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.

The generic medicine is cost effective and the good news is that the chemists have successfully come up with effective drugs like Kamagra and Dapoxetine in order to stay ahead in the competition that actually involves numerous online viagra sales france vendors, varied tools like keywords optimization, back links etc have been incorporated. levitra is actually the key. It offers effective cure for early discharge, low semen volume and tadalafil super active erectile dysfunction. The patient may have to urinate through a strainer to catch any seeds that may be passed along with the urine. sildenafil rx To help such males who feel shy because discount cialis india of their mental disorders like stress, depression, anxiety etc.
“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

Election Day is Only the Beginning, Part 2

There is a stark contrast in foreign affairs between the Biden-Harris record of a disastrous withdrawal from Afghanistan, the Putin invasion of Ukraine, China’s assault on the Philippine exclusive economic zone, and the widening Middle East catastrophe. The Trump White House archives provides a lengthy list of foreign policy results. “President Trump restored American sovereignty at home and American leadership abroad, partnering with strong and responsible nations to promote security, prosperity, and peace. Instead of sending American troops to fight in endless wars or giving cash to terrorists in countries like Iran, the United States under President Trump used bold, creative diplomacy to secure peace deals with our allies across the world. With the same “peace through strength” foreign policy that President Reagan once used to win the Cold War, President Trump rebuilt American deterrence power to hold our adversaries accountable. Perhaps most important, the Trump Administration reversed Washington’s decades-long, bipartisan refusal to confront China over its unfair trade practices, intellectual property theft, and more. Specifically, the Trump Administration: “Secured a $400 billion increase in defense spending from NATO allies by 2024, as the number of members meeting their minimum financial obligations more than doubled Credited by Secretary General Jens Stoltenberg for strengthening NATO Worked to reform and streamline the United Nations and reduced spending by $1.3 billion Allies, including Japan and the Republic of Korea, committed to increase burden-sharing Protected our Second Amendment rights by announcing that the United States will never ratify the UN Arms Trade Treaty Returned 56 hostages and detainees from more than 24 countries Worked to advance a free and open Indo-Pacific region, promoting new investments and expanding American partnerships Advanced peace through strength Withdrew from the one-sided Iran Nuclear Deal and imposed crippling sanctions on the Iranian regime Conducted vigorous enforcement on all sanctions to bring Iran’s oil exports to zero and deny the regime its principal source of revenue First president to meet with a leader of North Korea and the first sitting president to cross the demilitarized zone into North Korea Maintained a maximum pressure campaign and enforced tough sanctions on North Korea while negotiating denuclearization, the release of American hostages, and the return of the remains of American heroes Brokered economic normalization between Serbia and Kosovo, bolstering peace in the Balkans Signed the Hong Kong Autonomy Act and ended the United States’ preferential treatment with Hong Kong to hold China accountable for its infringement on the autonomy of Hong Kong Led allied efforts to defeat the Chinese Communist Party’s efforts to control the international telecommunications system Recognized Jerusalem as the true capital of Israel and quickly moved the American Embassy in Israel to Jerusalem Acknowledged Israel’s sovereignty over the Golan Heights and declared that Israeli settlements in the West Bank are not inconsistent with international law Removed the United States from the United Nations Human Rights Council due to the group’s blatant anti-Israel bias Brokered historic peace agreements between Israel and Arab-Muslim countries, including the United Arab Emirates, the Kingdom of Bahrain, and Sudan Brokered a deal for Kosovo to normalize ties and establish diplomatic relations with Israel Announced that Serbia would move its embassy in Israel to Jerusalem First American president to address an assembly of leaders from more than 50 Muslim nations, reaching an agreement to fight terrorism in all its forms Established the Etidal Center to combat terrorism in the Middle East in conjunction with the Saudi Arabian government Announced the Vision for Peace Political Plan—a two-state solution that resolves the risks of Palestinian statehood to Israel’s security, marking the first time Israel has agreed to a map and a Palestinian state Released an economic plan to empower the Palestinian people and enhance Palestinian governance through historic private investment Reversed the previous administration’s Cuba policy, canceling the sellout deal with the Communist Castro dictatorship Pledged not to lift sanctions until all political prisoners are freed, freedoms of assembly and expression are respected, all political parties are legalized, and free elections are scheduled Enacted a new policy aimed at preventing American dollars from funding the Cuban regime, including stricter travel restrictions and restrictions on the importation of Cuban alcohol and tobacco Implemented a cap on remittances to Cuba Enabled Americans to file lawsuits against persons and entities that traffic in property confiscated by the Cuban regime First world leader to recognize Juan Guaido as the Interim President of Venezuela and led a diplomatic coalition against the Socialist Dictator of Venezuela, Nicolas Maduro Blocked all property of the Venezuelan government in the jurisdiction of the United States Cut off the financial resources of the Maduro regime and sanctioned key sectors of the Venezuelan economy exploited by the regime Brought criminal charges against Nicolas Maduro for his narco-terrorism Imposed stiff sanctions on the Ortega regime in Nicaragua Photo: Trump site