IV. How can we ensure the availability of drugs, vaccines, and diagnostic tests when they are needed to combatinfectious disease emergencies?

An improved global surveillance and response system will supply U.S. Government agencies with timely, reliable information onoutbreaks of infectious disease that occur anywhere in the world.To control the spread of these outbreaks, that information mustbe evaluated and acted on as quickly and effectively as possible.This section concerns responses that are made on an emergencybasis to control incipient epidemics.

U.S. Government role in response to epidemics overseas

At the present time there is no Government agency or interagencygroup that has the mandate, the flexibility, or the fundsnecessary to respond to international infectious diseaseemergencies. Therefore, the capacity of the U.S. Government toprovide assistance to control epidemics overseas is limited, atbest. Concerned individuals in different Government agenciesscramble to find resources and solutions on an ad hoc basis.Response is made even more difficult by the occasional occurrenceof widespread shortages of drugs, vaccines, and antisera.Moreover, there is virtually no surge capacity for producing manyof the unique medical supplies needed on an emergency basis.

Nevertheless, the international public health community reliesheavily on U.S. expertise and on U.S.-supported institutionsoverseas. CDC, NIH, DoD, and USAID may provide technicalassistance to WHO when a disease outbreak occurs, and USAID oftenprovides communications facilities as well as financial andlogistical support. However, CDC, DoD, and USAID (as well asother U.S. agencies) all face legal, financial, or jurisdictionalobstacles when they strive to respond to international infectiousdisease emergencies. Our ability to respond ensures that we learnof outbreaks quickly. Thus, it is critical to retain thatcapability.

Supply, production, and distribution of emergency medicalsupplies

Medical supplies that are frequently required during an epidemicinclude the following.

Diagnostics
If a country suspects an outbreak of a re-emerging disease (suchas Venezuelan equine encephalitis in Peru, plague in India, orcholera in Brazil), health practitioners may lack the diagnosticreagents to confirm the nature of the threat. Without timelyconfirmation, it is not possible to institute effective controlmeasures or to rule out known diagnoses if a new, or re-emergingdisease is suspected. In many cases, diagnostic reagents areavailable as research tools, but not as standardized commercialproducts. In such cases, training may be needed to use theseresearch tools appropriately.

Vaccines
If a disease is reliably diagnosed as one that is preventable byvaccine (e.g., diphtheria and yellow fever), vaccinating peoplein the surrounding area represents the most cost-effective way toprotect those people and prevent the disease from spreading.Indeed, smallpox has been eradicated worldwide using a vaccine,saving millions of dollars (see "Savings Due to Vaccination,"). By the year 2000, polio is targeted for eradication aswell. Logistical considerations may prevent delivery of doses ofa vaccine in time to stop transmission promptly. Where a vaccineis appropriate, a coordinated response network can help gainrapid access to an adequate supply of quality products that meetlocal requirements. However, if supply needs are greater than canbe met by redistribution, the time required for additionalproduction can be lengthy. In such cases, a coordinatinginfrastructure may be able to mobilize the industrial surgecapacity required to meet increased production needs.

Immunoglobulins and Antisera
Individuals who recover from certain infections produceprotective antibodies that are present in the bloodstream. Whencommercially prepared serum from the plasma of former patients istransferred by injection to another person, these antibodies (orimmunoglobulins) can provide temporary protection from thatdisease when a vaccine is not available. Antisera can be made byimmunizing animals, such as horses, and the resultinghigh-titered animal antisera can be used for treatment.Immunoglobulins and antisera can be very important in somesituations, but are of limited use for long-term control. Inaddition, available supplies are generally limited.

Drugs
Many infectious diseases are caused by microorganisms that aresusceptible to antibiotic drugs. However, there are occasionalregional shortages of antibiotics and in some cases, there may beonly a single manufacturer of the material from which thefinished product is made. These shortages may worsen as moremicrobes become drug-resistant and fewer antibiotics remaineffective. Antiviral drugs may be of value in some situations,and appropriate studies may be needed to determine theireffectiveness.

When an epidemic occurs, diagnostics, drugs, vaccines, and/orantisera are often needed in considerable quantities. However, inmany cases they may not be available in sufficient quantities orat the necessary site, and there may be no company or agency withthe surge capacity to produce more of them. The supply of medicalproducts is driven by multiple factors, including internationalmarket forces; the needs anticipated by U.S. agencies, foreigngovernments, and international organizations; and the needsstimulated by Government incentives, such as the Orphan Drug Actand national vaccine plans. Some supplies may be available fromother countries. However, most countries have national qualitycontrol requirements that need to be met. Harmonization ofstandards internationally along with strengthened localenforcement may enhance the acceptance of emergency medicalsupplies.

When a drug or vaccine shortage is extensive, the best solutionmay be to initiate production of additional supplies. However,emergency production is often hampered by insufficientmanufacturing facilities, the complexity of production methods,the length of time needed for production and quality controltesting, licensure requirements, concerns over liability issues,distribution problems, and/or lack of funds. These difficultiescan cause significant delays, giving diseases time to spread.Early detection and rapid coordination should shorten theresponse time.

Moreover, if the disease is newly emergent, and no treatments orvaccines are available, it is necessary to mobilize the researchand public health communities to begin seeking new solutions.

In times of need, interagency Government groups and ad hoccommittees try to find remedies as best they can. FDA, CDC, and pharmaceuticalmanufacturers have successfully worked to redistribute availablesupplies of drugs, vaccines, immunoglobulins, and antisera, andto accelerate the production, testing, and release of newsupplies to meet shortfalls. In certain emergencies they haveresorted to modifying immunization schedules. When necessary, adhoc coordination of activities of the NIH, CDC, FDA, DoD, andUSAID has redirected resources to research and developmentefforts. In the vaccine area, coordination activities have beenassigned by legislation to the Director of the National VaccineProgram Office. The FDA has limited authority under the PublicHealth Service Act to prepare biologic products for FDA or otheragencies' use, although resources are required to utilize thisauthority. Both the National Vaccine Plan and the draft PandemicInfluenza Plan contain provisions that authorize payment for someproduction of vaccines against influenza and childhood diseases,for use in the United States. However, in most cases there is noU.S. Government mechanism to oversee procurement or production ofemergency medical supplies.

There is a critical need for coordination and strategic planningto rethink and upgrade efforts for emergency preparedness forresponding to disease outbreaks. Many groups are needed toparticipate in this effort, including CDC, NIH, and FDA; the DoD,the Department of State, and USAID; state and local healthdepartments; and the private sector, including pharmaceuticaltrade organizations and research universities.

Shortages of drugs or vaccines can hinder attempts to controldisease outbreaks of influenza, diphtheria, TB, and otherdiseases. The CISET Working Group on Emerging and Re-emergingInfectious Diseases recommends that a U.S. Government agency orinteragency group be granted the necessary mandate and authorityto procure emergency medical supplies when a disease outbreakoccurs, as is currently granted to USAID for disaster assistance.

To fulfill this function, a designated U.S. Government groupmight identify potential suppliers of the drug or vaccine andenter into production agreements with one or more of them whomight require

• Financial support to expand, re-establish, or setup a newproduction system;
  
• A commitment to use or purchase the product, once it is madeand tested;
  
• Human and financial resources to conduct pre-clinical andclinical trials, if needed;
  
• Indemnification against liability;
  
• Government or contractual support to ensure that appropriateregulations were followed;
  
• Assistance and support in working with the governments ofthe countries where the problem exists to enable cooperation indevelopment efforts and in the design and conduct of clinicaltrials.

In addition, the designated group might need

• Access to emergency funding sources;
  
• The flexibility to by-pass the usual rules, such asGovernment contracting procedures;
  
• The ability to seek emergency legislative provisions, suchas waivers or exemptions from export rules, or liabilityindemnification for the producer; and
  
• The cooperation and commitment of all relevant governmentagencies.

Once thought under control, TB is now spreading throughout Asia,Africa, and the Americas, and it is once again common in someU.S. cities. Left untreated, TB spreads from person to person,and when treated inadequately, drug resistance emerges. Recently, many of the drugs most commonly used to treat TB werein short supply. These included streptomycin, para-amino salicylic acid andisoniazid. Although these shortages have been resolved, theypoint out the weaknesses in the system for responding to emergingdiseases.

Strategic planning

As described in Section V, it is strongly suggested that anInteragency Task Force be established to coordinate theimplementation of the recommendations in this report. One of thefunctions of that Task Force (or its subcommittee) will be toanalyze the gaps in U.S. emergency response capacity and todetermine which gaps may be filled by improved interagency orpublic/private sector coordination. The Task Force will beencouraged to draw on industrial, academic, and othernon-governmental expertise, as needed. The Task Force should alsocoordinate U.S. efforts with those of United Nations agenciesincluding WHO, UNHCR, UNDP, and UNICEF.

To aid in this work, it is recommended that the Task Force

1. Determine which Governmental or non-governmentalorganizations participate in mobilizing emergency production ofmedical supplies by producing drugs, diagnostics, vaccines, orantisera, "stockpiling" nonperishable supplies, research,recommending where necessary and development of relevant medicalproducts, providing capacity for emergency responses ("surge"capacity), anticipating the need for emergency production

2. Determine which known diseases are of highest concern, basedon their likelihood of occurrence and potential impact, andconsider whether vaccines, drugs, or diagnostic reagents arepresently available to treat them, and if so, whether surgecapacity exists for their production, distribution, and use.

• Using this information, the Task Force may consider how to

• Develop a coordinated Government mechanism for responding toinfectious disease emergencies in other countries,
  
• Maintain an on-going dialogue with the private sector, andwith researchers in industry as well as in academia, through aprivate sector subcommittee that includes representatives of theU.S.
  
• Prepare for outbreaks of "high priority" diseases by

• - evaluating U.S. and foreign capacity for production ofexisting drugs and vaccines,
  - recommending research to develop and evaluate new drugs,vaccines, and diagnostic reagents, where existing products areinadequate,
  - anticipating the likelihood of occurrence throughpredictions based upon epidemiologic, environmental, climatic,and social data.
  

• Develop a program to promote the rapid development ofstandardized diagnostic tests for new and re-emergent diseases.
  
• Assess existing strategic plans for producing vaccines,drugs, and diagnostics for targeted diseases.
  
• Strengthen the capacity to produce medical supplies oflimited market value, such as vaccines for Argentinianhemorrhagic fever and drugs for Lassa fever.
  
• Consider the utility of stockpiling certain priorityvaccines, drugs, and diagnostics, based upon estimates of thelikelihood of occurrence and potential impact. Recently, the NOAAhas developed the capacity to forecast changes in climate due toEl Nino currents, which can increase the incidence of infectiousdiseases. Predictive tools like this one may be useful in guidingstockpiling decisions.

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