Regulatory approval for new pharmacogenomic tests: A comparative overview

Food and Drug Law Journal

Volumn 66, Issue 1, 2011, Pages

  Joly, Yann ^a   Koutrikas, Georgia ^a   Tassé, Anne Marie ^a   Issa, Amalia ^b   Carleton, Bruce ^c   Hayden, Michael ^c,d   Rieder, Michael J ^e   Ramos Paque, Emma ^a   Avard, Denise ^a  

^a MCGILL UNIVERSITY   (Canada)

^b UNIVERSITY OF HOUSTON   (United States)

^c UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^d Centre for Molecular Medicine and Therapeutics   (Canada)

^e LONDON HEALTH SCIENCES CENTRE   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

CISPLATIN;

DRUG LEGISLATION; DRUG RESEARCH; DRUG SAFETY; GERM CELL TUMOR; HEARING IMPAIRMENT; HUMAN; NEUROBLASTOMA; OTOTOXICITY; PHARMACOGENOMICS; POSTMARKETING SURVEILLANCE; REVIEW;

CANADA; CISPLATIN; DRUG DESIGN; DRUG DISCOVERY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; EUROPE; GENETIC TESTING; HUMANS; PHARMACOGENETICS; TECHNOLOGY, PHARMACEUTICAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84872022122     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

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156. Id. at 4.
157. Id. at 3.
158. Tucker, supra note 11, at 3.
159. As genetic tests are considered to be highly complex, standards for proficiency testing of genetic tests have been recommended, but have not been adopted, "A draft report by the Secretary's Committee on Genetics, Health and Society (SACGHS) [...] recommended that the [HHS] take specific steps to increase the use of proficiency testing for genetic tests": SACGHS, supra note 150.
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161. SACGHS supra note 151.
162. Id. at 1.
163. Id. at 4.
164. Id. at 5.
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182. Goodsaid, supra note 179, at 435.
183. Id. at 435.
184. Id. at 435.
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186. FDA, DRUG-DIAGNOSTIC CO-DEVELOPMENT CONCEPT PAPER (DRAFT), April 2005, at 1.
187. Id. at 2.
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189. Id. §5.
190. Id. §3.
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192. Council Directive 98/79/EC, art. 4, 1998 O.J. (L331).
193. Id. art. 9.
194. Id. Annex III, art. 3.
195. UK Pharmacogenetics Study Group, Policy Issues in Pharmacogenetics (2006) at 10, available at http://www.york.ac.uk/media/satsu/res-pgx/ PGxpolicyissues2006.pdf.
196. Eleni Zika, Pharmacogenetics and Pharmacogenomics: State-of-the-art and potential socioeconomic impact in the EU, at 82, (2006).
197. Council Directive 98/79/EC, Annex III, art. 6, 1998 O.J. (L331).
198. UK Pharmacogenetics Study Group, Policy Issues in Pharmacogenetics (2006) at 10, available at http://www.york.ac.uk/media/satsu/res-pgx/ PGxpolicyissues2006.pdf.
199. Zika, supra note 197, at 82.
200. Id. at 120.
201. Id. at 96.
202. Council Directive 98/79/EC, art. 9(13), 1998 O.J. (L331).
203. Zika, supra note 197, at 96.
204. Council Directive 98/79/EC, art. 1(5), 1998 O.J. (L331).
205. Zika, supra note 197, at 123.
206. Id. at 96.
207. Id. at 95.
208. Id. at 96.
209. See Council Directive 98/79/EC, Preamble at para. 8, 1998 O.J. (L331).
210. Zika, supra note 197, at 124.
211. UK Pharmacogenetics Study Group, Policy Issues in Pharmacogenetics (2006) at 10, available at http://www.york.ac.uk/media/satsu/res-pgx/ PGxpolicyissues2006.pdf (last visited October 22, 2010).
212. Zika, supra note 197, at 79.
213. Id. at 120.
214. Id. at 86.
215. Id. at 124.
216. EMA, Reflection paper on co-development of pharmacogenomic biomarkers and Assays in the context of drug development, (2008), http://www.ema.europa.eu/ docs/en-GB/document-library/Scientific-guideline/2010/07/WC500094445.pdf (last visited October 22, 2010).
217. UK Pharmacogenetics Study Group, Policy Issues in Pharmacogenetics (2006) at 10, available at http://www.york.ac.uk/media/satsu/res-pgx/ PGxpolicyissues2006.pdf (last visited October 22, 2010).
218. EMA, Guideline on Pharmacogenetics Briefing Meetings, at 5, (2005), http://www.ema.europa.eu/ema/pages/includes/document/open-document.jsp? webContentId=WC500003886 (last visited October 22, 2010).
219. FDA, European Commission & European Medicines Agency, General Principles Processing Joint FDA EMEA Voluntary Genomic Data Submissions (VGDSs) within the framework of the Confidentiality Arrangement, (2006), http://www.ema.europa.eu/ema/pages/includes/document/open-document.jsp? webContentId=WC500003887) (last visited October 22, 2010).
220. See 75 Fed. Reg. 34,463-34,464 (June 17, 2010).
221. Michele Schoonmaker, The U.S. Approval Process for Medical Devices: Legislative Issues and Comparison with the Drug Model, at 20, (2005), http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/RL3282603232005. pdf
222. Health Canada, Draft Guidance for the Risk Based Classification System of In Vitro Diagnostic Devices, at 6, (1998) http://www.hc-sc.gc.ca/dhp-mps/alt- formats/hpfb-dgpsa/pdf/md-im/ivd-rsk-idiv-rsq-eng.pdf (last visited October 22, 2010).
223. Yann Joly & Bartha M. Knoppers, Pharmacogenomic data sample collection and storage: ethical issues and policy approaches, 7 PHARMACOGENOMICS 219, 219 (2006).
224. FDA, Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System - Guidance for Industry and FDA Staff, http://www.fda.gov/MedicalDevices/DeviceRegulation-andGuidance/ GuidanceDocuments/ucm077933.htm (last visited October 22, 2010);
225. Council Directive 98/79/EC, art. 9, 1998 O.J. (L331).
226. FDA noted that novel tests could become available more quickly as LDTs; see 61 Fed. Reg. 10,484-10,485 (March 14, 1996).
227. 75 Fed. Reg. 34,463-34,464 (June 17, 2010).
228. See Lena H. Sun & Carol D. Leonnig, Georgetown U. Hospital closes lab after problems with breast cancer tests, WASHINGTON POST, Aug. 6, 2010.
229. 75 Fed. Reg. 34,463-34,464 (June 17, 2010).
230. Juliana Han, The Optimal Scope of FDA Regulation of Genetic Tests: Meeting Challenges and Keeping Promises, 20 HARVARD JOURNAL OF LAW & TECHNOLOGY 423, 430 (2007).
231. For example, Han suggests that the distinction between device and laboratory service is increasingly semantic. For an interesting analysis on this issue, see id. at 430-441.
232. Constitution Act, 1867, 30 & 31 Vict., Ch. 3 (U.K.), as reprinted in R.S.C., No. 5 (Appendix 1985) § 91-92.
233. Medical Devices Regulations, S.O.R./98-282 § 2(a).