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Concept FRQ Practice

Question 1

Prompt

The Food and Drug Administration (FDA) is the federal agency responsible for the approval, regulation, and control of prescription medications. All prescription medications must complete an extensive FDA approval process, which can take years. In an attempt to expedite this process, Congress passed the Biologics Price Competition and Innovation Act in 2009, which created a faster approval pathway for biologic products that are highly similar to existing FDA-approved medications. The law applies only to biologic products, those produced with living organisms, but not to chemically produced drugs. Insulin is a vital prescription medication used to treat diabetes. Over an eight-year period, beginning in 2009, the average price of insulin increased from $90 to $275 a vial. Since insulin was not regulated as a biologic, the time necessary to gain FDA approval prevented new companies from developing less expensive alternatives.

In 2017, public attention to the rising cost of insulin led the FDA to reclassify the drug as a biologic, thereby lessening the amount of time it took for new companies to get FDA approval. With more manufacturers competing in the marketplace, prices would likely drop.

After reading the scenario, respond to 1, 2, and 3 below.

  1. Referencing the scenario, describe the executive branch authority used by the FDA in reclassifying insulin as a biologic and explain how this use of the FDA’s authority might affect the success of the Biologics Price Competition and Innovation Act.
  2. Referencing the scenario, explain how Congress could have addressed the increasing cost of insulin prior to 2017.
  3. Describe an informal power the president could use to influence the FDA’s decision to reclassify insulin as a biologic. Explain how the use of that informal power relates to the principle of separation of powers.

Response

  1. The FDA utilized its regulatory authority by reclassifying insulin as a biologic, leveraging executive branch powers to enforce and interpret the Biologics Price Competition and Innovation Act of 2009. This decision broadened the scope of the Act, facilitating a quicker approval process for biosimilar products of insulin, which was previously categorized outside of this streamlined pathway. By doing so, the FDA aimed to increase market competition for insulin, likely leading to lower prices and improved access for patients. This action exemplifies how the FDA's use of authority can directly influence the healthcare market and potentially enhance the effectiveness of healthcare legislation.
  2. Prior to 2017, Congress could have taken legislative actions to mitigate the rising costs of insulin, such as enacting laws to regulate drug pricing directly or to promote generic and biosimilar competition. They could have also amended existing healthcare legislation to specifically include provisions for essential medications like insulin, ensuring faster approval processes or price controls. Another approach could have involved increasing funding or resources to the FDA to expedite the review and approval of affordable insulin alternatives. These steps would have demonstrated a proactive approach to healthcare policy, addressing the affordability and accessibility of crucial medications.
  3. The President could use the power of persuasion as an informal tool to influence the FDA's decision-making, by publicly addressing the issue of high insulin prices and advocating for the reclassification of insulin as a biologic. This strategy could involve speeches, social media campaigns, or engaging with stakeholders to raise awareness and build public support for the change. Such actions wouldn't directly alter FDA policies but could generate significant public and political pressure, leading to quicker regulatory adjustments. This use of informal presidential power highlights the interplay between public opinion, executive influence, and regulatory decision-making within the framework of the U.S. government's separation of powers.

Question 2

Prompt

In January 2005, the Senate Foreign Relations Committee held two public hearings to consider Condoleezza Rice for the position of U.S. Secretary of State. During the hearings, senators asked Ms. Rice a series of questions about her experience and record as National Security Advisor for President George W. Bush, and views on a variety of foreign affairs issues. Members of the Foreign Relations Committee had previously met with Condoleezza Rice in a series of one-on-one meetings.

On January 26, 2005, the Senate confirmed Condoleezza Rice as U.S. Secretary of State by an overwhelming and bipartisan vote. All 53 Republican senators and 32 Democratic senators voted in favor of confirmation, while 12 Democratic senators and one Independent senator opposed her confirmation.

Secretary Rice became the first African American woman to hold the position of Secretary of State. She succeeded General Colin Powell, who previously held the position from 2001 to 2005.'

After reading the scenario, please respond to 1, 2, and 3 below.

  1. Referencing the scenario, describe the constitutional step that would have occurred before Condoleezza Rice was considered by the Senate and explain why the Constitution requires Senate confirmation.
  2. In the context of the scenario, explain how the Senate confirmation process influenced the president’s choice of Condoleezza Rice.
  3. Describe how the qualifications of Condoleezza Rice mentioned in the scenario match the role for which she has been nominated, and explain how she could influence the executive branch in her role.

Response

  1. Before Condoleezza Rice was considered by the Senate for the position of U.S. Secretary of State, the constitutional step that occurred was her nomination by the President of the United States, George W. Bush. The Constitution requires Senate confirmation for positions like the Secretary of State to ensure a system of checks and balances between the executive and legislative branches. This process allows the Senate to scrutinize the qualifications and suitability of the president's nominees, thereby preventing the concentration of power in the executive branch and ensuring that appointees have the competence and integrity to serve in high offices.
  2. The Senate confirmation process influenced President George W. Bush's choice of Condoleezza Rice by necessitating a nominee who could gain bipartisan support and withstand the scrutiny of the Senate Foreign Relations Committee. Knowing that the nominee would face detailed questions about their record and views on foreign affairs, the president likely chose Rice based on her experience as National Security Advisor and her ability to articulate and defend the administration's foreign policy. The overwhelming and bipartisan vote in favor of Rice's confirmation suggests that the president accurately assessed her acceptability to a broad spectrum of senators.
  3. The qualifications of Condoleezza Rice mentioned in the scenario, including her experience as National Security Advisor and her extensive background in foreign affairs, closely match the role of Secretary of State, which involves advising the president on foreign policy and representing the U.S. in international matters. Her prior position provided her with a deep understanding of national security and foreign policy challenges, making her well-equipped to lead the Department of State. In her role, Rice could significantly influence the executive branch by shaping foreign policy decisions, negotiating with foreign leaders, and promoting American interests abroad, leveraging her experience and expertise to advance the administration's diplomatic goals.