Setting the Standard

Jun 01, 2006

Founded 1820, the United States Pharmacopeia (USP) is the standard-setting body for many drugs throughout the world. But new pressures on cost, an increasingly globalized industry tainted with substandard drugs, and the prospects of returning to an age when doctors—or in this case, manufacturers—compound drugs depending on the patient, means USP needs new ways to ensure quality. Here, Roger Williams, USP's CEO, sits down with Pharm Exec and offers some straight talk about how the organization is changing its role from a facilitator of quality to the engine driving it. What follows is an edited transcript of that discussion.

PHARM EXEC: USP was in the spotlight because of its role in developing formulary guidelines, which outline the categories of medications covered under Medicare Part D. What was it like to be on the inside of the organization?

WILLIAMS: The first year was incredibly intense. We pulled together a committee out of the existing members of our council of experts—our standards-setting body—and I think they did a terrific job. There were many philosophical and policy and political and economic and scientific issues they had to struggle with. But at the end of the day, they delivered, on time and unanimously, the model guidelines for the first round of drug plan formularies.

It seems that USP had to make a lot of tough decisions about which drugs are truly necessary.

That gets at the core issue—access. Interestingly, a healthy tension built up in the first committee, and it continued into the second committee that just completed its deliberations [for the revised model guidelines]. One side of that tension says, "If you want to assure beneficiary access, have a very granular structure to the formulary because then you make everything available." The other says, "If you want to assure access, start watching cost." And that leads to a less granular structure with fewer categories and classes of drugs.

Model Guidelines: Version 2.0
In the first round, the committee solved that issue by creating two approaches. One was the model guidelines, and the other was what we call the formulary key-drug types. The law said you had to have two drugs in every category class of the model guidelines, but you only have to have one in each formulary key-drug type. The difference between one and two has a lot of impact on the competitive bidding process.

How do formulary key-drug types work in practice?

Formulary key-drug types create unique categories, which allow new molecules and medicines to enter into the thinking of the committee. We then say to CMS, "You should have at least that one drug in the category." But over time, as we gain experience with that molecule and start getting a sense of comparisons with other similar agents, it may move back into the model guidelines and disappear as a discrete category.

I'll give you an example—SSRIs and SNRIs. When the first SNRI was coming out, the committee would have wanted to create that category in formulary key-drug types and put that one drug in it. Pretty soon, you'd have a group of drugs there, and people would start asking, "What are the difference between the SNRIs and the SSRIs?" Over time if there is no difference, they'll be in the model guidelines just as antidepressants.

How did the drug plans react to the idea of these new types of categories?

You could almost predict how they'd respond. The plans didn't like the formulary key-drug types because they added granularity and a requirement to have one drug in each group. But the plans did like the model guidelines.