Casey Myburgh's picture

21st Century Cures Act: A Prescription for Change?

Late last week, the U.S. House of Representatives approved the 21st Century Cures Act, legislation that is designed to streamline the U.S. Food and Drug Administration (FDA) drug approval process and fundamentally change how the pharmaceutical industry does business, “from the discovery of clues in basic science, to streamlining the drug and device development process, to unleashing the power of digital medicine and social media at the treatment delivery phase,” according to the House Energy & Commerce Committee.

 

The legislation, which passed the House with an overwhelming majority (344 vs. 77), is being heralded as a “remarkable spectacle of bipartisan cooperation,” according to The Atlantic. But this overwhelming House passage does not guarantee that Cures will become law, at least in its current form. It is now the Senate’s turn to review and vote – perhaps in the same cooperative spirit as their House contemporaries. Only time will tell what changes are made and the impact this bill will have, but it is worth noting that the passage of this legislation during the current congressional session is a top priority for the Republican-controlled congress.  

 

The bill has a laundry list of supporters not limited by party affiliations. Healthcare industry thought leaders and top associations are among these enthusiasts, including - most importantly - the Pharmaceutical Research and Manufacturers of America (PhRMA). “There may be no higher public health priority than enhancing the system for researching, developing, and delivering innovative healthcare treatments for patients in the United States and around the world,” expressed John J. Castellani, President and CEO of PhRMA, in a formal letter of support.

 

What would change with the 21st Century Cures Act?

The 21st Century Cures Act would do many things, primarily across pharmaceutical development and drug research processes. This includes:

  • working to make research collaborations easier, specifically public-private scientific cooperation;
  • promoting therapies like biomarkers to enhance personalized drug treatments, such as immunotherapies;
  • putting patients at the center of drug development by prioritizing quality of and impact on life while using new treatments;
  • reforming and streamlining clinical trials and making it less challenging and expensive for companies to bring new drugs to market, including treatments for rare or orphan diseases;
  • creating incentives for developing drugs for rare or uncommon but deadly diseases;
  • establishing an Innovation Fund to encourage young scientists to do path-breaking research; and
  • putting more money into both the National Institutes of Health (NIH) and FDA to make these innovations work.

The legislation includes $8.75 billion worth of new research dollars for the NIH. It also overhauls the process that the FDA uses to assess and approve new medicines.

 

From the 77 on the Other Side: 

While the House committee and full House passed this legislation with overwhelming support, some view the Act, which includes $2 billion in mandatory annual spending, as further contributing to the greater issue of government over spending and national debt. The White House, too, expressed a handful of concerns about the House version of the legislation, including funding the measure through the sale of oil from the U.S. Strategic Petroleum Reserve. At the same time, the White House said it looked forward to working with lawmakers to move the legislation forward. In addition to the financial concerns, others expressed apprehension over streamlining the FDA’s drug review process, believing it would lower the standards for approval, potentially putting patients at risk.

 

For ongoing updates, comments and information, reference the #Cures2015 hashtag on Twitter.