{"id":202333,"date":"2019-05-17T17:30:41","date_gmt":"2019-05-17T22:30:41","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=202333"},"modified":"2022-04-21T07:20:03","modified_gmt":"2022-04-21T12:20:03","slug":"defies-fda-dispense-abortion-pills-illegally","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/defies-fda-dispense-abortion-pills-illegally\/","title":{"rendered":"Group vows to defy FDA, continues dispensing abortion pills illegally"},"content":{"rendered":"
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Just days after 100 lawmakers sent a letter<\/a>\u00a0to the Food and Drug Administration (FDA) — which oversees drug safety — requesting that the FDA monitor abortion group Aid Access for illegally dispensing abortion pills, Aid Access announced<\/a> its intent to defy the FDA’s\u00a0warnings<\/a> to “immediately cease” dispension of the drugs.<\/p>\n

Aid Access founder Rebecca Gomperts\u00a0published<\/a>\u00a0her response on Aid Access’s\u00a0website<\/a> as well as on Women on Waves, another organization Gomperts founded<\/a> in 1999. Gomperts claims, “Last year, I prescribed 2,581 medical abortions out of 11,108 women who consulted me.”<\/p>\n

Gomperts states in part:<\/p>\n

On March 8, 2019, I received a\u00a0letter from the FDA\u00a0<\/a>ordering my new (since 2018) organization,\u00a0Aid Access<\/a>, to stop providing telemedical abortion services to women who cannot otherwise access safe abortions because of costs, domestic violence, distance, or other reasons, and who do not have access to other doctors willing or able to prescribe misoprostol and mifepristone.<\/em><\/p>\n

This letter was\u00a0applauded by Republican members of Congress<\/a>, of whom 92 percent are male.<\/em><\/p>\n

But I will not be deterred. When U.S. women seeking to terminate their pregnancies prior to 9 weeks consult me, I will not turn them away. I will continue to protect the human and constitutional right of my patients to access safe abortion services.<\/em><\/p>\n

Notably, the Congressional letter<\/a> was signed by a number of women in Congress, including Reps. Martha Roby, Carol D. Miller, Virginia Foxx, Liz Cheney, Ann Wagner,\u00a0Jenniffer Gonz\u00e1lez Col\u00f3n, Debbie Lesko, and several medical doctors<\/em> who also serve in the House of Representatives, among many others.<\/p>\n

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Rebecca Gomperts founder of Aid Access defiant to offer illegal abortion pills online (Image: Twitter)<\/p><\/div>\n

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In a statement to Live Action News, the FDA wrote:<\/p>\n

As noted in the FDA\u00a0warning letter<\/a>\u00a0to AidAccess issued on March 8, 2019, failure to correct the violations of the law may result in FDA regulatory action, including seizure or injunction, without further notice. We cannot comment on a potential future action at this time, but we remain very concerned about the sale of unapproved mifepristone for medical termination of early pregnancy on the Internet, because this bypasses important safeguards designed to protect women\u2019s health. Unapproved drugs purchased from foreign internet sources are not the FDA-approved versions of the drugs, and therefore, they are not subject to FDA-regulated manufacturing controls or FDA inspection of manufacturing facilities. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.<\/em><\/p>\n<\/div>\n<\/div>\n<\/div>\n

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The statement went on to say that “The FDA\u2019s regulation and oversight of the drug approval process and drug distribution helps to protect patients by applying rigorous scientific and safety standards, requiring labeling review for accuracy and completeness, and working to ensure that counterfeit and unsafe medicines do not enter the U.S. drug supply. When these requirements are not met, FDA can step in to help protect consumers.” The FDA reiterated that it has warned AidAccess.org and Rablon that they are in violation of the Federal Food, Drug, and Cosmetic Act for causing the introduction of unapproved new drugs into U.S. commerce.<\/p>\n<\/div>\n<\/div>\n<\/div>\n

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Drugs are tightly regulated by the FDA for a reason, and under current requirements, the abortion pill — also known as Mifeprex or Mifepristone — is only permitted to be dispensed in hospitals or clinics by medical personal who are approved prescribers of the pill. FDA placed Mifeprex under a tighter regulatory system known by the acronym REMS (Risk Evaluation and Mitigation Strategy<\/a>), \u201ca safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use.\u201d<\/p>\n<\/div>\n<\/div>\n<\/div>\n

Under the Mifepristone REMS Program, the FDA states, \u201cMifeprex and the approved generic version of Mifeprex\u201d may:<\/p>\n