42 U.S.C. § 300hh; § 2801 of the PHS Act; U.S. Department of Homeland Security, National Response Framework (January 2008), available at <http://www.fema.gov/pdf/emergency/nrf/nrf-core.pdf> (last visited January 3, 2013).+(last+visited+January+3,+2013).>Google Scholar

42 U.S.C. §§ 243(c), 247d-6b(a); §§ 311 and 319F-2 of the PHS Act.Google Scholar

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; § 319 of the PHS Act, 42 U.S.C. § 1320b-5, § 1135 of the Social Security Act; see also, U.S. Department of Health and Human Services, Public Health Emergency Declaration, available at <http://www.phe.gov/Preparedness/legal/Pages/phedeclaration.aspx> (last visited January 3, 2013). (last visited January 3, 2013).' href=https://scholar.google.com/scholar?q=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;+§+319+of+the+PHS+Act,+42+U.S.C.+§+1320b-5,+§+1135+of+the+Social+Security+Act;+see+also,+U.S.+Department+of+Health+and+Human+Services,+Public+Health+Emergency+Declaration,+available+at++(last+visited+January+3,+2013).>Google Scholar

U.S. Department of Health and Human Services, 2012 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy, at 5, available at <http://www.phe.gov/Preparedness/mcm/phemce/Documents/2012-PHEMCE-Strategy.pdf> (last visited January 3, 2013).+(last+visited+January+3,+2013).>Google Scholar

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); 42 U.S.C. §§ 247d-6d, 247d-6e; §§ 319F-3 and 319F-4 of the PHS Act.Google Scholar

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); § 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.Google Scholar

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 <http://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx> (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 slip-and-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(c); § 319F-3(c) of the PHS Act.+(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+slip-and-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(c);+§+319F-3(c)+of+the+PHS+Act.>Google Scholar

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.Google Scholar

These declarations are currently in effect through December 31, 2015. PREP Act declarations and amendments are published in the Federal Register and posted by HHS. See U.S. Department of Health and Human Services, supra note 7; U.S. Department of Health and Human Services, “Pandemic Influenza Vaccines – Amendment,” supra note 7; U.S. Department of Health and Human Services, “Pandemic Influenza Antivirals – Amendment,” Federal Register 74 (June 19, 2009): 29213; 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; 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; 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; 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; 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.Google Scholar

Two lawsuits challenging PREP Act coverage of H1N1 pandemic influenza vaccination have been filed in state courts. In Parker v. St. Lawrence County Public Health Department, 954 N.Y.S. 2d 259 (November 21, 2012), the plaintiff claimed that a nurse employed by the county committed negligence and battery by vaccinating her child during a school vaccination clinic without parental informed consent. The trial court upheld the plaintiff's claims, asserting that Congress had not intended to preclude informed consent claims under the PREP Act. The appellate court dismissed the case for lack of subject matter jurisdiction, finding that the preemption provision and broad liability protections under the PREP Act preempted such claims. The court observed that the PREP Act provides alternate remedies under the Countermeasures Injury Compensation Program and a federal cause of action for willful misconduct claims. The court noted that “we must presume that Congress fully understood that errors in administering a vaccination program may have physical as well as emotional consequences, and determined that such potential tort liability must give way to the need to promptly and efficiently respond to a pandemic or other public health emergency.” Id. 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.Google Scholar

42 U.S.C. § 247d-6e; § 319F-4 of the PHS Act; Health Resources and Services Administration, “Countermeasures Injury Compensation Program (CICP); Administrative Implementation, Interim Final Rule,” Federal Register 75 (October 15, 2010): 63656; Health Resources and Services Administration, Countermeasures Injury Compensation Program, available at <http://www.hrsa.gov/gethealthcare/conditions/countermeasurescomp/> (last visited January 3, 2013); 42 C.F.R. § 110.+(last+visited+January+3,+2013);+42+C.F.R.+§+110.>Google Scholar

“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. Roos, R., “HHS: 386 Injury Claims Filed over H1N1 Countermeasures,” CIDRAP News, March 16, 2011, available at <http://www.cidrap.umn.edu/cidrap/content/influenza/swine-flu/news/mar1611claims.html> (last visited January 3, 2013).+(last+visited+January+3,+2013).>Google Scholar

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 FD&C 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).Google Scholar

Courtney, B. and Sadove, E., “Medical Countermeasures: Emergency Preparedness and Response Roles and Authorities,” in Adams, D. G. Cooper, R. M. Hahn, M. J. and Kahan, J. S., eds., Food and Drug Law and Regulation (FDLI, 2012): at 829–850.Google Scholar

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> (last visited January 3, 2013). (last visited January 3, 2013).' href=https://scholar.google.com/scholar?q=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++(last+visited+January+3,+2013).>Google Scholar

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; see U.S. Department of Health and Human Services, “Expanded Access to Investigational Drugs for Treatment Use,” Federal Register 74 (August 13, 2009): 40900; 21 C.F.R. § 312, Subpart I (2011).Google Scholar

21 U.S.C. § 360bbb-3, § 564 of the FD&C Act; see also, Food and Drug Administration, Guidance – Emergency Use Authorization of Medical Products (July 2007), available at <http://www.fda.gov/RegulatoryInformation/Guidances/ucm125127.htm> (last visited January 3, 2013).+(last+visited+January+3,+2013).>Google Scholar

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.Google Scholar

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> (last visited January 3, 2013). For additional information on the use of peramivir during the pandemic, see, e.g., Yu, Y. 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; for 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.CrossRefGoogle Scholar

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); 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.Google Scholar

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; 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> (last visited January 3, 2013).+(last+visited+January+3,+2013).>Google Scholar

“The term ‘stakeholder(s)’ means the public agency or its delegate that has legal responsibility and authority for responding to an incident, based on political or geographical, e.g., city, county, tribal, State, or Federal boundary lines, or functional, e.g., law enforcement or public health range or sphere of authority to prescribe, administer, deliver, distribute, or dispense doxycycline in an emergency situation.” See Food and Drug Administration, “Authorization of Emergency Use of Oral Formulations of Doxycycline; Availability,” supra note 20.Google Scholar

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.Google Scholar

Provision of kits is limited to eligible United States Postal Service (USPS) employees and their household members. See Food and Drug Administration, supra note 22.Google Scholar

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/medical-countermeasures> (last visited March 19, 2013).+(last+visited+March+19,+2013).>Google Scholar