| ![]() ![]() Tackling the critical question of drug regulation Peter Folb Medical Research Council South Africa ![]() ![]() ![]() What might be done to address the situation 1. Set standards that are essential for sound medicines, taking into account a global risk-benefit perspective in relation to the needs of patients. 2. Do not allow unrealistic, expensive, and unnecessary defensive research. 3. Arrange early dialogue meetings with NRAs, at which applicants describe their plans for development and testing of their drugs with expert knowledge, authority, understanding, and strategy, to be repeated if necessary later in the development process. 4. Strengthen the WHO prequalification system. 5. Set strict limits on the claims and indications for new drugs, confined to the essential purpose for which they are developed. 6. Encourage a regional approach to evaluation of critically needed new medicines so that expertise and administrative load in the review process might be shared and expedited, and systems put in place for post-marketing surveillance so that the best standards for safety review are assured even after registration approval. These actions, taken together, would help address the weaknesses in the present system and the isolation in which NRAs currently make their decisions. It is not being proposed that standards should be lowered. On the contrary, the idea is to raise them in a manner that will make it possible for altruistic and competent organisations to discover and develop new drugs for neglected diseases that no-one else dares (or cares) to do. 1 This refers to the International Conference on the Harmonization of Technical Requirements of Pharma-ceuticals for Human Use. It is an initiative spearheaded by the international pharmaceutical industry and the national drug regulatory authorities of the US, Europe, and Japan, with the WHO and other countries having (and accepting) observer status. The Rotavirus Vaccine Story In 1999, a new vaccine against rotavirus was taken off the market in the US due to a small number of adverse effects (approximately 20 cases out of half a million children vaccinated). Rotavirus infections cause 3 million cases annually in the US, but only around 100 deaths in children. Given the small chance of death, it was considered that the vaccine-related increase in occurrence of intussusception (a potentially life-threatening bowel obstruction) was an unacceptable risk to the population. So the vaccine did not make it to the market and a million children died every year due to the lack of a vaccine. Philippe Kourilsky, Le Monde, 07.02.04, "L'éthique du Nord sacrifie les malades du Sud" (trs). Today, a new rotavirus vaccine, Rotateq, made by Merck is at last available for patients in the US (FDA approval 3 February 2006). At $187.50 for three oral doses, this is one of the most expensive vaccines sold, unaffordable by the rest of the world, where children continue to die. | ||||||||
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