Federal Legal Preparedness Tools for Facilitating Medical Countermeasure Use during Public Health Emergencies

Journal of Law, Medicine and Ethics

Volumn 41, Issue SUPPL. 1, 2013, Pages 22-27

  Courtney, Brooke ^a,b   Sherman, Susan ^c   Penn, Matthew ^d  

^a Office of Counterterrorism and Emerging Threats   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^c U S DEPARTMENT OF HEALTH AND HUMAN SERVICES   (United States)

^d CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DISASTER PLANNING; DRUG APPROVAL; DRUG CONTROL; HUMAN; LEGAL ASPECT; LEGAL LIABILITY; MASS IMMUNIZATION; OFF LABEL DRUG USE; PRODUCT SAFETY; PUBLIC HEALTH; UNITED STATES;

CONSUMER PRODUCT SAFETY; DISASTER PLANNING; DRUG AND NARCOTIC CONTROL; HUMANS; INVESTIGATIONAL NEW DRUG APPLICATION; LIABILITY, LEGAL; MASS VACCINATION; OFF-LABEL USE; PUBLIC HEALTH; UNITED STATES;

EID: 84877006185     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/jlme.12033     Document Type: Article

References (43)

1. 42 U.S.C. 300hh
2. 2801 of the PHS Act
3. U.S. Department of Homeland Security, National Response Framework (January 2008), available at http://www.fema.gov/pdf/emergency/ nrf/nrf-core.pdf
4. 42 U.S.C. 243©, 247d-6b(a)
5. 311 and 319F-2 of the PHS Act.
6. Such authorities may include emergency use of MCMs, as discussed in this article, and waiver of certain conditions of participation of Medicare, Medicaid, the Children's Health Insurance Program, and sanctions under the Health Insurance Portability and Accountability Act. 42 U.S.C. 247d
7. 319 of the PHS Act, 42 U.S.C. 1320b-5, 1135 of the Social Security Act;
8. U.S. Department of Health and Human Services, Public Health Emergency Declaration, available at http:// www.phe.gov/Preparedness/legal/Pages/phedeclaration.aspx
9. U.S. Department of Health and Human Services, 2012 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy, at 5http://www.phe.gov/ Preparedness/mcm/phemce/Documents/2012-PHEMCEStrategy. pdf
10. Department of Defense, Emergency Supplemental Appropriations to Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act of 2006 (Pub. L. 109-148) (December 30, 2005)
11. Liability immunity means that no legal claim can be filed. Both federal and State claims are precluded, as the PREP Act contains an express preemption of State law. 42 U.S.C. 247d-6d(b)(8)
12. 319F-3(b)(8) of the PHS Act. The declaration must include provisions describing the scope of liability immunity provided, including the following: the category of disease, health condition, or threat to health for which the Secretary recommends MCM; effective time period that the declaration is in effect; target population; geographic area for administration; any limitations on means of distribution; and additional persons qualified to prescribe, administer, or dispense the MCM. 42 U.S.C. 247d-6d(b)(2), (i)(8); 319F-3(b)(2), (i)(8) of the PHS Act.
13. Administration includes actual provision of an MCM to a patient and activities directly related to management and operation of programs or facilities for MCM delivery, distribution, and dispensing. This definition appears in declarations issued by the HHS Secretary. See U.S. Department of Health and Human Services, Public Readiness and Emergency Preparedness Act, available at (last visited January 3, 2013). Although the term is not defined in the Act, the Secretary interprets the term to mean that, when a declaration is in effect, the Act precludes, for example, liability claims alleging negligence by a manufacturer in creating a vaccine, or negligence by a health care provider in prescribing the wrong dose, absent willful misconduct. Likewise, the Act precludes a liability claim relating to the management and operation of a countermeasure distribution program or site, such as a slipand- fall injury or vehicle collision by a recipient receiving a countermeasure at a retail store serving as an administration or dispensing location that alleges, for example, lax security or chaotic crowd control. However, a liability claim alleging an injury occurring at the site that was not directly related to the countermeasure activities is not covered, such as a slip and fall with no direct connection to the countermeasure's administration or use. In each case, whether immunity is applicable will depend on the particular facts and circumstances. U.S. Department of Health and Human Services, "Pandemic Influenza Vaccines - Amendment," Federal Register 77 (March 6, 2012): 13329. The only exception to this broad protection is when claims arise from willful misconduct, a standard more stringent than any form of negligence or recklessness. 42 U.S.C. 247d-6d©; 319F-3© of the PHS Act.
14. 42 U.S.C. 247d-6d(i), 319F-3(i) of the PHS Act as amended by section 402(g) of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013.
15. U.S. Department of Health and Human Services, "Pandemic Influenza Antivirals - Amendment," Federal Register 74 (June 19, 2009): 29213
16. U.S. Department of Health and Human Services, "Declaration under the Public Readiness and Emergency Preparedness Act [pandemic influenza diagnostics, personal respiratory protection devices, and respiratory support devices]," Federal Register 73 (December 22, 2008): 78362
17. U.S. Department of Health and Human Services, "Declaration Under the Public Readiness and Emergency Preparedness Act [anthrax countermeasures]," Federal Register 73 (October 6, 2008): 58239
18. U.S. Department of Health and Human Services, "Declaration Under the Public Readiness and Emergency Preparedness Act [smallpox countermeasures]," Federal Register 73 (October 17, 2008): 61869
19. U.S. Department of Health and Human Services, "Declaration Under the Public Readiness and Emergency Preparedness Act [acute radiation syndrome countermeasures]," Federal Register 73 (October 17, 2008): 61866
20. U.S. Department of Health and Human Services, "Declaration Under the Public Readiness and Emergency Preparedness Act [botulism countermeasures]," Federal Register 73 (October 17, 2008): 61864.
21. In Kehler v. Hood, 2012 WL 1945952 (E.D. Mo) 4:11CV1416 (May 30, 2012), the U.S. district court dismissed third-party claims against the H1N1 pandemic vaccine manufacturer for lack of subject matter jurisdiction, noting that the parties agreed that the PREP Act precluded such claims and pointing out that the statute provides exclusive jurisdiction to hear federal claims under the PREP Act to the U.S. District Court for the District of Columbia. The district court remanded to state court remaining negligence claims against the physician who administered the vaccine to the adult plaintiff. A decision on that case was still pending as of the date of this article.
22. 42 U.S.C. 247d-6e
23. 319F-4 of the PHS Act
24. Health Resources and Services Administration, "Countermeasures Injury Compensation Program (CICP)
25. Administrative Implementation, Interim Final Rule," Federal Register 75 (October 15, 2010): 63656
26. Health Resources and Services Administration, Countermeasures Injury Compensation Program, availablehttp://www.hrsa.gov/gethealthcare/conditions/countermeasurescomp/
27. 42 C.F.R. 110.
28. "The CICP covers only the monovalent version of the 2009 H1N1 vaccine. The 2009 H1N1 virus was included in the 2010- 11 seasonal flu vaccine, which is covered by the VICP [Vaccine Injury Compensation Program]." Claims have also been filed for other countermeasures, including anthrax and smallpox vaccines. R. Roos, "HHS: 386 Injury Claims Filed over H1N1 Countermeasures," CIDRAP News, March 16, 2011http://www.cidrap.umn.edu/cidrap/content/influenza/swineflu/ news/mar1611claims.html
29. FDA's authorities to regulate medical products, including reviewing and approving products, enforcing FDA's laws and regulations, and communicating important product information to the public and health care practitioners, are derived from the FDC Act and the PHS Act. See 21 U.S.C. 301 et seq.; 21 C.F.R. (Food and Drugs); 42 U.S.C. 262; 21 C.F.R. 601.2(a).
30. B. Courtney and E. Sadove, "Medical Countermeasures: Emergency Preparedness and Response Roles and Authorities," in D. G. Adams, R. M. Cooper, M. J. Hahn, and J. S. Kahan, eds., Food and Drug Law and Regulation (FDLI, 2012): at 829-850.
31. 21 C.F.R. Part 312 (2011). "Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA. During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development." Food and Drug Administration, Investigational New Drug (IND) Application, available at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/ApprovalApplications/ InvestigationalNewDrugINDApplication/default.htm
32. INDs providing expanded access to investigational drugs for treatment use have specific regulatory requirements. The emergency use IND is intended for individual/single patient access for serious diseases. 21 C.F.R. 312.310. The expanded access trial under an IND is for intermediate-sized patient populations. 21 C.F.R. 312.315. The treatment IND is for widespread access. 21 C.F.R. 312.320
33. Food and Drug Administration, Guidance - Emergency Use Authorization of Medical Products (July 2007), http:// www.fda.gov/RegulatoryInformation/Guidances/ucm125127. htm
34. The HHS Secretary may make a declaration that the circumstances exist justifying a product's emergency authorization based on: (1) a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a CBRN agent or agents; or (2) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces of attack with a CBRN agent or agents; or (3) a determination by the HHS Secretary that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad, and that involves a CBRN agent or agents, or a disease or condition that may be attributable to such agent(s); or (4) the identification of a material threat pursuant to section 319F-2 of the PHS Act sufficient to affect national security or the health and security of United States citizens living abroad.
35. After an EUA is issued, notice is published in the Federal Register. See Food and Drug Administration, Emergency Use Authorization - Archived Information, available at http:// www.fda.gov/EmergencyPreparedness/Counterterrorism/ ucm264224.htm
36. Y. Yu et al., "Peramivir Use for Treatment of Hospitalized Patients with Influenza A(H1N1)pdm09 under Emergency Use Authorization, October 2009-June 2010," Clinical Infectious Diseases 55, no. 1 (2012): 8-15
37. Additional information on the H1N1 EUA terminations, see Food and Drug Administration, "Termination of Declarations Justifying Emergency Use Authorizations of Certain In Vitro Diagnostic Devices, Antiviral Drugs, and Personal Respiratory Protection Devices," Federal Register 75 (June 25, 2010): 36432.
38. Because these EUAs are already in effect, new EUAs for doxycycline mass dispensing and for the NPM would not need to be issued during an actual anthrax emergency. U.S. Department of Homeland Security, Determination Pursuant to 564 of the Federal Food, Drug, and Cosmetic Act (September 23, 2008
39. U.S. Department of Health and Human Services, "Renewal of Declaration Regarding Emergency Use of All Oral Formulations of Doxycycline Accompanied by Emergency Use Information," Federal Register 77 (July 6, 2012): 40060.
40. CDC requested this EUA. Food and Drug Administration, "Authorization of Emergency Use of Oral Formulations of Doxycycline; Availability," Federal Register 76 (August 4, 2011): 47197
41. Food and Drug Administration, "Interim Questions and Answers: Emergency Use Authorization for Oral Formulations of Doxycycline for Post-Exposure Prophylaxis of Inhalational Anthrax," available at http://www.fda.gov/ EmergencyPreparedness/Counterterrorism/ucm269226.htm
42. The HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) requested this EUA, which amended a previously-issued EUA. Food and Drug Administration, "Amended Authorization of Emergency Use of Doxycycline Hyclate Tablet Emergency Kits for Eligible United States Postal Service Participants and Their Household Members; Availability," Federal Register 76 (November 28, 2011): 72935.
43. FDA, for example, has been working to address these challenges, primarily through the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, Public Law 113- 5, which was signed into law by the President on March 13, 2013. For recent FDA developments on this law and EUAs, see Food and Drug Administration, Medical Countermeasures Initiative, available at http://www.fda.gov/medicalcountermeasures