcing will continue there will be a new move towards big pharma building R&D centers in China, and India.
8. Drug Imports: Congress will pass regulation to allow drug imports from a limited list of countries. This will be vetoed by the President.
9. Congress will discuss adding the ability for the Government to negotiate with drug companies for drugs covered by Medicare but legislation will fail.
10. Food Safety: Food safety will become an important topic and there will likely be at least one or two more national incidents involving more than 100 people. There will be talk in Congress of combining the USDA and the FDA food safety together but this will not happen.

Well, there they are in print and we’ll see at the end of 2007 how accurate these are.

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