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Unpublished Paper
Where Babies and Death-row Inmates Intersect: Is Arbitrary Agency Decision-making Supported Under Existing Law?
ExpressO (2013)
  • Lisa C. Blanton, BS., MJ., Loyola University Chicago, Law School
Abstract

The Food and Drug Administration (FDA) is the executive branch regulatory agency primarily responsible for protecting the nation’s drug products.[1] The FDA recently made highly inconsistent decisions surrounding a new drug for the prevention of pre-term birth, Makena™ (hydroxyprogesterone caproate). During a lengthy approval process, FDA made laudatory public announcements and demonstrated high programmatic preference to expedite approval of Makena by assigning orphan status[2] and granting accelerated “fast-track” approval time-frames.[3] Despite these actions, within weeks of the approval, the FDA issued aggressive public statements against the product’s efficacy and safety and made supportive comments about a non-FDA approved, non-regulated compounded version.[4] The FDA also refused to engage in enforcement actions against the production and sales of the non-approved, now unlawful compound, a de facto violation of FDA regulations.[5]

Makena’s manufacturer, K-V Pharmaceuticals sued the FDA under the Administrative Procedures Act (“APA”)[6] to compel agency enforcement action against the makers of the non-approved compound.[7] The D.C. District Court denied the claims; citing case law barriers regarding judicial oversight of agency decision-making stemming ex ante from Chevron U.S.A. Inc. v. Natural Res. Def. Council, Inc.[8] and Heckler v. Chaney[9]. The deference to administrative agency independence under current case law leaves the FDA with an expectation of acquiescence from the courts and encourages erratic and dangerous decision-making.

In the months following the FDA decisions regarding Makena, dramatic spikes in illness and deaths from improper manufacturing of compounded products were discovered. One prestigious review found a 77 percent increase in deaths in the eighteen months after the Makena decision versus the entire decade prior.[10]

Congress must take the steps available as the responsible governing body to prevent arbitrary behavior within FDA regulatory actions; assuring their statutes are implemented consistently and insisting the agency remains the sentinel for excellence in providing for the nation’s health.[11]

[1] U.S. Food and Drug Administration, Statement of FDA Mission. See UCM298331.pdf, available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM298331.pdf (Accessed Aug. 6, 2013).

[2] 21 U.S.C.A. § 360 (West 1999).

[3] U.S. Food and Drug Administration , Drugs - Guidance for Industry Development and Approval Process, available at www.fda.gov http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/default.htm (Accessed July 4, 2013)

[4] U.S. Food and Drug Administration , FDA Press Release, For Immediate Release: February 4, 2011. Available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm242234.htm (Accessed July 4, 2013)

[5] 21 U.S.C.A. § 321 (West). See (p)(1). See also 67 Fed. Reg. 39, 409 (June 7, 2002). ["[a]ny drug (except a new animal drug . . .) [that] is not generally recognized . . . as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof."]

[6] 5 U.S.C.A. §§ 701-706 (West).

[7] K-V Pharm. Co. v. United States FDA, 889 F. Supp. 2d 119, 132 (D.D.C. 2012)

[8] Chevron U.S.A. Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837 (1984).

[9] Heckler v. Chaney, 470 U.S. 821 (U.S. 1985).

[10] U.S. Illnesses and Deaths Associated with Compounded Medications (2001-Present), The Pew Charitable Trust Health Initiative. www.pewhealth.org Available at http://www.pewhealth.org/uploadedFiles/PHG/Content_Level_Pages/In_the_News/DSP%20compounding_Web-final.pdf (Accessed August 5, 2013)

[11] 5 U.S.C.S. §§ 701-702 (LexisNexis 2006). See (a)(2). 5 U.S.C.A. §§ 801-808 (West 1999).

Keywords
  • Administrative agency,
  • regulation,
  • drug safety
Publication Date
September 2, 2013
Citation Information
Lisa C. Blanton. "Where Babies and Death-row Inmates Intersect: Is Arbitrary Agency Decision-making Supported Under Existing Law?" ExpressO (2013)
Available at: http://works.bepress.com/lisa_blanton/1/