1 For a discussion of the various types of adult stem cells, including MSCs, see David A. Prentice, Adult Stem Cells, 19 ISSUES L. & MED. 265 passim (2004). Adult stem cells, which have limited differentiation potential, are nonetheless important because they are found in most organs an d could potentially treat many diseases. Further, most adult stem cell treatments involve autologous transplants, thus avoiding complications associated with immune system rejection. See generally RUSSELL KOROBKIN, STEM CELL CENTURY (2007) (providing a comprehensive analysis of the legal and political issues surrounding the use of stem cells, including the more ethically problematic use of embryonic stem cells).

2 See Affidavit of Dr. Christopher Centeno at 5, United States v. Regenerative Scis., LLC, 878 F. Supp. 2d 248 (D.D.C. 2012) (No. 1:10-cv-01327-RMC) [hereinafter Centeno Affidavit].

3 See id.

4 See generally United States v. Regenerative Scis., LLC (Regenerative I), 878 F. Supp. 2d 248 (D.D.C. 2012).

5 See generally United States v. Regenerative Scis., LLC (Regenerative II), 741 F.3d 1314, 1318 (D.C. Cir. 2014). Regenerative Sciences indicated it would not appeal to the Supreme Court. Alexander Gaffney, Appeals Court Says Stem Cells May Be Regulated as Drugs, Affirming Low Court's Decision, REGULATORY AFFAIRS PROF’LS SOC’Y (Feb. 4, 2014), http://www.raps.org/focusonline/news/news-article-view/article/4593/appeals-court-says-stem-cells-may-be-regulated-as-drugsaffirming-low-courts-de.aspx. Other circuits would likely accept the D.C. Circuit's ruling and rationale because of the circuit's experience with FDA law.

6 See 21 C.F.R. § 1271.3(a) (2013).

7 See, e.g., Mary Ann Chirba & Alice A. Noble, Our Bodies, Our Cells: FDA Regulation of Autologous Adult Stem Cell Therapies, BILL OF HEALTH (June 2, 2013), https://blogs.law.harvard.edu/billofhealth/2013/06/02/our-bodies-our-cells-fda-regulation-ofautologous-adult-stem-cell-therapies/ (arguing that FDA must “get a firm handle on what kinds of techniques and treatments present tolerable levels of risk when balanced with the need for innovation and the basic right of patients to use their own cells” (emphasis added)).

8 See 21 C.F.R. § 1271.10(a)(1).

9 See id. § 1271.3(f)(1)-(2) For structural tissue, minimal manipulation means “processing that does not alter the original relevant characteristics of the tissue relating to the tissue's utility for reconstruction, repair, or replacement”; and for cells or nonstru ctural tissues, it means “processing that does not alter the relevant biological characteristics of cells and tissues.”

10 42 U.S.C. § 264(a) (2012).

11 See Kevin Outterson, The Law of Health Care Markets (unpublished manuscript) (on file with author) (describing information asymmetry and its role in healthcare economics). Information asymmetry exists when parties to a market transaction have differing levels of knowledge material to the transaction, which, in turn, may lead to economic inefficiencies. For example, in a doctor-patient relationship, a doctor has knowledge of medicine that a patient does not, while a patient has knowledge of his or her own medical conditions and symptoms that he or she may not share with a doctor. If both parties cannot achieve a mutual understanding of all the relevant facts and possible treatment options, then a patient may not receive the optimal therapy. Patients can be harmed if complications arise because the wrong therapy was chosen. These negative outcomes can be attributed, in part, to the imperfect, and therefore inefficient, knowledge exchange between the doctor and patient.

13 See New Drug Application (NDA), U.S. FOOD & DRUG ADMIN., http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/newdrugapplicationnda/default.htm (last updated Feb. 21, 2013).

14 See What Does FDA Do?, U.S. FOOD & DRUG ADMIN., http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194877.htm (last updated May 6, 2013).

15 At the very least, as the field of personalized medicine develops, FDA should take into account issues of patient autonomy when assessing public health.

16 See 42 U.S.C. § 264 (2012).

17 See 21 U.S.C. §§ 301, 393 (2012).

18 42 U.S.C. § 262.

19 Regenerative I, 741 F.3d 1314, 1317-18 (D.C. Cir. 2014); Regenerative II, LLC, 878 F. Supp. 2d 248, 256 (D.D.C. 2012).

20 42 U.S.C. § 264.

21 21 U.S.C. § 331(a).

22 Id. § 331(k).

23 Id. § 321(g)(1). This Note will refer to most drugs as articles throughout in keeping with this convention.

24 21 C.F.R. § 201.128 (2013).

25 21 U.S.C. § 321(g)(1)(D).

26 Id. § 351(a)(2)(B).

27 See 21 C.F.R. § 211 (outlining regulations for (1) organizat ion and personnel, (2) buildings and facilities, (3) equipment, (4) components of drug product containers and closures, (5) production and process controls, (6) packaging and labeling control, (7) holding and distribution, (8) laboratory controls, (9) records and reports, and (10) returned and salvaged drug products).

28 See 21 U.S.C. § 352.

29 Id. § 352(f)(1).

30 21 C.F.R. § 201.5.

31 21 U.S.C. § 353(b).

32 Regenerative I, 878 F. Supp. 2d 248, 260 (D.D.C. 2012).

33 21 U.S.C. § 353(b)(4)(A).

34 See 21 U.S.C. 333(b); Inspections, Compliance, Enforcement, and Criminal Investigations, U.S. FOOD & DRUG ADMIN., http://www.fda.gov/ICECI/default.htm (last updated Feb. 5, 2013).

35 21 U.S.C. § 332(a); 42 U.S.C. § 262(j) (2012).

36 See 21 U.S.C. § 355; Chirba, Mary Ann, FDA Oversight of Autologous Stem Cell Therapies: Legitimate Regulation of Drugs and Devices or Groundless Interference with the Practice of Medicine?, 7 J. HEALTH & BIOMEDICAL L. 233, 247-48 (2011)Google Scholar.

37 FDA also approves generic drugs and generic biologics (biosimilars) under less onerous pathways. For an explanation of the generic drug and biosimilar pathways, see PIÑA, KENNETH R. & PINES, WAYNE L., A PRACTICAL GUIDE TO FDA's FOOD AND DRUG LAW REGULATION 150-56, 165-70 (Food & Drug Law Inst., 4th ed. 2012)Google Scholar. A discussion of generic drugs and biosimilars is outside the scope of this paper because more than minimally manipulated cellular therapies are considered new drugs.

38 21 U.S.C. § 321(p)(1).

39 Id. § 393(b) (defining the mission of the FDA as “promot[ing] the public health … by ensuring that … human and veterinary drugs are safe and effective”); see also id. § 355(c).

40 See id. § 355; 21 C.F.R. §§ 310, 312, 314 (2013).

41 See 21 U.S.C. § 331(d).

42 Mozlon, Justina, The Common Technical Document: The Changing Face of the New Drug Application, 2 NATURE REVS.: DRUG DISCOVERY 71, 71 (2003)Google Scholar; Investigational New Drug Application, U.S. FOOD & DRUG ADMIN., http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm (last updated Oct. 18, 2013).

43 Investigational New Drug Application, supra note 42.

44 Id.

45 Mozlon, supra note 42, at 71. See generally 21 C.F.R. § 312.21 (2013) (describing information and protocols necessary to complete each successive phase).

46 Mozlon, supra note 42, at 71.

47 See 21 C.F.R. § 312.22(a).

48 See id.

49 See id.

50 See id.

51 21 U.S.C. § 355(a) (2012). An Abbreviated New Drug Application (ANDA) can be filed for generic drugs and generally do not require pre-market animal or human testing. Investigational New Drug Application, supra note 42.

52 Investigational New Drug Application, supra note 42.

53 21 U.S.C. § 355(k)(1); see also 21 C.F.R. §§ 310.303, 310.305.

54 See 21 C.F.R. § 600.80.

55 21 U.S.C. § 355(o).

56 Id. § 355(p).

57 Id. §355-1(a).

58 See 42 U.S.C. § 262 (2012); WENDY H. SCHACT & JOHN R. THOMAS, CONG. RESEARCH SERV., R41483, FOLLOW-ON BIOLOGICS: THE LAW AND INTELLECTUAL PROPERTY ISSUES (2012), available at http://www.fas.org/sgp/crs/misc/R41483.pdf.

59 42 U.S.C. § 262(i)(1).

60 See SCHACT & THOMAS, supra note 58; Frequently Asked Questions About Therapeutic Biological Products, U.S. FOOD & DRUG ADMIN., http://www.fda.gov/Drugs/DevelopmentApprovalProcess/%20HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm113522.htm (last updated Dec. 24, 2009).

61 Nash, Steven A. & Workman, Rebecca, A New Pathway for Follow-On Biologics, 20 FED. CIR. B.J. 193, 195-97 (2010)Google Scholar.

62 Id.

63 Id.

64 Id.

65 Id.

66 Id.

67 42 U.S.C. § 262(a)(1).

68 Id. § 262(a)(2)(C)(i).

69 Id. § 262(a)(1).

70 Id. § 262(j) (applying the FDCA to biologics but excepting the NDA requirement).

71 See generally 21 C.F.R. § 601 (2013).

72 Id. § 312.2.

73 Chirba, supra note 36, at 248.

74 See 42 U.S.C. § 262(j).

75 Id. § 264.

76 Chirba, supra note 36, at 251.

77 Id.

78 Id. at 248.

79 Id.

80 Id. at 249.

81 21 C.F.R. § 1271.3(d) (2013).

82 Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing, 66 Fed. Reg. 5447, 5448 (Jan. 19, 2001) (codified as 21 C.F.R. pts. 207, 807, & 1271).

83 Chirba, supra note 36, at 249.

84 21 C.F.R. §1271.1(a).

85 Chirba, supra note 36, at 250 (“[This] category of products, comprised of human organs for transplantation, whole blood and blood-derived products, and extracted human products such as collagen and bone marrow, are [sic] not regarded as human cell or tissue-based products, and therefore, they are [sic] not subject to the 21 C.F.R. secti on 1271 regulations.”); see 21 C.F.R. §§ 1271.3(d), 1271.15.

86 21 C.F.R. §1271.3(c).

87 Human Cells, Tissues, and Cellular and Tissue-Based Products, 66 Fed. Reg. at 5549; Chirba, supra note 36, at 250; see also 21 C.F.R. § 1271.10.

88 21 C.F.R. § 1271.3(c) (defining “homologous use” as “the repair, reconstruction, replacement, or supplementation of a recipient's cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor”).

89 Exceptions include combining with “water, crystalloids, or a sterilizing, preserving or storage agent, provided the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P.” 21 C.F.R. § 1271.10(a)(3).

90 21 C.F.R. § 1271.10(a) (emphasis added).

91 Chirba, supra note 36, at 251-52.

92 21 C.F.R. § 1271.20.

93 See id. § 601.2.

94 Id. § 210.1(c).

95 Id.

96 Id. § 1271.3(f) (emphasis added).

97 Ward, Shane M., Global Harmonization of Regulatory Requirements for Premarket Approval of Autologous Cell Therapies, 55 FOOD & DRUG L.J. 225, 226 (2000)Google ScholarPubMed.

98 Id.

99 Id.

100 Id.

101 See generally OFFICE OF COMBINATION PRODS. & CTR. FOR BIOLOGICS EVAL. & RESEARCH, U.S. FOOD & DRUG ADMIN., GUIDANCE FOR INDUSTRY AND FDA STAFF: MINIMAL MANIPULATION OF STRUCTURAL TISSUES JURISDICTIONAL UPDATE (2006), available at http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM085439.pdf.

102 Id. at 2.

103 Id.

104 Human Cells, Tissues, and Cellular and Tissue-Based Products, 66 Fed. Reg. 5447, 5457 (Jan. 19, 2001) (to be codified at 21 C.F.R. pts. 207, 807, and 1271).

105 Id.

106 42 U.S.C. § 262 (2012); 21 C.F.R. §§ 1271.10-.20 (2013); see also Halme, Dina Gould & Kessler, David A., FDA Regulation of Stem-Cell-Based Therapies, 355 NEW ENG. J. MED. 1730, 1731 (2006)CrossRefGoogle ScholarPubMed.

107 Halme & Kessler, supra note 106, at 1731.

108 Centeno Affidavit, supra note 2, at 1-2.

109 Id. at 5.

110 Id.

111 Id. at 6.

112 Id. at 6-7.

113 Id. at 7.

114 Id. at 8.

115 Id.

116 Id.

117 Id. at 9.

118 Id. at 14.

119 Id. at 9.

120 Id. at 9.

121 “Karyotyping is a test to examine chromosomes in a sample of cells, which can help identify genetic problems as the cause of a disorder or disease.” Karyotyping, NIH (last updated Feb. 26, 2014) available at http://www.nlm.nih.gov/medlineplus/ency/article/003935.htm.

122 Centeno Affidavit, supra note 2, at 9.

123 Id. at 9.

124 Id. at 63.

125 Id.

126 Id.

127 Id. at 64. Platelets are present in blood and are responsible for blood clotting. Id. They also secrete chemicals to aid the body in healing wounds. Id.

128 Id. at 64.

129 Id.

130 Letter from Mary A. Malarkey, Office of Compliance & Biologics Quality, U.S. Food & Drug Admin., to Christopher J. Centeno, Medical Dir., Regenerative Scis., Inc. (July 25, 2008), available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/ucm091991.htm.

131 von Tigerstrom, Barbara, The Food and Drug Administration, Regenerative Sciences, and the Regulation of Autologous Stem Cell Therapies, 66 FOOD & DRUG L.J. 479, 482-83 (2011)Google ScholarPubMed.

132 Id. at 483. Regenerative Sciences offers many other procedures that are currently legal. Id. at 236-37.

133 Complaint at para. 16, United States v. Regenerative Scis., LLC, 878 F. Supp. 2d 248 (D.D.C. 2012).

134 Id. at para. 24.

135 Id. at para. 29 (citing 21 C.F.R. § 1271.10 (2013)).

136 Id. at para. 1.

137 Id. at 251.

138 Regenerative II, 741 F.3d 1314, 1316 (D.C. Cir. 2014).

139 Id. at 1317.

140 Id. at 1324.

141 See id.

142 Id.; see supra Part II (discussing the definition of a drug).

143 Regenerative II, 741 F.3d at 1318, 1324-25.

144 Regenerative II, 741 F.3d at 1318, 1324-25; see also supra Part II (discussing the definition of biologics).

145 Regenerative II, 741 F.3d at 1319-20.

146 Id. at 1322.

147 Id. at 1319.

148 Id. at 1319-21.

149 Id.

150 Id. 1319-20 (discussing the scope of 21 U.S.C. §§ 360(g)(2) & 374(a)(2)(B)).

151 Id.

152 Id.

153 Id.

154 Id.

155 Id. at 1320 (quoting Gonzales v. Raich, 545 U.S. 1, 17 (2005)).

156 Id. This aggregation argument can also be seen in Wickard v. Filburn, 317 U.S. 111 (1942).

157 Id.

158 Wickard, 317 U.S. at 128-29.

159 Raich, 545 U.S. at 32-33.

160 Regenerative II, 741 F.3d at 1320.

161 Id. at 1320.

162 Id. at 1320-21 (citing 21 U.S.C. 331(k) (2012)).

163 Regenerative II, 741 F.3d at 1320-21.

164 See id. (citing United States v. Dianovin Pharmaceuticals, Inc., 475 F.2d 100, 102-03 (1st Cir. 1973)); Baker v. United States, 932 F.2d 813, 814 (9th Cir. 1991).

165 Regenerative II, 741 F.3d at 1321.

166 Id.

167 See id. at 1321-22.

168 Id. at 1321.

169 Id. This statement leaves open the possibility that courts may analyze further the minimal - manipulation question. The court went on to state that it reached its conclusion “based on evidence, and not merely by deferring to FDA's statement in the preamble to Pa rt 1271 Regulations that expansion of MSCs in culture automatically constitutes more than minimal manipulation. Id. Though the statement was a response to Regenerative Sciences’ argument that FDA's preamble constituted an “invalid legislative rule that the FDA now seeks to enforce,” it hints at an increased judicial scrutiny of FDA's factual findings in this case. The district court gave tremendous deference to FDA's factual findings, which was probably appropriate under current law, but similar language does not appear in the appeals court opinion. See Regenerative I, 878 F. Supp. 2d 248, 258 (D.C. Cir. 2012).

170 Regenerative II, 741 F.3d at 1322.

171 Id.

172 Id. at 1322.

173 Id. (citing United States v. First City Nat’l Bank of Houston, 386 U.S. 361, 366 (1967)) .

174 Id.

175 Id. at 1323.

176 Id.

177 Id.; see supra Part II (discussing labeling requirements for non-prescription and prescription drugs). Regenerative also claimed its cellular product was a legally compounded drug. The court dismissed the argument because MSCs were not a recognized “bulk drug substance.” Regenerative II, 741 F.3d at 1323.

178 Despite variations between state laws, the practice of medicine can be defined as the diagnosis of medical conditions, prescribing medications, and surgical intervention. Noah, Lars, Ambivalent Commitments to Federalism in Controlling the Practice of Medicine, 53 U. KAN. L. REV. 159, 162 (2004)Google Scholar.

179 21 U.S.C. § 396 (2012) (“Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner -patient relationship.” (emphasis added)). This section applies only to medical devices but is still persuasive.

180 Chirba, supra note 36, at 241-43.

181 Noah, supra note 178, at 175.

182 See Regenerative I, 878 F. Supp. 2d 248, 255-61 (D.C. Cir. 2012). For a general discussion regarding the extent to which the federal government may regulate the practice of medicine, see Noah, supra note 178.

183 See Noah, supra note 178, at 161 (stating that “direct regulation of physicians should not falter on federalism grounds unless it falls beyond the reach of the commerce, spending, or other enumerated powers”) (citing Linder v. United States, 268 U.S. 5, 22 -23 (1925) (internal quotations omitted)).

184 Regenerative I, 878 F. Supp. 2d at 261 (quoting Wash. Legal Found. v. Friedmann, 13 F. Supp. 2d 51, 56 (D.D.C. 1998)).

185 Regenerative II, 741 F.3d 1314, 1320 (D.C. Cir. 2014).

186 Id. at 1320 (citing United States v. Dianovin Pharmaceuticals, Inc., 475 F.2d 100, 102-03 (1st Cir. 1973)); Baker v. United States, 932 F.2d 813, 814 (9th Cir. 1991).

187 21 U.S.C. § 321(g)(1)(D) (2012) (including in the definition of interstate commerce any “articles intended for use as a component” of a drug).

188 Id. § 331(k).

189 See supra Part III.

190 21 C.F.R. § 1271.3(f)(2) (2013).

191 Centeno Affidavit, supra note 2, at 5.

192 This is not entirely true. There may be some residual MSCs left over at the site of injury to maintain a dormant “pool” of stem cells that will activate and differentiate when subsequent injury occurs. Regardless, the majority will differentiate into new cartilage relieving the patient of pain associated with an arthritic joint.

193 21 C.F.R. § 1271.3(f)(2).

194 See supra, Part 2(discussing structural and functional HCT/Ps).

195 See generally Halme & Kessler, supra note 106.

196 Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing, 66 Fed. Reg. 5447, 5457 (Jan. 19, 2001) (to be codified at 21 C.F.R. pts. 207, 807, and 1271).

197 See Regenexx-SD (Same Day) Stem Cell Procedure Overview, REGENEXX, http://www.regenexx.com/regenexx-procedures-family/the-regenexx-procedure-explained (last visited Apr. 14, 2014).

198 Id.

199 Jacque Wilson, Meningitis Outbreak: What is a Compounding Pharmacy?, CNN (Oct. 12, 2012), http://www.cnn.com/2012/10/11/health/compounding-pharamcies-explainer/index.html.

200 Elizabeth Cohen, Danielle Dellorto & William Hudson, Meningitis Outbreak Highlights Failed Oversight Efforts, CNN (Oct. 12, 2012), http://www.cnn.com/2012/10/10/health/meningitis-exposure/index.html.

201 Wilson, supra note 199.

202 Id.

203 Id.

204 Thomas M. Burton, James V. Grimaldi & Timothy W. Martin, Pharmacies Fought Controls; Industry at the Focus of Meningitis Outbreak Beat Back More Federal Oversight, WALL ST. J. (Oct. 17, 2012), http://online.wsj.com/article/SB10000872396390444657804578052972230404046.html.

205 Cohen, supra note 200.

206 Though Governor Deval Patrick did accuse the pharmacies of misleading regulat ors. Wilson, supra note 199.

207 Burton, Grimaldi, & Martin, supra note 204.

208 Johan Lehrer, Why Did Kobe Go to Germany?, GRANTLAND (April 12, 2012), http://www.grantland.com/story/_/id/7796225/kobe-bryant-dr-chris-renna-regenokine-knee-treatment.

209 Id.

210 See id.

211 See id.

212 See id.

213 See id.

214 Id. (Thirty-three is old for a basketball player. The average peak is between twenty-four and twenty-seven years old, with a steep decline taking place soon after).

215 Id. Currently Regenerative Sciences offers a similar procedure known as Regenexx-SCP. See Regenexx-SCP: A Superior Form of Platelet Rich Plasma/PRP, REGENEXX, http://www.regenexx.com/regenexx-scp-platelet-rich-plasma-prp/ (last visited Apr. 14, 2014).

216 See, e.g., Cyranoski, David, Stem Cells in Texas: Cowboy Culture, 494 NATURE 166, 168 (2013)CrossRefGoogle ScholarPubMed (describing comments made during a conference on use of stem cells as a drug including a speaker “bemoaning the FDA's crippling bureaucratic infrastructure” and anothe r participant remarking that “[t]he FDA is trying to screw you” (internal quotation marks omitted)); Toni Clarke, U.S. Compounding Pharmacies Start to Register with FDA, REUTERS (Jan. 9, 2014), http://www.reuters.com/article/2014/01/10/us-compounding-pharmacies-fdaidUSBREA0903120140110 (discussing how the FDA was blamed for not acting more quickly to shut down the New England Compounding Center after the 2012 meningitis outbreak).

217 Letter from Mary A. Malarkey, Office of Compliance & Biologic Quality, U.S. Food & Drug Admin., to David G. Geller, Chief Exec. Officer, Celltex Therapeutics Corp. (Sept. 24, 2012), available at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm323853.htm. For background information regarding FDA regulation of the Celltex procedures, see generally Cyranoski, supra note 216 (stating that in order to fall outside FDA's jurisdiction the cells would have to be “minimally manipulated” and implanted for “homologous use” and summarizing the debate between FDA and Celltex on whether the stem cells meet this standard); Susan Berfield, Stem Cell Showdown: Celltex vs. FDA, BLOOMBERG BUSINESSWEEK (Jan. 3, 2013), http://www.businessweek.com/printer/articles/90936-stem-cell-showdown-celltex-vs-dot-the-fda (“Are stem cell infusions and injections biologic drugs like vaccines, which require FDA oversight, or are they part of the practice of medicine, which falls under the exclusive jurisdiction of the [state]? The answer turns on the notion of ‘minimal manipulation.’ If the cells are more than minimally manipulated in the lab, they’re considered a drug.”); Alexander Gaffney, Stem Cell Processor, IRB Targets of Related Warning Letters from FDA, REGULATORY FOCUS (Oct. 17, 2012), http://www.raps.org/Default.aspx?TabId=913&article=2412&stem-cell-processor-irb-targets-ofrelated-warning-letters-from-fda (noting that FDA's authority to regulate stem cell therapies as drugs has been reinforced by a July 2012 D.C. District Court decision but the case remains on appeal).

218 See Tigerstrom, supra note 131, at 481-82 (noting that Regenerative will open a clinic in the Cayman Islands, in addition to already licensing the procedure to clinics in Argentina and China); Susan Berfield, Celltex Says It's Moving Its Stem Cell Business to Mexico, BLOOMBERG BUSINESSWEEK (Jan 31, 2013), http://www.businessweek.com/articles/2013-01-31/celltex-wants-tobring-its-stem-cell-business-to-mexico (Celltex will work with doctors in Mexico to offer the procedure while at the same time conducting clinical trials in the U.S. to obtain FDA approval).

219 42 U.S.C. § 262(k)(7) (2012).

220 See Washington v. Glucksberg, 521 U.S. 702, 710 (1997) (stating that Washington State's assisted suicide ban is “not [an] innovation,” but rather “[a] longstanding expression of the States’ commitment to the protection and preservation of all human life”).

221 See Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach, 495 F.3d 695, 706 (D.C. Cir. 2007) (“The fact that a drug has emerged from Phase I with a determination that it is safe for limited clinical testing in a controlled and closely-monitored environment after detailed scrutiny of each trial participant does not mean that a drug is safe for use beyond supervised trials. FDA regulation of post-Phase I drugs is entirely consistent with our historical tradition of prohibiting the sale of unsafe drugs.”). The FDA, in response to Abigail Alliance, more readily permits terminal ill patients access to experimental drugs under compassionate use regulations. See Romano, Leah Voigt & Jacobson, Peter D., Patient Access to Unapproved Therapies: The Leading Edge of Medicine and Law, 2 J. HEALTH & LIFE SCI. L. 45, 57-59 (2009)Google Scholar.

222 Physician assisted suicide could be regulated on grounds that another person (the doctor) is involved in the procedure. Stating that the doctor patient relationship can be regulated, however, is different than allowing the government the ability to completely deny the right itself. The best analogy is abortion. There is an absolute right for a woman to have an abortion, though the government can regulate the procedure by requiring abortion doctors obtain medical licenses, or prohibiting partial birth abortions. Unlike physician assisted suicide, however, states may not outlaw abortion. They cannot even place an “undue burden” on women trying to access the procedure.

223 See Cruzan v. Dir., Missouri Dep't of Health, 497 U.S. 261, 281 (1990)(“It cannot be disputed that the Due Process Clause protects an interest in life as well as an interest in refusing life -sustaining medical treatment”).

224 Abigail Alliance, 495 F.3d at 695, 702 (citing Glucksberg, 521 U.S. at 720-21). A substantivedue- process analysis also requires a “careful description” of the asserted fundamental liberty interest; however, the Abigail Alliance court assumed arguendo that this prong was satisfied. Abigail Alliance, 495 F.3d at 702.

225 Planned Parenthood of Se. Pa v. Casey, 505 U.S. 833, 853 (1992) (recognizing that the abortion decision is similar to the decision to use contraception, insof ar as both “involve personal decisions concerning not only the meaning of procreation but also human responsibility and respect for it”); Eisenstadt v. Baird, 405 U.S. 438 (1972) (extending the right to contraceptives recognized for married couples in Griswold to individuals); Griswold v. Conn., 381 U.S. 479, 485-86 (1965) (holding that the right to contraceptives for married couples is under the penumbral right of privacy because forbidding the use of contraceptives would enable the government to invade th e privacy surrounding the marriage relationship).

226 Roe v. Wade, 410 U.S. 113, 154 (1973) (concluding that the right to an abortion is under the right of personal privacy but that the right to an abortion is not absolute and must be weighed against state interests).

227 The original panel in Abigail Alliance recognized a version of this principle when comparing a patient's right to access life-saving therapies to the Cruzan holding permitting patient's to refuse life-saving treatment, stating that “[i]n both instances, the key is the patient's right to make the decision about her life free from government interference.” Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach, 445 F.3d 470, 472 (2006), vacated, 495 F.3d 695 (D.C. Cir. 2006). Courts, however, will not enumerate a fundamental right based on the abstract concept of personal autonomy as there is a risk of protecting too much behavior. See id. at 491. Instead courts require a “careful description of the fundamental liberty interes t.” See id. at 477 (citing Glucksberg, 521 U.S. 721-23). This theory inevitably leads endless pages of debate in judicial opinions devoted to the proper framing of the right at issue.

228 Epstein, Richard A., The Erosion of Individual Autonomy in Medical Decisionmaking: Of the FDAs and IRBs, 96 GEO. L.J. 559, 569 (2008)Google Scholar

229 See Chirba, supra note 36, at 242 (stating that shipment of drugs in interstate commerce is banned unless a New Drug Application has been filed describing the drug's intended uses and showing that the drug is safe for those uses).

230 See id. at 241 (noting that although the FDCA expanded federal regulatory authority, Congress never intended the FDA to regulate “the practice of medicine”).

231 See generally Jacobs, supra note 12, at 604-05 (describing how public outrage of a health disaster with widespread media coverage leads to reactionary policy-making and overregulation by the government).

232 See, e.g., MEDICAL BOARD OF CALIFORNIA, GUIDE TO THE LAWS GOVERNING THE PRACTICE OF MEDICINE 57-59 (2013), available at http://www.mbc.ca.gov/About_Us/Laws/laws_guide.pdf. But see von Tigerstrom, supra, note 131 at 496-97 (arguing these methods of regulation are not effective).

233 See generally Drabiak-Syed, Katherine, Challenging the FDA's Authority to Regulate Autologous Stem Cells for Therapeutic Use: Celltex Therapeutics’ Partnership with RNL Bio, Substantial Medical Risks, and the Implications of United States v. Regenerative Sciences, 23 HEALTH MATRIX 493, 504-14 (2013)Google ScholarPubMed (describing Celltex Therapeutics’ business model and how it may harm patients because the science does not support findings of safety and efficacy for autologous stem cell transplants).

234 See supra Part II.C (discussing the D.C. Circuit opinion).

235 For a discussion of possible alternative regulatory regimes for stem cell therapies, see Hyun, Insoo, Allowing Innovative Stem Cell-Based Therapies Outside of Clinical Trials: Ethical and Policy Challenges, 38 J.L. MED. & ETHICS 277, 280-84 (2010)CrossRefGoogle ScholarPubMed.

236 See id. at 283-84 (The International Society for Stem Cell Research has drafted guidelines for doctors’ use of stem cell therapies, which allow for medically innovative uses in certain circumstances but mandate independent peer review and approval of any proposed therapy in order to protect the patient).

237 See Chirba, supra note 36, at 268-70 (explaining that “aggressive oversight” by the FDA of innovative treatments that are provided and marketed on a small scale and will not reach the general public undermines the FDA's main goal to advance public health).

238 See id. at 252-54. (noting that practicing doctors are most likely to use autologous therapies but least likely to be aware of minor changes in the federal regulations and that the FDA first implemented a separate regulatory framework for autologous cellular therapies because regulating cellular therapies as standard drugs did not make sense).