Clinical research on some drugs for pregnant and lactating women sometimes tries to stop for legal, ethical and safety reasons, when there is not enough clinical evidence to give them the desired reliability. This is because some drugs used in this population group have a potential risk of adverse effects for children.

Animal experimentation is not applicable in most cases due to the unique characteristics of pregnancy in humans.

A recent revision of the “Common Rule” that regulates who should be the candidates to participate in clinical trials, eliminated pregnant women from the classification as a “vulnerable” population, so they can be included in the study populations of these trials. This measure can change the conditions of research and facilitate the research and development of useful and safe drugs in pregnancy and lactation according to specialists (see HERE).

An article published in “American Journal of Obstetrics and Gynecology” supports the expansion of medical research in this group of women, to respond to the current challenges presented by obstetric pharmacology and to explore alternative strategies for future investigations of therapeutics of accuracy in pregnant and lactating women.

The study also highlights the reluctance of pharmaceutical laboratories to investigate in this field because they understand that the investment does not compensate for the potential economic benefits, given the obstacles and delays that the approval of a new drug in this field by the U.S. Food and Drug Administration may suffer.

Bioethical assessment

A correct balance of the benefit/risk ratio of research in pregnant and lactating women should mark the limits of future trials, which, in this way, will contribute to improving the therapeutic arsenal available for the needs of this population.

As is the case with rare diseases, pharmaceutical research for which future profitability difficulties are foreseen, as it is aimed at relatively small populations, should be promoted by public bodies in order to ensure that these patients have equal access to the necessary treatments of conditions with the rest, as established by the bioethical principles of Justice, Solidarity and Subsidiarity.


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