Raise your hand if you know someone who could be helped by a drug that’s currently awaiting FDA approval. Whether it’s you, a family member, or a friend, chances are that someone you know could benefit from accelerated access to a breakthrough drug or device. (there are some good reasons for this protracted process, but more on that later)
With an average timeline of 12 years to get a new drug from the laboratory to the pharmacy shelf (and more than $350 million in research and development costs), many people miss out on the opportunity to access lifesaving drugs and devices before it’s too late. And, because of the time and cost to develop a new therapy, rare diseases are less attractive for pharmaceutical companies. With that in mind, it’s no surprise that H.R. 6, the 21st Century Cures Act, which is being considered this week in the House, seeks to encourage biomedical innovation and the development of new treatments and cures.
Don’t have time to read up? Here’s your cheat sheet.
WHAT IS BEING PROPOSED?
Some elements of the bill include:
- $8.75 billion in mandatory funding for the National Institutes of Health (NIH) over the next five years for the NIH and Cures Innovation Fund. Funds will go to support high-risk, high-reward research and explore next generation treatments (think biomarkers and precision medicine)
- Modernizing clinical trials and supporting inclusion of diverse populations in clinical research.
- Incentives for companies developing drug therapies for rare or dormant diseases.
- $550 million in new resources for the FDA over the next five years to support improvements to how the FDA approves new drugs and devices, including the streamlining of data review, the use of biomarkers, evidence from clinical experience, and the establishment of a priority review program for breakthrough devices.
- Incentives for finding new purposes for old medicines.
WHO SUPPORTS IT?
The bill has broad bipartisan support. It was authored by full committee Chairman Fred Upton (R-MI), Oversight and Investigations Subcommittee Ranking Member Diana DeGette (D-CO), full committee Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Chairman Joe Pitts (R-PA), and Health Subcommittee Ranking Member Gene Green (D-TX).
It has been championed by patient advocates, and the pharmaceutical, biotechnology, and device industries.
WHERE DOES IT CURRENTLY STAND?
The House Energy and Commerce Committee unanimously (51-0) approved the legislation on May 21, 2015. It should be on the floor of the House this week (likely on Friday). It is expected to pass and will likely move through the Senate in the fall.
WHAT’S NOT TO LIKE?
- “Mandatory funding” for NIH means that it is guaranteed and bypasses the yearly budget and appropriations process. This helps to counteract the effects of sequestration and budget cuts that have reduced the purchasing power of the NIH to its lowest level in years. However, some argue that it eliminates tough funding decisions and contributes to already bloated spending obligations.
- It does nothing to expand Medicare payments for telemedicine technology or move the ball forward on state telemedicine licensure issues.
- A streamlined FDA approval process has the potential to result in reduced safety and efficacy of drugs and devices. Once the FDA starts its review, it approves new medications about as quickly as any regulatory agency in the world.
Stay tuned – this bill has the potential to deliver better, faster cures, to more patients, but is likely to see major changes in the Senate. What do you hope to see as part of the bill?