Video: Questioning FDA Regulation of Private Sperm Donation
11/18/2012
07/12/2012
ABC News Reports On Cause of Action’s Suit Against the FDA
Read the full article here. ABC News
“This means the FDA can reach into your bedroom and tell you how to procreate,” said her lawyer, Amber Abbasi, chief counsel for regulatory affairs at government accountability advocacy organization Cause of Action.”The FDA taking the position that donors, even when there’s no commercial element, are ‘an establishment,’ just like a sperm bank and have to register,” said Abbasi, “this is a serious burden on the reproductive freedoms of both the recipient and the donor.”
Abbasi said her client wanted to obtain fresh donor sperm from an individual she selected and implant it herself in a process known as intracervical artificial insemination — injecting the semen into her cervix — using a syringe, which does not require medical supervision. According to the lawsuit, Doe felt it was important for the biological father to be present in her child’s life, if he or she so desired. Doe did not want to visit a sperm bank for an anonymous sample, a process noted to be “costly and burdensome” for couples looking to get pregnant…”It is a real problem for [the FDA] to treat women like Ms. Doe, who has to become pregnant by artificial insemination because she’s in a lesbian relationship,” said Abbasi…”
07/11/2012
KKSF Radio: Amber Abbasi Discussing Suit Against the FDA
Amber Abbasi joined Gil Gross to discuss Cause of Action’s suit against the Food and Drug Administration for their unfair regulation of sperm donation.
07/9/2012
SFGate: Woman sues FDA for right to use donor’s free sperm
Read the full story here. SF Gate
“So “Jane Doe,” as she calls herself, is suing. Cause of Action, a government accountability group, has filed a lawsuit in U.S. District Court for the Northern District of California on her behalf against the FDA… Those rules, argues Cause of Action in the lawsuit filed last week, are “costly and burdensome” and “unconstitutional to the extent that they operate to regulate noncommercial, sexually intimate choices and activity.”
“If there are donors like this who are not charging as a service, and not serving as a business, the FDA should not be intervening,” said Amber Abbasi, the group’s chief counsel for regulatory affairs….”
07/6/2012
Fox News: Woman sues FDA for right to select sperm donor, bypass sperm bank
Woman sues FDA for right to select sperm donor, bypass sperm bank
By Judson Berger Published July 03, 2012
A California woman pursuing artificial insemination is suing the federal government for the right to choose how she’ll get the sperm.
The unusual case was filed Monday in U.S. District Court. On the heels of the Supreme Court decision upholding the federal health care overhaul, the plaintiff in this case is challenging another area of federal health care regulation.
At issue are Food and Drug Administration rules that set standards for sperm banks — like requiring tests for communicable diseases. But the woman in the California suit doesn’t want to go through a standard sperm bank or other clinic. The anonymous plaintiff instead, according to the suit, wants to use the sperm of someone she knows — at no cost — without going through all the federal regulatory rigmarole.
She and her lawyers call the FDA rules an unconstitutional violation of her rights — that is, her right to start a family with whomever she wants.
“When you are regulating private decisions between two individuals in a non-commercial context that have to do with something so intimate and personal as whether they want to have a child together, then the FDA regulations should not apply,” Amber Abbasi , attorney in the case, told FoxNews.com.
Abbasi’s group Cause of Action filed the suit on the California woman’s behalf.
The plaintiff did not release her identity, but according to Abbasi her situation is as follows:
She’s in a relationship with another woman and would like to conceive a child. She does not want to go to a regulated sperm bank because she wants to know the biological father and wants the child to know the father as well — and she’s concerned about the cost of going through a sperm bank.
The argument may have gotten a boost with the high court ruling last week, which upheld the health care overhaul but at the same time affirmed limits on the Constitution’s so-called Commerce Clause.
“The Commerce Clause is not a blank check,” Abbasi said. Their suit claims, among other things, that the federal regulations on sperm donation overstep the Commerce Clause.
The FDA rules stem from a 1944 law passed by Congress allowing for regulations to prevent the spread of communicable diseases. The FDA later applied those regulations to sperm banks and donors, as part of the effort to prevent infection from a range of diseases.
Abbasi, in explaining her client’s concern, pointed to the FDA’s 2010 decision to order one California sperm donor to cease and desist over concerns he wasn’t following FDA standards.
Their current lawsuit questions the extent to which the rules have been applied, suggesting there’s a double standard.
The plaintiff “does not want to be forced to engage in sexual intercourse with a male partner to conceive a child, even though such a male partner would not be subject to FDA-required screening and testing and other FDA-mandated donor-eligibility requirements,” the suit says.
The plaintiff in the case wants the court to declare as unconstitutional any rule that would regulate “private, uncompensated” sperm donations.
A representative with the FDA did not return a request for comment on the case.
07/6/2012
Media Highlights CoA Lawsuit Against the FDA
Cause of Action filed a lawsuit last week in the U.S. District Court of Northern California on behalf of a Bay-Area woman whose plans to start a family have been blocked by overregulation by the Food and Drug Administration (FDA). This is an important case related to government overreach and constitutional issues. Read the following stories to see how the media are covering the issue:
Woman sues FDA for right to select sperm donor, bypass sperm bank
Woman sues FDA over right to select her own sperm donor
07/2/2012
Cause of Action Sues FDA For Overreach Into Private Lives
CAUSE OF ACTION SUES FDA FOR OVERREACH INTO PRIVATE LIVES
FDA prohibits a form of artificial insemination, attempts to define relationships
WASHINGTON – Cause of Action, a nonpartisan nonprofit based in Washington, DC, filed a lawsuit today in the U.S. District Court of Northern California on behalf of a Bay-Area woman whose plans to start a family have been blocked by overregulation by the Food and Drug Administration (FDA).
Citing FDA regulations on sperm donation, Cause of Action states that the plaintiff’s ability to become pregnant through the means of her choice has been directly affected. Cause of Action argues that the right to procreate is fundamental and one that cannot be regulated by a government agency.
“We don’t think the FDA’s intentions are bad—they are trying to protect the public from communicable diseases—but this is literally stepping between two people who have agreed to have a child; the FDA should not regulate that,” said Cause of Action’s Chief Counsel for Regulatory Affairs Amber Abbasi.
Abbasi explains in Cause of Action’s complaint that the plaintiff wants to conceive a child by means of artificial insemination without a medical intermediary such as a donor bank, but is prohibited from doing so by FDA regulations.
Federal regulations set standards for manufacturing and distributing human cells, tissues, and tissue-based products, but they treat noncommercial, individual actors the same as commercial establishments, making any individual a potential human cells, tissue, and tissue-based product producer. Once an individual is labeled as a manufacturer, he is subject to the same regulatory standards as sperm banks. The FDA does exempt people engaged in sexually intimate relationships from the standard, but it is with the government’s attempt to define “relationship” that Abbasi and Cause of Action take the most issue.
“Essentially, the FDA is trying to define a personal relationship and regulate individuals’ intimate decisions,” said Abbasi. “These actions grossly exceed the reach of the FDA’s regulatory authority. If unchecked, it could set a dangerous precedent for the future.”
The lawsuit asks the federal district court to declare the FDA’s regulatory overreach unconstitutional, which will allow the plaintiff to start a family as she desires.
“This case really highlights how arbitrary regulations can take away freedom,” said Dan Epstein, executive director of Cause of Action. “Cause of Action is committed to exposing instances like these where the government is threatening freedom with rogue regulations.”
About Cause of Action:
Cause of Action is a non-partisan, non-profit organization that uses public advocacy and legal reform tools to ensure greater transparency in government, protect taxpayer interests and promote economic freedom. For more information, visit www.causeofaction.org.
To schedule an interview with Amber Abbasi, Cause of Action’s Chief Counsel for Regulatory Affairs, contact Mary Beth Hutchins or Briton Bennett at 202-507-5880.
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