Medical Product Development and Innovation Event

Introduction

Public policy hearings are essential because they allow examining specific problems that affect the population of the US and locate solutions. The particular meeting that will be discussed in the following sections of this paper focuses on opioid addiction, rare diseases, and medical innovation approaches that can help mitigate these issues. This paper aims to identify the purpose, participants, agenda, logistics, and outcomes of the Medical Product Development and Innovation event.

Meeting Description

The purpose of this meeting was to locate information that would help improve the 21st Century Cures Act, which was implemented in 2017. As was mentioned by Senator Alexander, the crucial component of any legislation is the approaches taken towards ensuring that the law works as was intended (“Medical innovations,” 2017). Overall, the committee plans on having several meeting that involves a close examination of various components of the legislation in question, such as electronic health records or mental health.

Key participants include Dr. Scott Gottlieb and Dr. Francis Collins, who testified, and the members of the committee. The first witness is a representative of the Food and Drug Administration, while the second one is the director of the National Institutes of Health (NHI). All of the senators present in this event are part of the United States Senate Committee on Health, Education, Labor, and Pensions (HELP).

Essential agenda items are the opening statements, followed by an introduction of witnesses who will provide the necessary information. Then, Gottlieb and Collins will present their testimony in regards to the legislation and the issue of opioids. The senators will have an opportunity to ask questions, and each will have five minutes to address the information that he or she considers necessary. Meeting logistics include the presence of committee members and witnesses who presented the report regarding the current state of the 21 Century Cures Act implementation. Additionally, the specific funding information and outcomes of programs are enabled by the legislation.

Committee Information

HELP is a committee that is responsible for investigating and finding solutions to problems in the field of education, help, labor, and several others. Overall, there are twenty-two Senators in three sub-committees, led by Lamar Alexander and Patty Murray (“About,” n.d.). In the specific hearing that this paper focuses on, the members examined issues of healthcare and legislation that would enable better allocation of resources and efforts, which should result in overcoming several difficulties.

While currently, HELP is responsible for various problems, it was initially established as an institution that encompassed education in the US. However, in 1884 labor laws and employment became a severe concern in the country; thus, this was added as the agency’s competency (“About,” n.d.). While HELP has to be aware of problems that differ in nature, the decision to create three sub-committees provides an opportunity to dedicate time and effort to each of the topics.

Outcomes

One specific topic that was discussed in this meeting is biomedical research and its implications. More specifically, Dr. Gottlieb anticipates that innovation will help diagnose severe and costly diseases such as Alzheimer’s early and prevent their development (“Medical innovations,” 2017). Other issues included heart disease that requires transplantation and diabetes, all of which should have a valid medical solution due to emerging approaches. Another problem discussed at that event was opioid addiction, which affects many individuals in the US, and approaches to overcome it.

The primary outcome is the ability to evaluate the legislation and specific actions that FDA and NIH take to overcome the issue mentioned above. The committee process requires a hearing and evaluating the information presented during the testimony, which will further help the Senate to review the 21 Centaury Cures Act and implement necessary changes (“The role of committees in the legislative process,” n.d.). Through this, the government officials can ensure that the funding is allocated correctly and that patients and other individuals benefit from the law in question.

The key stakeholders in this meeting are the FDA and NIH because the institutions regulate the administration of drugs in the US and approaches to health management, and both issues were discussed in this meeting. In addition, the outcomes will affect every citizen of the country; however, FDA and NIH can be considered representatives of these people. The interactions that occurred at this event are connected to the discussion of the issues. Each member had a specific timeframe in which he or she could present information without being interrupted. Afterward, the two individuals who provided their testimony answered questions from senators. Thus, the event was structured in a manner that provided an opportunity for a respectful and thorough discussion.

Conclusion

Overall, this meeting of the HELP committee aimed to examine the topic of opioids, funding for rare illnesses, and medical innovations. The purpose was to locate approaches for adequately implementing the 21st Century Cures Act. Both FDA and NHI representatives participated because their organizations are the key stakeholders that will be affected by the outcomes of the meeting. It can be concluded that the event helps the committee to make necessary changes to the legislation that will enable proper medical innovation.

References

About. (n.d.). 

Medical innovations. (2017).

The role of committees in the legislative process. (n.d.). Web.

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StudyCorgi. 2021. "Medical Product Development and Innovation Event." July 23, 2021. https://studycorgi.com/medical-product-development-and-innovation-event/.

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