Strategic Questions for 2K10 (Part 2 of 2)

Here is the second of two posts outlining major topics that I'll be watching in 2010, framed as strategic questions with links to relevant background posts. Please feel free to add your own strategic questions in the comments.

Strategic Questions for 2K10 (Part 1 of 2) appeared on Tuesday.

I'll be returning to regularly scheduled blogging tomorrow.

STRATEGIC QUESTIONS (#5 to #8)

5) Who will dominate the specialty channel? Specialty pharmaceuticals reach patients in two primary ways--via a wholesale distribution-to-provider channel and via a central-fill specialty pharmacy channel. I see specialty pharmacy channel growing faster than the provider channel given the bundling of specialty services with pharmacy benefit management and the reduced provider profitability for injection/infusion therapies under traditional buy-and-bill systems. But it will be an interesting turf battle.

• Specialty Spending Soars (for now)
• The Walgreens-McKesson Specialty Handoff
• Provider Pain in the Healthcare Supply Chain

6) How will brand drug manufacturers adapt to the new channel strategy challenges? Previously distinct distribution, dispensing, and contracting channels are converging into unified operating models that will seek to leverage influence against pharmaceutical manufacturers. These new organizations are aggressively competing with each other to gain a privileged position as consumer and clinical access agents. This competition (usually) benefits payers at the expense of generic and brand manufacturers. There will be new challenges in the coming year. Alas, the most interesting situations never make the news and hence I can’t report them on Drug Channels.

• The Evolving Retail Pharmacy Channel: Implications for Manufacturers
• Medco Takes on Eli Lilly
• How Generics Change the Market

7) Will a truly global drug wholesaler emerge in 2010? The drug wholesaling industry is in a period of relative stability. The fee-for-service transition is over; major contracts have been renewed (albeit at lower margins, naturally); the largest wholesalers are forward-integrating in specialty distribution and independent pharmacies; and overall market growth seems solid. International expansion—or a major acquisition by an international wholesaler—looks like a logical next step as the credit markets improve and the retail generic price war accelerates.

• Drug Wholesalers and the Generic Price War
• A Peek at Drug Wholesalers' Economics
• Profit Headwinds for Cardinal Health
• Why the UPS-Merck Deal Won’t Hurt Wholesalers

8) Will we ever get national supply chain security standards? Here’s another unanswered question from my 2009 list. Things have been very quiet ever since California pushed its e-pedigree deadline over the horizon to 2015, although some manufacturers are still proceeding with small e-pedigree and/or serialization trials. The Food and Drug Administration Amendments Act of 2007 empowered the FDA to take a stronger hand in these matters with Section 913, entitled “Assuring Pharmaceutical Safety.” (Click here to read this section.) Look for news from the FDA in March 2010.

• Federal Pedigree Sand Trap
• The FDA and EC Dive into Supply Chain Security
• Gray Market: I'm Not Dead Yet
• New FDA Chief's Surprising Link to Drug Wholesaling

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Any other suggestions for topics that I missed?