The Impact and Implementation of the 21st Century Cures Act: Part 1

Healthcare Lobbying

Effects on Medical Technology and Research Funding (Part I of IV)

In this four-part blog series, we will review the impact the 21st Century Cures Act will have on the healthcare, pharmaceutical, and insurance industries. We will discuss what this Act entails, how it will impact medical technologies, healthcare practices, patient safety, and research funding.

What Is the 21st Century Cures Act?

One of President Obama’s last acts before leaving office was to sign into law this Act, which passed both the House and Senate in December with unsurpassed bipartisan support, partly due to proactive healthcare and pharmaceutical lobbying efforts. The Act provides an overhaul of current Food and Drug Administration (FDA) processes and procedures for new healthcare devices and drugs and how they are currently approved.

Under previous guidelines, there were few, if any, provisions for fast-tracking a drug or new medical device, without the direct intervention of various government agencies and offices. Under the new Act, there will be special provisions in place to relax current requirements and make it easier to get certain medical devices and drugs through approval stages faster.

The Act calls to invest $4.8 billion into different research areas through the Nation Institutes of Health (NIH). Among these, former Vice President Biden was able to secure $1.8 billion for cancer research alone.

In addition, the Act gives the NIH permission to authorize financing for special circumstances, where there are high rewards for making advances in medical research, but which also come with high risks. In the past, funding for high-risk, high-reward research would require lengthy submissions to secure grants and other specialized funds through various agencies.

There are also a number of other areas where the estimated $6.3 billion in total funds tied into the Act are to be spent over of the next ten years, including:

  • The Precision Medicine Initiative will receive $1.4 billion. This program will collect genetic data from volunteers and help to further the development of new products, devices, and treatments.
  • The BRAIN Initiative will receive $1.56 billion. This project involves developing and implementing new technologies to map the human brain in greater detail to help develop a more comprehensive understanding of the brain’s functions and, eventually, develop new treatments for current brain-related ailments and diseases.
  • Over $1 billion in funding will be provided for addressing prescription drug abuse. The funding will be awarded to states that develop new programs to educate, prevent, and treat this growing type of drug addiction and substance abuse.

The 21st Century Cures Act also contains specific provisions for creating new employment opportunities at the United States Department of Health and Human Services, with positions focused on substance abuse treatment, substance abuse research, and mental health.

Pharmaceutical Lobbying

In Part II of our four-part blog series, we will review one of the key components of the Act that focuses on fast-tracking the development and approval of new medical devices and drugs. To learn more about lobbying or to retain the services of a Washington DC lobbyist to ensure your voice is heard by those who matter, please feel free to contact LobbyIt at 202.587.2736 today.

Source

1. http://www.cbsnews.com/news/21st-century-cures-act-congress-health-care-passed/

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