Evaluation of Agency's Human Resources Management
Running Head: AGENCY ANALYSIS 1
AGENCY ANALYSIS 10
Agency Analysis
Natashia Richmond
PAD 599
Dr. A. Smith
May 2, 2020
Agency Analysis
The selected agency for analysis in this report is the U.S. Food and Drug Administration (FDA). It is a government agency that has a mandate of protecting public health. The agency achieves this by guaranteeing efficacy, safety, and the security of medical products (GAO Reports, 2018). Other areas of focus for FDA are offering quality, efficient and science and health information to the public. FDA is an affiliate of the U.S. Department of Human Services (DHS) and with an obligation of managing human and animal drugs.
History of FDA
FDA was established in 1862 to address administrative issues in food products (U.S. Food & Drug, 2019). The primary focus was on meat and poultry. It also encompassed problems in animal and human drugs. Today, the agency operates a budget of about $4 and twenty district offices (U.S. Food & Drug, 2019). It has a hundred and fifty laboratories and field offices and more than 9,100 staff. Its existence is reinforced by the Federal Food and Drug Act.
Goals and Objectives of the FDA
Regulating the manufacture and distribution of substances like tobacco to promote public health
Speeding the rate of innovation in medicine and foods science
Offering scientific and accurate information to the public to improve health
Safeguarding the supply chain of medical and food products
Vision
FDA is committed to achieving world-class competencies as a regulatory agency that is driven by science with a mission of public health. The organization aims to provide effective and innovative leadership, both internationally and locally. It aims to prevent illness, protect health, promote wellness, and extend life.
Organizational Design
FDA has changed its design as it adopts new responsibilities. Its design is hierarchical layers, with the topmost departments being the Office of the Commissioner of Food and Drugs that is headed by the commissioner (GAO Reports, 2018). This department reports directly to DHS. The commissioner is supported by two other executives of secretariat and counsel. Below this department is supporting organizations that report directly to the commissioner. This is the second administrative layer that is made up of Centers for Food Safety and Applied Nutrition, Tobacco Products, Regulatory Affairs, and Drugs Evaluation (U.S. Food & Drug, 2019). The third layer comprises the deputies that report directly to the commissioners. The offices include Food Policy, Clinical Policy, and Operations.
The FDA’s Organizational Chart
Deputy Commissioner Deputy Food Policy
Deputy Commissioner Clinical Policy and Operations
Center for Tobacco Products
Center for Drugs Evaluation
Centers for Food Safety and Applied Nutrition
Center for Regulatory Affairs
Office of the Executive Secretariat
Office of the Commissioner
Office of the Chief Counsel
The organizational design of the FDA is vertical. All the heads of the department report directly to the office of the commissioner. It implies that power also emanates from the same office and trickle down to different centers and officers. This structure gives the agency a well-defined chain of command where the decisions from policies and decisions move from the top to various layers at the bottom. This implies that the FDA has a clear and quicker decision making process. Every staff has clear roles and responsibilities, which reduce the risks of ambiguity and redundancy (Haffer, 2012). This design can be attributed to the efficiency and success of this agency. A vertical organization structure promotes efficiency, and collaboration, and offer opportunities for further development and innovation that forms the foundation of organizational growth. The design has been effective in creating a culture where employees are included. This ensures that the workflow of the agency is not deterred by challenges such as poor communication between departments.
Assessment of Organizational Design
The proposed restructure of the FDA would be the incorporation of a Management Committee in the hierarchy of the agency. It should be the decision unit for the agency to support the Office of the Commissioner. This committee should comprise a technical team such as legal officers and H.R. executives among other experts. It should replace the offices of Executive Counsel and Executive Secretariat. However, it should be chaired by the commissioner of the agency. This restructuring is proposed to enable the FDA to meets its goals and objectives and in delivering quality services. Management Committee directs the activities of an organization by ensuring that it runs and deliver the outcomes that are embedded in the missions and visions of the organization (Haffer, 2012). It is an effective office that ensures the decisions and interests of individuals do not dominate the agency. The existing structure has the Office of the Commissioner with the sole responsibility of making decisions in the agency. The committee will assume the role of setting strategic direction to govern and direct the activities of the organization.
Recommended FDA’s Organizational Chart
Management Committee (Chaired by of the Commissioner)
Deputy Commissioner Deputy Food Policy
Deputy Commissioner Clinical Policy and Operations
Center for Tobacco Products
Center for Drugs Evaluation
Centers for Food Safety and Applied Nutrition
Center for Regulatory Affairs
Evaluation of Planning and Implementation
One of the driving factors for the success of the FDA is numerous streams of income. About 45% ($2.6b) of the revenue for the agency is generated internally (GAO Reports, 2018). The federal government support is about 55% of the budget. The regulatory activities of the organization in Human Drugs account for 33% of its budget. The user fees in the industry generate much of this income, amounting to 65%. Activities of food regulation contribute to 19% of the annual expenditure of the company. The biologic regulatory process amounts to 7% of the budget, and 40% of the income is paid for from the fees of users (GAO Reports, 2018). The regulation of animal feeds and drugs contribute to 4% of the budget each year. All the regulatory requirements for tobacco are catered for by the users in the industry.
Another critical factor to the success of the FDA is faster approval of rates. This competency was facilitated by the users' fees that create a cycle of continuous efficiency. It has also increased the rates of approval. For example, 95% of all the products that were submitted for review in 2015 were approved in comparison to only 36% of what was approved a decade earlier (Hilzenrath, 2016). The agency achieves this without compromising the quality standards of biologics and new drugs. The result is efficacy, safety, and quality products that hit the market for the public.
A major drawback that impends the agency in implementing its policy is regulatory requirements. The agency is governed by the Prescription User Fee Act (PDUFA). It requires the agency to lobby with players in the industry for funds. The requirement hinders some operations of the organization because it risks the infiltration of some large corporations in laying out the goals for the agency (David, 2009). It also translates to a lack of full independence that FDA needs to implementation of its decision. In situations where the agreement fails, it would be unclear if the agency can go on with its activities because the pharmaceutical industry has extraordinary influence over the company. This issue can risk the potential of the organization in protecting consumers.
Another challenge that impends the achievement of the goals and objectives of the company is ethical concerns among the staff. This challenge has impacted the success of the agency and impacted its image in public. For example, the FDA approved a controversial drug eteplirsen to treat muscular dystrophy (Hilzenrath, 2016). The decision was made solely by Robert Califf, who was in charge of running and approving clinical trials for drugs. The officer established that the drug had no clinical significance but went ahead in approving its marketing.
Recommendations for Planning and Implementation
FDA should embark on training its staff on ethics. Communicating and enforcing ethical behaviors is an effective organizational strategy that improves its competency and reliability in public. Training programs on ethics are integral in ensuring that an organization does not compromise the quality of its product or services. It helps an organization build an impressive and acceptable image in public. The training should be reinforced by an independent evaluation committee that assesses the quality standards of the review process of the FDA before approving products.
FDA can improve its planning and implementation of the policy by lobbying Congress to lift the requirement of user fee negotiation. The FDA is a government agency and has a unique position for engaging various stakeholders in the enactment of a policy that eliminates this policy (Cassanelli, 2019). The result can be an increase in the independence of this agency to implement its policies without being influenced by third parties. Being funded partly by drug manufacturers implies that the FDA can easily be influenced to their advantage. The engagement of Congress in amending the PDUFA means that the government has a mandate of increasing the funding for FDA from the current 55% to at least 90%. The agency will stop relying on the user fee and conduct its activities independently. It can be the most efficient effort of the company in achieving its goals and objectives.
Cause and Effect Diagram
Regulatory Requirement
Prescription User Fee Act
Lobbying for funds
Compromised quality
Lack of Efficiency
Inaccurate approval
Lack of external review
Ethical Issues
References
Cassanelli, N. A. (2019). Management of R & D projects, considerations for organization structure. Journal of Project Management 10(1), 143-153
David, E. (2009). Vision and will: The future of the FDA. Oncologist; Vol. 14 Issue 4, p317-319, 3p
GAO Reports. (2018). FDA can build on existing efforts to measure progress and implement key activities.
Haffer, J. (2012). Organizational structure of companies versus project management effectiveness. Torun Business Review, Vol 11, Iss 11, Pp 233-248 (2012)
Hilzenrath, S. D. (2016). FDA depends on industry funding; Money comes with “strings attached.
U.S. Food & Drug. (2019). Fact sheet: FDA at a glance. Retrieved from https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance