The 21st Century Cures Act was recently signed by President Obama and will allocate over $6 billion to health-care initiatives in the next ten years.

By Daniel Witke

The 21st Century Cures Act was recently signed by President Obama and will allocate over $6 billion to health-care initiatives in the next ten years.

$4.8 billion will be distributed to three signature research programs: Vice President Joe Biden’s Cancer Moonshot, the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative and the Precision Medicine Initiative. The proposed legislation would also give states one billion to fight the opioid crisis and deliver an additional $500 million to the FDA. The bill received overwhelming bipartisan support after a 392-26 vote in the House and a 94-5 vote in the Senate.

As we begin 2017, it is important to understand how these provisions will play a role in the ever-changing landscape of health-care.

Winners: Pharmaceutical and Medical Device Companies, Medical Centers and Mental Health Facilities

The $4.8 billion allocated over the next ten years will help the Cancer Moonshot, BRAIN and PMI by providing the funding needed for research. Universities and medical centers will use the funds for research grants towards cancer, neuroscience and genetic medicine. The bill attracted lobbying activity from 60 schools, 36 hospitals and several dozen groups representing physician organizations.

With opioid-related deaths continuing to rise in this country, the one billion in state grants over the next two years will be allocated to facilities and research.

Representative Tim Murphy (R-Pa.), who is also a psychologist, was a driving force behind the bill because of the provisions that will fund mental health-care programs.

“To all the families who brought their stories out of the shadows, that dared to share their sorrows, their hopes, their shattered dreams, today is a day of joy,” said Murphy.

The Cures Act has provisions that will allow drug and device companies to push their products through the FDA faster. The massive lobbying effort from 58 pharmaceutical companies, 24 device companies and 26 biotech companies supported this provision.  According to the Advanced Medical Technology Association, which represents 300 medical device companies, the Cures Act will allow a quicker path for breakthrough medical technologies to help patients with life threatening conditions.

“Passage of this important legislation is a milestone in improving the innovation ecosystem for medical technology and ensuring the availability of new lifesaving, life-enhancing devices and diagnostics for patients,” said Advanced Medical Technology’s CEO, Scott Whitaker.

However, the bill has been the subject of debate. It includes provisions that will greatly impact the FDA, Consumer and Patient Safety Groups, and Public Health.

Losers: The FDA, Consumer and Patient Safety Groups, and Public Health

One notable opponent of the bill was Senator Elizabeth Warren (D-Mass). One of Warren’s biggest criticisms is the faster approval of prescription drugs and medical devices.

“Pushing treatments without scientific evidence that they work is fraud – fraud that can hurt people,” said Warren.

The FDA is currently the fastest regulatory system in the world and can be potentially life-threatening if the approval process is pushed even faster. Rita Redberg, editor of the journal for JAMA Internal Medicine wrote this bill could amount to a dangerous trade-off: “In our rush to find new effective treatments, we should not harm our patients with ineffective toxic ones.”

The legislation also affects consumer and patient safety groups.

Dr. Michael Carome, Director of Public Citizen’s Health Research Group, said he was especially concerned about the provisions relating to the drug approval process.

“The summary data could hide important information about the safety and effectiveness from the FDA scientist reviewing the data,” Carome said. “I’m disappointed to see it. ’’

Finally, the bill will cut $3.5 billion over the next ten years from the Prevention and Public Health Fund, which was established under the Affordable Care Act. The fund sets aside money for prevention programs to help battle Alzheimer’s disease, hospital acquired infections and chronic illnesses.

With this legislation affecting so many different areas of health-care, it is more vital than ever to monitor these provisions. No matter the time, day or year, TogoRun is beyond ready to tackle the challenges ahead.