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WASHINGTON – U.S. Senator Jerry Moran (R-Kan.) – member of the Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies – yesterday questioned Admiral Brett Giroir, Assistant Secretary for Health at the Department of Health and Human Services (HHS), during an Appropriations Subcommittee hearing on a recent request for information HHS released that could create new manufacturing opportunities for Thermo Fisher Scientific based out of Lenexa. 

“We were alerted, just recently, about an HHS request for information that was posted last week, soliciting interests from laboratories that could scale up with additional equipment from Thermo Fisher Scientific,” said Sen. Moran. “Thermo Fisher is located in Kansas, and recently expanded to create more test tubes for COVID-19 tests.”

Click HERE to watch Sen. Moran’s full questioning or find the transcript below.

 

 

Transcript of full exchange:

Sen. Moran: We were alerted, just recently, about an HHS request for information that was posted—I think it was posted last week. It was soliciting interests from laboratories that could scale up with additional equipment from Thermo Fisher Scientific. Thermo Fisher is located in Kansas, and we have—just recently they had an expansion to create more test tubes to do the test results. Could you tell me what the ultimate plans are, assuming that you receive interests from these laboratories? And more specifically, what's the budget for this strategy? How many labs do you intend to support and how much more testing will get accomplished?

Admiral Giroir: So, let me just say first, it was an NIH solicitation, and we received information from about 27 universities that had interest. Let me just say a top-line piece, particularly now, is that they're certain types of assays, like Hologic, like Roche, like Cephied, that are relatively flat, but there's huge supply of other outstanding assays of which Thermo Fisher has. They have a huge industrial capability; they have instruments; they have everything that goes with it: soup to nuts, full “Happy Meal,” however you want to say it. So, we're trying to encourage laboratories around the country, including universities, to use these because Thermo Fisher could make tens of millions of high-quality laboratory-based assays. We've supplied some of these to private laboratories like Sonic and Aegis, and we’re also trying to make sure that the universities use what they have, but also if they need help we’re happy to fund this. This is a relatively small amount of money to get them the capability to do assays, and Thermo Fisher has been really good to work with about really knocking down the prices, particularly for surveillance. So, it's really another way to try to get the message out. We talk of thousands of universities, but Thermo is just one of those assets that we have a lot of. It's an excellent test; it's a great company; we want people to use it.

Sen. Moran: And, too early to tell whether there's a response? Whether your outreach is having any effect?

Admiral Giroir: Seriously, probably three times a week we match a major laboratory up with Thermo Fisher, getting their instruments together with their supplies. So, it is absolutely having an effect. Again, we have a lot of capability; we just want to make sure that people understand where the capabilities are, and Thermo's one of them.

 

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WASHINGTON, D.C. – U.S. Senator Jerry Moran (R-Kan.), today joined a bipartisan group of Senators in calling for a prompt response from the Health Resources and Services Administration (HRSA) to address recent actions of pharmaceutical companies that threaten to undermine the 340B Drug Pricing Program during the COVID-19 public health emergency.

The 340B program requires drug companies to sell discounted prescription drugs to safety-net hospitals, rural health facilities and other entities that provide care in underserved communities. Savings from the 340B program ensure that these “covered entities” are able to continue to serve their patients. However, drug manufacturers have recently announced new requirements and limitations on eligible entities within the 340B program.

In a letter to Health and Human Services (HHS) Secretary Alex Azar, the bipartisan group of Senators urged the administration to take immediate enforcement action to halt these tactics and ensure safety-net providers are able to continue providing life-saving medications to patients across the country.

“In the midst of the ongoing COVID-19 pandemic, where providers have seen drops in revenue and available resources, it is critically important that 340B covered entities, including federally qualified health centers (FQHCs), FQHC Look-Alikes, children’s hospitals, Ryan White HIV/AIDS clinics, and other safety-net hospitals and providers are able to continue to serve the individuals who seek out their care,” the Senators wrote. “As these threats to the Program progress, we fear the potential exacerbation of these shortfalls in resources for providers at a time when they are needed most.”

The bipartisan letter was led by Sen. Tammy Baldwin (D-Wis.) and signed by Senators Rob Portman (R-Ohio), Debbie Stabenow (D-Mich.), Shelley Moore Capito (R-W.V.), John Thune (R-S.D.), Ben Cardin (D-Md.), Patty Murray (D-Wa.), Susan Collins (R-Maine), Ron Wyden (D-Ore.), Jon Tester (D-Mont.), Mike Rounds (R-S.D.), Doug Jones (D-Ala.), Joni Ernst (R-Iowa), Gary Peters (D-Mich.), John Boozman (R-Ark.), Bob Casey (D-Pa.), Cindy Hyde-Smith (R-Miss.), Mark Warner (D-Va.), Roger Wicker (R-Miss.), Angus King (I-Maine), Kevin Cramer (R-N.D.), Chuck Schumer (D-N.Y.), Thom Tillis (R-N.C.), Chris Van Hollen (D-Md.), Elizabeth Warren (D-Mass.), Sherrod Brown (D-Ohio), and Kirsten Gillibrand (D-N.Y.).

This bipartisan effort is supported by the American Hospital Association (AHA), America’s Essential Hospitals, American Association of Medical Colleges (AAMC) and 340B Health, as well as many health providers across Kansas who rely on this program to provide services to patients.

“The AHA thanks this bipartisan group of senators for their important effort to protect the 340B program, and the vulnerable communities it benefits, from big drug companies’ efforts to harm the program,” said Tom Nickels, AHA Executive Vice President. “The AHA continues to call on the Department of Health and Human Services to take action against drug companies and to protect the patients and communities the 340B program helps serve.”

“The AAMC appreciates Senators from both sides of the aisle working together to protect the 340B program and patients,” said Karen Fisher, JD, Chief Public Policy Officer of the Association of American Medical Colleges. “Particularly in the midst of the COVID-19 pandemic, it is unwarranted that several major drug companies are attempting to undermine this important program that allows safety net hospitals, including many teaching hospitals, to provide critical health care services to vulnerable patients in communities across the country.”

“340B has a long history of bipartisan support in Congress. Drug companies must stop denying discounts on expensive outpatient drugs in violation of the 340B statute,” said Maureen Testoni, President and CEO of 340B Health. “We appreciate the efforts of these Senate leaders in making that message crystal clear.”

The full letter is available here and below.

Dear Secretary Azar:

We write to express our concerns regarding recent actions from pharmaceutical manufacturers that threaten to undermine the role of contract pharmacies in the 340B Drug Pricing Program. In the midst of the ongoing COVID-19 pandemic, where providers have seen drops in revenue and available resources, it is critically important that 340B covered entities, including federally qualified health centers (FQHCs), FQHC Look-Alikes, children’s hospitals, Ryan White HIV/AIDS clinics, and other safety-net hospitals and providers are able to continue to serve the individuals who seek out their care. As these threats to the Program progress, we fear the potential exacerbation of these shortfalls in resources for providers at a time when they are needed most. While we understand that the Health Resources and Services Administration (HRSA) is further investigating these actions, we urge HRSA to take immediate and appropriate enforcement action to halt these tactics and ensure safety-net providers are able to continue providing life-saving medications to patients across the country.

As you are aware, on September 1, 2020, Eli Lilly announced that the company would no longer allow 340B covered entities to receive discounts for products that are shipped to a contract pharmacy, with an exception for insulin. This follows similar actions from AstraZeneca, which announced in August that it would refuse 340B pricing to hospitals with on-site pharmacies for any drugs dispensed through contract pharmacies. Similarly, other companies have imposed additional and burdensome reporting requirements on all contract pharmacy claims.  For covered entities, and in particular rural hospitals and other rural covered entities that rely disproportionately on contract pharmacies, these changes could have long-lasting repercussions that will challenge a covered entity’s ability to support its community now during this pandemic and in the future.

The Public Health Service Act requires that manufacturers wishing to participate in Medicaid and Medicare Part B enter into agreements with the Department of Health and Human Services (HHS) that “require that the manufacturer offer each covered entity covered outpatient drugs for purchase at or below the applicable ceiling price if such drug is made available to any other purchaser at any price.” Further, HRSA has recognized the importance of contract pharmacies by acknowledging such arrangements in current guidance. We believe these recent actions by pharmaceutical manufacturers run counter to the statute and create a dangerous and negative precedent for the 340B Program and the providers and patients it serves.

To ensure pharmaceutical manufacturers continue to comply with the 340B statute and provide discounts to safety-net providers, we call on HRSA to take appropriate, prompt enforcement action to address violations of the Public Health Service Act. We appreciate your attention to this important issue and look forward to partnering with you and stakeholders to ensure the 340B program continues to support access to quality health services with proper oversight and transparency.

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WASHINGTON – U.S. Senator Jerry Moran (R-Kan.) spoke on the Senate floor yesterday to commend President Donald Trump, Secretary of State Mike Pompeo and others in the administration for facilitating the historic Abraham Accords Peace Agreement that will normalize relations between Israel and the United Arab Emirates and Bahrain.

“These historic agreements begin the process of normalizing relations between the two Gulf countries and the Jewish state,” said Sen. Moran. “After seven decades of isolation in the region, the Abraham Accords signify Israel’s existence is finally being accepted by Arab countries, opening new prospects for greater economic, security, and cultural cooperation that will benefit all those in the region and all of us around the world. I commend President Trump, Secretary Pompeo, and many others in this administration for facilitating this historic agreement and advancing the cause of peace and prosperity in the region.”

Click HERE to watch Sen. Moran’s full speech

Remarks as delivered:

“Earlier today at the White House, President Trump hosted Israeli Prime Minister Benjamin Netanyahu and the foreign ministers from the United Arab Emirates and Bahrain to sign the Abraham Accords.

“These historic agreements begin the process of normalizing relations between the two Gulf countries and the Jewish state. After seven decades of isolation in the region, the Abraham Accords signify Israel’s existence is finally being accepted by Arab countries, opening new prospects for greater economic, security, and cultural cooperation that will benefit all those in the region and all of us around the world.

“I commend President Trump, Secretary Pompeo, and many others in this Administration for facilitating this historic agreement and advancing the cause of peace and prosperity in the region.

“This came to many of us as a surprise, but a welcome surprise, and I’m very pleased at this relationship.

“Over the past several years, President Trump and Secretary Pompeo have cultivated relationships in Jerusalem, Abu Dhabi, and Manama. And for longer than that, Israel and Arab countries have cooperated on important matters behind closed doors. Capitalizing on a changing Middle East, President Trump and his Administration have helped to shepherd these relationships into the open.

“Today’s signing is just a beginning for the three countries and the region as a whole. More work obviously need to be done, and no agreement is easily accomplished, but my hope is that more Arab countries will follow the path of publicly recognizing Israel. Eighteen Arab states have yet to make this move, preventing relationships that can benefit the entire region.

“Israel’s right to exist is unquestionable, and to refuse to recognize that is to deny reality. I, along with so many other members of this chamber, have worked to ensure Israel’s security and prosperity. With more days like today, we can hope for a region that is secure and prosperous, as well for all.

“Madam President, thank you, I use this opportunity to commend this accomplishment and I hope that we are able to bring more peace and stability to this region and to the rest of the world.”

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WASHINGTON – U.S. Senator Jerry Moran (R-Kan.) – member of the Senate Commerce Subcommittee on Transportation and Safety – today announced a $21 million Better Utilizing Investment to Leverage Development (BUILD) grant for the City of Wichita to replace and modernize the single-lane system connecting I-235 to I-135, K-96 and K-254.

“This is great news for the city of Wichita,” said Sen. Moran. “This grant will invest significant resources into the efficiency and safety of this interchange that joins three major highways in Wichita and helps connect nearby businesses, Wichita State University, rural communities, downtown Wichita and local commuters with the rest of the city and state. Modernizing our highway system not only improves commerce in the area, but will also increase travel throughout south central Kansas.”

This grant will fund construction of a new two-lane system ramp, a flyover ramp, continuous auxiliary lanes and improvements to the bridge. Sen. Moran joined Sen. Pat Roberts (R-Kan.) and U.S. Representative Ron Estes (R-Kan.) earlier this year in urging U.S. Department of Transportation Secretary Elaine Chao to invest in this project.

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Sen. Moran Applauds the Opening of Thermo Fisher Scientific’s New Lenexa Manufacturing Site

Facility To Increase Production of COVID-19 Test Tubes

Aug 31 2020

WASHINGTON – U.S. Senator Jerry Moran (R-Kan.) today participated in the ribbon cutting ceremony for the opening of Thermo Fisher Scientific Inc.’s new $40 million production site in Lenexa dedicated to manufacturing viral transport media (VTM)-filled tubes for COVID-19 testing. The facility has created more than 300 new full-time jobs and added significant manufacturing capacity.

In early May, Thermo Fisher received a contract from the U.S. government to provide a significant quantity of highly specialized VTM-filled tubes for COVID-19 sample collection. VTM are available in a plastic tube that is suitable for collection and transport of clinical specimens containing viruses. This ensures that the sample collected from a COVID-19 nose swab maintains viability while it is transported to a lab for testing. Thermo Fisher has responded quickly to meet increased demand for VTM by ramping up production in Lenexa from 50,000 units per week to now more than 8 million per week.

“Widespread testing is a necessary component to keep the American economy running safely,” said Sen. Moran. “Thermo Fisher has stepped up to produce additional test tubes to help meet the national demand for COVID-19 testing and has created 300 new jobs by expanding its manufacturing base in Lenexa. Kansans never fail to do their part in our country’s time of need and this is no different. Thermo Fisher’s ability to manufacture test tubes and significantly increase production is important for making certain Americans can feel secure in their health and safely return to work.”

“Thermo Fisher is proud to support virtually every aspect of the global COVID-19 response and our colleagues in Lenexa have a key role in those efforts. Thanks to their hard work, Lenexa increased production of VTM units by more than 15,000%,” said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. “The team has worked with unrelenting intensity to build out and open a new site in just six weeks. They understood the urgent national need, accepted the challenge and have delivered for Thermo Fisher, for the American people and for Kansas.”

To ensure the accuracy of COVID-19 test results, VTM must be manufactured and dispensed into tubes in an aseptic environment. The new facility is dedicated to accelerating production and ensuring quality control by utilizing the proven blueprint for high-quality VTM production that has been developed in Lenexa. In addition to supporting America’s pandemic response, the products will be used for collection and sampling for the flu and other viruses. 

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Sens. Moran, Klobuchar Urge FTC to Address Privacy Issues Surrounding Mobile App “Premom”

A recent investigation from the International Digital Accountability Council (IDAC) found that the mobile app Premom may have engaged in deceptive practices by compromising user privacy

Aug 28 2020

WASHINGTON – U.S. Senator Jerry Moran (R-Kan.) – Chairman of the Senate Commerce Subcommittee on Manufacturing, Trade, and Consumer Protection – and Sen. Amy Klobuchar (D-Minn) – Ranking Member of the Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights – sent a letter to Federal Trade Commission (FTC) Chairman Joseph Simons urging the FTC to take action to address the troubling data collection and sharing practices of the mobile application (“app”) Premom. 

Premom is a mobile app that helps users track their fertility cycles to determine the best time to get pregnant, relying on personal and private health information. As of November 2019, the app has been downloaded over half a million times, and it is one of the top search results among fertility apps in the Apple App and Google Play stores.

Sens. Moran and Klobuchar were joined by Ranking Member of the Senate Commerce Committee, Maria Cantwell (D-Wash.), Richard Blumenthal (D-Conn.), Shelley Moore Capito (R-W.V.), Elizabeth Warren (D-Mass.), and Mark Warner (D-Va.).

“A recent investigation from the International Digital Accountability Council (IDAC) indicated that Premom may have engaged in deceptive consumer data collection and processing, and that there may be material differences between Premom’s stated privacy policies and its actual data-sharing practices,” the Senators wrote. “Most troubling, the investigation found that Premom shared its users’ data without their consent.”

The full text of the letter can be found HERE and below:

Dear Chairman Simons:

We write to express our serious concerns regarding recent reports about the data collection and sharing practices of the mobile application (“app”) Premom and to request information on the steps that the Federal Trade Commission (FTC) plans to take to address this issue.

Premom is a mobile app that helps users track their fertility cycles to determine the best time to get pregnant. As of November 2019, the app has been downloaded over half a million times, and it is one of the top search results among fertility apps in the leading app stores. To use Premom, users provide the app extensive personal and private health information.

A recent investigation from the International Digital Accountability Council (IDAC) indicated that Premom may have engaged in deceptive consumer data collection and processing, and that there may be material differences between Premom’s stated privacy policies and its actual data-sharing practices. Most troubling, the investigation found that Premom shared its users’ data without their consent. IDAC sent a letter to the FTC on August 6, 2020, to describe these undisclosed data transmissions along with other concerning allegations including conflicting privacy policies and questionable representations related to their collection of installed apps for functionality purposes.

While Premom claimed to only share “nonidentifiable” information in its privacy policy, the IDAC report found that Premom collected and shared—with three third-party advertising companies based in China including Jiguang, UMSNS, and Umeng—non-resettable unique user device identifiers that can be used to build profiles of consumer behavior. Additionally, users of the Premom app were not given the option to opt out of sharing their personal data with these advertising companies, and reports also allege that one of the companies that received user data from Premom concealed the data being transferred—which privacy experts say is an uncommon practice for apps that is used primarily to conceal their data collection practices.

While we understand that Premom has taken steps to update its app to halt the sharing of its users’ information with these companies, it is concerning that Premom may have engaged in these deceptive practices and shared users’ personal data without their consent. Additionally, there may still be users who have not yet updated the Premom app, which could still be sharing their personal data—without their knowledge or consent.

In light of these concerning reports, and given the critical role that the FTC plays in enforcing federal laws that protect consumer privacy and data under Section 5 of the Federal Trade Commission Act and other sector specific laws, we respectfully ask that you respond to the following questions:

1.  Does the FTC treat persistent identifiers, such as the non-resettable device hardware identifiers discussed in the IDAC report, as personally identifiable information in relation to its general consumer data security and privacy enforcement authorities under Section 5 of the FTC Act?

2.  Is the FTC currently investigating or does it plan to investigate Premom’s consumer data collection, transmission, and processing conduct described in the IDAC report to determine if the company has engaged in deceptive practices?

3.  Does the FTC plan to take any steps to educate users of the Premom app that the app may still be sharing their personal data without their permission if they have not updated the app? If not, does the FTC plan to require Premom to conduct such outreach?

4.  Please describe any unique or practically uncommon uses of encryption by the involved third-party companies receiving information from Premom that could be functionally interpreted to obfuscate oversight of the involved data transmissions.

5.  How can the FTC use its Section 5 authority to ensure that mobile apps are not deceiving consumers about their data collection and sharing practices and to preempt future potentially deceptive practices like those Premom may have engaged in?

Thank you for your time and attention to this important matter. We look forward to working with you to improve Americans consumers’ data privacy protections.

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WASHINGTON – U.S. Senator Jerry Moran (R-Kan.) today announced a $50.8 million Federal Transit Administration (FTA) grant for the Kansas City Streetcar Main Street Extension project. The grant will fund a 3.5-mile extension for the streetcar connecting Union Station to the University of Missouri – Kansas City (UMKC).

Last month, Sen. Moran joined Senators Roy Blunt (R-Mo.) and Josh Hawley (R-Mo.) and U.S. Representatives Sharice Davids (D-Kan.), Emanuel Cleaver (D-Mo.) and Sam Graves (R-Mo.) in supporting the Kansas City Streetcar Authority’s application for funding.

“These new resources from the federal government will help build on the already successful streetcar extending the line to UMKC, connecting neighborhoods and businesses along the way,” said Sen. Moran. “I was pleased to join my colleagues in advocating for this grant and look forward to seeing the new opportunities and economic growth this project will bring to the Kansas City area.”

The project must still meet statutory and program requirements before the FTA can approve the grant agreement.

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WASHINGTON – U.S. Senator Jerry Moran (R-Kan.) – a member of the Senate Committee on Indian Affairs – led a group of 11 Senators in urging Senate Majority Leader Mitch McConnell and U.S. House of Representatives Minority Leader Kevin McCarthy to include priorities for tribal governments in a future COVID-19 relief package, especially providing flexibility for tribal governments in how they use funds provided in the CARES Act.

“As you continue negotiations on the next relief package, we want to express our continued support for resources to help Indian Country address the unique challenges they face in this difficult time,” the Senators wrote. “As you know, Indian Country has suffered particularly high rates of coronavirus with complicating factors such as obesity, diabetes, and other preexisting conditions. Tribal governments deserve greater flexibility to spend these funds in a manner that meets the individual needs of each tribe. Allowing greater flexibility would enable tribal governments to use their resources in the most efficient manner.”

This letter was signed by Sens. John Barrasso (R-Wyo.), Steve Daines (R-Mont.), Mike Rounds (R-S.D.), Todd Young (R-Ind.), Kevin Cramer (R-N.D.), Lisa Murkowski (R-Alaska), Cory Gardner (R-Colo.), Roger Wicker (R-Miss.), Cindy Hyde-Smith (R-Miss.), Marco Rubio (R-Fla.) and Martha McSally (R-Ariz.).

The full letter can be found here or below.

August 21, 2020

Dear Leader McConnell and Leader McCarthy:

We wish to thank you for all your efforts in addressing the COVID-19 virus that has so deeply impacted our country. As you continue negotiations on the next relief package, we want to express our continued support for resources to help Indian Country address the unique challenges they face in this difficult time. As you know, Indian Country has suffered particularly high rates of coronavirus with complicating factors such as obesity, diabetes, and other preexisting conditions.

If funding is provided to state and local governments, we strongly encourage the inclusion of funding for tribal governments, as well. There remain tremendous obligations in Indian Country for health care, social programs, housing assistance, and other direct service programs, and additional support is critical to help tribal governments address the needs of their citizens.  

Additionally, tribal governments deserve greater flexibility to spend these funds in a manner that meets the individual needs of each tribe. Allowing greater flexibility would enable tribal governments to use their resources in the most efficient manner. Further, we ask that tribes be given additional time beyond the December 30, 2020, deadline to spend any funds provided by the Coronavirus Relief Fund established by Title V of the CARES Act.

Again, these issues are critical to Indian Country as tribal governments continue to provide services to their citizens as they struggle to combat this virus. We appreciate you taking the time to consider our views on this important issue.

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