Doctor Group Sues FDA To Lift Dispensing Restrictions On Medication Abortion Pill
The lawsuit requests an emergency order lifting regulations requiring patients in the United States to pick up the drug at a hospital or medical facility. An attorney with the ACLU said that requirement puts patients at risk during the pandemic. News on the agency is also on relaxing food label rules and impurities in diabetes medicine.
Roll Call:
Physicians, ACLU Sue FDA Over Abortion Pill Limits
A group of medical providers represented by the American Civil Liberties Union sued the Food and Drug Administration on Wednesday, challenging federal requirements that limit how medication abortions are dispensed. The medical group coalition, led by the American College of Obstetricians and Gynecologists, opposes an FDA restriction on mifepristone, a drug used to end a pregnancy or for miscarriage management. Medication abortions use a two-pill regimen to end a pregnancy. (Raman, 5/27)
NPR:
Lawsuit Asks FDA To Lift Restrictions On Abortion Pill
In a federal lawsuit filed in Maryland on behalf of the American College of Obstetricians and Gynecologists (ACOG) and other groups, the American Civil Liberties Union requests an emergency order lifting regulations requiring patients in the United States to pick up the drug at a hospital or medical facility. Julia Kaye, an attorney with the American Civil Liberties Union, said that requirement is putting patients at risk during the COVID-19 pandemic. (McCammon, 5/27)
Bloomberg:
Doctor Groups Sue FDA To Ease U.S. Restrictions On Abortion Pill
“When it comes to patients who need to end an early pregnancy or treat a miscarriage, the administration is forcing them to travel unnecessarily to a hospital, clinic, or medical office just to pick up a pill they are already permitted to swallow later at home,” ACLU attorney Julia Kaye said in a statement. “It is unconscionable that the administration is singling out these patients for life-threatening risks.” The FDA regulates more than 20,000 drugs, but the abortion pill is the only one that the FDA requires be picked up in person, according to the ACLU. Mifepristone is sold as a brand drug by Danco Laboratories LLC and in a generic pill by GenBioPro Inc. (Koons, 5/27)
The Washington Post:
The FDA Relaxes Food Label Rules For Fifth Time During The Pandemic
The Food and Drug Administration has temporarily loosened labeling and information rules for food manufacturers for the fifth time during the novel coronavirus pandemic. The changes are intended to ease manufacturers’ supply-chain snags, but advocacy groups say they are concerned that the changes will become permanent and that they will present problems for consumers concerned about tracking the provenance of their food. (Reiley, 5/27)
Stat:
FDA Finds 'Unacceptable' Levels Of Possible Carcinogen In Diabetes Pill
After months of testing, the Food and Drug Administration reported finding unacceptable levels of a possible carcinogen in some metformin diabetes pills, marking the third time in two years that the same impurity was discovered in a widely used medicine. In a brief statement, the agency noted that traces of a possible carcinogen known as NDMA were found in extended-release versions of metformin, but not in immediate-release versions. As a result, the FDA is contacting manufacturers to take “quick and appropriate action,” but did not say whether any recalls have so far occurred. (Silverman, 5/27)
