A Hypothetical Case:

UNITED STATES of America, Plaintiff, v. 
Clonaid Company, a Biotechnology Corporation, Defendant

Food and Drug Law
Professor Peter Barton Hutt
March 2003
(Course Requirement)

Chun-Ying Wu
LL.M. Candidate of 2003
cwu@law.harvard.edu

TABLE OF CONTENTS

CASE SUMMARY
PROCEDURAL POSTURE:
OVERVIEW:
OUTCOME:

I. BACKGROUND:
1.1 Clonaid Company:
1.2 SCNT technology:
1.3 The Food and Drug Administration (FDA):
1.4 FDA’s authority to regulate SCNT technology:
1.5 The Suit: UNITED STATES of America v. Clonaid Company

II. LEGAL STANDARD:

III. ANALYSIS:
3.1 The Statutory Authority Arguments:
3.2 The Role of FDA in Morally and Ethically Controversial Issues:
3.3 The Procreation Right Arguments:
3.4 The Religious Liberty Issues:
3.5 The Scientific Research Freedom Issue:
3.6 The Safety Issues:
3.7 The Utility Issues:

IV. ORDER

DATED: March 3, 2003

A hypothetical Case: 
UNITED STATES of America, Plaintiff, v. 
Clonaid Company, Defendant

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF FLORIDA
		March 2, 2003, Decided
		March 3, 2003, Filed
CASE SUMMARY
PROCEDURAL POSTURE: 
The government took the place of FDA to bring a suit against Clonaid Company to grant preliminary injunction to enjoin defendant Clonaid Company from cloning human beings and using human embryos in SCNT research in violation of the Federal Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. §321 et seq and the Public Health Service Act (PHSA), 42 U.S.C. §262 et seq.   
OVERVIEW:
In response to government’s motion for injunction, the defendant, Clonaid, first challenges the statutory authority of FDA to regulate human cloning. Then Clonaid asserts that FDA should not play a role in this ethically and morally debated issue. Secondly, Clonaid argues that its activity of human cloning is a right to procreate and a right of religious liberty. Human cloning research is a kind of speech, which should be protected by Federal First Amendment. In response to FDA’s major concern – safety issue, Clonaid asserts that safety is not an issue here. And Clonaid argues from the utility viewpoint that SCNT is a very promising biotechnology. Prohibiting SCNT technology will deter patients from receiving better treatments.
The court has read the plaintiff’s moving and defendant’s responding documents and heard the argument of counsel. The court preliminarily enjoins defendant Clonaid Company from cloning human beings and using human embryos older than 14 days in SCNT research without FDA’s regulation. 
OUTCOME:
The court preliminarily enjoins defendant Clonaid Company from cloning human beings and using human embryos older than 14 days in SCNT research without FDA’s overlook. Using human embryos younger than 14 days in SCNT research is not prohibited. 

CHUN-YING WU, United States District Judge

ORDER GRANTING PRELIMINARY INJUNCTION
Plaintiff government’s motion for preliminary injunction was heard by the court on January 22, 2003. The court has read the plaintiff’s moving and defendant’s responding documents and heard the argument of counsel. The court preliminarily enjoins defendant Clonaid Company from cloning human beings and using human embryos older than 14 days in somatic cell nuclear transfer (SCNT) research without Food and Drug Administration (FDA)’s overlook. Using human embryos younger than 14 days in SCNT research is not prohibited.

I. BACKGROUND:
1.1 Clonaid Company:
Clonaid is a private human cloning company founded in February 1997. This company is established by Rael who is the leader of the Raelian Movement, a religious group believes that human beings are created by aliens with genetic engineering method. Clonaid offers services to clone human beings for their potential clients, such as infertility couples, homosexual couples, or persons losing their beloved relatives, etc. On December 27, 2002, Rael announced that the first human clone, a baby girl named “Eve,” has been born in Florida. By February 4th, 2003, Clonaid has announced five clone babies born by their company. For security reasons, Clonaid does not explore the location of its company and the exact birth places of the clone babies. Actually, the authenticity of the clone babies has never been proved. Many scientists doubt the ability of Clonaid to clone human beings. 

1.2 SCNT technology:
	Although Clonaid does not explain how they clone human beings, it is believed that Clonaid applies the same techniques developed for Dolly, the somatic cell nuclear transfer (SCNT) technology, to clone human beings. SCNT is a kind of cloning technique. Cloning is a method to make genetically identical copies of biological materials, such as DNA fragments, cells, plants, animals, or human beings. Currently, there are three kinds of cloning technology. Molecular cloning and cell culture are the first type of cloning, which is widely used in laboratories and is less controversial. This type of cloning replicates DNA or RNA fragments, cultivate different kinds of cells in vitro, or even creates unique cell lines. The second type of cloning technology is called “embryo splitting”. Occasional embryo splitting occurs naturally and leads to twins, or triplets. This technology uses the splitting ability of the early embryos, the blastomere stage, to make genetically identical embryos. The third kind of cloning is SCNT technology. SCNT is a biotechnology to transfer a somatic cell nucleus into an enucleated oocyte. After the transfer, serial reprogramming mechanisms are activated to direct the cell developing into an embryo. The embryo is a precise genetic copy of the somatic cell nucleus donor except the mitochondrial DNA. 
	 Although SCNT technology has been successfully used to clone many species of animals, SCNT technology is still not a mature technique. Take Dolly for example, Dolly was the only one survivor to birth out of 277 successful SCNT. And she only lives 6 years, about half of the normal life expectancy for sheep. The very high rate of developmental failure and abnormalities as well as the premature aging and death are very common in the cloned animals. Even the apparently normal cloned animals may have potential abnormal gene expression. These unfortunate consequences come from the flaws in the current SCNT technology. The most difficult part for SCNT technology is the reprogramming of the fused oocytes. A somatic cell nucleus is a differentiated and aged nucleus. When the somatic cell nucleus is transferred into an enucleated oocyte, serial complex mechanisms, such as cell cycle regulation, DNA methylation patterns, X-chromosome inactivation or telomere length readjustment, should be regulated precisely to induce the oocyte to become an embryo. If any part of the mechanisms are not well controlled, gestational or neonatal fatality and premature death will occur. Researchers have shown in animal studies that no reprogramming of the genome results in immediate death of SCNT embryos. Partial reprogramming allows the embryos to survive, but leads to abnormalities and/or lethality at various stages of development. Precise reprogramming of the genome will produce normal animals. The problem is that current SCNT technology is unable to provide a reliable and faithful reprogramming to clone a human embryo. Current SCNT technology is far away from a safe and efficient technique to clone a human being. 
According to its application, SCNT can be divided into reproductive SCNT and therapeutic SCNT. Reproductive SCNT is the technology used in Dolly to clone a biological creature. Another SCNT is called “therapeutic” cloning, in which embryos are created through SCNT technology to provide stem cells, then induced to differentiate into different types of cells, tissues or even organs. This kind of SCNT technology is promising to provide plenty histocompatible cells, tissues and organs for a wide range of diseases of patients, including motor neuron degeneration diseases, stroke, myocardial infarction, diabetes, liver cirrhosis, spinal cord injury patients, etc. Although the promise of the therapeutic SCNT technology is questioned by many people, 40 Noble laureates have expressed support for the work, they said “if there is a dearth of scientific evidence, proponents of the research say, it is only because cloning is in its infancy.” 

1.3 The Food and Drug Administration (FDA):
The Food and Drug Administration (FDA) is the major government agency responsible for the safety and efficacy of foods, drugs, medical devices, cosmetics, and biologics. According to the Food, Drug and Cosmetic Act of 1938 (FDCA) , 21 U.S.C. §321 et seq, and the Public Health Service Act (PHSA) , 42 U.S.C. §262 et seq, FDA has the authority to regulate drugs, medical devices and biologics. Take drugs for example, the pharmaceutical companies must prove the safety of their products before testing the products on human subjects by completing an Investigational New Drug Application (IND). Before the marketing, the pharmaceutical firms have to comply with the requirements of the New Drug Application (NDA) to show that their drugs were safe and effective. Generally, a new drug must proceed three stage and three phase studies to confirm its safety and efficacy before marketing: 
Stage I: basic investigation to understand the possible mechanisms
Stage II: preclinical in vitro study using animal and human tissues 
Stage III: clinical trials using human beings
Phase I: testing safety in a small group of volunteers
Phase II: evaluating efficacy in the target patients
Phase III: recruiting a larger group of patients to confirm the safety and efficacy. 
After the marketing, FDA asks the pharmaceutical companies to perform phase IV studies (post-marketing surveillance) to follow up the possible side effects and long-term efficacy of their products. With these strict regulations and high standards, FDA has established its reputation in overlooking the safety and efficacy of drugs, medical devices, or biological products.

1.4 FDA’s authority to regulate SCNT technology:
Shortly after the announcement of Dolly’s birth, a Chicago physicist, Dr. Richard Seed declared he will use SCNT technology to clone babies for infertility couples. These two events attracted worldwide attention and lead to widespread anxiety and uneasiness. Many people believed that the United States government should enact some bills to prohibit the human cloning nightmares or to empower some agencies to regulate the technology. At this moment, FDA announced it authority to overlook the human cloning in 1998. FDA declared its jurisdiction based on the Federal Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. §321 et seq, and the Public Health Service Act (PHSA), 42 U.S.C. §262 et seq. In a letter to Senator Kennedy from FDA Deputy Commissioner for External Affairs, Sharon Smith Holston wrote:
FDA already has jurisdiction over such experiments and is prepared to exercise that jurisdiction. While FDA's authority does not address the larger question of whether or not creating a human being using cloning technology should be altogether prohibited, this authority will ensure that such experimentation does not proceed until basic questions about safety are answered.
Creating a human being using cloning technology is subject to FDA regulation under the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. Under these statutes and implementing regulations, clinical research on the creation of a human being using cloning technology may proceed only when an investigational new drug application (IND) is in effect.
In the announcement, FDA only vaguely stated its authority based on FDCA and PHSA, but did not clearly quote any specific provisions. In the following years, FDA has persistently asserted its authority, but many scholars have challenged the legitimacy of its claim. 

1.5 The Suit: UNITED STATES of America v. Clonaid Company
When the first clone sheep, Dolly, died at age 6 on February 14, 2003, the government took the place of FDA to bring a suit against Clonaid Company to grant preliminary injunction to enjoin defendant Clonaid Company from cloning human beings and using human embryos in SCNT research in violation of the Federal Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. §321 et seq and the Public Health Service Act (PHSA), 42 U.S.C. §262 et seq.
FDA claims its motion based on the following facts. Firstly, Clonaid offers an unsafe SCNT technology for its clients without FDA approval. Secondly, Clonaid’s behavior has led to irreparable and imminent harm to the public health.  
	In response to FDA’s claims, Clonaid first challenges that FDA has no statutory authority to regulate human cloning. Even if the court interprets that FDA has statutory authority, FDA should not play a role here in the morally and ethically debated issue. Clonaid contests that human cloning is a kind of right to procreate for the infertility or homosexual couples and it should be respected and protected. According to the religious belief of Raelian Movement, to clone a human being is the way toward their ultimate goal – immortality. Clonaid’s conduct is a religious action, which should be protected by Federal First Amendment. Using human embryos in SCNT experiment is a scientific research, which is also within the scope of the First Amendment protection. FDA’s prohibition will deter the progress of science. In response to the FDA’s major concern – safety issue, Clonaid does not agree with FDA’s opinion that current SCNT technology is unsafe. Even though current SCNT technology is not absolutely safe, it does not make the clone babies worse off. And FDA should allow Clonaid to continue SCNT research to improve its safety and efficacy. Finally, Clonaid argues from the utility viewpoint that SCNT is a very promising biotechnology in curing a wide range of diseases for hundreds of thousands of patients. Prohibiting SCNT research will deter patients from receiving better treatments.

II. LEGAL STANDARD:
	Whether a preliminary injunction should issue between two private litigants turns upon four factors: (1) a likelihood of plaintiff’s success on the merits; (2) the possibility of irreparable injury if relief is not granted; (3) the relative difficulty to the parties; (4) public interest advanced by relief. The court generally evaluates the “balance of harm” test before the “likelihood of success” analysis. The more balance of harm toward the plaintiff, the less the plaintiff has to prove the likelihood of success. 
	The standard for issuing a preliminary injunction brought by the government pursuant to the FDCA and PHSA is doubtless different from the above standard. It is not to say that violation of a federal statute will justify the injunction, but it certainly alters the “balance of harm” test toward the government. In the current case, FDA moves for preliminary injunction to prohibit Clonaid from continuing illegal human cloning activity and research in violation of FDCA and PHSA, which leads to irreparable harm to the public. We confirm the “balance of harm” test toward FDA and we will directly examine the likelihood of success on the merits.

III. ANALYSIS:
3.1 The Statutory Authority Arguments:
Clonaid first challenged that FDA has no statutory authority to regulate SCNT technology or human cloning, although FDA has announced its jurisdiction to regulate human cloning since 1998. Clonaid argued that FDA has refused to regulate human organ transplantation because human organs can not be classified as either as a drug, a medical device, or a biological product. Similarly, human cloning can not be classified into any categories which FDA has authority to overlook. 
Clonaid argues that FDCA gives FDA authority to regulate foods, drugs, medical devices, and cosmetics; PHSA gives FDA authority to regulate biological products. According to FDCA §321(g)(1), “drug” is defined as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” and “articles intended to affect the structure or any function of the body of man or other animals.” According to FDCA §321(h), “device” is defined as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory.” To fit within the scope of “drug” or “device”, the regulated object should be an “article.” An “article” should be restricted to a tangible commercial product. Clonaid argues that a human embryo or a human clone should not be treated as an article. And a cloned embryo is not intended for “use in the diagnoses, cure, mitigation, treatment, or prevention of disease”, or “to affect the structure or any function of the body of man.” Some might argue that human cloning can be used as a medical device to treat “infertility.” However, this argument is not persuasive at all because FDA has refused the idea to treat organ transplantation as a medical device to cure organ failure. Clonaid asserts that FDA can not regulate human cloning under FDCA §321(g)(1) or §321(h). 
According to PHSA §262(a), a “biological product” is defined as “any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivatives, allergenic product, or analogous product, or arsphenamine or its derivatives, applicable to the prevention, treatment, or cure of diseases or injuries of a man …”
FDA broadly interprets the “analogous product” to include gene and ES cell therapies, as well as human cloning. However, Clonaid argues that human cloning should not be treated as an analogous biological product because of the following reasons. Firstly, a human embryo is significantly different from the listed products, such as virus, serum, toxin, or blood. The product listed in PHSA §262(a) is only a component of the body, but a human clone is a complete entity. Secondly, Congress seems to limit FDA’s authority within the detailed listing. We can not find any Congress intent in this provision to give FDA authorization to extend the provisions beyond the traditional definition. 
Since January 2001, FDA asks “establishments that manufacture human cells, tissues and cellular and tissue-based products (HCT/P’s)” to register their facilities and list their products. Reproductive tissues and cells are within this scope. Clonaid asserts that the purpose of the FDA’s new regulatory framework is “to prevent the introduction, transmission, and spread of communicable disease by HCT/P’s”, not to regulate human cloning. Clonaid argues that FDA should not interpret its authority too broad to reach human cloning. 
To establish FDA’s authority to regulate SCNT technology or human cloning, several conditions must be met. Firstly, SCNT technology must be used in clinical trials involving human subjects. Secondly, SCNT technology must be used to make some products into the market. Thirdly, the products must be classified into one of the categories in the statutes. Fourthly, the products must be marketed to interstate commerce. Clonaid uses SCNT technology to clone a human for their worldwide clients, including the Americans. There is no question that Clonaid uses SCNT technology in human subjects and the technique is used in to clone babies into the market, an interstate market. The only questionable point here is how to classify human cloning into the categories of the statutes.
We agree with Clonaid that the statutory authorization of FDA over human cloning actually looks obscure. Human cloning should not be classified into a “drug” or a “medical device.” And it is too arbitrary to interpret human cloning as an “analogous biological product.” We agree that FDA can ask Clonaid to register its facilities and list its products according to 21 C.F.R. §1271.1, but FDA should not extend this provision to regulate human cloning. 
However, the vacuum in statutes to overlook human cloning does not necessarily mean that human cloning can escape the regulation of the government. Just as the letter written by FDA Deputy Commissioner for External Affairs, Sharon Smith Holston “this authority will ensure that such experimentation does not proceed until basic questions about safety are answered.”  If the safety of SCNT technology is still not resolved, we agree that using SCNT technology to clone human beings should be within the scope of FDA regulation. Although it is not convincing to support FDA’s statutory authorization on human cloning by current provisions, the court endorses FDA’s decision to fill the vacuum when we can not find any other more suitable governmental agency to take the responsibility. Before Congress giving the more definite statutory authorization to a suitable agency, it is the duty of the court to fill in the gap. Therefore, we agree with FDA’s assertion to regulate human cloning.
In addition to the efforts of the court to fill the gap, Congress is also very eager to end this chaos. Congress chooses FDA again to regulate human cloning. On February, 27, 2003, H.R.801, also known as “Cloning Prohibition Act of 2003,” has been passed in the House to ban all human cloning, including baby-making and experiments using SCNT technology in biomedical research. This bill amends FDCA by adding one chapter at the end – human cloning. This bill not only outlaws human cloning, but also punishes $1 million fine and up to 10 years in prison. Although we have no idea whether this bill can be passed in the Senate, we believe Congress has the intent to give FDA authority to regulate human cloning. 

3.2 The Role of FDA in Morally and Ethically Controversial Issues:
Clonaid argues that even if FDA has authority to regulate human cloning, it is not suitable for FDA to play a role here in this moral and ethical debated battlefield, since FDA should be a “product-oriented,” but “morally and ethically neutral” agency. Firstly, ethical or moral consideration is not and should not within scope of FDA’s obligation. And FDA has announced its ethical neutral position during the recombinant DNA debates. We agree that FDA should not be involved in the moral or ethical debates, since safety and efficacy are the only considerations of FDA. However, the neutral attitude in morality and ethics does not mean FDA has no authority to regulate a highly controversial issue. If safety is still the issue for the current SCNT technology to clone human beings, FDA has authority to regulate SCNT technology.

3.3 The Procreation Right Arguments:
Clonaid asserts that using SCNT technology to clone human babies for the infertile or homosexual couples is a kind of the procreation rights. It is a deeply rooted social value in the United States to have the freedom to decide whether or not to have offspring. The procreation liberty not only exists in the right of abortion, but also in the right of reproduction. Our society has widely accepted the idea that infertile or homosexual couples have the right to use assisted reproductive techniques, such as IVF or surrogacy, to have their babies. Using SCNT technology to have offspring is just as another option for these couples. Someone might argue that using SCNT technology to clone a baby is significantly different from other forms of assisted reproduction. What SCNT technology produces is not only an offspring, but a genetically identically offspring. Clonaid claims that using SCNT technology to clone offspring is one kind of genetic selection measures. And many genetic selection procedures have been practiced daily in prenatal examinations. Clonaid claims that there is no standpoint to reject using SCNT technology to clone offspring. 
Clonaid’s contention about procreation liberty is not a strong argument. Although many developed countries have moved to recognize the right of procreation by passing statutes to regulate the assisted reproduction, the legal viewpoint about reproductive technology is still controversial in the United States. The Supreme Court has recognized the pre-conception right to procreation by confirming the right to take contraception measures in Griswold v. Connecticut, and the post-conception right to procreation by permitting abortion in Roe v. Wade. These Supreme Court opinions are about the right not to procreation. In confirming the right not to procreation, the Supreme Court not only consider the procreation liberty but also the woman’s personal autonomy and bodily integrity. Although not to procreation has been recognized as a right, should we extend the right to procreate? We can not find any Supreme Court decision supporting the defendant’s assertion. In Goodwin v. Turner, where the right to procreation has been discussed, the Court of Appeals denied the prison’s right to procreate. The popular practice of assisted reproduction in our society does not itself justify a right deserved protection. Even if we recognize the right to procreate, we do not believe using SCNT technology to clone offspring is a reasonable option for infertility or homosexual couples. Just as National Bioethics Advisory Commission (NBAC) reported that current SCNT technology “would be a premature experiment that would expose the fetus and the developing child to unacceptable risks.” Before the maturation of SCNT technology in human cloning, FDA’s injunction is a reasonable and necessary measure to prevent unacceptable risks in the cloned human babies. 
Clonaid claimed that SCNT technology is another kind of genetic selection procedure. In the extreme sense of genetic selection, Clonaid’s contention is correct. However, current prenatal genetic screening is a negative screening procedure to find congenital anomalies during pregnancy. It is a kind of right not to deliver a baby with severe disabilities. Although many legal scholars challenge its legitimacy, genetic screening is at least within the scope of right not to procreation. SCNT technology is a positive screening and is apparently beyond the scope. 
	Clonaid argued that SCNT technology is not only an alternative assisted reproductive technique for infertility and homosexual couples. SCNT technology can also be used in cloning embryos or existing children. Using SCNT technology to clone embryos is helpful in IVF practice by increasing the number of embryos or decreasing IVF cycles. Using SCNT technology to clone an existing child is sensible in the following situations: 1) to clone an existing child who has died; 2) to clone an existing child for providing organs; 3) to clone an existing child just as a little twin. Clonaid claimed that these indications are beyond the power of current assisted reproductive technology and they all fall within the scope of procreation freedom.  
	We agree that SCNT technology is more powerful than current assisted reproductive technology in several aspects. Even if SCNT technology is helpful in IVF practice; however, we do not recognize the freedom to procreation as a right. Whether should we admit the right to procreation is a highly debated issue, which is beyond the scope of the court and we had better leave it to the public deliberation. For the indications to use SCNT technology in cloning an existing child, we believe it will more controversial when the human dignity of the clones is still a major concern. 

3.4 The Religious Liberty Issues:
Clonaid argues that cloning human beings is one of the Raelian Movement’s major religious beliefs. Raelian Movement believes that all human beings in the world were clones from aliens and cloning human beings is the first step to achieve their ultimate goal – immortality. Using SCNT technology to clone human beings is an action of religious liberty for the Raelian Movement and it should be protected by the Federal Constitution’s First Amendment. Any governmental regulation violating the First Amendment clause is invalid. The United States Supreme Court has confirmed the right to free exercise of religion in Sherbert v. Verner and Wisconsin v. Yoder. Congress also enacted the Religious Freedom Restoration Act of 1993 (RFRA) to offer more strong statutory protections for religious liberty. According to these cases and provisions, the government can not regulate religious activity except in the situation with “compelling government interest.” In current case, human cloning is a kind of assisted reproductive technology and a promising means to cure many diseases, which does not lead to a “clear and imminent danger” to the public. FDA should not prohibit the Clonaid’s religious activity; otherwise FDA will violate the religious liberty. 
In response to Clonaid argument, we must exam the balance test standards applied in the Sherbert and Wisconsin cases. In these two cases, the United States Supreme Court has developed a standard to determine whether a government regulation has violated the free exercise of religion. The standard is “whether the regulation substantially burdened a religious practice and if so, whether the burden was justified by compelling government interest.” This test was abolished later in Employment Div., Dept. of Human Resources of Ore. v. Smith. In the Smith decision, the court applied neutral laws of general applicability to religious practice even without compelling government interest. The court said “it is not within the judicial ken to question the centrality of particular beliefs or practices to a faith, or the validity of particular litigants' interpretations of those creeds." In response to the Smith case, Congress enacted the Religious Freedom Restoration Act of 1993 (RFRA) to restore the government compelling interest requirement. The constitutionality of the RFRA is still under debate until now.
In the present case, even if we apply the stricter standards developed in the Sherbert of Wisconsin cases, or the RFRA criteria, to restrain the freedom of religious exercise, Clonaid’s behavior still fulfilled the “compelling government interest” requirement by using the immature SCNT technology to clone human babies. In the Wisconsin case, the court invalided the mandatory school-attendance state law to Amish parents. We totally agree that the United States governments should respect every person’s religious freedom. Government has no standpoint to make moral or ethical judgment in the religious liberty. However, the parents’ decision to refuse to send their children to school is quite different from the decision to make their children as clones. We can not agree that the parents have right to make such a decision for their babies, especially when the safety and the human dignity issues for the clones are not totally resolved. With the currently available evidence about mammals cloning, we agree with FDA’s attitude that Clonaid’s activity has threatened “compelling government interest.” 
Another issue here is whether FDA’s regulation burdens Clonaid’s religious practice? In current case, Clonaid does not explain the real risk and drawback of reproductive SCNT technology to the parents. If these parents can have a more clear understanding of the risk and drawback, we believe that using SCNT technology to clone their babies might not be compatible with their expectation. And Clonaid never complies with the IND and NDA requirements by FDA, although its activity and product involve human subjects. We can not find any statute or case law opinions granting religious liberty the right to preempt public safety issue. Asking Clonaid to comply with FDA’s regulation and explain the possible risk to its client does not burden Clonaid’s religious practice. In current case, we do not agree that FDA’s regulation violates religious liberty. 

3.5 The Scientific Research Freedom Issue:
 Clonaid argues that any statute prohibiting human cloning research violates the First Amendment of the Constitution. Clonaid claims that it does so in two ways. First, human cloning research is a protected speech. Second, the speech should be protected by the First Amendment. Clonaid asserts that using human embryos to perform reproductive SCNT research should be treated differently from using SCNT technology to clone human beings. The issue of using human embryos in research has been noted since the late 1970s. The Ethics Advisory Board, Department of Health, Education and Welfare, has accepted the scientists to create human embryos in developing IVF technology since 1979.
	Defendant’s assertion that scientific research is an expressive conduct which should be protected by the First Amendment is very understandable. Although the Supreme Court never held that the freedom to do scientific research should be protected by the First Amendment, most legal scholars agree with this idea. Some probably will challenge that scientific research involves actions and it should not be treated as speech. A particular action that may eventually be used in some expression does not necessarily make the action itself an expression. We agree that scientific research can not be protected as pure speech. Then is it reasonable to assert that scientific research can be protected as a form of conduct containing elements of speech? In Spence v. Washington, 418 U.S. 405 (1974), the Supreme Court has established the test for First Amendment protection: “it is necessary to show intent to communicate with the others.” Many scientific researches do not necessarily contain this intent. In that case, scientific researches do not qualify for First Amendment protection. When we apply the Spence test to the current case, we do not find human cloning research has any intent to communicate with the others. The human cloning research does not deserve the First Amendment protection.
Clonaid has cited the report by Ethics Advisory Board about research human embryos in IVF studies. According to the report, federal funding can be approved if the embryos not transferred back into uterus will not be sustained for more than two weeks. If Clonaid’s human cloning research has manipulated embryos exceeding the 14 days limitation suggested by the Ethics Advisory Board, it is subject to the regulation by FDA. FDA’s overlook does not violate the First Amendment.

3.6 The Safety Issues:
Clonaid does not agree with FDA’s viewpoint that the current SCNT technology is not safe. Clonaid claimed that the Dolly was murdered at age 6 instead of dying naturally. And there is no sufficient evidence to show that the clone animals will be born with much more congenital anomalies and died or aged prematurely. At least, Clonaid asserted that the five clone babies by their company’s technology were born in healthy condition. FDA responds that the five so-called clone babies born by Clonaid are never be verified by trustworthy scientists. The current cloned animals by SCNT technology, take Dolly for example, has proved SCNT technology as an unsafe and inefficient measures in cloning mammals. 
	Clonaid claimed that even the current SCNT technology is not safe enough; using SCNT technology to clone human beings does not make the clone baby worse off. When we say that a drug or a medical device makes somebody worse off, it means that the drug or the medical device makes the person even worse than before. However, human cloning can not make the clone baby worse than never been born. Even though current SCNT technology is not mature enough and it possibly leads to some unfortunate consequences, it is still not worse than the clone baby never been created by SNCNT technology. 
Clonaid’s argument is similar to the IVF debates in the early 1980s. Shortly after the first IVF baby, Louise Brown, was born in England in 1978, tons of literatures have discussed whether the IVF technique has made the IVF babies worse off. Just as the contention in the IVF debates, we agree with Clonaid’s assertion that using SCNT technology to clone a baby does not necessarily make the clone baby worse off. However, it does make the parents worse off. Just as FDA’s assertion, using current SCNT technology to clone a human being can not be justified because of its immaturity. Besides the SCNT technology, there are other much safer and matures assisted reproductive measures that infertility or homosexual couples can choose to create their babies. Clonaid does not inform its clients of other alternative options or advise them the potential drawbacks of using SCNT technology to clone their babies. Clonaid’s behavior has made the parents worse off than choosing other assisted reproductive techniques or avoiding human cloning. 

3.7 The Utility Issues:
Clonaid argues that even if its SCNT research can not be protected as a right under procreation liberty, religious or scientific research freedom, it should be not be prohibited under the consideration of utility policy. 
Clonaid asserted that if FDA moves for the injunction to prohibit human cloning by SCNT technology because of its unsafety, there is no reason for FDA to enjoin Clonaid from doing basic SCNT research to improve the safety. SCNT technology is not only a useful means to clone human beings, but also a promising technique to cure a wide range of diseases. SCNT research is helpful in understanding the mechanisms of reprogramming adult somatic cells and thereby providing abundant histocompatible cells, tissues or organs for hundreds of thousands of patients, including motor neuron degeneration diseases, stroke, myocardial infarction, diabetes, liver cirrhosis, spinal cord injury patients, etc. According to the report of UK Chief Medical Officer’s Expert Group on Therapeutic Cloning, the potential benefit “justify the transitional research involving the creation of embryos” by SCNT. To prohibit SCNT research will deter the patients from receiving better treatments. 
With the promise of SCNT technology in providing cure and therapy for many medical diseases, we agree with Clonaid that we should not totally forbid SCNT research. The question is where we should draw a line between legal and illegal, ethical and unethical. We believe the court is not the proper institution to make the decision. We rely on the standards developed by the medical profession and the report of Ethics Advisory Board, Department of Health, Education and Welfare, in 1979 that it is justified if the embryos are used in the stage younger than 14 days. If this standard can be applied to previous research involving human embryos in the past two decades, the court can not find any reason to refuse applying the same criteria in current case. 

IV. ORDER
	Clonaid, its officers, agents, servants, employees, attorneys and those in active concert or participation with them who receive actual notice of this order are hereby enjoined from continuing any human cloning activity and using human embryos older than 14 days in SCNT research without FDA’s overlook. This order shall take effect 10 days from the date on which it is filed. Nothing in this order prohibits Clonaid from using human embryos younger than 14 days in SCNT research. 

DATED: March 3, 2003
CHUN-YING WU
United States District Judge