by Edward L. Korwek, Ph.D, J.D.

Having been involved in the regulation of biotechnology and in many “biotech debates” for over 25 years, I was asked to write an article on non-patent U.S. issues that exist today. In trying to do so, it was difficult for several reasons. Many of the issues are not confined only to the United States but now are global or international in nature. Further, modern biotechnology sciences have developed rapidly over the past decade to encompass not only a continuing myriad of pharmaceutical-related applications, but also significant diagnostic and agricultural uses. Drug, medical device and food topics often dominate the federal regulatory landscape, sometimes with food matters surprisingly having the edge, particularly in terms of public controversy.  Then, too, developments can occur so rapidly, sometimes on a daily or even hourly basis, that it is difficult to keep up with them, particularly in terms of the latest applicable referenced literature or other citations.

Lastly, it is virtually impossible to summarize accurately or fairly all of the legal, scientific, social, ethical, policy, economic, and other issues or debates, particularly without doing a disservice to any one or all of them and to the benefits of the technologies  or products themselves. Nevertheless, I will attempt to address a few topic areas and select controversies, primarily in the context of Food and Drug Administration (FDA) regulatory considerations, and sometimes with a passing mention of other federal agencies as well as the international milieu.

The top four choices are clearly quite subjective. They pertain mainly to the relatively newer products or newer applications of modern biotechnology methods. One choice relates more to older products or older applications. Some areas are more emerging or evolving than others, particularly in terms of regulation.

Personalized Medicine (PM)

A topic that has garnered much attention in the trade and public media over the past few years is the development of new medicines tailored to an individual’s particular genetic makeup, sometimes called personalized medicine (PM) or pharmacogenomics. A result of the human genome initiative to map the 23 pairs of human chromosomes, PM has the ability to target medicines, including dosing regimens, to those who presumably would benefit the most. One goal is therefore to differentiate patient populations who do not respond or who experience significant adverse effects.

PM also has led to other “omics,” including toxicogenomics, proteomics, and metabolmics. These areas involve, respectively, the elucidation of genetic responses to toxic agents, the identification of proteins and their variations in various disease states, and the study of metabolites under normal and other conditions. PM has further resulted in an increased awareness of the importance of biomarkers and of their development in the context of diagnostics, resulting in, for example, an FDA website dedicated to biomarkers¹ and a memorandum of understanding among FDA, the National Cancer Institute (NCI) and Centers for Medicare and Medicaid Services (CMS) related to improving collaboration in the development of biomarkers as tools that will facilitate cancer therapy improvements.²

Although PM and other such newer approaches to drug therapy could limit market sizes and product revenues,³ they, nonetheless, have often been regarded as the future of healthcare. Whether all of the hype and optimism of such differentiated medical approaches is misguided still remains to be seen. Cost, reimbursement,⁴ technical feasibility, genetic discrimination and privacy considerations, and regulatory obstacles are a few concerns that have been raised.⁵

A widely recognized real life example of PM and of the significance of the related diagnostic biomarker component is Herceptin (trastuzumab). This product, approved in 1998, is a monoclonal antibody for the treatment of metastatic breast cancer in patients who over express the HER2 protein, which can make the cancer more aggressive. Since testing for HER2 protein is key to the selection of patients for Herceptin treatment, a new test to measure the biomarker was also developed and approved by the Center for Devices and Radiological Health (CDRH).⁶ Similarly, but more on the diagnostic side, FDA cleared in late 2004 the first DNA microassay test for a certain gene that is responsible for the metabolism of specific commonly prescribed drugs;⁷ the test helps physicians select medications that will benefit patients based on their genetic information.

FDA has been incrementally addressing various regulatory aspects of genomics, particularly most recently involving genetic testing. The topic’s importance is recognized as part of the agency’s Critical Path to New Medical Products⁸ and an FDA website dedicated to genomics exists.⁹ The agency has also published a number of relevant guidances, including one on pharmacogenomic data submissions.

It outlines when FDA’s regulations are interpreted to require that pharmacogenomic data be submitted as part of an investigational new drug application (IND) or an approved application or can be provided voluntarily. A draft regulatory guidance has just issued on the utilization of algorithms involving proteonomic and genomic data to guide medical treatments or other decisionmaking.¹¹

This particular initiative has been controversial for a variety of reasons, in part because opponents argue legal authority for the regulation of such tests lies with the CMS under the Clinical Laboratory Improvement Amendments.¹² Other guidelines exist on pharmacogenetic and genetic tests for heritable markers¹³ and on the development of combination drug products involving diagnostic assays.¹⁴

Follow-On Biologics

This topic involves older products of modern biotechnology methods. No biological drug topic has generated as much trade press and regulatory debate than “generic biologics,” “follow-on biologics,” or “follow-on biotechnology products.” The traditional generic notion behind approving follow-on biologics is to encourage competition, typically after patents expire, in an effort to lower drug costs. The various controversies have engaged all the main branches of the federal government. As before, a variety of different issues are involved, including legal, economic, policy, social, and scientific. Interestingly, the European Union (EU) seemingly has been more active in the regulation of such products, known as biosimilars.¹⁵

Some of the U.S. debate involves the interplay between different statutory and regulatory schemes for biological and non-biological drugs.¹⁶ Non-biological drugs are approved under the Federal Food, Drug, and Cosmetic Act (FDCA), whereas biological drugs are licensed under section 351 of the Public Health Service Act (PHSA). Unlike the FDCA that contains provisions for approving generic or other versions of innovator non-biological drugs, the PHSA does not contain any similar abbreviated pathways for innovator biological drugs. Moreover, at the core of the discussions are the possibly different scientific considerations for ensuring the safety and efficacy of copies or other follow-on versions of innovator small molecule and macromolecular drugs, particularly immunogenicity concerns.¹⁷ Additional technical issues relate to whether traditional generic drug concepts of chemical structure “sameness” or pharmaceutical equivalence and whether the drug substitution criteria that apply to smaller molecule drugs can be adapted to apply to macromolecular drugs that typically are biologics.

A variety of citizens’ petitions, workshops, and other communications and initiatives have occurred pertaining to a range of different legal, regulatory, and scientific topics.¹⁸ These include arguments about constitutional rights in data submitted in approved applications for innovator products and the information that is necessary to demonstrate the comparability of biological molecules.¹⁹

Several potentially significant developments have occurred in the last several months. FDA approved, in late May 2006, a macromolecular human growth hormone product, Omnitrope, which is a follow-on version of Genotropin. This followed initial EU approval in April and occurred on the heels of a court decision that required FDA to make a decision on the application.²⁰ Although Omnitrope is not a biological drug because it is a hormone, its approval demonstrates at least to some degree the scientific feasibility of generic biologics, according to proponents. Concomitantly with the approval of Omnitrope, however, FDA set forth, in a separate letter responding to various citizens’ petitions related to Omnitrope, its scientific and regulatory basis for denying those petitions arguing that Omnitrope should not be approved.²¹ In its denial, the agency seemingly treats the approval of Omnitrope as sui generis.²²

Another potentially important occurrence is the introduction recently by Congressional democrats of companion legislation in the House and Senate to establish a PHSA process for competitive versions of innovator biological drugs, known as the “Access to Life-Saving Medicine Act.” The bills would create a mechanism for the approval of follow-on biologics based on comparability. They could establish a legislative agenda for addressing the topic during the next session of Congress, particularly since the Democrats are now the majority in both the House of Representatives and the Senate.²³

Plant Transgenics

The field-testing and commercialization of plants containing genes from diverse sources that confer agronomic traits, such as pest resistance or herbicide tolerance, have been around for quite some time. The regulation of such transgenics, in terms of environmental considerations, is largely handled by the Environmental Protection Agency (EPA) and the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA). The topics of the safety of environmental releases of diverse organisms that are bioengineered and their regulation continue to generate significant debates.²⁴ Safety issues involving non-pesticidal traits and labeling considerations related to food from bioengineered plants are handled by FDA pursuant to its 1992 policy governing voluntary consultation procedures for new plant varieties.²⁵

Despite the obvious success of transgenic plants in production agriculture, the regulation of food from them by FDA remains controversial for two primary reasons. Opponents argue that special labeling should be required of the fact that foods are derived from bioengineered plants and that a mandatory premarket clearance system should be implemented. FDA has taken the position for a variety of reasons that no such special labeling is generally required²⁶ and although a mandatory scheme was proposed,²⁷ none has been adopted.

The lack of a special labeling requirement and the current use of a voluntary notification system continue to put the U.S. in an ongoing international tug-of-war over the regulation of and trade in foods from bioengineered plants, particularly with the EU, where both a labeling requirement and an approval system exist. A recent successful World Trade Organization biotech challenge by the U.S. against the EU and the adoption of an international treaty, the Convention on Biodiversity and its subsidiary agreement, the Cartagena Biosafety Protocol, have tended to aggravate international tensions because the US is not a signatory.

Perhaps no development has galvanized protests about the adequacy of U.S. regulation than the discovery in 2000 of the widespread presence of StarLink corn in human food. StarLink was approved in the U.S. for animal feed and other industrial non-human food uses, but accidentally found its way into the domestic human food supply and into international trade channels,²⁸ causing significant economic losses and international regulatory turmoil, among other effects. In addition to issues of allergenicity that were never fully resolved, the StarLink corn episode also brought to public light the recurrent possibility of the accidental or adventitious presence (AP) of low levels of bioengineered plant traits appearing in conventional or organic food crops and in commodity grain in trade channels. Such AP, which can occur by various means, such as through pollen flow or commingling of products, remains an intractable domestic and international issue. Federal agencies are still trying to address the subject through policy statements²⁹ and other vehicles such as Codex.³⁰ Compatibility and coexistence issues have also been raised with organic agriculture.³¹ The topic of “zero tolerances” for transgenic plant contaminants continues to dominate domestic and international regulatory and trade debates.

Pharma Plants

Given the StarLink incident and other experiences involving, most recently, transgenic rice,³² the subject of the use of food plants to produce human drugs, including biologics, continues to be especially contentious, particularly in the context of AP. A significant contributing factor is the finding in 2002 that 500,000 bushels of soybeans intended for human consumption contained drug-producing corn.³³ Although according to FDA no human safety issue was present,³⁴ APHIS fined the company involved for violation of relevant regulatory confinement requirements, among other actions, and has since been particularly cautious about the environmental aspects of field testing of pharma plants.³⁵

Different centers or divisions within both FDA and USDA have developed, for example, a guidance that addresses a variety of drug and device manufacturing considerations, particularly confinement measures related to control of seed stocks, field-grown plants, harvested material, processing facilities, and waste material.³⁶ Nonetheless, USDA has already been successfully sued on various administrative and environmental law grounds over its regulation of the field-testing in Hawaii of pharma plants.³⁷

Animal Cloning and Transgenics

Although animal genetic manipulation by modem biotechnology methods is still somewhat of an emerging regulatory area, the topic is already being engulfed in some of the same or similar food safety, labeling, and environmental debates that exist in the bioengineered plant arena. An added controversy, however, is animal welfare or ethical concerns.

Animal cloning procedures today typically involve the creation of duplicate animals utilizing so-called somatic cell nuclear transfer techniques, similar to those involved with the development of Dolly the sheep that received wide notoriety in 1996. The creation of transgenic animals, however, such as those with agronomic traits related to improved growth rate or disease resistance, utilizes different technologies, namely, selective gene transfer methods, which are similar to those involved in the creation of transgenic plants. Nonetheless, the food safety, environmental, ethical, and regulatory issues have often been quite similar for both sets of animal technologies, particularly in terms of public controversy.

The Center for Veterinary Medicine (CVM) has said that transgenic technologies trigger the new animal drug provisions of the FDCA that require premarket clearances, including the submission of investigational new animal drug applications (INADs) for experimental studies. In 2003, follow-up regulatory action was taken in at least one instance regarding the failure of some transgenic experimental work to meet INAD requirements.³⁸

Although such regulation has been controversial, especially in the context of transgenic fish,³⁹ the agency seems not to have changed its position, despite some recent reports to the contrary. Opponents question, for example, whether ecological aspects are adequately addressed and the lack of transparency of the new animal drug process.

With regard to cloning, in 2001 CVM requested that industry engage in a voluntary moratorium on the marketing of cloned food. Also in 2001 FDA commissioned the National Academy of Sciences (NAS) to consider scientific information on animal biotechnology.⁴⁰

The NAS concluded that more data are needed, even though there is no current evidence that food from cloned animals or their off-spring present a food safety concern. It also stated that biotechnology applications “can have adverse effects on the welfare of animals.”⁴¹ Animal welfare advocates worry about the harm that may be inflicted by the use of different genetic methods, including pain and suffering.⁴²

Food from Clones

Most recently, debate has centered on CVM’s long-awaited final assessment of the safety of meat and milk derived from cloned animals and their off-spring and how it will regulate such animals and food. In late October 2003 the agency released a draft summary risk assessment concluding that such food does not appear to pose increased risks relative to that from conventionally bred animals.⁴³ The FDA Veterinary Medicine Advisory Committee met in November 2003 to review the draft assessment.⁴⁴ Now CVM reportedly is close to releasing a final report that says clones pose no risk to human health⁴⁵ and that apparently proposes a risk management regulatory plan for handling any animal and food safety concerns that may exist.

Seemingly in anticipation of issuance of the final report, which will be open for public comment, a variety of consumer groups already have filed a citizen’s petition demanding that CVM require producers of animal clones to comply with the FDCA new animal drug provisions.⁴⁷ They also request that CVM require the preparation of an environmental impact statement for each new animal drug application, among other demands. A recent survey of consumer attitudinal trends indicates that a majority of consumers are apparently wary of animal cloning and are unlikely to purchase foods from cloned animals.⁴⁸

The topic of animal pharming, involving the use of transgenic animals to produce pharmaceuticals, has garnered much less regulatory and public attention, so far. In 1995, FDA published a guidance on the manufacture and testing of therapeutic products from such animals.⁴⁹ Recently, the EU approved the first transgenically-produced medicine, antithrombin, which is derived from goats that have a gene for human antithrombin and which is reportedly in clinical trials in the United States.⁵⁰

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1. Table of Valid Genomic Biomarkers in the Context of Approved Drug Labels, available at www.fda.gov/cder/genomics/genomic_biomarkers_table.htm.
2. Oncology Biomarker Qualification Initiative, MOU number 225-06-8001, available at www.fda.gov/oc/mous/domestic/FDA-NCI-CMS.html.
3. F-D-C- Reports, The Pink Sheet, Personalized Medicine Will Not Destroy Blockbuster Model—Pfizer Exec, p. 16 (May 22, 2006).
4. K. Rowson, 1 The RPM Report, The Next Hurdle: Pharmacogenomics as a Formulary Control Tool 24 (Nov. 2006), available at http://www.windhover.com/ezine/pdf/Payors0611.pdf.
5. See generally Symposium: Legal Liabilities at the Frontline of Genetic Testing, Part I and Part II, 41 Jurimetrics 1-275 (Fall, Winter 2000). See also Symposium: Human Genetic Sampling: Ethical, Legal, and Social Considerations, 45 Jurimetrics 111-271 (Winter 2005).
6. HHS News, New Monoclonal Antibody Approved for Advanced Breast Cancer (Sept. 25, 1998) available at http://www.fda.gov/bbs/topics/NEWS/NEW00655.html.
7. FDA News, FDA Clears First of Kind Genetic Lab Test (Dec. 23, 2004) available at http://www.fda.gov/bbs/topics/news/2004/new01149.html.
8. The Critical Path to New Medical Products, available at www.fda.gov/oc/initiatives/criticalpath/ and Challenge and Opportunity on the Critical Path to New Medical Products (Mar. 2004), available at www.fda.gov/oc/initiatives/criticalpath/whitepaper.html.
9. Genomics at FDA, available at http://www.fda.gov/cder/genomics/default.htm.
10. Guidance for Industry, Pharmacogenomic Data Submissions (Mar. 2005), available at www.fda.gov/cder/guidance/6400fnl.pdf.
11. Draft Guidance for Industry, Clinical Laboratories and FDA Staff, In Vitro Diagnostic Multivariate Index Assays (Sept. 2006), available at www.fda.gov/cdrh/oivd/guidance/1610.pdf.
12. For a discussion of some of the debates, see F-D-C- Reports, The Pink Sheet Daily, Momentum Intensifies to Enhance Oversight of Lab-Produced Genetic Tests (Oct. 3, 2006).
13. Pharmacogenetic Tests and Genetic Tests for Heritable Markers (Feb. 2004), available at www.fda.gov/cdrh/oivd/guidance/1549.pdf.
14. Draft Drug-Diagnostic Co-Development Concept Paper (Apr. 2005), available at http://www.fda.gov/cder/genomics/pharmacoconceptfn.pdf.
15. See F-D-C- Reports, The Pink Sheet Daily, Valtropin is the Second Biosimilar Product Approved in Europe (May 4, 2006). See also note 17 infra.
16. For a more detailed discussion of some of the debates, see Edward L. Korwek, Towards Understanding the “Generic” Debate About Biologics, 7 J. Biolaw & Bus. 27 (2004).
17. See, e.g., FDA Week, Inside Health Policy, FDA Guidance Agenda Silent on Biogeneric Papers, Except Immunogenicity 4 (2006).
18. See, e.g., FDA, Scientific Considerations Related to Developing Follow-On Protein Products, 69 Fed. Reg. 50386 (2004).
19. See, e.g., FDA, Center for Biologics Evaluation and Research, Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived Products (Apr. 1996), 61 Fed. Reg. 818612 (1996) (announcing availability of the guidance); FDA, Center for Biologics Evaluation and Research, Draft Guidance on Comparability Program Protocols: Chemistry Manufacturing Controls Information (Feb. 2003), 68 Fed. Reg. 8772 (2003) (announcing availability of the guidance).
20. Sandoz, Inc. v. Leavitt, 427 F. Supp. 2d 29 (D.D.C. 2006) (memorandum opinion).
21. Letter from Steven K. Galson, M.D., MPH, Director, CDRH to Morgan Lewis & Bockius LLP, Biotechnology Industry Organization, and Genentech Re: Dockets Nos. 2004P-0231/CP1 and Sup1, 2003P-0176/CP1 and EMC1, 2004P-0171/CP1 and 2004N-0355, (May 30, 2006).
22. See FDA, Omnitrope (somatotropin [rDNA origin]), Questions and Answers, available at http://www.fda.gov/cder/drug/infopage/somatropin/qa.htm.
23. F-D-C- Reports, The Pink Sheet Daily, Rep. Waxman Becomes Key Legislator On Biopharma Issues With House Flip (Nov. 7, 2006).
24. See, e.g., USDA, APHIS, Environmental Impact Statement; Introduction of Genetically Engineered Organisms, Notice of Intent to Prepare and Environmental Impact Statement and Proposed Scope of Study, 69 Fed. Reg. 3271 (2004) (notice by APHIS of intent to reexamine its current regulations for the purpose of updating them with respect to current and future products). See also the APHIS website entitled “A Programmatic Environmental Impact Statement (EIS); Introduction of Genetically Engineered Organisms,” available at http://www.aphis.usda.gov/brs/eis/eis_participate.html; U.S. Department of Agriculture, Office of Inspector General, South West Region, Audit Report, Animal and Plant Health Inspection Service Controls Over Issuance of Genetically Engineered Organism Release Permits (Dec. 2005) (identifying a number of regulatory weaknesses) and APHIS responses, Biotechnology Regulatory Services (BRS), Office of Inspector General (OIG) Report, Frequently Asked Questions (FAQ) available at http://www.aphis.usda.gov/brs/brs_oig.html; National Research Council, Genetically Modified Pest-Protected Plants, Science and Regulation, Board on Agriculture and Natural Resources (2000).
25. FDA, Statement of Policy: Foods Derived From New Plant Varieties, 57 Fed. Reg. 22984 (1992).
26. See id. at p. 22991.
27. FDA, Premarket Notice Concerning Bioengineered Foods, 66 Fed. Reg. 4706 (2001).
28. See The Pew Initiative on Food and Biotechnology, Michael R. Taylor and Jody S. Tick, The StarLink Case: Issues for the Future (2001), available at http://www.pewagbiotech.org/resources/issuebriefs/starlink/starlink.pdf.
29. See, e.g., FDA, Guidance for Industry; Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use, 71 Fed Reg. 35688 (2006) (announcement of the availability of the guidance); Environmental Protection Agency, Pesticides; Draft Guidance for Pesticide Registrants on Small-Scale Field Testing and Low-Level Intermittent Presence in Food of Plant Incorporated Protectants (PIPs), 71 Fed. Reg. 57509 (2006) (announcement of the availability of a draft pesticide registration notice).
30. See, e.g., S. Clapp, Pesticide and Toxic Chemical News, US Authors Revise Codex Adventitious Presence Proposal (Oct. 16, 2006), pp. 24-25.
31. See generally Peaceful Coexistence Among Growers of Genetically Engineered, Conventional and Organic Crops, Summary of a Multistate Workshop, sponsored by the National Association of State Departments of Agriculture and The Pew Initiative on Food and Biotechnology (2006), available at http://pewagbiotech.org/events/0301/.
32. See, e.g., R. Weiss, Biotech Rice Saga Yields Bushel of Questions for Feds, The Wash. Post, p. A3 (Nov. 6, 2006).
33. See S. Clapp, Food industry alarmed by biopharm contamination incidents, 44 Food Chem. News (Nov. 18, 2002).
34. FDA, FDA Talk Paper, FDA Action on Corn Bioengineered to Produce Pharmaceutical Material (Nov. 19, 2002) available at http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01174.html.
35. See, e.g., USDA, APHIS, Biotechnology Regulatory Services, Draft Guidance for APHIS Permits for Field Testing or Movement of Organisms With Pharmaceutical or Industrial Intent (Mar. 31, 2006), available at www.aphis.usda.gov/brs/pdf/Pharma_Guidance.pdf.
36. Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (Sept. 2002), available at www.fda.gov/cber/gdlns/bioplant.pdf.
37. See Center for Food Safety v. Johanns, ___F. Supp. 2d_ __, 2006 W.L. 2568023 (D. Hawaii Sept 1, 2006)(Civ. No. 03-00621 JMS/BMK), available at http://www.earthjustice.org/library/legal_docs/hawaii-biopharm-order-81096.pdf.
38. CVM reported in 2003 that it had investigated the improper disposal of bioengineered pigs that may have entered the food supply but which apparently posed no public health risks. See FDA, FDA Talk Paper, FDA Investigates Improper Disposal of Bioengineered Pigs (Feb. 5, 2003), available at http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01197.html. See also Letter from Gloria J. Dunnavan, Director, Division of Compliance, Office of Surveillance and Compliance, CVM, to Melanie J. Loots, Associate Vice Chancellor for Research, University of Illinois at Urbana-Champaign (Sept. 29, 2003) (advising of violations of CVM INAD regulations), available at http://www.fda.gov/cvm/FOI/UIUCLetter.htm and the Department of Health and Human Services, FDA, Form 483 Inspectional Observations (listing failure to monitor INADs regarding investigational transgenic pigs) (Jan. 1, 2003), available at http://www.fda.gov/ora/frequent/483s/3003291927_uill/FEI3003291927_02.html.
39. See The Pew Initiative on Food and Biotechnology, Future Fish: Issues in Science and Regulation of Transgenic Fish (2003), available at http://www.pewagbiotech.org/research/fish/fish.pdf.
40. See The NAS, Animal Biotechnology: Science-Based Concerns, Board on Agriculture and Natural Resources (2002), available at http://www.nap.edu/books/0309084393/html/.
41. Id. Executive Summary at 12.
42. See generally The Pew Initiative on Food and Biotechnology, Exploring the Moral and Ethical Aspects of Genetically Engineered and Cloned Animals (2005), available at http://pewagbiotech.org/events/0124/.
43. See Animal Cloning: A Risk Assessment, DRAFT Executive Summary, available at www.reproductivecloning.net/FDA.pdf.
44. A transcript of the meeting held on Nov. 4, 2003 is available at http://www.fda.gov/cvm/CVM_Updates/03VMACTrans.htm.
45. R. Weiss, FDA is Set to Approve Milk, Meat From Clones, The wash. PosT, p. A1 (Oct. 17, 2006).
46. Center for Food Safety, et al., Citizen Petition, Petition Seeking Regulation of Cloned Animals, 2006P-0415, Oct. 12, 2006 available at www.fda.gov/OHRMS/DOCKETS/DOCKETS/06p0415/06p0415.htm.
47. International Food Information Council, Food Biotechnology: A Study of US Consumer Attitudinal Trends, 2006 Report, available at http://ific.org/research/biotechres.cfm.
48. FDA, Points to Consider in the Manufacture and Testing of Therapeutic Products for Human Use Derived from Transgenic Animals (1995), available at www.fda.gov/cber/gdlns/ptc_tga.txt.
49. See F-D-C Reports, The Pink Sheet Daily, Transgenic Goat Antithrombin Gains EU Nod (Aug. 2, 2006).

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Update 2007, Issue 1
With Permission from FDLI, www.fdli.org