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Unpublished Paper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

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 (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 (Accessed July 4, 2013)

[4] U.S. Food and Drug Administration , FDA Press Release, For Immediate Release: February 4, 2011. Available at (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. Available at (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).

  • 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)
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