Improving the health care regulatory environment: the 21st Century Cures initiative

While there is a broad assumption that most of the health care policy issues that Congress is addressing revolves around Obamacare, which keeps any “real” policy from getting done, in fact there is significant bipartisan cooperation and interest in working on other issues that improve patient care that go beyond Obamacare. This month, we will explore one of those: the 21st Century Cures initiative¹, which provides life sciences companies the opportunity to discuss problems, opportunities and challenges that they have with the drug regulatory process with policy makers. 

The Committee has encouraged AGG to provide feedback on the initiative to improve the regulatory environment – to give them a sense of the problems and challenges that companies face in seeking to create new and innovative products, and ways that the process could be improved. This presents an opportunity for AGG clients to raise issues and policies of concern, as well as suggestions for improvement, with an audience that is in a position to help facilitate a response and are anxious to help. 

The House Subcommittee on Health has convened a number of bipartisan hearings and meetings in Washington and around the country to solicit feedback on accelerating cures and treatments for patients: “how we can make a significant reduction in the time and costs associated with the discovery, development, and delivery of safe and innovative new treatments and cures for patients who need them.”

“We must ensure that our laws and regulations keep pace so that innovation in this space continues.”

The National Institutes of Health (NIH), Food and Drug Administration (FDA), and other agencies, as well as a number of prominent scientists and companies, have testified and submitted ideas. 

The areas of focus for the initiative are:

Discovery

The U.S. has led the way in early discovery, but as other countries invest more public and private resources in basic research, that leadership role may be threatened.

While global research is a positive development, the initiative is exploring ways to ensure that the U.S retains its innovative and leadership role.

Development

Developing treatments, and turning ideas into treatments, is another vital component. 

Other countries are attracting inventors and investment, while the U.S. industry is slowing. The initiative seeks feedback on this important component. 

Delivery

New uses for drugs and devices may often emerge after initial approval, often in combination with other therapies. What can be done to foster continued research and investment in additional uses for a drug or device.

The specific topics that the initiative has covered include:

• patients and patient care, including examining the role of incentives in advancing patient care and treatment;
• digital health care; 
• modernizing clinical trials; 
• barriers to evidence development; and
• personalized medicine and the regulation of laboratory tests. 

Additional hearings and roundtables and ideas are still being developed.