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
07/3/2012
The Legal Eagle Eye: The Impact Of The SCOTUS Healthcare Decision
Why Chief Justice Roberts’s Opinion in NFIB v. Sebelius May Ultimately Advance Economic Freedom and Promote Limited-Government and Federalism Values
By Cause of Action Staff
Although at first blush it may appear that Chief Justice Roberts’s opinion in NFIB v. Sebelius upholding the Affordable Care Act’s individual mandate will lead to a dramatic expansion of federal regulatory authority, proponents of economic freedom, federalism, and limited government may be surprised to learn that Chief Justice Roberts’s opinion reaffirmed and strengthened important limits on the scope of federal power.
First, Chief Justice Roberts concluded that the Commerce Clause—even as augmented by the Necessary and Proper Clause—does not allow Congress to regulate inactivity: “The Court today holds that our Constitution protects us from federal regulation under the Commerce Clause so long as we abstain from the regulated activity.” (The four dissenting Justices—Scalia, Alito, Kennedy, and Thomas—agreed.) Second, Chief Justice Roberts—joined by Justices Breyer and Kagan—concluded that the Medicaid expansion was unconstitutional, reasoning that the portion of the law requiring the States to “either accept a basic change in the nature of Medicaid, or risk losing all Medicaid funding,” exceeded limits on Congress’s Spending Clause authority. (The four dissenting Justices reached the same conclusion.) He not only reaffirmed the principle that “Congress has no authority to order the States to regulate according to its instructions” but placed a new limit on Congress’s exercise of its Spending Clause powers: Congress can no longer use “coercive” financial incentives to compel States to adopt changes that it wants. Chief Justice Roberts went so far as to describe the Medicaid expansion as “a gun to the head” of the States and “economic dragooning” that is contrary to our system of federalism and principles of dual sovereignty.
With that said, Chief Justice Roberts’s opinion in NFIB v. Sebelius leaves open important questions that the Court may be required to answer in subsequent cases:
(1) Although Chief Justice Roberts noted that “Congress’s ability to use its taxing power to influence conduct is not without limits,” it is unclear what those limits are.
(2) It is uncertain whether Chief Justice Roberts’s conclusion that the individual mandate was unconstitutional under the Commerce Clause is part of the Court’s holding (and thus binding precedent) or merely dicta that other courts may ignore.
(3) It remains to be seen whether the fact that a majority of the Court believed that the individual mandate exceeded Congress’s Commerce Clause authority indicates a willingness to revisit—and scale back—prior case law interpreting Congress’s authority under that clause expansively.
(4) The extent to which Chief Justice Roberts’s new limiting principle for Congress’s use of its Spending Clause power will leave other federal statutes conditioning receipt of federal money on States adopting federal regulatory and policy mandates vulnerable to constitutional challenge is unclear.
Finally, it is worth briefly noting that Chief Justice Roberts’s opinion upholding the individual mandate should not be read as a ringing endorsement of the Affordable Care Act but rather as an invitation for “We the People”—the ultimate sovereign in our constitutional system of limited government—to resolve the issue through the democratic process:
The Framers created a Federal Government of limited powers, and assigned to this Court the duty of enforcing those limits. The Court does so today. But the Court does not express any opinion on the wisdom of the Affordable Care Act. Under the Constitution, that judgment is reserved to the people.
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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