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.
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References
1.
Abrams v. United States, 40 S.Ct. 17, 22 (1919) (Holmes, J., dissenting); J.Milton, “Areopagitica” (London, 1644), in E.Sirluck, ed., 2 Complete Prose Works of John Milton (1959): at 486; J. S.Mill, “On Liberty,” in R.McCallum, ed., On Liberty and Considerations on Representative Government (1946): at 13-48.
2.
S.Ingber, “The Marketplace of Ideas: A Legitimizing Myth,”1984Duke Law Journal1 (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.
3.
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).
4.
See, e.g., E. H.Turnerat al., “Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy,”New England Journal of Medicine358 (Jan. 17, 2008): 252-260.
5.
FDA Transparency Working Group, “Blueprint for Transparency at the U.S. Food and Drug Administration,”Journal of Law, Medicine & Ethics45, no. 4, Suppl. (2017): 7-23.
6.
Id.; A. S.Kesselheim and J.Avorn, “Approving a Problematic Muscular Dystrophy Drug: Implications for FDA Policy,”JAMA316, no. 22 (2016): 2357-2358.
7.
Blueprint, supra note 5, at 27-28; J. M.Sharfstein and B. M.Psaty, “Evaluation of the Cardiovascular Risk of Naltrexone-Bupropion: A Study Interrupted,”JAMA315 984, no. 10 (2016): 984-986.
8.
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).
9.
21 C.F.R. §§ 312.7, 812.5(b), 812.7.
10.
W. W.Vodra, N. G.Cortez, and D. E.Korn, “The Food and Drug Administration’s Evolving Regulation of Press Releases: Limits and Challenges,”Food & Drug Law Journal61, no. 4 (2006): 623-651, at 634.
11.
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).
12.
Vodra et al., supra note 10, at 638.
13.
Id.
14.
M. D.Petty, “Pre-Approval Promotion of Medical Devices,”Food & Drug Law Journal49 (1994): 541-552, at 546.
15.
Vodra et al., supra note 10, at 638.
16.
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).
17.
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.
18.
Vodra et al., supra note 10, at 638, 647-648.
19.
U.S. v. Harkonen, 510 Fed. Appx. 633 (9th Cir. 2013).
20.
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).
21.
Id.
22.
21 C.F.R. § 20.82.
23.
Blueprint, supra note 5, at 29.
24.
21 C.F.R. § 20.82(b)(1).
25.
Blueprint, supra note 5, at 28-29.
26.
Id., at 30.
27.
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).
28.
Pearson v. Shalala, 164 F.3d 650, 657 (D.C. Cir. 1999).
29.
See, e.g., FDA, Talk Paper T03-18: FDA Warns Public about Misrepresentations in Marketing Claims About Drug to Treat Cancer (Mar. 14, 2003).
30.
See N.Cortez, “Adverse Publicity by Administrative Agencies in the Internet Era,”BYU Law Review2001, no. 5 (2011): 1371-1454. 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.
31.
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).
