Setting the Standard - Pharmaceutical Executive


Setting the Standard

Pharmaceutical Executive

Despite that, in the first round, the committee had a lot of success. About 75 plans use the model guidelines. It'll be interesting to see how many use them the second go around, which will start this spring when CMS begins to evaluate the formularies for January '07.

What was different about developing the second model guidelines?

That tension I spoke about seemed to resolve in an interesting way. For new drugs with a defined new pharmacologic effect, the committee in this cycle wanted to create the category in the formulary key-drug types. Yet they were also willing to consolidate the model guidelines.

Another point of note is that the committees themselves decided they wanted to be more evidence-based. With the development of the first model guidelines and the formulary key-drug types, we relied on practitioner experience—doctors that say, "I really need that drug." Going forward, we would like to have it based more on evidence, and more on the literature.

I'm pleased about that, but also a little concerned. This is one of those initiatives that Congress authorized, but didn't appropriate. Every year, we have to argue with the CMS bureaucracy for support. And let's face it, they're not willing to give us much. I don't know why that is. You would think they'd give us some resources to do what could be a very powerful job on their behalf. We're a very small part of this gigantic enterprise they're engaged in, but I think not an unimportant part.

It does seem that USP flies under the radar of other stakeholders as well—most consumers have never even heard of the group.

No Room for Error
USP is very unusual in the pharmacopeias of the world in that it's a practitioner-based organization. And yet, as part of their day-to-day lives, practitioners don't care much about the standards. But they do care about some of the healthcare information and safety programs (see "No Room for Error").

Why don't they care? Do they just take high-quality medications for granted?

They do. They assume that FDA's looked at it, USP's on the beat, and that manufacturers are trying to do a good job—which for the most part is quite true. When they use their ibuprofen tablets, they don't usually question, "Do they have ibuprofen in them? Is it the right amount of ibuprofen? What about the release?" They assume that the fact that it is on the market is a manifestation of its adherence to good quality standards.

Isn't that at least kind of true?

FDA and industry and USP have done a terrific job of relieving the practitioner of that burden. But in some areas, it's not quite true. In the area of dietary supplements, FDA oversight was diminished substantially, and even now, we don't have GMPs [for manufacturers of dietary supplements]. For them, adherence to a USP monograph is optional. So all those safeguards that give practitioners assurance about the quality of a dietary supplement are diminished.


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