EIWH pays tribute to pioneer in public health and patient safety.

17 August 2015 – Last week, Dr. Frances Oldham Kelsey, the FDA regulator and worldwide pioneer in medicines safety and the protection of patients, died at the age of 101. As a young scientific officer, freshly employed by the FDA, she stubbornly questioned the evidence of the safety data submitted for the market authorization of Thalidomide.  The drug became notorious for causing birth defects when taken by pregnant women against morning sickness.

Frances Kelsey’s persistence to refuse authorization in light of fierce pressure from the manufacturer of Thalidomide, spared American women from experiencing the series of tragic birth defects and death the drug had caused in Europe where the medicine was available.

She also changed regulatory history: following the Thalidomide disaster, the US government revised the regulation of pharmaceutical products. Medicines approval is now based on the criteria of quality; safety and efficacy, which is still the gold standard, used today by the FDA and here in Europe by the European Medicines Agency (EMA) and national medicines agencies.

From the scientific, societal and women’s health perspective this was an enormous achievement for a young female scientist in the 1960s and we can only hope for another pioneer like Frances who will take us to the next rigorous step of patient protection.

Even today we are faced with a situation where approval data is not always robust for women and older people since, for safety reasons, they are still all too often excluded from clinical trials, yet these population groups are the heaviest medicine takers. In addition, it is estimated that currently around 80% of pregnant women take medicines during pregnancy often due to already existing chronic conditions.

As more and more women postpone pregnancy until later years, this will become a societal concern that needs urgently addressing”,

said Peggy Maguire, EIWH Director General.

A step forward will be provided by the new EU Clinical Trial Regulation, which came into effect in May 2016.  This new legislation will require population group analysis according to gender and age. The number of men and women included in the trial will have to be made more transparent, while strict protective measures to include pregnant and lactating women in clinical trials will be required.

Our recent EUGenMed Roadmap conference, which examined sex and gender in pharmaceutical regulation, recommended that Europe improve rigorous sex- and age-specific pharmacovigilance reporting for existing products.  In order to address the current knowledge gap, a regulatory framework should be developed for safe use of medicines during pregnancy, which should include post-marketing data collection and common rules for pregnancy exposure registries,“

concluded Hildrun Sundseth, EIWH President.

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