The House of Representatives is expected today to pass the 21^st Century Cures Act, bipartisan legislation negotiated with the Senate to reform and streamline the federal research and treatment approval process, incentivize the development of live-saving cures, and bring many other needed improvements to the delivery of health care in the US.

   Among its many specific provisions, the bill includes significant reforms to our fractured mental health systems, and major provisions to help patients with Lyme disease by establishing a national, patient-centric working group championed by U.S. Rep. Chris Smith (NJ-04) and others for many years.

  “We have seen that despite the tremendous advances in research that are unlocking the mysteries behind some of the most debilitating diseases, cures and treatments remain stymied by institutional biases and outdated and bureaucratic procedures at NIH and FDA,” said Smith, co-chairman of numerous bipartisan health caucuses including those on Autism, Alzheimer's, Lyme disease, and Heart and Stroke. “With enactment of the 21^st Century Cures Act we will provide the catalyst that puts more treatments—and more affordable treatments—in the hands of patients and families who now have limited, if any, options.”

Breakthrough Lyme Disease Working Group:

   Speaking during the debate in the House of Representatives today, Smith reminded his colleagues that as far back as 1992 he brought together medical officials at NIH and CDC with Lyme Disease Association President Pat Smith and other advocates from New Jersey who highlighted the alarming increasing prevalence of Lyme.  Smith later introduced the first bill to bring patients and their advocates into the process—as well as doctors, researchers and on-the-ground officials from state and county health organizations—by creating an interagency Task Force.

   “My original legislation ensured the individuals impacted by federal policies would have a seat at the table when the decisions are made,” said Smith. “It has taken many years, and several drafts but thankfully today’s Cures package includes similar language that will begin the process of addressing the great unmet needs in the Lyme community in an open and transparent manner. 

   "I am thankful to Majority Leader Kevin McCarthy, Chairman Fred Upton and Lyme community leaders, like Pat Smith of LDA for their tenacity and commitment in getting this done”

   Specifically, the Cures package will create a Working Group comprised of federal and non-federal members tasked with reporting to Congress on scientific advances, research questions, surveillance activities and emerging strains in species of pathogenic organisms.

   The members must also represent a “diversity of views,” bringing hope to American’s suffering from chronic Lyme, Smith noted.  “Many have suffered for decades with this debilitating disease, only to be told that their illness does not exist.  Enactment of the Cures package will move us one step closer to acknowledging and addressing the root problems of chronic Lyme,” he said.  The CDC estimates that there were over 380,000 cases of Lyme disease in the US last year, with more than 48,000 cases in New Jersey, which consistently ranks among the top five hardest hit states.

Mental Health Reform:

   It is estimated that one in five Americans has experienced a mental health issue, but only 44 percent of adults with diagnosable mental health problems and less than 20 percent of children and adolescents receive needed treatment. Of the estimated 10 million Americans living with serious mental illnesses, including schizophrenia, bipolar disorder or major depression, almost 70 percent remain untreated.

   “Currently, even though the federal government operates more than 100 programs intended to address mental illness and spends roughly $130 billion on research and services, there are rising rates of substance abuse and many families struggle to obtain help for their loved ones,” Smith said. “The Cures package includes a better plan—one that takes a holistic approach and helps address the deficiencies in our system.”

   The overall Cures package, which now moves to the Senate for consideration, will boost funding for biomedical research at the National Institutes of Health (NIH), promote interagency data collection and sharing, and reform the Food and Drug Administration (FDA) to bring new therapies and treatments to market sooner. It is designed to accelerate the full cycle of discovery, development and delivery of new treatments and cures for patients in need.

  Currently, of the estimated 10,000 known diseases, only 500 have effective treatments or cures and an estimated 95 percent of rare disease have no FDA approved treatment. NIH estimates it now takes 14 years and $2 billion dollars to develop a new drug. As a remedy, the Cures Act will:

• Create "Innovation Accounts" to provide for dedicated funding for NIH and FDA Cures-related activities;

• Require NIH to develop and issue a six-year strategic plan to ensure biomedical research investments match the needs of patients;

• Provide $4.8 billion for NIH—the world's premier biomedical research organization—to boost our investment in life-enhancing research that not only mitigates the impact debilitating diseases have on individuals, families and caregivers, but saves money in the long run, as care and services become less expensive and more accessible;

• Incentivize the development of drugs for pediatric diseases and reform the FDA approval process for new and innovative medical devices;

• Modernize clinical trials to better facilitate the sharing of information and increase representation of underrepresented communities;

• Create a National Neurological Diseases Surveillance System to build the infrastructure necessary to advance data collection regarding neurological diseases, such as Multiple Sclerosis, and Parkinson's and Alzheimer's diseases; and

• Provide $1 billion to fund the recently-enacted Comprehensive Addiction and Recovery Act and improve our opioid abuse response.

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