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What We’re Reading: Health Care Antitrust Portal; CAR T Label Updates; Weight-Loss Shots and Fertility

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Government agencies have created an online portal for the public to report potential anticompetitive practices in health care; there are changes coming to the “boxed warning” section for chimeric antigen receptor T-cell therapies (CAR T) to highlight T-cell blood cancer risk; questions about the safety of obesity medications during pregnancy have arisen in women on them who previously struggled with fertility issues.

Federal Government Launches Health Care Antitrust Reporting Portal

The Justice Department, Federal Trade Commission (FTC), and HHS have created an online portal for the public to report potential anticompetitive practices in the health care sector, according to Modern Healthcare. HealthCompetition.gov is the latest effort from the Biden administration and government agencies to promote competition in health care markets in hopes ofing lower care and prescription drug costs. Examples of health care business practices that can hinder competition include collusion or price fixing among competitors, and limiting choice and fair wages for employees. The Justice Department’s Antitrust Division and the FTC will review complaints, which may lead to further action.

FDA Mandates CAR T Label Updates

The FDA has announced that cancer therapies using chimeric antigen receptor T-cell (CAR T) technology will require changes to their “boxed warning” to highlight the associated risk of T-cell blood cancer, according to Reuters. The therapies affected include those made by Johnson & Johnson, Gilead Sciences, and Novartis. The FDA is also requiring updates to other sections of the label, including patient counseling information and medication guide, warnings and precautions, and postmarketing experience. It explained that those receiving treatment with these products should be monitored throughout their life for secondary malignancies, and the manufacturer should be notified of any new malignancy.

Ozempic Babies Spark Debate About Weight-Loss Shots Used as Fertility Treatment

Questions about the safety of obesity medications during pregnancy have arisen as pregnancies are increasingly being seen in women taking them who previously struggled with fertility issues, according to Bloomberg. These stories have encouraged doctors to use them to treat polycystic ovary syndrome (PCOS), one of the leading causes of infertility in US women; however, they are doing so without much data on how the drugs impact pregnancy. Consequently, researchers are conducting studies to figure out if the drugs work for PCOS, and regulators have asked companies to collect any data they can about their use during pregnancy. The safety data look promising so far, as a recent study found no increase in birth defects among those who used the drugs in very early pregnancy compared with those who took insulin; the researchers noted that additional confirmation is needed, especially in women without diabetes.

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