Purpose: The purpose of this report is to describe the Food and Drug Administration’s (FDA) administrative process, describe how FDA powers are limited, and to provide an overview of the FDA’s premarket review process for drugs, biologics, and medical devices. I. Brief Introduction of Administrative Agencies and the FDA The FDA and other federal administrative agencies are created from and derive their powers from laws passed by Congress, and Congress derives the power to create administrative agencies from Article I, Section 8, of the U.S. Constitution. Passed in 1906 by Congress, the Pure Food and Drug Act prohibited interstate commerce of adulterated and misbranded food and drugs, and established the Bureau of Chemistry which later became …show more content…
A court will give more deference to an agency’s substance decision that was made during the rulemaking process. “Only if the substance determination is arbitrary or capricious, constitutes an abuse of discretion, or lacks substantial evidence will a court substitute its judgment for that of an agency.” Appeals based on the FDA not adhering to the procedural requirement of agencies following the rulemaking process garner the strictest review and will result in the court voiding the FDA’s action. Another ground for appealing the FDA’s decision is that the agency misinterpreted its enabling statute by exceeding its authority, or violating the …show more content…
First, the FDA is a federal administrative agency and the head of the FDA is appointed by the President. As the current commissioner’s term expires, the President has the power to appoint the new commissioner, subject to the advice and consent of Congress. Additionally, if the FDA acts in a way that the President strongly objects to, he or she can dismiss the FDA commissioner at any time with little or no reason. Second, the President can veto an enabling act that expands (or reduces) the power of the FDA. C. Legislative Federal legislative power is both direct and indirect, and Congress directly controls the FDA in multiple ways. First, since Congress wrote the enabling act that created the FDA. Second, by Constitution, Congress controls the amount of money appropriated to the FDA. Third, Congress specifies reporting requirements whereby the FDA is required to report metrics of multiple FDA activities. Fourth, Congress controls the FDA through “sunset laws” where powers given to the FDA are subject to termination or renewal at specific dates or time intervals. Additionally, there are multiple devices that Congress employs to indirectly control the FDA and other administrative
The President of the United States is instrumental in the running of the country. He serves as the chief executive, chief diplomat, commander in chief, chief legislator, chief of state, judicial powers, and head of party. Article II of the Constitution states that the President is responsible for the execution and enforcement of the laws created by Congress. He also is tasked with the authority to appoint fifteen leaders of the executive departments which will be a part of the President’s cabinet. He or she is also responsible for speaking with the leaders the CIA and other agencies that are not part of his cabinet because these agencies play a key role in the protection of the US. The President also appoints the heads of more than 50 independent
As ordered by the Legislative Reorganization Act of 1946, Congress was given the power to “exercise continuous watchfulness” over the executive branch and its subsidiary agencies and programs. The Legislative Reorganization Act of 1970 went one step further in granting oversight powers to Congress by authorizing House and Senate committees to “review and study, on a continuing basis the application, administration and execution” of laws.
The FDA was given the authority to approve pharmaceutical products for marketing in the U.S. as a result of the Federal Food, Drug, and Cosmetic Act, passed in 1938 (FDA par 2). In 1960’s, the agency issued final regulations for prescription drug advertising, which stipulated that these ads must not be false or misleading, present a “fair balance” of information describing both the risks and benefits of a drug, include facts that are “material” to the product’s advertised uses, and include a “brief summary” that mentions every risk described in the product’s ...
Legislative vests its power in Congress, which consists of the Senate and House of Representatives. Executive to the President of the United States, and Judicial is invested in the Supreme Court. Our constitution outlines these ideals. Each branch does not overrule another, and all are equal. Doc B.
The FDA was empowered by the United States Congress to enforce the Federal Food, Drug, and Cosmetic Act, which serves as the primary focus for the Agency; the FDA
Instead, Congress often delegates to federal entities authority to craft rules and regulations needed to carry out the mandates of laws. In order to maintain oversight over the entities that Congress grants authority to, Congress has established a requirement to publish a notice in the Federal Register detailing their proposed rules. Interested parties are then allowed a time period to express their concerns over said methods.
To begin, the Federal Food and Drug Administration does not have the power to regulate supplements like it does with drugs. Once a product is out on the market, the FDA has to prove that it is dangerous or has illegal additives before it can be removed. The FDA has targeted around seventy tainted weight loss products after learning that they had been mixed with undeclared stimulants, diuretics, and antidepressants (Trebilcock 2). The Federal Food, and Drug, Administration is responsible for ensuring that the manufacturers of foods provide safe ingredients and the correct amount of dosages for their products.
The FDA stands for The Food and Drug Administration. The FDA is an agency of the
Every year approximately 200,000 souls die from prescription drug reactions, with another 80,000 dying from medical malpractice (The International). Where is the FDA based? Why do they continue to allow doctors to prescribe these drugs? How could they get to this point? What once was believed to be a panacia for depression has turned into Pandora's box (Tracy).
Today Congress regularly issues directives so broad that the executive is tasked with formulating and executing policy. As a head of his representative party, the president appoints members of his own party to head agencies, in which he chooses agency heads that agree with his policies, so his appointments shape the political agenda. More importantly though, when president does this, he assumes an inherent power to direct them and their agencies on how to implement laws. So, he’s basically direct the way the government acts. Though one might argue president is not the only executive power in the government and that there are several different agencies with their own functions and ability. But these agencies are, in my opinion, just tools that the government has, to make policy and to implement
Furthermore, their regulatory measure can quickly eliminate ineffective drugs from the market. Also, it can promote price competition between pharmaceutical companies by providing information on benefits and side-effects of drugs to patients. Moreover, as we covered in class, complementary measure was introduced such as fast track designation which expedites development and review of drugs that address unmet medical need in the treatment of serious or life-threatening
Office, U. A. (2002). Prescription drugs: FDA oversight of direct-to-consumeradvertising has limitations (GAO-3-177). Washington, D.C.
In conclusion, The Legislative Branch is the most powerful branch of the United States government not only because of the powers given to them by the Constitution, but also the implied powers that Congress has. There is also Congress’s ability to triumph over the Checks and balances that limits their power. The only thing truly holding The Legislative Branch back from gaining all the power, is the large amount of people involved in the process and their difference and ideologies, and that Congress is split into multiple houses, with public opinion and elections affecting half of the branch of government. Therefore, The Legislative Branch is the most powerful branch of the United States Government.
As a result the Legislative branch is the one I consider the most powerful and has the most influence on others. My facts stated proves why the legislative branch has the most influence and me and United State citizens as a whole than the other two branches. The founding fathers of the constitution planned it themselves for this branch to have the most abilities and power.
review or pending approval unless the information has been in the public. The FDA has no legal