WHO MODEL DRUG FORMULARIES ARE DESIGNED FOR DEVELOPING NATIONS, COULD BE MISUSED IN WESTERN COUNTRIES BY INTERNATIONAL CONSUMER ORGANIZATIONS, PMA SAYS
Executive Summary
Model drug formularies being developed by the World Health Organization could be used by international consumer groups to influence drug use patterns in Western countries as well as in developing nations, PMA International VP Jay Kingham maintained at a Nov. 25 press conference. Pointing out that World Health Organization staff "has begun work on what they call a model formulary for the world," Kingham noted that "during the course of this work, WHO will necessarily make judgments about the comparative safety, efficacy and general merits of competing therapies." Kingham said WHO maintains "that the formulary is really designed for the developing countries." However, PMA believes the formulary "would be highly susceptible to misuse by consumer activists and others in the developed countries who could point to decisions by WHO as to which drugs are better than others." For PMA, Kingham added, the concern about "the list of WHO recommendations as to which drugs are better than others is more here at home than it is in the developing countries." Consumer activist groups could use "the prestige of the World Health Organization on a list of drugs or formulary to say that it was the gospel and lobby for that point of view in the U.S. and Europe," Kingham said. He explained that "our concern is worldwide, but the majority of the sales of our companies occurs in Western countries, and we are concerned particularly about the misuse of these WHO guidelines in the West." The U.S. government, Kingham said, "as well as some other European, Western, governments oppose this type of work by WHO. That is, any effort to make comparative judgments on the merits of different drugs, whether it is done under this rubric of a formulary or otherwise. They oppose it because it ignores the differences in medical practice which occurs among nations, and because it also ignores the very legitimate differences between regulatory authorities around the world." Association President Mossinghoff commented that "there is a strong feeling that a bureaucratic system in Geneva is exactly the wrong approach to what are medical judgments based on national and local circumstances. So I think there is a broad concern." The threat of a WHO formulary has arisen just as concern about a marketing practices code was subsiding. WHO "does not have the resources to put out a version of the Merck Manual. They don't have the money to do that. As far as I know they only have one doctor working on this, and he is not a specialist in these areas. It is just a presumptuous thing for them to be doing, to try to be telling the world what medicine is better."
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth