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Institute of Medicine (US) Forum on Medical and Public Health Preparedness for Catastrophic Events; Institute of Medicine (US) Forum on Drug Discovery, Development, and Translation. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington (DC): National Academies Press (US); 2010.

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The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary.

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Partners in a Single Mission, Diverse Concerns and Challenges

Over the course of the workshop, participants highlighted some of the challenges, gaps, and barriers facing those involved in the countermeasures enterprise. While by no means a comprehensive review, these are some of the more pressing concerns that informed the subsequent discussions on optimizing the countermeasures enterprise. A vast array of structural, strategic, technical, financial, and even cultural elements are involved in the research, development, production, and deployment of medical countermeasures for public health emergencies.

The Growing Threat of Bioweapons

D. A. Henderson, former director of the Office of Public Health Emergency Preparedness, and distinguished scholar at the Center for Biosecurity of University of Pittsburgh Medical Center (UPMC), stressed that countermeasures development needs to be approached with a real sense of urgency, noting that the situation with regard to anthrax is not much better than it was 8 years ago. Today, he said, we do not have that sense of real urgency we felt after 9/11, and yet there is an equal likelihood that an event could occur tomorrow.

Compared to nuclear and other weapons technology, bioterrorism is “relatively easy.” In a recent editorial, former senators Bob Graham and Jim Talent said they believed it is unlikely that the United States can ever prevent bioterrorism (Graham and Talent, 2009). Rather, the senators stressed that America’s best long-term strategy for biodefense is redefining its prevention efforts, striving to reach a level of preparedness that effectively removes bioweapons from the category of weapons of mass destruction (WMDs).

With this in mind, Graham, Talent, and Randy Larson, who served as executive director of the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, formed the Bipartisan WMD Terrorism Research Center, a 501(c)(3) organization operational as of March 1, 2010. The organization’s primary focus will be education, ensuring that those in leadership positions in the federal government understand the imminent threat that biological weapons present.

Larson urged workshop participants working with and within government on the countermeasures enterprise to request the Department of Homeland Security Office of Science and Technology’s population threat assessment briefing. The threat is real, Larson said, but people do not have a full understanding of that threat and therefore do not always apply themselves fully toward solutions.

Gaps and Barriers to International Collaboration

Maria Julia Marinissen of ASPR reminded participants that the threat of terrorism with chemical, biological, radiological, and nuclear agents, and the spread of pandemics and other potential emerging infectious diseases, are global issues. The United States has experienced a steadily increasing demand for the supply of medical countermeasures to foreign countries. However, it is virtually impossible for a single country to fund research and development, acquisition, and stockpiling programs for medical countermeasures for all, or even most, threat agents. A global infrastructure for countermeasures is needed.

In its recommendations to the new administration, the IOM Committee on the U.S. Commitment to Global Health stated that “good health is a necessary condition for economic development and global prosperity” and concluded that this country can improve the lives of millions around the world, while reflecting America’s values and protecting and promoting the nation’s interests (IOM, 2008). However, the United States cannot become the world’s provider and pharmacy for medical countermeasures. A sustainable U.S. infrastructure depends on a larger marketplace for these products.

Over the past 2 years, Marinissen said, ASPR has been pursuing a strategy to work with international partners to build a sustainable global infrastructure for medical countermeasures. For developed countries, one effort under way uses the Global Health Security Initiative (GHSI).8 ASPR held GHSI medical countermeasure workshops in 2008 and 2009 to determine areas of interest for collaboration and to identify current gaps and barriers to international collaboration. GHSI will conduct an exercise to consider a single threat (anthrax) as a case study to identify gaps and concrete areas for collaboration. Major gaps and barriers to international collaboration identified included

  • Countries perceive threats differently. There is a need for improved surveillance of threats, increased information sharing, and joint development of assessment tools.
  • There is a need for information sharing to maximize resources and avoid duplication of efforts, for harmonized country regulatory requirements for market authorization and expedited clinical trial processes, and for innovative and modernized vaccine production processes.
  • Countries should collaborate on point-of-care diagnostic tools, stockpiles, emergency deployment plans, and harmonization of treatments and use policies.

With regard to the developing world, Marinissen said that ASPR is initiating international discussions on a framework and strategic plan to create regional, independent, and sustainable influenza vaccine production capacity in developing and emerging economy countries. Such capabilities could then be used as a platform for surge capacity for pandemic vaccine.

Gillian Woollett, chief scientist, Engel & Novitt, LLP, cautioned that the United States might not want biopharmaceutical companies selling their countermeasures all around the world, and questioned the ability to control the use of an effective countermeasure. This could make the situation worse, she said, if the United States spent large amounts of money to develop a countermeasure, and someone buys it in order to protect his or her own people or engineers a different or resistant threat.

Issues for Federal Agencies Engaged in Countermeasures Development

Systemic Concerns

Philip Russell, Major General, U.S. Army (ret.), former senior advisor in HHS’s Office of Public Health Preparedness and current member on the Board of Trustees of the Sabin Vaccine Institute, highlighted a number of systemic concerns impacting the effectiveness of the countermeasures enterprise. Reliance on an unwieldy and ineffective contracting process is a primary challenge across the board for all participants in the countermeasures enterprise. The Federal Acquisition Regulation (FAR) is unsuitable for product development in the pharmaceutical field, Russell said. The FAR restricts communication, and contractors generally lack experience and capability in the full range of skills needed to bring a medical product to licensure.

All product development paths must ultimately lead to the FDA, and the regulatory process can be cumbersome and fraught with uncertainty. Two key barriers were highlighted by workshop participants. The first, which will also be discussed later in this report, is the absence of a clear and consistently applied regulatory pathway for medical countermeasures. The Animal Rule is also presenting itself as a barrier. The Animal Rule says FDA may grant approval when “the results of those animal studies establish that the drug is reasonably likely to produce clinical benefit in humans.” However, the guidance is significantly more restrictive than the Animal Rule itself and is being appropriately administered relative to the regulation of vaccines for biodefense, Mary Pendergast and Russell said.

As will be discussed later in the report, the lack of central leadership impacts the ability to bring together the numerous agencies involved in the countermeasures enterprise. (This topic was also a focus of a meeting hosted by the NBSB.) This viewpoint was shared by many workshop participants. However, others cautioned that although it is important to ensure that the DoD’s efforts are aligned and coordinated, it may also be important to maintain a level of independence due to complementary, but separate, missions.

Project Bioshield and BARDA Resources

The Project BioShield Act became law in July 2004 (Public Law 108–276) and provides for procurement of countermeasures. However, many of the products it seeks to acquire are not yet available for purchase. As BARDA Director Robin Robinson explained, the 2006 Pandemic and All Hazards Preparedness Act (Public Law 109–417) included a corrective measure, establishing BARDA and provisions for supporting advanced development of products. BARDA is responsible for advancing projects funded by the NIH and the DoD, by moving them across the high risk advanced development zone (the “valley of death”) to a point where acquisition and stockpiling can be achieved.

Although BARDA is off to an enormously good start, said Eric Rose, chief executive officer (CEO) and chair of Siga Technologies, it is a young organization on a steep learning curve. An economic analysis by Bradley Smith of the Center for Biosecurity, UPMC, and colleagues found that the advanced development mission of BARDA is underfunded by at least 10-fold and consequently its portfolio is very thin (Matheny, 2008).

As part of the Project BioShield Act, money for countermeasures procurement was set aside in escrow so that purchases could be made without needing to go back to Congress for an appropriation. Procurement authority for Project BioShield acquisitions using the Special Reserve Fund rests with BARDA. Chuck Ludlam, former counsel to Senator Joseph Lieberman and former principal lobbyist for the Biotechnology Industry Organization, and other participants expressed concern that money from the Special Reserve Fund is being diverted to other initiatives. For example, in the 2009 Omnibus Appropriations Act, $412 million was transferred to other programs to support countermeasure advanced research and development and pandemic influenza preparedness and response. In FY2010 an additional $305 million has been proposed to be transferred to support countermeasure advanced research and development. This could have serious repercussions on the government’s ability to guarantee a suitable marketplace for future countermeasure procurement. This also leads to continued uncertainty among the private sector about long-term, stable funding for countermeasures research and development.

FDA Funding and Scientific Infrastructure

To highlight the challenges facing FDA today, Gail Cassell, workshop chair and vice president, Scientific Affairs, at Eli Lilly and Company reviewed the findings of the report FDA Science and Mission at Risk (FDA, 2007). The FDA Science Board Subcommittee on Science and Technology, chaired by Cassell, was charged by then-Commissioner Andrew von Eschenbach to review science and technology across the agency to answer the question of whether FDA is prepared to address emerging technologies in science. The subcommittee concluded that “science at the FDA is in a precarious position: the [a]gency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” Major findings of the report are presented in Box 4. The Subcommittee found that the deficiencies had two main two sources:

Box Icon

BOX 4

FDA Science and Mission at Risk: Major Findings. The Food and Drug Administration’s (FDA’s) scientific base has eroded and its scientific organizational structure is weak. FDA’s scientific workforce does not have sufficient capacity (more...)

  • The demands on the FDA have soared due to the extraordinary advance of scientific discoveries, the complexity of the new products and claims submitted to FDA for premarket review and approval, the emergence of challenging safety problems, and the globalization of the industries that FDA regulates.
  • The resources have not increased in proportion to the demands. The result is that the scientific demands on the agency far exceed its capacity to respond. This imbalance is imposing a significant risk to the integrity of the food, drug, and device regulatory system, and hence the safety of the public. This also raises the issues of the threats associated with a bioterror attack and the critical role of FDA in the development of medical countermeasures.

Cassell noted that FDA had been given more than 100 unfunded mandates over the previous 15 years, while staffing did not increase concurrently to meet these new mandates. The agency is also responsible for conducting inspections at more than 300,000 sites in 100 countries. The FDA has a huge economic impact, regulating 25 cents of every dollar that Americans spend—over $1 trillion worth of products ranging from cosmetics to pet food. Yet in 2007, FDA had an appropriated budget of only $1.6 billion, which is about 1.5 cents per day per American.

While the agency has made progress in addressing each of the major deficiencies noted in the report, much more needs to be done because regulatory and information sciences are the very foundation of the FDA’s mission. They are critical to the agency’s role in development of medical countermeasures for biodefense. Although the world of drug discovery and development has undergone revolutionary change—shifting from cellular to molecular and gene-based approaches—FDA evaluation methods have remained largely unchanged over the past half century. Likewise, evaluation methods have not kept pace with major advances in medical devices and use of products in combination.

The Subcommittee noted that the impact of the deficiency is profound precisely because science is at the heart of everything FDA does. The world looks to FDA as a leader—to integrate emerging understandings of biology with medicine, technology, and computational mathematics in ways that will lead to successful disease therapies. Today, not only can the agency not lead, it cannot even keep up with the advances in science. Due to constrained resources and lack of adequate staff, FDA is engaged in reactive regulatory priority setting or a firefighting regulatory posture instead of pursuing a culture of proactive regulatory science.

The Subcommittee identified the following eight emerging science and technologies that are the most challenging to the FDA: systems biology (including genomics and other “omics”), wireless healthcare devices, nanotechnology, medical imaging, robotics, cell- and tissue-based products, regenerative medicine, and combination products. Each of these emerging areas is developing at an exponential rate and each generates novel scientific, analytic, laboratory, and/or information requirements. These areas are also precisely those that have been identified as being critical to development of medical countermeasures. Furthermore, the FDA cannot fulfill its surveillance mission because of inadequate staff and IT resources to implement cutting-edge approaches to modeling, risk assessment, and data analysis. The status of regulatory and information sciences at FDA must consider our ability to successfully address the threats of bioterrorism. Other participants concurred, noting that there is no surge capacity at the FDA, or that in fact it is already operating at surge capacity.

Challenges Facing the Innovative Biopharmaceutical Industry

A focus of the workshop was to identify how to improve innovation in ways that respond to national priorities, including how to better engage the nation’s commercial drug, biologic, and device manufacturers in the countermeasures enterprise. Participants from industry described a variety of barriers and challenges to commercial involvement.

Risk and Uncertainty

Most new or in-development pharmaceutical products fail, said John Rex, vice president and medical director for infection at AstraZeneca. Philosophically, a company starts with that understanding, and designs programs to manage risk and to identify failures quickly and cheaply, without committing too many resources, until there is a reasonable level of confidence in the product. The pharmaceutical industry is very good at models and methods to help address the scientific, technical, formulation, and safety risks, for example. The risks that drive industry away occur when changes happen that cannot be readily anticipated—for example, when regulatory guidance is not clear.

Regulatory uncertainty at the FDA was a recurring theme during the discussions. For small companies in particular, this uncertainty can be compounded by a limited understanding of the regulatory pathway. The investment community also has a keen interest in the success or failure of industry pursuits. A participant from an investment bank, Stephen Brozak of WBB Securities, LLC, noted that “Wall Street hates uncertainty.” FDA adds uncertainty because financial analysts have no way to quantify how long the approval process will be for a product. The new draft guidance from the FDA caused significant uncertainty that hampered investors’ ability to predict regulatory, and consequently, revenue trends. If the FDA could establish a clear regulatory pathway in biodefense, it would allow the analysts some sort of metric to be able to say “if a company does this, that will happen.” That is likely to foster greater interest and investment in companies doing research in countermeasures, a point highlighted by multiple workshop participants.

Material threat determinations (the list of pathogens of concern) are public, but material threat assessments and population threat assessments are classified. So while the PHEMCE does provide some highly desirable predictability with regard to identification of the targets for discovery and development, companies have no information regarding the planning scenario for which they are trying to build a product. Although it is understandable that industry is not included in the PHEMCE, this leaves the countermeasures enterprise itself with a critical lack of business and capital markets expertise. The PHEMCE implementation plan itself provides limited guidance and is essentially a list of pathogens and agents that the government hopes to acquire. This kind of checkbox approach obscures product shortcomings and regulatory gaps. Participants also suggested that the implementation plan is somewhat counterproductive in that it defines the market, arbitrarily, as either above or below $100 million. Consequently this means that companies will not invest in developing products predicted to gross less than $100 million.

Not knowing how a product is going to be commercialized is also a risk that industry prefers to avoid. The manufacturing of biologics is complex, and there is an enormous difference in manufacturing, for example, 200,000 doses versus 40 million doses. Companies need guidance regarding volume so they can develop manufacturing plans.

The acquisition process (for initial stockpiles until product licensure), which is essentially guided by the Federal Acquisition Regulation, is perceived by the industry to be lengthy, opaque, unpredictable. In particular, the transition trigger from advanced development to acquisition Request For Proposals (RFP) is unclear. After acquisition, there is a perceived improved communication compared to acquisition process, but some aspects remain unclear, particularly FDA coordination with BARDA. As a result, Goodman’s key principle of end-to-end partnering, including highly interactive and collaborative engagement and outcomes-oriented management, takes on an increasingly important role.

Financial and Resource Concerns

The most often mentioned financial barrier to engaging bio-pharmaceutical companies in the countermeasures enterprise is lack of market incentive. Wesley Yin, assistant professor in the Department of Economics at Boston University, said that firms simply are not going to be able to recoup the fixed costs of research and development of countermeasures. Unlike a standard low-prevalence disease, not only is demand low, but it is also uncertain. If there is demand, it usually comes in times of public health emergency. Plus, there is pressure, real or perceived, to sell these technologies at or just above marginal costs. In addition, if a company overcomes the revenue risks and pursues development of a product, it is at risk for product liability issues, which are also a financial and resource burden.

Lack of market incentive aside, Thomas Monath of Kleiner Perkins Caufield & Byers pointed out, participation in the countermeasures enterprise has a huge opportunity cost—taking away a company’s ability to focus on its commercial opportunity market. Woollett, of Engel & Novitt, added that the industry is actively making products that are saving lives, and asked whether those lives are any less important than a putative potential threat. Simply adding a capability is not an option unless we are prepared to take away from something else, she said.

Participants also highlighted that while companies are interested in countermeasures development, the long-term financing piece must be addressed to be able to make a more rational business case for devoting company resources to countermeasures. The ability to plan for the future can speed up everything tremendously (e.g., if the first step is successful, the company can move to the next step, and already be planning for the next clinical trial, without an interim funding step).

An issue for biotechnology companies is that they are generally small, unprofitable entities that are sustained by private capital and government grants and contracts. Many do not survive. But these companies are an integral part of the PHEMCE implementation plan. Rose of Siga Technologies said BARDA has been an excellent, responsive development partner for the biotechnology industry. BARDA funding for direct project costs are reasonable, realistic, and flexible. He said, however, that the funding for indirect costs is only a fraction of actual costs, and has to be supplemented by in-house funding and private capital in order to keep these projects going for the 8 to 12 years that drug development generally takes. For small innovative companies, programs may start and stop, but funding cannot be discontinued and started again. Small organizations depend on that ongoing revenue to continue to employ staff.

Another enormous drain on resources for small biotechnology companies is the RFP process, said David Wurtman, vice president at NexBio. Although it can be quite constructive for companies to think through the entirety of a development-to-manufacturing plan, if the company is small, research may come to a halt as all hands focus on the RFP. Despite the efforts companies make to respond to an RFP, they often do not find out if they have been awarded a contract, which can present difficulties in planning for the future, especially if the company is small. From a human resources perspective, advanced development manufacturing is really an apprentice model. University training to grow a pool of talent is limited, if it even exists, said Phillip Gomez of PRTM. Therefore, it is important to provide opportunities for partnerships between academia and industry, where the advanced development manufacturing expertise rests. This will help grow the base of people with this expertise and help people learn from a variety of perspectives in the enterprise.

Intellectual Property and FDA Approval

The protection of intellectual property is at the core of the industry’s ability to earn a return on research investments and remain competitive. The ideal situation, according to Bruce Artim of Eli Lilly and Company, would be for an innovator to be awarded a patent by the Patent and Trademark Office (PTO) on the same day FDA approval is granted. However, in practice, FDA product approval review generally takes much longer than PTO patent application review, effectively reducing the patent protection period. A significant policy challenge is balancing two needs: (1) the need of the innovator drug company both to recoup costs and to profit and grow so it can continue to innovate, and (2) the need to bring less expensive generic versions of products to market. The 1984 Drug Price Competition Patent Term Restoration Act, commonly referred to as the Hatch-Waxman Law, is extremely complex, but at its core, it allows a generic drug manufacturer to refer to the pioneer drug developer’s data when applying for FDA approval of the generic form.9 The pioneer also receives additional years of patent term to compensate for some of the time the drug was already on patent while still under the lengthy clinical development and FDA review periods. The pioneer also receives 5 years of data exclusivity. During that time, FDA cannot approve any generic drug applications for a comparable product. Basically, Artim said, this incentive system places more importance on patent term as an intellectual property tool than data protection. Therefore, companies invest resources where they believe they have strong patent protection. However, no correlation exists between the patent protection and the scientific or clinical value of the molecule.

Special Considerations for Antibiotics

Because small-molecule antibiotics have dual uses (both as standard medical care and as medical countermeasures), one might think they would be the countermeasure with the simplest development pathway. But this is not necessarily the case, said Rex of AstraZeneca.

A variety of considerations are specific to the development of antibiotics. First, Rex said, discovery and development are iterative. Simple “gateway indications” provide the entry point, and securing approval for the gateway indication (e.g., community-acquired pneumonia) opens the door to many other uses down the road, including countermeasures. But if a company cannot achieve approval for the basic clinical indication, nothing will follow. Second, bacterial resistance drives the need for novel antibiotics. The ideal comparative clinical trials—new drug versus the drug to which the organism is resistant, or a placebo-controlled superiority study—simply cannot be done for obvious ethical reasons. Rather, non-inferiority designs versus an active agent must be used. This approach has caused significant regulatory confusion. Non-inferiority trial design is more difficult to implement than superiority designs. Following approval, the new drug is subsequently perceived as only non-inferior rather than superior because its activity when other drugs would be resistant is not apparent. Finally, there is the paradox of antibiotic value. A new antibiotic may be deemed so important that it is not used, reserved only for situations when all else fails, which presents a problem for companies who plan to recover some of their development costs though sales. Pricing of the new antibiotic is also a challenge, especially when the new drug has only been shown to be non-inferior to an existing generic drug, raising the question of why it should then cost more.

Research Infrastructure and Resources

Tools and Methodology

Infrastructure for rapid countermeasure development requires common data elements in both research and practice across the board, summarized Marietta Anthony from the Critical Path Institute. A unique scientific issue for countermeasures research is not having the disease to study in many cases, and the development of clinical disease/clinical injury models for trial simulation would be very useful to help speed the process. Innovation also needs to be brought to clinical trial design (e.g., adaptive clinical trial design). Biomarkers that are qualified for use by the FDA to reliably and accurately detect diseases in the field, or detect changes in the field, are also needed. Rapid point-of-care testing and resistance testing was cited as a need by state health departments.

Whether products are to be for engineered threats or natural pathogens, other research needs include vaccine adjuvants, cell culture manufacturing, expansion of biologics manufacturing capacity, and decontamination and remediation protocols after an attack or exposure.

Academia

In general, academic research, and to a large extent government research, are not intended to produce products. In academia, grant funding and publications are highly valued and are the currency for tenure or promotion, noted Brett Giroir, vice chancellor for research at Texas A&M. Product development, intellectual property, and commercialization, while not discouraged, are generally not fostered or rewarded.

The basic research funded by government and conducted in academia is, in general, not prioritized by national need. If research is successful in identifying a potential product, there are no transition partners lined up and no clear pathways for investigators to carry their discovery forward. As a result, it is likely that government and industry are aware of only a very small fraction of the innovations from academic laboratories that could eventually lead to products, Giroir said.

Liability

While believing that the 2006 Public Readiness and Emergency Preparedness (PREP) Act (Public Law 109-148)10 went a long way to address liability issues, a number of participants cautioned that there are gaps and holes that have not been filled. For example, it is unclear if PREP Act declarations preempt state tort law, which can result in continued liability concerns for end users. There is also liability in terms of what must be disclosed for informed consent in case of an emergency.

End Users: Challenges for Public Health and Providers

Although public health officials at the state and local levels are not directly involved in the research and development of countermeasures, they are responsible for ensuring the safety of the public by implementing whatever comes out of the countermeasures enterprise. Therefore, the needs of the public health as end users should inform the target product profiles. State and local public health and healthcare providers all play a critical role in the delivery of countermeasures. The need to integrate these individuals much earlier into the process of research and development of the countermeasures, perhaps through an advisory board to BARDA, was highlighted at the workshop as an opportunity.

Susan Cooper, commissioner of the Tennessee Department of Health, commented that although an abundance of product variations may seem like a benefit, it adds significant complexity to state implementation activities. For example, influenza vaccines come in single-dose syringes, multidose vials, and intranasal mists, each with its own labeled uses in different subpopulations. These different products are shipped as they became available, making distribution to different real-time providers a challenge. She also noted that the variety of forms of the vaccine confounds public health messaging. The Advisory Committee on Immunization Practices guidelines, for example, identified the priority groups to be vaccinated first as pregnant women, children with chronic diseases, healthcare workers, persons between the ages of 6 months and 24 years, and persons from ages 25 through 64 years who are at higher risk for novel H1N1 because of chronic health disorders or compromised immune systems. Unfortunately, following statewide media campaigns urging these groups to be vaccinated, the first product received in Tennessee was the intranasal mist—which cannot be given to pregnant women, children with chronic disease, and those over the age of 50, which would include many healthcare workers. So although states understand the challenges of developing countermeasures and acknowledge that choice is important, an abundance of choices can actually complicate implementation.

Although not a focus of this workshop, a recurring theme was the importance of investing in the public health infrastructure and delivery, noting that the most effective products have no value if you cannot get them to people who need them, or if people do not trust the product. State and local public health departments will require epidemiologic and laboratory capacity; robust emergency drill programs; management, logistics, and communication capacity; strong links with healthcare systems; and integration across a variety of non-health sectors (e.g., police, transportation, education). Participants specifically called out rapid point-of-care testing and resistance testing as current needs, noting that the ability to detect resistance in anything close to real time is very difficult.

Footnotes

8

GHSI is a forum for high-level discussion concerning the coordination of public health emergency preparedness and response policies for CBRN threats and pandemic influenza. It was launched in 2001 by the ministers of health of Canada, France, Germany, Italy, Japan, Mexico, the United Kingdom, the United States, and the European Commission. The World Health Organization serves as an expert advisor. A ministerial-level summit is held every year to share information and coordinate efforts to improve global health security. See http://www​.ghsi.org/.

9

In filing an Abbreviated New Drug Application, the generic manufacturer does not have to conduct clinical trials; rather, it must demonstrate that the generic product is bio-equivalent to the innovator drug.

10

A “PREP Act declaration” by the HHS Secretary provides immunity from tort liability (except for willful misconduct) for claims of loss associated with the administration or use of medical countermeasures to threats that are deemed by the Secretary to constitute a public health emergency, to those involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures (http://www​.hhs.gov/disasters​/discussion/planners​/prepact/index.html).

Copyright © 2010, National Academy of Sciences.
Bookshelf ID: NBK50751

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