It is exceedingly rare for important legislation to gain broad bipartisan support. The 21st Century Cures Act , introduced by Rep. Fred Upton (R-Michigan) in 2015, is an exception. The measure, introduced by a Republican, was signed into law by President Obama yesterday.

It provides for a NIH and Cures Innovation Fund for for biomedical research, including high-risk, high-reward research and research conducted by early stage investigators, and allows the development and implementation of a strategic plan for biomedical research.

The House of Representatives’ Energy and Commerce Committee summarizes the new law:

“THE 21ST CENTURY CURES ACT [is] An innovation game-changer, a once-in-a-generation, transformational opportunity to change the way we treat disease. The House Energy and Commerce Committee and the Senate HELP Committee have engaged in a public, nonpartisan conversation with patients, researchers, innovators, and health care providers about what steps can be taken to expedite the discovery, development, and delivery of new treatments and cures and maintain America’s global status as the leader in biomedical innovation. The 21st Century Cures Act (“Cures”) is the product of that conversation.

“The National Institutes of Health will get $4.8 billion in new funding that is fully offset. These dollars will help advance the Precision Medicine Initiative to drive research into the genetic, lifestyle and environmental variations of disease ($1.5 billion); bolster Vice President Biden’s “Cancer Moonshot” to speed research ($1.8 billion); and invest in the BRAIN initiative to improve our understanding of diseases like Alzheimer’s.

“The pace of scientific advancement over the past two decades, including the mapping of the human genome, has been impressive. Translating these discoveries into new FDA-approved treatments, however, has proven difficult. Cures will advance new therapies for patients by:

Modernizing clinical trials and the means by which safety and efficacy data is accumulated and analyzed.
Putting patients at the heart of the regulatory review process. • Supporting broader, more collaborative development, qualification, and utilization of biomarkers, which help assess how a therapy is working, and on whom, earlier in the process.
Streamlining regulations and provides more clarity and consistency for innovators developing health software and mobile medical apps, combination products, vaccines, and regenerative medicine therapies.
Incentivizing the development of drugs for pediatric diseases and medical countermeasures, and empower FDA to utilize flexible approaches in reviewing medical devices that represent breakthrough technologies.
Providing FDA with $500 million for regulatory modernization and give the agency the ability to recruit and retain the best and brightest scientists, doctors, and engineers.

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“The development of new drugs and devices is meaningless unless they are delivered to the right patients at the right time. Cures will help improve delivery by:

ensuring electronic health record systems are interoperable for seamless patient care and help fully realize the benefits of a learning health care system.
Improving education for health care providers and help facilitate seniors’ access to the latest medical technology.

“Our work to advance meaningful mental health reforms has been a multi-year, multi-Congress effort. The mental health reforms included in the revised 21st Century Cures Act are based largely on H.R. 2646, the Helping Families in Mental Health Crisis Act, authored by Rep. Tim Murphy (R-PA), which passed the House in July by a vote of 422-2. This legislative effort represents the most significant reforms to the mental health system in more than a decade. These landmark reforms will:

Create a new Assistant Secretary for Mental Health and Substance Use to replace the Administrator at SAMHSA and coordinate mental health programs across the federal government.
Establish the National Mental Health and Substance Use Policy Lab to drive evidencebased grant making within SAMHSA.
Direct the Secretary of HHS to undertake guidance to clarify when communication can take place under HIPAA to help ensure communication among providers, families, and patients to improve mental health treatment.
Improve mental health care for children with serious emotional disturbance, or adults with serious mental illness, through targeted authorizations and reauthorizations, including expansion of Assisted Outpatient Treatment.
Strengthen the nation’s mental health workforce.”

Vice President Biden, who lost his son Beau to cancer, was particularly gratified at the enactment of the CURES legislation. He noted:

“[It’s] personal for me and for millions of Americans: The 21st Century Cures Act invests $1.8 billion to help us end cancer as we know it. For over a year, I’ve been leading our National Cancer Moonshot to fundamentally change the culture of our fight against cancer and inject a sense of urgency into it. This bill goes a long way to help us — investing in promising new therapies, enhancing prevention and detection efforts in every community regardless of zip code, and bringing us closer to the day when there are vaccines for all kinds of cancer, just as we have them for measles or mumps.

“While I was presiding in the Senate, my colleagues from both sides of the aisle renamed the section of this bill on cancer research for my son, Beau, who lost his battle with brain cancer, but like countless Americans who lost their own battles, inspires us to do everything we can for the loved ones we can save. My thanks goes out to the bipartisan leadership — Democrats and Republicans in the House and the Senate — who ensured that this important bill became law. Without this true bipartisan support, this piece of legislation, which will help millions of Americans, would not have been possible.”

Quick Analysis

Judge Juan Merchan Must Recuse Himself from Hearing the Case of Donald Trump

Judge Juan Merchan Must Recuse Himself from Hearing the Case of Donald Trump By John H. Wilson In April and May of 2023, we discussed several of the weaknesses of the criminal case brought against former President Donald Trump. In particular, we described the legal insufficiency of the indictment, which does not “asserts facts supporting every element of the offense charged and the defendant`s…commission thereof with sufficient precision to clearly apprise the defendant…of the conduct which is the subject of the accusation.” We also noted that the majority of the charges brought against Trump are most likely time-barred by New York’s Statute of Limitations. https://www.usagovpolicy.com/is-trumps-indictment-beyond-the-statute-of-limitations/ In both articles, we also noted that the Judge assigned to hear the case against the former President, Juan Merchan, had previously donated small sums to several anti-Trump organizations, and was unlikely to dismiss the charges on either of these grounds. According to the New York Post, Merchan “donated $35 to Democratic causes in 2020, including $15 to President Biden’s campaign and $10 to a group dedicated to ‘resisting … Donald Trump’s radical right-wing legacy.’ Federal Election Commission records show Merchan made three small-dollar donations within the span of two days in July 2020 through ActBlue, the Democratic Party’s preferred online fundraising platform. The veteran judge contributed $15 earmarked for the ‘Biden for President’ campaign on July 26, 2020, and then the following day made $10 contributions to the Progressive Turnout Project and Stop Republicans” . Given the small amounts involved, no one seriously argued that Judge Merchan should be removed from the case after having made these contributions, even though “FEC records show that Merchan listed his occupation as ‘judge’ on the donation form, and his employer as the New York State Office of Court Administration.” This is, however, an issue of some seriousness. Under Rule 100.5(A)(1) of the Rules of the Chief Administrative Judge for the State of New York, “[n]either a sitting judge nor a candidate for public election to judicial office shall directly or indirectly engage in any political activity except (i) as otherwise authorized by this section or by law, (ii) to vote and to identify himself or herself as a member of a political party, and (iii) on behalf of measures to improve the law, the legal system or the administration of justice. Prohibited political activity shall include…(h) soliciting funds for, paying an assessment to, or making a contribution to a political organization or candidate. (Emphasis added.) This means that despite the modest sums donated by Judge Merchan, he is prohibited from making ANY contribution, in ANY amount, to the Biden campaign, or any other political organization. It’s not as if Judge Merchan wouldn’t be aware of these rules. According to CNN, “Merchan launched his legal career in 1994…as an assistant district attorney in the trial division in the Manhattan District Attorney’s Office…[i]n 2006, New York Mayor Michael Bloomberg…appointed Merchan to Family Court in the Bronx, and Democratic Gov. David Paterson appointed him to the New York State Court of Claims in 2009, the same year he began serving as an acting New York Supreme Court judge.” With more than 23 years of experience as a judge, Juan Merchan would certainly know he is prohibited from making contributions in any amount to political campaigns and organizations. But he did it anyway. Further, under Rule 100.3(E)(1) “[a] judge shall disqualify himself or herself in a proceeding in which the judge’s impartiality might reasonably be questioned.” Making campaign contributions to the current President, and then hearing the case of that President’s opponent in this year’s election would certainly qualify as a reasonable question regarding Merchan’s impartiality. But this is only one basis under which Judge Merchan’s removal from the Trump case is both appropriate and necessary. There is more substantial basis for this matter to be taken away from Judge Merchan. Rule 100.3(E)(1) continues as follows; “[a] judge shall disqualify himself or herself in a proceeding in which the judge’s impartiality might reasonably be questioned, including but not limited to instances where… (d) the judge knows that the judge or the judge’s spouse, or a person known by the judge to be within the sixth degree of relationship to either of them, or the spouse of such a person…(iii) has an interest that could be substantially affected by the proceeding.” According to the website Living DNA, a First Degree of Relationship is a Parent to a Child, while a Sixth Degree is a second cousin. In between are Grandparents and grandchildren, great-grandparents and great-grandchildren, Aunts, Uncles, Nieces, Nephews and First Cousins. It stands to reason, then, that if Judge Merchan had a cousin, or a nephew, or a grandchild who was known to the Judge, and that person had “an interest that could be substantially affected” by a proceeding over which Judge Merchan was presiding, he would have to legally and ethically recuse himself from the handling of that matter. But what if that person is of the first degree of relationship, that is, a child of the Judge? Meet Loren Merchan, who is, according to the New York Post, “president of Authentic Campaigns, a Chicago-based progressive political consulting firm whose top clients include Rep. Adam Schiff (D-Calif.), who was the lead prosecutor in Trump’s first impeachment trial, and the Senate Majority PAC, a major party fundraiser…Schiff’s campaign for US Senate scored an eye-popping $20 million in aid since he began soliciting donations off the presumptive GOP presidential front-runner’s unprecedented 34-count indictment last April, according to Federal Election Commission records…The Senate Majority political action committee, which supports Democratic Senate campaigns, pocketed $73.6 million since it also began firing off fundraising emails following the ex-president’s indictment…The super PAC has done more than $15 million in business with Authentic since 2019, including email fundraising and branding assistance, while Schiff’s Senate campaign paid Authentic more than $10 million for digital advertising and other consulting services the past year, records show.” Let us understand what the New York Post has revealed here. Loren Merchan is the president of an organization that has been paid ten million dollars by the Senate Majority PAC, which has earned the money to pay Loren’s company by fundraising that is, at least, […]

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Weak Foreign Policy’s Dangers

Cameron Hamilton, a former Navy SEAL and Republican Congressional Candidate for Virginia’s 7th district, describes how the Biden administration’s weak leadership has promoted instability and conflict around the world. Another fascination conversation follows as author Jason Morgan describes the perilous situation in the Indo-Pacific. If your missed the program on your local TV station, watch it at https://drive.google.com/file/d/1sIo2JVHjF6_hPQzr6CVrMegRF_7YxSnp/view?ts=66295e0a