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FDA and the Marketplace of Ideas for Medical Products

Published online by Cambridge University Press:  01 January 2021

Abstract

The market can produce skewed information about investigational products awaiting FDA approval. But the FDA rarely steps in to correct such misleading information, despite statutory authority to do so. This article evaluates a recommendation by the FDA Transparency Working Group that FDA more clearly signal when and how it will correct misleading information about investigational products, and why such a recommendation is particularly important after the 21st Century Cures Act.

Type
Symposium Articles
Copyright
Copyright © American Society of Law, Medicine and Ethics 2017

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References

Abrams v. United States, 40 S.Ct. 17, 22 (1919) (Holmes, J., dissenting); Milton, J., “Areopagitica” (London, 1644), in Sirluck, E., ed., 2 Complete Prose Works of John Milton (1959): at 486; Mill, J. S., “On Liberty,” in McCallum, R., ed., On Liberty and Considerations on Representative Government (1946): at 13–48.Google Scholar
Ingber, S., “The Marketplace of Ideas: A Legitimizing Myth,” 1984 Duke Law Journal 1 (1984): 5. In Sorrell v. IMS Health, 564 U.S. 552, 583 (2011), Justice Breyer’s dissent invokes the “marketplace of ideas” analogy, citing Justice Holmes’ dissent in Abrams v. United States, supra. However, Breyer notes that for commercial speech, information about goods and services is rightly regulated, and that such regulation is subject to intermediate rather than strict scrutiny.Google Scholar
For example, cancer patients and investors both take great interest in abstracts and study results released at conferences held by the American Society for Clinical Oncology (ASCO).Google Scholar
See, e.g., Turner, E. H. at al., “Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy,” New England Journal of Medicine 358 (Jan. 17, 2008): 252260.CrossRefGoogle Scholar
FDA Transparency Working Group, “Blueprint for Transparency at the U.S. Food and Drug Administration,” Journal of Law, Medicine & Ethics 45, no. 4, Suppl. (2017): 723.CrossRefGoogle Scholar
Id.; Kesselheim, A. S. and Avorn, J., “Approving a Problematic Muscular Dystrophy Drug: Implications for FDA Policy,” JAMA 316, no. 22 (2016): 23572358.CrossRefGoogle Scholar
Blueprint, supra note 5, at 27-28; Sharfstein, J. M. and Psaty, B. M., “Evaluation of the Cardiovascular Risk of Naltrexone-Bupropion: A Study Interrupted,” JAMA 315 984, no. 10 (2016): 984986.CrossRefGoogle Scholar
But see Warning Letter from FDA to Presby Corp. (Jan. 7, 2000) (objecting to press materials on the company’s web site promoting an investigational product).Google Scholar
21 C.F.R. §§ 312.7, 812.5(b), 812.7.Google Scholar
Vodra, W. W., Cortez, N. G., and Korn, D. E., “The Food and Drug Administration’s Evolving Regulation of Press Releases: Limits and Challenges,” Food & Drug Law Journal 61, no. 4 (2006): 623651, at 634.Google Scholar
In 1995, the Washington Legal Foundation (WLF) filed a Citizens Petition asking the FDA to allow public companies to disclose IND study results in SEC filings. The FDA responded that 21 C.F.R. § 312.7(a) does not bar such disclosures. FDA Docket No. 96P-0001; FDA Letter to Washington Legal Foundation (Mar. 19, 2001); Vodra et al., supra note 10, at 634 n.57, 637. See also 21 C.F.R. § 812.7(a).Google Scholar
Vodra et al., supra note 10, at 638.Google Scholar
Petty, M. D., “Pre-Approval Promotion of Medical Devices,” Food & Drug Law Journal 49 (1994): 541552, at 546.Google Scholar
Vodra et al., supra note 10, at 638.Google Scholar
U.S. Securities and Exchange Commission, SEC and FDA Take Steps to Enhance Inter-Agency Cooperation (Feb. 5, 2004), available at <https://www.sec.gov/news/press/2004-13.htm> (last visited November 2, 2017).+(last+visited+November+2,+2017).>Google Scholar
See, e.g., SEC Release No. 34-49513 (suspending trading for VasoActive Pharmaceuticals); SEC Release No. 34-49546 (suspending trading for BioCurex, Inc.); Vodra et al., supra note 10, at 647.Google Scholar
Vodra et al., supra note 10, at 638, 647-648.CrossRefGoogle Scholar
U.S. v. Harkonen, 510 Fed. Appx. 633 (9th Cir. 2013).Google Scholar
SEC, Litigation Release No. 23503, SEC v. AVEO Pharmaceuticals, Inc., et al., Civil Action No. 1:16-cv-10607-NMG (D. Mass. 2016), available at <https://www.sec.gov/litigation/litreleases/2016/lr23503.htm> (last visited November 2, 2017).+(last+visited+November+2,+2017).>Google Scholar
21 C.F.R. § 20.82.Google Scholar
Blueprint, supra note 5, at 29.Google Scholar
21 C.F.R. § 20.82(b)(1).Google Scholar
Blueprint, supra note 5, at 28-29.Google Scholar
Id., at 30.Google Scholar
FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration (May 2010), at 48-49 (Draft Proposal 16).Google Scholar
Pearson v. Shalala, 164 F.3d 650, 657 (D.C. Cir. 1999).Google Scholar
See, e.g., FDA, Talk Paper T03-18: FDA Warns Public about Misrepresentations in Marketing Claims About Drug to Treat Cancer (Mar. 14, 2003).Google Scholar
See Cortez, N., “Adverse Publicity by Administrative Agencies in the Internet Era,” BYU Law Review 2001, no. 5 (2011): 13711454. Note that the Blueprint recommends giving the company advanced notice, but also calls for the FDA to be able to “move quickly to protect patients in response to urgent public health needs,” Blueprint, supra note 5, at 30, echoing earlier recommendations. Cortez, Adverse Publicity, at 1437.Google Scholar
21st Century Cures Act § 3022, Pub. L. No. 114-255, __ Stat. ___ (2016). Indeed, the statute defines “real-world evidence” as “data … derived from sources other than randomized clinical trials.” Id. at § 3022, codified at 21 U.S.C. § 355f(b).Google Scholar