Author: MIL-OSI Publisher

Source: United States Senator for New Jersey Bob Menendez

JERSEY CITY, N.J. – U.S. Senators Bob Menendez and Cory Booker (both D-N.J.) today announced $1,835,885 in federal funding from the U.S. Department of Health and Human Services (HHS) to support mental health services provided by the New Jersey Department of Human Services.

“The mental health challenges facing our country, especially our young people, must be addressed,” said Sen. Menendez, a senior member of the Senate Finance Committee that sets national health policy. “Whether it is a rise anxiety disorders, depression, or in the worst and most tragic cases — the loss of young people from suicide — we know that this growing crisis started long before the pandemic. This funding will help residents across the state receive the help and treatment they need.”

“The pandemic has spotlighted the importance of accessible and affordable mental health services,” said Sen. Booker. “This federal funding will help New Jerseyans access the care they need.” 

 

In recent months, the Senate Finance Committee has held hearings on youth mental health and is developing a package of policies to address mental health in America. During a recent hearing, Sen. Menendez noted the mental health disparity that exists in communities of color and sought answers on how the government can better target resources for minority youth and ensure health care and child care providers are equipped to handle these unique challenges.

At another hearing, Sen. Menendez highlighted his bill, The Pursuing Equity in Mental Health Act, which would address growing issues of suicide and mental health facing young people, particularly in socially and economically disadvantaged communities that have disproportionately faced disparities in access to mental health treatment and outcomes before and during the COVID-19 pandemic.

Source: United States Senator for Ohio Rob Portman

Source: United States Senator for Delaware – Tom Carper

Bipartisan Senators Urge Ambassador Tai to Support American Research and Development of Life-Saving Tools in Negotiations on a Possible IP Waiver Expansion for Therapeutics and Diagnostics

WASHINGTON, D.C. – U.S. Senators Tom Carper (D-Del.) and Pat Toomey (R-Pa.) led a bipartisan group of senators in writing U.S. Trade Representative Katherine Tai to urge the Biden Administration to safeguard American innovation in the World Trade Organization’s (WTO) negotiations on whether to expand its waiver of IP rights enforcement for COVID-19 vaccines to also include therapeutics and diagnostics, and to seek additional information about the Biden Administration’s approach to these deliberations.

In June 2022, WTO members agreed to waive obligations under the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement for COVID-19 vaccine patent subject matter for a five-year period. This requires the United States to not enforce certain IP rights on behalf of U.S.-based companies at the WTO. The expansion under consideration would enable eligible WTO member countries to ignore otherwise enforceable intellectual property (IP) protections for therapeutics and diagnostics that treat COVID-19.

“Intellectual property protections are a key driver of research and development (R&D) and job creation in Delaware and across the United States, and our innovation ecosystem has been critical for the development and deployment of tools to combat the COVID-19 pandemic,” said Senator Carper. “As World Trade Organization (WTO) member countries consider intellectual property waivers for COVID therapeutics and diagnostics, I strongly encourage the Biden Administration to consider the impact of these possible waivers on American innovation when developing a negotiating position. I look forward to receiving more detail on how the Administration is approaching the WTO negotiations, and I am eager to continue working with U.S. Trade Representative Katherine Tai on this important issue.”

“Strong protections for intellectual property are the bedrock of American innovation, as evidenced by the record development of multiple vaccines to combat COVID-19. Unfortunately, the Biden Administration continues to threaten to again abrogate American IP protections, which will have devastating, long-reaching effects on access to treatments beyond those used for COVID-19. The United States must reject any effort to extend the already erroneous waiver for vaccine IP to the much broader categories of therapeutics and diagnostics,” said Senator Toomey.

“The United States is a global leader in research and development (R&D) and innovation in part because of our strong protections for IP. Additionally, the United States will continue its leadership with our partners across the globe to ensure developing countries have access to the tools and treatments needed to combat COVID, and we believe this can be accomplished without undermining U.S. leadership in medical innovation,” wrote the Senators. “American companies are committed to numerous cooperative agreements to increase global access to therapeutics and diagnostics in addition to vaccines. In fact, many countries that initially proposed this waiver are producing their own products and have not indicated that domestic demand exceeds their own supplies.”

The Senators are requesting answers to several questions surrounding this waiver, including:

1.       What economic analysis USTR has conducted regarding the impact of the COVID-19 vaccine waiver on global vaccine supply, and how this information may inform a U.S. position on a possible waiver expansion;

2.       How the WTO will define a “diagnostic” and a “therapeutic”;

3.       Whether USTR has produced any analysis on the effect that waiving additional IP protections will have on R&D; and

4.       How USTR is meeting its legal requirement to consult transparently with Congress prior to December’s decision deadline at the WTO.

Senators Bill Cassidy (R-La.), Chris Coons (D-Del.), John Barrasso (R-Wyo.), Kyrsten Sinema (D-Ariz.), Thom Tillis (R-N.C.), Robert Menendez (D-N.J.), Richard Burr (R-N.C.), and Jon Tester (D-Mont.) also signed onto the letter. The full letter is available here.

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Source: United States Senator Marsha Blackburn (R-Tenn)

WASHINGTON, D.C. – U.S. Senators Marsha Blackburn (R-Tenn.) and Brian Schatz (D-Hawaii) introduced the Identifying Propaganda on Our Airwaves (IPA) Act, bipartisan legislation to help disclose foreign propaganda on American broadcast television and radio. The bill authorizes the Federal Communications Commission (FCC) to require that broadcasters check foreign media databases to better identify groups sponsoring programming. Companion legislation has been introduced in the U.S. House of Representatives by U.S. Representative Anna Eshoo (D-Calif.).

“Americans deserve the right to make informed decisions about the media they consume,” said Senator Blackburn. “Under current regulations, the New Axis of Evil can use shell companies to broadcast regime-funded propaganda across American airwaves. This legislation will protect consumer transparency by requiring the disclosure of foreign government-sponsored content.”

“Foreign governments shouldn’t be able to hide behind shell companies to fund misinformation and propaganda on American airwaves,” said Senator Schatz. “By giving the FCC the authority to require disclosure of this foreign propaganda, our bipartisan bill will help stop this practice and improve programming transparency on TV and the radio.”

“In July, the D.C. Circuit struck down a portion of the FCC rule that required clearer foreign sponsorship disclosures for radio broadcasters, claiming that the FCC did not have such authority. This was a disastrous decision. The rule required that broadcasters simply check two federal sources to verify an ad sponsor’s identity, a rule implemented at my urging. The American people deserve to know when radio programming they hear on public airwaves is foreign government-funded propaganda,” said Representative Eshoo. “Our legislation unambiguously grants the FCC the authority to require broadcasters to conduct reasonable diligence to identify foreign agents and their shell companies so Americans will know who is funding the information on our public airwaves.”

In 2021, the FCC unanimously issued rules requiring broadcasters to verify the real identity of programming sponsors by mandating they check the Department of Justice’s Foreign Agents Registration Act (FARA) website and the Commission’s U.S.-Based Foreign Media Outlets reports. These rules were designed to prevent foreign governments from funding propaganda through obscure shell companies. To take two examples showing how essential this verification is, “RM Broadcasting” and “Potomac Radio Group,” names of programming sponsors, are actually front groups for the Russian and Chinese governments.

In July, however, the D.C. Circuit struck down the FCC’s authority to do this. The IPA Act re-implements this authority, requiring broadcasters check the sources to identify foreign agents and their shell companies when entering into and renewing airtime lease agreements for sponsored programming. The bill would not prohibit foreign governments from sponsoring content on U.S. airwaves, but would make local stations think twice before airing foreign influence operations.

“The principle that the public has a right to know the identity of those who solicit their support is a fundamental and long-standing tenet of broadcasting,” said FCC Chairwoman Jessica Rosenworcel. “Consumers deserve to trust that public airwaves aren’t being leased without their knowledge to foreign governments. I appreciate the leadership of Senators Schatz and Blackburn, and Representative Eshoo for their efforts to increase transparency and ensure consumers know who is behind the information transmitted over public airwaves.”

“The fact that foreign governmental entities are covertly broadcasting on our television and radio stations is alarming. The American people have a right to know the identity of those using the public airwaves in order to be informed and make their own decisions in separating truth from disinformation. I thank Senators Schatz and Blackburn, and Representative Eshoo, for their leadership in ensuring that broadcasters do their due diligence to disclose the true source of foreign state-sponsored programming. The Communications Act – and fundamental notions of transparency – require no less,” said FCC Commissioner Geoffrey Starks. 

The full text of the bill is available here.

Source: United States Senator for Nevada Cortez Masto

October 19, 2022

Washington, D.C. – U.S. Senator Cortez Masto (D-Nev.) announced that over $107 million is headed to Nevada to support companies manufacturing and recycling components of lithium-ion batteries, which play a crucial role in the country’s growing clean-energy economy. The U.S. Department of Energy (DOE) will award $57,744,831 to the American Battery Technology Company (ABTC) to help develop new lithium extraction techniques in Tonopah, as well as $50,000,000 to Lilac Solutions to develop a lithium manufacturing facility in Fernley, Nevada. Together, these projects will support over 300 new, good-paying jobs in Nevada and further boost the area’s growing economy.

This funding was made possible thanks to Senator Cortez Masto’s efforts to ensure the Bipartisan Infrastructure Law included her Battery Material Processing and Component Manufacturing Act to promote battery manufacturing and recycling projects in Nevada and across the country.

“Nevada’s clean-energy economy is booming, and I made sure the Bipartisan Infrastructure Law included funding to create even more good-paying jobs in this industry,” said Senator Cortez Masto. “Nevada is leading the way in domestic battery manufacturing and recycling, and we’re perfectly positioned to turn these investments into lasting economic growth, and expand our global competitiveness.”

“We are very honored and excited to have been selected as an awardee of this program enabled by President Biden’s Bipartisan Infrastructure Law. This funding directly supports the much-needed acceleration and ramp up of secure domestic manufacturing and refining capacity of Nevada-based battery metals, and we greatly appreciate the confidence the administration has placed in us by making this investment towards our sustainable future,” said American Battery Technology Company CEO Ryan Melsert. “Many thanks to our Nevada congressional delegation, including Senator Cortez Masto, for her continued support throughout this process.”

“Lilac is thrilled to be selected for this award by the Department of Energy, and to accelerate our Nevada expansion,” said Nick Goldberg, Chief Legal Officer for Lilac Solutions. “Our Fernley manufacturing facility will produce the materials that form the backbone of next generation lithium projects in the United States and around the world. We are grateful for the support we’ve received from the state of Nevada to date, and we look forward to Fernley becoming a significant hub for the domestic battery materials supply chain.”

More information on ABTC’s project can be found in Senator Cortez Masto’s letter of support for ABTC’s grant application here. This grant funding will support ABTC with the design, construction, commissioning, and operations of a new, commercial-scale facility in Tonopah to manufacture battery-grade lithium hydroxide. This process uses less energy and water than traditional methods and will help expand the domestic-US lithium resource base. ABTC will partner with UNR and other institutions for the project. The project is expected to create 150 new jobs.

More information on Lilac’s project can be found in Senator Cortez Masto’s letter of support for Lilac’s grant application here. Lilac aims to construct a manufacturing facility in Fernley that will produce lithium extraction materials for use at lithium projects in the United States and abroad that utilize Lilac’s lithium extraction technology. Lilac’s technology is environmentally friendly and greatly improves the efficiency of lithium production. The Fernley project is expected to create over 150 new local jobs and have over $200 million of local economic impact.

Through her Innovation State economic agenda, Senator Cortez Masto has been a longtime proponent of renewable and sustainable energy. The Bipartisan Infrastructure Law includes legislation Cortez Masto secured to promote Nevada’s mining and emerging battery industries and set up a sustainable critical mineral supply chain. She recently introduced legislation to strengthen the domestic supply chain for rare-earth magnets manufactured in the United States by creating a production tax credit for companies that create these magnets. She has also introduced legislation to expand the solar manufacturing supply chain in the U.S. Pieces of these bills were included in the Inflation Reduction Act, providing significant tax credits to create jobs, and spur Nevada’s growing clean-energy economy. In 2020, she secured an extension of the Investment Tax Credit and the residential renewable energy tax credit for solar. Senator Cortez Masto was also able to successfully advocate for two additional years of renewable energy tax credits for the solar industry and its workers.   

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Source: United States Senator Ron Wyden (D-Ore)

Source: United States Senator Ron Wyden (D-Ore)

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Next Article

Source: United States Senator for Oklahoma James Lankford

10.19.22

OKLAHOMA CITY, OK – Senators James Lankford (R-OK), Roger Marshall, M.D. (R-KS), Shelley Moore Capito (R-WV), and Marsha Blackburn (R-TN) sent a letter to the US Food and Drug Administration (FDA) questioning the agency’s response to stopping the opioid epidemic. The letter follows industry feedback on the FDA’s lack of communication and clarity regarding its guidance for the development of new non-addictive pain medicine. The FDA’s guidance has had a significant impact on manufacturer development timelines and potential new treatment options for both patients and health care providers.

In their letter, the Senators wrote in part,

“The opioid epidemic affects millions of Americans. Since 1999, more than 932,000 people have died from a drug overdose, and the rates have only accelerated in recent years… While FDA has made efforts to confront the opioid crisis over the past several years, opioid addiction, abuse, and misuse remain major public health issues across the country… In February, FDA issued the guidance providing recommendations to pharmaceutical manufacturers developing non-opioid analgesics for acute pain lasting up to 30 days… No new analgesic medications were approved in 2021. The few pain management drugs that were approved by the FDA in the immediately preceding years were primarily in migraine or postoperative pain indications… The need for better engagement is underscored by an industry report highlighting that clinical success in drug development has been extremely difficult for this therapy class… It is our understanding that this issue has not been resolved and has caused delays in development timelines and potential new options for patients… Now is the time to provide patients with safe and effective non-opioid alternatives to prescription opioids for pain management…”

The Senators concluded their letter with a series of questions for the FDA related to the agency’s efforts to fully execute provisions in the SUPPORT for Patients and Communities Act for developing non-addictive pain medications, and requested the FDA answer their questions no later than November 9, 2022.

Lankford remains actively engaged in the national conversation that continues to impact Oklahoma and the nation. In 2017, following the White House’s declaration of a national emergency for the opioid crisis, the Senate approved an additional $3.7 billion for cracking down on opioid abuse. Lankford also appeared in a documentary called Killing Pain focused on the impact of the opioid crisis in Oklahoma. In 2018, Lankford supported the passage of H.R. 6, the Opioid Crisis Response Act.

You may click HERE to read the Senators full letter to the FDA or read below.

Commissioner Califf: 

The US Food and Drug Administration (FDA) serves a key role in accelerating the development and approval of breakthrough medicine to address unmet needs. None is more critically important than addressing the ongoing opioid epidemic. Physicians and other health care providers strive to keep patients out of the hospital and at home, healthy with their loved ones. Having the best tools and resources in their toolkit helps them achieve that mission. Therefore, we request the FDA prioritize new drug and device applications for non-opioid therapies for the treatment of pain and to help patients suffering from substance use disorder (SUD).  

The opioid epidemic affects millions of Americans. Since 1999, more than 932,000 people have died from drug overdose, and the rates have only accelerated in recent years. However, substance use disorder and related deaths as a result of prescription opioids are decreasing. Specifically, synthetic opioids including fentanyl are killing more people than heroin or prescription opioids. This decrease can be attributed to physicians and other health care providers’ leadership in utilizing other treatments for pain and increasing patient awareness. In a recent report released by the American Medical Association, opioid prescribing continues on a downward trend. In fact, physicians reduced opioid prescribing in every state by nearly 50 percent. They also increased use of state prescription monitoring programs and other resources, some of which were provided by Congress. 

Since the start of the opioid crisis, Congress has taken swift action to save lives, promote better alternatives for treating pain, and help patients with SUD on their road to recovery. And Congress frequently collaborated with the US Department of Health and Human Services (HHS) to achieve these goals. In 2017, the then-Acting HHS Secretary declared the opioid epidemic a public health emergency and announced a five-point strategy to reduce these rates. Among the strategies, HHS supported advancing the practice of pain management. Under the previous Administration, the FDA approved the first non-opioid treatment to help adult patients manage opioid withdrawal symptoms after non-use. Since its approval, health care providers have found it more helpful than previous methods. In a study published this year, nearly two-thirds of patients treated in an outpatient setting managed with this product reached opioid-free status at 30 days post-withdrawal. This result included patients discontinuing heroin and fentanyl and the medication achieved more success than previous treatment models. This treatment option also allowed for a better transition into long-term care including medications to treat SUD (i.e. Naloxone) and non-medication methods. In 2020, the FDA approved a new non-opioid combination therapy for patients suffering from mild-to-moderate pain of acute musculoskeletal disorders. It was approved two months ahead of the PDUFA goal date.

In 2018, the FDA Commissioner announced the agency would start to work on developing industry guidance to spur innovation on non-opioid therapies while Congress’ was collaborating with his team on new initiatives to include in the SUPPORT for Patients and Communities Act. This law is Congress’ most comprehensive response to the opioid epidemic. It included dozens of individual bills related to prevention, education, coverage, treatment, workforce, and law enforcement. Among the provisions, Congress directed the FDA to issue guidance to help address challenges in developing non-addictive pain therapies and foster the development of novel analgesic drugs by assisting sponsors with the development of non-opioid alternatives for acute and chronic pain management. They maintained active communication with prospective sponsors in mitigating potential uncertainty and risk for developing these products. 

While FDA has made efforts to confront the opioid crisis over the past several years, opioid addiction, abuse, and misuse remain major public health issues across the country. And in the midst of the COVID-19 pandemic, FDA assured Americans that it would continue prioritizing the opioid crisis and use all facets in their regulatory authority to combat this growing threat.

In February, FDA issued the guidance providing recommendations to pharmaceutical manufacturers developing non-opioid analgesics for acute pain lasting up to 30 days. While the guidance specifically states that FDA “encourages early discussion of products that could eliminate or reduce opioid analgesic use and may be suitable for expedited reviews,” the current availability of non-opioid therapies for pain management remains alarmingly insufficient. This is especially true for treatment of chronic pain (including low back pain), which may present the greatest opportunity to avoid long-term opioid use and risk of addiction. 

No new analgesic medications were approved in 2021. The few pain management drugs that were approved by the FDA in the immediately preceding years were primarily in migraine or postoperative pain indications. In reaching out to pharmaceutical manufacturers on the status of innovation of bringing non-opioid therapies to market, we learned that FDA has been unwilling to work collaboratively with sponsors to rapidly develop new product candidates. This was also stated in comments submitted in response to the guidance. 

The need for better engagement is underscored by an industry report highlighting that clinical success in drug development has been extremely difficult for this therapy class. There is only a two percent probability of FDA approval from phase 1, compared to an overall 10 percent success rate across all diseases. The report also highlighted how private company investment, as measured by venture capital into US companies with lead stage programs in pain, is 3.6 percent of total drug development venture funding. For venture funding of novel R&D, pain has received 17 times less venture capital than oncology over the last decade. 

It is our understanding that this issue has not been resolved, and as a result, it has impacted development timelines and potential new options for patients. We seek to hold FDA accountable for fully executing these provisions directed under the SUPPORT for Patients and Communities Act. We therefore ask that you provide a response to this letter with answers to the following questions:

1. Regarding the guidance, has the FDA acknowledged issues outlined by industry stakeholders on FDA-sponsor engagement? 
2. Regarding the guidance, how will FDA reconsider the issue of potentially deincentivizing pharmaceutical manufacturers from developing non-opioid therapies for the indication of general or chronic pain?   
3. As stated in the PDUFA letter, the FDA agreed to enhance and expand communication with drug sponsors. How is FDA working to ensure agency staff are currently communicating with sponsors in a timely manner? 
4. Has FDA received new drug applications eligible for Fast Track, Priority Review, or Breakthrough Therapy designation for non-opioid products for pain management within the last four years? If so, how many have received designation for either Fast Track, Priority Review, or Breakthrough Therapy? How many applications have received final agency action? If not, how is FDA working with developers to provide a clear and predictable regulatory path to incentivize and encourage development of non-opioid pain treatments? How is the agency considering the risks and benefits for patients of non-opioid pain treatments given the potential public health benefit?
5. What has the FDA done to achieve its stated goal of prioritizing the review and approval of non-opioid therapies for acute and chronic pain?

Now is the time to provide patients with safe and effective non-opioid alternatives to prescription opioids for pain management. The opioid crisis in this country cannot be successfully impacted without providing patients and physicians with better options for acute and chronic pain relief. We would appreciate a reply no later than Wednesday, November 9, 2022. Thank you for your attention to this matter. We look forward to your reply.

Sincerely, 

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