Introduction
This is a strategic plan analysis for Food and Drug Administration (FDA). The FDA is the US government agency within the Department of Health and Human Services (HHS) responsible for safety, effectiveness and quality of products, such as human and animal drugs, 80 percent of the food supply, biological products, medical devices, cosmetics, and radiation-emitting products (Food and Drug Administration, 2014). In addition, the FDA also controls tobacco usages through its health standards.
This document analyses the FDA strategic priorities for the year 2014 to 2018. It focuses on its objectives, resource allocation and budgeting to provide a view on how the agency addresses public health concerns.
Strategic Priorities Analysis
The agency’s strategic priorities consist of four major goals and objectives. These include the following:
- Enhancing oversight of FDA-regulated products.
- Improving and safeguarding access to FDA-regulated products to benefit health.
- Promoting better informed decisions about the use of FDA-regulated products.
- Strengthening organizational excellence and accountability.
To achieve these strategic goals and objectives, the FDA has adopted five Cross-Cutting Strategic Priorities for the year 2014 to 2018, which include:
- Regulatory Science – developing new tools, standards, and approaches.
- Globalization – an international operating model comprising four pillars, including information-sharing; data-driven risk analytics, enhanced intelligence and smart resource allocation.
- Smart Regulation – innovative approaches to protect public health.
- Safety and Quality- practices, integrity of the supply and methods for public protection.
- Stewardship – effective and efficient use of limited resources and maintain the system integrity.
The FDA believes that these strategic priorities and its principal goals and objectives offer an integrated approach to understand its roles in tackling contemporary public health issues.
The agency implements these strategic priorities through different levels. Specifically, top executives must include these core strategic plans into the fiscal year budget to guide formulation and execution processes (Food and Drug Administration, 2014). For instance, the FDA implements and evaluates specific activities at their basic levels in order to observe changes in certain key indicators that show improvement to the achievement of intended outcomes. It also takes into account senior and employee performance plans every year alongside program performance indicators. The agency relates its achievements to long-term strategic objectives and goals. It conducts regular reviews of its programs through the FDA-TRACK and senior executive review programs.
Enhance Oversight of FDA-Regulated Products
The agency has a critical role of oversight on production, manufacturing and the global supply chain. It focuses on post-market product usages to ensure safety of users and compliance with state and federal regulations. The agency strives to eliminate challenges experienced along the supply chain through implementing “standards and controls for manufactures to promote best practices and reduce product risks” (Food and Drug Administration, 2014, p. 11).
The FDA must ensure safety of patients and product consumers by identifying and intervening. It achieves these roles through constant inspections of production processes and facilities, vigorous watch of adverse outcomes and evaluation and reducing risks along the supply chain. These oversight roles ensure that the agency can detect unsafe practices, conditions and eliminate them before products reach the public and cause harm. For cases that could have evaded detection in early stages, the agency responds swiftly in a well-targeted manner.
Enhance and protect accessibility to the agency-regulated products for better health outcomes
The agency has a role of regulating a wide range of products. These include new products, innovations and other medical products and equipment. Consequently, the FDA must develop different approaches to determine safety of products. The agency engages in thorough pre-market activities, particularly by focusing on regulatory science. Regulatory science ensures that the FDA can effectively review new innovative products, collaborate with other stakeholders in both private and public organizations to help in product development and promotes efficient reviews of available or developed products.
The agency has developed different programs and models to facilitate its roles. These tools have made different impacts on the work of the agency. The food program initiatives have partial roles relative to drug program initiatives in promoting accessibility to safe products. As a result, the FDA has recognized that different products, specifically tobacco, require different language usages.
Thus, its approaches to tobacco products are narrowly defined to make effective sense for requirements. For tobacco products, the agency must conduct pre-market evaluations for new products to determine if they meet standards of existing products or if such products have new distinct characteristics that require different evaluation tools. Specifically, all current tobacco products have no health benefits. The FDA does not aim to restrict access to tobacco products, but to ensure responsible accessibility.
Promote Informed decision-making
The FDA plays a critical role in ensuring that Americans receive timely, precise and reliable information regarding all FDA-regulated products. All stakeholders, including patients, consumers and healthcare professionals, must gain access to reliable data regarding foods, tobacco products, medical products and equipment. The FDA ensures that all these stakeholders receive information for informed decision-making on product choices and usages.
The need to provide information to consumers has led the FDA to promote effective communication on critical issues such as regulations, policies, decision-making, expected standards and products regulated. The agency must continue to collaborate with its partners from different sectors to determine appropriate innovative methods of communicating to the public, develop effective communication tools for outreach programs and enhancing decision-making.
Strengthen Organizational Excellence and Accountability
One must appreciate the vast oversight roles that the FDA plays to protect the public. These activities include overseeing all production processes, supply chains, all medical products, tobacco products, radiation-emitting products and food supplies.
Today, the agency has received new authorities through new Acts of food safety and therefore it must strive to meet all public health challenges while utilizing its limited resources (Food and Drug Administration, 2014). The agency has noted the need to operate with limited resources and promote good stewardship among employees. Its major funding source is mainly the taxpayer.
While the agency has noted an increment in responsibilities, its resources have continued to remain scarce. Hence, it is even more crucial for the FDA to ensure organizational best practices and accountability in budgeting.
The FDA has allocated some of its resources to develop its “human resources, tools and infrastructures required for tackling current and emerging multifaceted challenges from the current complex operational environments” (Food and Drug Administration, 2014, p. 22). In addition, it has embarked on effective recruitment and retention strategies with a greater sense of flexibility to achieve its mission-critical objectives. The agency strives to be the best employer of choice. In addition, it seeks to work with vibrant, innovative institutions and contributors from different backgrounds to formulate and execute reliable solutions for its tools.
The agency is committed to develop a supportive workplace, transform management approaches by ensuring security and reliability and finally to make critical investment decisions in tools that can promote public health activities (Food and Drug Administration, 2014).
The FDA Budget and Resource Allocation Analysis
Financial resources are critical for the implementation and realization of the FDA strategic priorities. For instance, the FDA has demonstrated that budgets allow it to sustain its record of accomplishment in difficult periods when mandates and responsibilities have increased (Food and Drug Administration, 2013). In the previous years, FDA has touted its strong performances to justify budgetary allocations. For instance, the agency has continued to approval novel medicines and new forms of therapies to enhance human health and patient outcomes. The agency claims that it brings new drugs to the market fast and efficiently while maintaining benchmarks on drug safety and effectiveness. In the fiscal year 2013, the agency allocated its fiscal resources as follows.
Protecting Patients
A significant percentage of the agency’s budget resources went to patient protection by supporting FDA generic drug activities and drug performance reviews. The agency also focused on the development and review of biosimilar products. Still, the FDA aimed to enhance its capacity to detect and tackle risks associated with drugs, specifically from China. Finally, the agency also embarked on acquisition of new equipment to modernize its laboratory facilities.
Transforming Food Safety
Funds were allocated to create strong, reliable food safety programs to protect the public as required under the FDA Food Safety Modernization Act of 2011 (FSMA). In addition, there was a need to enhance detecting and tackling of food risks posed by imported foods from China. Additional resources supported cosmetic and food contact substance initiatives.
Advancing Medical Countermeasures
The FDA allocated financial resources to support partnership with key stakeholders. These stakeholders enhance MCM development and success rates. In this regard, the FDA improved the provision of technical assistance to MCM developers and other stakeholders.
Data Consolidation and IT Savings
The agency has noted the importance of data in shaping decision-making. Consequently, it has embarked on improving and consolidating its data centers with modern equipment.
The computing environment has reduced costs of IT equipment and installation, support services, but has increased agility. In addition, the FDA has saved on power costs and enhanced effective utilization of IT resources.
FDA Current Law User Fees
These financial resources support safe and reliable review of products and medical equipment. The agency has improved premarket review activities in addition to focus on tobacco products, evaluation of mammography equipment, review of food additive certification and other regulated products countrywide. It has also focused on the new Food Safety Modernization Act to promote safety.
Fiscal Year 2014-15
For the past few fiscal years, budgetary allocations have been difficult for the agency. However, the President had requested additional funding ($4.7 billion, an increase of 8.1% relative to the earlier allocated amount) for the agency in the fiscal year 2014 (Tootle, 2014).
To understand elements of the FDA budgetary scope, it is imperative to group critical areas of focus for clarity, as the agency has done in the previous budgets. The agency has focused on medical product and device safety and food safety. In these categories, it has concentrated on premarket reviews.
There was a significant increment ($61 million) for medical product safety activities. The Congress had approved user fee programs for such activities.
In the fiscal year 2014, the agency introduced a new role that involved funding for increased oversights of the pharmacy compounding industry (Tootle, 2014). It received $25 million. The decision was informed by events of the year 2012 after the outbreak of fungal meningitis that caused health scare by claiming lives and spreading to 20 states. It was established that the outbreak resulted from compounded drugs.
Compounded drugs consist of two or more drugs, but in this case, the drugs were manufactured in unsafe environments. Consequently, the agency embarked on promoting activities by relying on available resources and the Drug and Security Act. The Act resulted in additional responsibilities and authorities, but there were no immediately available resources to support activities. The agency must rely on trims ‘on the margins’ to fund these new responsibilities. The funds are not available in the Presidential proposed 2015 budget.
There is additional $263 million for food safety activities. A portion of this fund ($253 million) will support the implementation of the new Food Safety Modernization Act (FSMA). The FDA aims to be proactive rather than reactive in combating food-borne diseases spread from both local and imported foods. It has recognized that nearly 48 million Americans fall sick because of contaminated foods while nearly 3,000 die from such foods (Tootle, 2014).
In the fiscal year 2012, the FDA had estimated that it would require over $400 million for the implementation of the Act and its related provisions. Since then, it has got over $78 million to implement the Act.
A large sum of the “$253 million proposed for Fiscal Year 2015 would come from new user fees for imported foods, imposed on the industry” (Tootle, 2014). It is imperative to note that the agency currently lacks adequate resources to implement the rules, but it will continue to issue them. Consequently, this will affect effective implementation of the Act and food safety. The agency requires resources to inspect, guide and offer technical assistance to industries, associates and support systems.
The budget is also ambitious by promoting the development of new products to “prevent, combat or protect the public from any potential bioterrorism threats” (Tootle, 2014, p. 1). The FDA has allocated $25 million for this activity for the last two fiscal years (2014-15).
Criticism
In the past, the FDA has been accused of approving substandard products, criticized for corrupt practices, manipulating data and being too strict on its roles (Mundy & Favole, 2009). On the other hand, other critics have observed that the agency is unable to meet its objectives because of the complexity in the industries and lack of adequate resources.
Amidst these criticisms, the agency has continued to deliver quality services for American public.
Conclusion
Analysis of the FDA strategic priorities shows that it has both short-term and long-term core goals and objectives. It relies on tiered approaches to implement these goals. The FDA aims to align the core goals and objectives with financial resources. Through fiscal resource allocation, the FDA has been able to meet its core goals and objectives by delivering public health safety and solving health issues posed by products and services.
It aims to be proactive rather than reactive to public health issues. It has embarked on fast and efficient approval of products and new devices while focusing on imported products, specifically from China.
One must appreciate the complex environment in which the FDA must operate in, increased roles and authorities with limited resources.
References
Food and Drug Administration. (2013). U.S. Department of Health and Human Services Fiscal Year 2013: Justification of Estimates for Appropriations Committees. Maryland: U.S. Department of Health and Human Services.
Food and Drug Administration. (2014). Food and Drug Administration Strategic Priorities 2014-2018. Maryland: FDA.
Mundy, A., & Favole, J. F. (2009). FDA Scientists Ask Obama to Restructure Drug Agency. Wall Street Journal. Web.
Tootle, W. (2014). What’s new in the FDA’s 2015 budget? FDA Voice. Web.