One of the biggest agencies within the U.S. Department of Health and Human Services is the Food and Drug Administration (FDA). The Office of the Commissioner and four directorates administer the core functions of the agency which are medical products and tobacco, foods and veterinary medicine, global regulatory operations and policy, and operations. While being a huge, big named agency designed to protect and provide public health; there are necessary regulations and guidelines to ensure the purpose of the agency is being met. This paper will explore the needs, stakeholders, expected outcomes, and other regulatory action and implementation of the FDA.
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The FDASIA was officially signed into law on July 9th, 2012 by President Obama. The law also includes reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA), giving the FDA essential resources to sustain an effective review process for human drug and biological products. The Generic Drug User Fee Amendments (GDUFA) and the Biosimilars User Fee Amendments (BsUFA) are the two user-fee schemes created by the law. Beyond user fees, this legislation includes “inter alia”, which is foundations designed to encourage continued drug and device innovation, promote further pediatric clinical research, and bring attention to variety of developing issues in the FDA’s regulatory space. (Funding the FDA, O’Leary)
Infectious diseases are the root cause of premature deaths in the world affecting the lives of nearly 50,000 people each day. (Annals of Clinical Microbiology and Antimicrobial, 2012) The rise of antibiotic resistant bacteria has become a growing concern as the world population is at risk of recurrence of infectious diseases that were once believed to be under control. During the 1880s is when the bacterium Staphyloccoccus aureus, mainly known as staph, was first discovered. During this time period, staph infection commonly caused painful skin and soft tissue conditions.
MRSA, when transmitted, affects two categories of bacteria when classified. The first is Hospital Acquired, (HA-MRSA) which commonly affects people who had surgery or medical devices surgically implanted. The second is Community-Associated (CA)-MRSA, which concerns public health professionals because it can affect anyone. CA-MRSA is usually associated with a specific exposure in crowded settings such as close skin-to-skin contact, sharing of personal items like towels and razors, or anytime personal hygiene is in jeopardy.
Need + Authority:
MRSA has raised concern of the medical research community, clarifying the crucial need to establish better ways to diagnose and treat bacterial infections.
There are two main reasons the bill was swiftly accepted through a closely separated Congress. First, most policymakers understand that user fees have become essential components of the agency's budget because of continued underfunding of the FDA by the federal government. User fees were important behind the creation of legislation because medical-device manufacturers and pharmaceutical manufacturers have paid user fees while submitting applications to the FDA for the evaluation of new products. The idea was to reauthorize those statutorily defined user fees. The development of user fees allows funding for the FDA’s drug and device review programs. Moreover, user fees are essential in the daily operation of the agency as it completes its task in protecting the public health. Second, the FDA and industry presented Congress with their plans to guide the law's development, after agreeing on the important parts of the legislation.