Trending News Today: FDA Draft Guidance Encourages Broader Inclusion Criteria for Antidepressant Trials

In a new draft guidance, the FDA is encouraging drug manufacturers to include patients with a history of suicidal thoughts or behaviors in clinical trials for antidepressants, STAT reported. According to the article, drug manufacturers often exclude potential research participants with a recent history of suicidal thoughts or behaviors, citing safety concerns or other issues. Although the agency does not require companies to include these patients, the guidance states that trial sponsors that set restrictive criteria should be prepared to explain their decisions to the FDA, the article reported.

A new study found that women who develop high blood pressure during pregnancy may be more likely to experience risk factors for heart disease afterward, Reuters reported. According to the article, the researchers examined data on almost 59,000 women who gave birth for the first time between 1964 and 2008. Compared with women who had normal blood pressure throughout their first pregnancy, women who developed gestational hypertension were almost 3 times more likely to have high blood pressure again and women with preeclampsia had more than double the risk, the article reported.

Democratic Sens. Elizabeth Warren (Mass.) and Tina Smith (Minn.) are probing 9 drug distributors and pharmacy benefit managers (PBMs) over high drug prices, The Hill reported. According to the article, Warren and Smith are asking the companies to respond to Secretary of Health and Human Services Alex Azar’s comment that drug companies want to reduce prices but are being blocked by PBMs and drug distributors. Warren and Smith wrote letters to the companies asking if they had engaged in any discussions with drug companies seeking to reduce their prices and how they responded to those efforts.