2017 | Q3 Newsletter | Q & A with Health Advisory Council Member

Marsha Henderson

Associate Commissioner for Women’s Health, U.S. Food and Drug Administration 

Q. Please discuss your work and how it relates to FDA’s overarching mission.
A. I lead the FDA’s Office of Women’s Health (OWH) which works to protect and advance the health of women through scientific, educational, and outreach initiatives on issues impacting women across their lifespan. Our research helps the agency to better understand sex differences as they relate to product safety and effectiveness, and advance knowledge towards the diagnosis and treatment of health conditions that disproportionately impact women. In addition to our research efforts, OWH supports FDA’s public health mission through educational and outreach initiatives for health professionals so that they can make informed decisions about the safe use of the products FDA regulates. Our efforts support the Commissioner’s and FDA Center priorities…just using a sex and gender lens.

Q. How long have you been at FDA/OWH, and what do you love most about your job?
A. I have been working at FDA for 20 years. All of that time has been at the Office of Women’s Health. I have stayed at the Agency so long because I enjoy working with brilliant scientists and health professionals from a variety of disciplines who have dedicated their lives to improving the public health. I love the fact that FDA’s work touches almost every facet of women’s daily lives from life-saving medicines and vaccines to microwaves to foods and cosmetics. The importance of ensuring their safety and effectiveness cannot be understated. Whenever I travel abroad, I have great comfort knowing that the quality of our products is second to none and that FDA has set the gold standard for the world.   

Q. What are the biggest challenges and opportunities facing FDA/OWH today?
A. The fast pace of scientific advancement is our biggest challenge and our biggest opportunity. The science of women’s health and medical innovation is rapidly evolving — from gene therapies and in-silico clinical trials to biosimilars and miniaturization. This scientific innovation offers hope for new treatments and medical products to improve the health of women. But these advancements also mean that FDA must find new ways to evaluate the safety and effectiveness of the products it regulates. Over the years, the Office of Women’s Health has sponsored many innovative scientific programs. We offer staff expertise and reviewer training Agency-wide to make sure that the unique needs of women are considered in regulatory decision making, and also our knowledge to assist with rapidly changing technologies or emerging health issues such as the Zika virus and the opioids epidemic. As an agency we’ve made significant progress, and the FDA Office of Women’s Health has been there every step of the way to make sure that this progress benefits women. And as new scientific findings emerge, with new legislative demands, we will be a voice for the unique needs of women. 

Q. What FDA/OWH initiatives would you like to share with the Council?
A. A major focus for our Office is supporting research and educational outreach on chronic diseases affecting women in areas such as heart disease, diabetes, Alzheimer’s disease, HIV, and depression. OWH’s Diverse Women in Clinical Trials Initiative works to raise awareness and share best practices to promote women’s participation in clinical trials for these diseases and others. Our Take Time to Care outreach program conducts national campaigns and disseminates digital and print resources to promote safe medication use and support chronic disease management. We also work to improve the health of special populations of women such as pregnant women, minority women, caregivers, and women with disabilities. And our Women’s Health Research Roadmap will assure that 21st Century Cures will address sex as a biologic variable across the Agency to promote optimal health for women. 

Q. What does FDA/OWH value about membership in NCL’s Health Advisory Council?
A. Membership in NCL’s Health Advisory Council affords FDA/OWH the opportunity to meet and collaborate with public and private groups focused on helping consumers make informed healthcare decisions. The Council helps to share and cross promote messaging and resources for the general public and health influencers. It offers us the ability to continuously cultivate strong mutually supportive relationships to address key consumer health issues. Ultimately, our collective efforts will advance the health of all women and their families.

Issue 51 | September 7, 2017

#DataInsecurity Digest: Congress returns from recess with a full cybersecurity agenda

By John Breyault (@jammingecono, johnb@nclnet.org)
NCL Vice President of Public Policy, Telecommunications and Fraud

Subscribe here. Tell us what you think.

Editor’s Note: Welcome back to The #DataInsecurity Digest!

As D.C. reconvenes after a busy August recess, cybersecurity issues continue to garner attention. During the break, an unspecified number of “high profile” Instagram accounts were hacked, and nearly 4 million Time Warner Cable account records were compromised. Relief may be on its way for Delaware data breach victims as the state is set to enact legislation that will require reasonable data security practices and additional breach notifications. Back in Washington, three senior Energy and Commerce Democrats are raising questions as to how consumers should be protected in the wake of a data breaches that compromise personal information like Social Security numbers.

And now, on to the clips!

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Energy and Commerce Democrats: Current solutions for data breach victims may lull consumers into a false sense of security. Reps. Frank Pallone, Jr. (D-NJ), Diana DeGette (D-CO), and Jan Schakowsky (D-IL) sent a letter to the GAO questioning the merits of just offering credit monitoring in the wake of a data breach involving sensitive information. “Such services only existed for a finite amount of time, while Social Security numbers and other sensitive personal information gathered in a breach can be used indefinitely.” (Source: Federal News Radio)

Delaware strengthens state cybersecurity law. The new law expands the types of information that would require a breach notification and requires businesses to notify the Delaware Attorney General in the event of a breach of 500 or more residents. The law also establishes “requirements for Delaware businesses to maintain ‘reasonable’ data security practices.” (Source: Covington)

Breach du jour: “High profile” Instagrammers. While the Facebook-owned photo sharing company believes that only high profile accounts have been compromised, Instagram has alerted all of of its verified users of the data breach. @JonathanVanian reports that “hackers may have obtained the email addresses and phone numbers of some of the impacted users, but not their passwords.” (Source: Fortune)

Breach du jour part deux: Nearly 4 million Time Warner Cable records. An estimated 4 million account records — 600GB of them — were found unsecured on an Amazon server. @dellcam reports that “[t]he leaked data included usernames, email addresses, MAC addresses, device serial numbers, and financial transaction information—though it does not appear that any Social Security numbers or credit card information was exposed.” (Source: Gizmodo)

Quick hit: How safe are our nuclear weapons from hacking? @chathamhouse says we may not be as safe as we hope. Watch the short video here.

White House Advisory Group: “We’re in a pre-9/11 (cyber) moment.” The report issued by President Trump’s advisory group warned that, “There is a narrow and fleeting window of opportunity before a watershed, 9/11-level cyber attack to organize effectively and take bold action.” The report recommended a “bolstering of the (cyber) workforce, improving machine-to-machine information sharing and streamlining the security clearance process to eliminate the backlog…” (Source: FCW)

Hurricane Harvey could lead to more phishing scams. The Department of Homeland Security published an advisory which warned users that cyber criminals may be trying to capitalize on the natural disaster. The alert also reminded users to be on the lookout for scams and phishing attacks as, “Emails requesting donations from duplicitous charitable organizations commonly appear after major natural disasters.” (Source: The Hill)

Events

February 28, 2018 – Privacy Con 2018, Washington, DC
In February, the FTC will host its third Privacy Con, convening a broad array of academics, researchers, consumer advocates, government officials, and industry representatives to address the privacy implications of emerging technologies.

National Consumers League
Published September 7, 2017

Issue 50 | July 19, 2017

#DataInsecurity Digest: Russia behind Wolf Creek? Biometric data, 9-1-1 systems vulnerable 

By John Breyault (@jammingecono, johnb@nclnet.org)
NCL Vice President of Public Policy, Telecommunications and Fraud

Subscribe here. Tell us what you think.

Editor’s Note: Russia’s hacking of America’s critical infrastructure continues to worry security experts, with the hacking of the Wolf Creek nuclear facility in Kansas being the latest source of heartburn. Even our 9-1-1 systems could be at great risk of ransomware and other hacking attacks, according to a new report from Scripps News. A breach at self-service payment company Avanti is raising questions about the ability of companies to respond to breaches of biometric data. After all, while payment information breaches can be addressed by issuing new cards, breached entities can’t give consumers new fingerprints. Hacks at wrestling conglomerate WWE and a chain of family-owned movie theatres, B&B Theatres, suggest that hackers’ may be targeting entertainment companies next.

A quick programming note: The #DataInsecurity Digest will be taking a pause for the August recess after this issue. We’ll return to our normal bi-weekly publishing schedule after Labor Day.

And now, on to the clips!

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Russia believed to be behind the hacking of the Wolf Creek nuclear facility in Kansas. Officials stated that, “The possibility of a Russia connection is particularly worrisome,” as “Russian hackers have previously taken down parts of the electrical grid in Ukraine and appear to be testing increasingly advanced tools to disrupt power supplies.” Industrial Security expert Galina Antova writes, “We’re moving to a point where a major attack like this is very, very possible. Once you’re into the control systems—and you can get into the control systems by hacking into the plant’s regular computer network —then the basic security mechanisms you’d expect are simply not there.” (Source: Bloomberg)

Avanti Markets investigates potential payment system and biometric data breach. The company behind a popular self-service payment system is investigating a breach that may have compromised consumers’ credit card information and fingerprints. @briankrebs writes, “Credit cards can be re-issued, biometric identifiers are for life. Companies that choose to embed biometric capabilities in their products should be held to a far higher security standard than those used to protect card data.” (Source: Krebs on Security)

9-1-1 systems dangerously outdated, vulnerable to hacking and ransomware. State governments’ policies of diverting 9-1-1 funds to other unrelated projects has put consumers at risk. “Experts warn that the nation’s antiquated patchwork of 911 systems is an easy target for hackers who want to wreak havoc and criminals who want to hijack 911 and demand a ransom,” writes @greenblattmark. (Source: Scripps News)

Breach du jour: WWE wrestling. It was recently found that information on 3 million users of the WWE wrestling website was stored unprotected on an Amazon server for an undetermined amount of time. @branttom reports that compromised information could include “home and email addresses, birthdates, and the age ranges and genders of the account holders’ children,” or “addresses, telephone numbers, and names of WWE account holders.” (Source: PCMag)

Breach du jour part deux: B&B Theatres. The seventh-largest movie theatre chain in America is investigating a breach of its payment systems. @briankrebs reports that experts believe credit cards are estimated to have been exposed “between April 2015 and April 2017, meaning cyber thieves have likely been siphoning credit and debit card data from B&B Theatres customers for nearly two years undisturbed.” (Source: Krebs on Security)

Inspector General: OPM still not secure two years after breach. @Joseph_Marks_ reports that a newly-released report from the Office of Personnel Management’s Inspector General found that “two years after suffering a massive data breach, the Office of Personnel Management still isn’t sufficiently vetting many of its information systems.” (Source: NextGov)

Suggested reading: WIRED’s review of the most devastating breaches so far this year. @lilyhnewman brings us a great summary highlighting this year’s breaches from the state-sponsored WannaCry ransomware attack, to the Shadow Brokers’ use of the NSA’s leaked spying tools, and more. (Source: WIRED)

 

National Consumers League
Published July 19, 2017

Third Annual Spring Membership Meeting

June 6, 2017

Welcome and overview

Sally Greenberg, executive director, National Consumers League
Sally Greenberg welcomed attendees to the Third Annual Spring Membership Meeting of the Health Advisory Council. Greenberg thanked the Members of the Council for their support, engagement, and enthusiasm. She then introduced the distinguished panel of experts, who discussed the current health policy landscape, including the status of healthcare reform in the Senate. 

Health policy panel
The following panelists engaged in discussion and answered questions from Council Members about the current health policy landscape: 

• Moderator Janay Johnson, health policy manager, National Consumers League
• Joel White, president, Council for Affordable Health Coverage
• Theresa Chalhoub, health policy counsel, National Partnership for Women & Families
• Myra Simon, executive director, employer and commercial policy, America’s Health Insurance Plans
• Yvette Fontenot, partner, Avenue Solutions

Discuss the status of healthcare legislation in the Senate.

Joel White noted that there is a great deal of push and pull between moderates and conservatives in the Republican Party. There is a big push in the Senate to get a bill on the floor before the August recess, and to pass it under Reconciliation.

Discuss the possibility that the Senate bill will be ‘AHCA-lite.’

Yvette Fontenot said that it appears that the Senate bill will contain about 85 percent of the current House bill’s provisions. AHCA would cut financial assistance to low-income individuals, roll back protection for individuals with pre-existing conditions, and allow the Essential Health Benefits (EHB) requirements to be waived. A major issue that is currently being negotiated in the Senate is the implementation of per-capita caps for Medicaid. Theresa Chalhoub explained that the proposed cuts to Medicaid funding and implementation of per-capita caps would gut the system and have a negative impact on maternity care, since Medicaid currently covers approximately 50 percent of all births in the United States. With such a sharp decrease in federal support for Medicaid, states will have no choice but to cut eligibility, benefits, and/or provider payment rates.

Fontenot noted that in addition to completely restructuring Medicaid, the Senate is also debating the design of tax credits to try to make them more effective and efficient. All of the panelists expressed concern that Congress is not addressing how to bring down the cost of health care.

Discuss the current and future impact of uncertainty on health insurance plans.

There is a great deal of uncertainty regarding the government’s willingness to fund the Cost Sharing Reductions (CSR). If the government will no longer reimburse insurers for these costs, premiums will rise. Myra Simon highlighted a study recently done in Pennsylvania that found that with certainty on the CSR’s and the individual mandate, premiums would rise by 8.8 percent next year. However, without this certainty, premiums would rise by over 35 percent. 

Discuss New York Governor Andrew Cuomo’s actions to keep insurance companies in New York’s Exchange by prohibiting companies that withdraw from the Exchange from participating in Medicaid or New York’s children’s health plan.

Myra Simon said that other states will certainly observe what New York is doing, and some may follow suit if it appears to be a success. However, this could potentially create a problem for some insurers that successfully offer Medicaid managed care plans but simply are not set up to function in the Exchange.

Discuss the reauthorization of the Children’s Health Insurance Program.

Yvette Fontenot and Joel White said that while it’s possible that CHIP reauthorization will be rolled into Reconciliation, it’s more likely that it will be packaged up with User Fee bills or some other must-pass legislation. Governors caution that CHIP must be reauthorized before the summer in order to allow them to develop their state budgets. 

Discuss the recent Washington Post editorial that suggested that Medicare funding could be slashed without negatively impacting patients.

Joel White noted that there is a lot of waste in the healthcare system. Medication adherence, which NCL works to advance through its Script Your Future campaign, could save the Medicare system millions of dollars by improving patient outcomes and reducing hospitalizations. Yvette Fontenot added that delivery system reforms that incentivize value-based care can be utilized to achieve better quality care at a lower cost.         

National Consumers League’s health program priorities

Karin Bolte, health policy director, National Consumers League
Following the panel discussion, Karin Bolte gave an overview of NCL’s health programs and policy priorities. NCL carries out its health policy work through research, education, advocacy, and convening. NCL’s key priorities are:

• Ensuring access to quality affordable healthcare, including working to protect the Affordable Care Act, supporting the FDA, and ensuring that consumer-friendly quality measures are developed, and that there is subsequent reporting by healthcare providers and institutions on compliance with measures and standards, and that patient-centered outcomes are emphasized.
• Safe and appropriate use of medicines, including medication adherence, vaccines, counterfeit drugs, and compounded drugs.
• Helping consumers to navigate the health care system, including improving healthcare provider-patient communication, promoting health literacy, and improving health care transparency on price, quality, and safety.

Information sharing from Health Advisory Council Members 

Following the overview of NCL’s health programs, Health Advisory Council Members had the opportunity to share updates on their programs, priorities, and initiatives with each other. Please see the Q2 2017 Health Advisory Council newsletter for a brief summary of member updates. 

Closing remarks

Sally Greenberg
Greenberg thanked the Health Advisory Council Members for attending the meeting and for their continued support of NCL. She encouraged Members to contact NCL with ideas and suggestions for Council activities.

2017 | Q2 Newsletter | Q & A with Health Advisory Council Members

Gay Johnson

CEO, National Association of Nurse Practitioners in Women’s Health

Q. Please discuss your work at the National Association of Nurse Practitioners in Women’s Health (NPWH) and how it relates to NPWH’s overarching mission. 
A. As the CEO, I’m responsible for delivering on the organization’s overall mission, which is to help improve access to quality care by nurse practitioners who focus on women’s health, as well as to serve as a leading voice for courageous conversations about women’s health throughout their lifespan. NPWH elevates the health issues others overlook and unmasks family, cultural, and economic issues that impact women’s health—both in and outside of the exam room. I work closely with NPWH’s Board of Directors, comprised of top academics and practicing nurse practitioners (NPs) in women’s health, to ensure that we are engaged in research and policy discussions that can best inform the field and ensure that women have access to quality health care. I build strategic partnerships and help our team convene a very robust set of policy discussions and continuing education programs for NPs around the country.

Q. How long have you been at NPWH, and what do you love most about your job?
A. I started at NPWH in 1997, making this my 20^th year with this terrific organization. In 2012, I was asked to lead the organization as the CEO—after having served as Vice President and CFO and starting as the Finance Administrator. What I love most about my job is knowing we are making a difference in women’s lives everyday by supporting Nurse Practitioners in many ways, from academia where future NPs are just starting out, to those who are in clinical practice providing the best possible care to their patients.

Q. What are the biggest challenges and opportunities facing NPWH today?
A. The ongoing healthcare debate and passage of the American Health Care Act is a huge challenge—not only for NPWH, but for women all over America. NPWH is working tirelessly to ensure that women across the lifespan will still have access to safe, quality healthcare, and NPs understand how changes in legislation may impact how they provide care so they can continue to serve their patients the best they can. We routinely write and sign on to letters to Congress with other healthcare and women’s health organizations, and attend Congressional briefings and coalition meetings to ensure we understand what is happening as it happens. However, in the midst of the challenges we also have exciting opportunities. The number of nurse practitioners in the United States has risen dramatically in recent years, and is expected to continue to rise. NPWH works closely with nursing schools around the country, and there’s huge opportunity there to encourage students to become certified as a Women’s Health Nurse Practitioner. As the number of NPs (and our membership) grows, we look forward to having an even wider reach and being able to positively affect even more women’s lives.

Q. What NPWH initiatives would you like to share with the Council?
A. Since so much of women’s health is focused on the childbearing years, we see our role as central to bringing awareness to quality women’s healthcare across the entire lifespan—particularly women’s sexual health. We have a number of conferences and continuing education opportunities we offer, along with resources for clinicians and their patients, and we are part of advising the field on practice guidelines. We will convene the second annual “Healthy at Any Age: A Summit on Women’s Health After 50,” in November 2017. We also hold the only NP conference dedicated exclusively to women’s sexual health in the country. Our fifth annual Women’s Sexual Health Course for NPs will be held in June 2018 in partnership with the International Society for the Study of Women’s Sexual Health. This October, we will convene our 20^th annual NPWH Premier Women’s Healthcare Conference. We also continue to update our well-woman visit mobile app—a fourth edition with a new menopause module is coming soon—and we are in the process of building a comprehensive online patient portal that will focus on educational materials for consumers. In addition, we are one of four partner organizations in the ACOG-led Women’s Preventive Services Initiative (WPSI). WPSI is charged with recommending updates to the Women’s Preventive Services Guidelines, as well as making new recommendations. These guidelines are routinely used by clinicians to determine what screenings and other various preventive health services they should offer their patients, so the project will have an important impact on women’s health.

Q. What does NPWH value about membership in NCL’s Health Advisory Council?
A. NPWH is proud to partner with NCL and so many organizations dedicated to improving healthcare, particularly for women in America. The collaboration between both consumer and healthcare organizations is hugely beneficial as we work together to identify new ideas and insights that ultimately provide support for those who participate in the Council as well as NCL.

 

Tracy Valorie, Sr. Vice President, General Manager

Bausch + Lomb & Valeant Women’s Health
Valeant Pharmaceuticals 

Q. How would you describe your role at Valeant Women’s Health?
A. I am the Senior Vice President and General Manager of Bausch + Lomb (a subsidiary of Valeant) and Valeant Women’s Health. For Bausch + Lomb, I lead the Ophthalmology portfolio, which includes ophthalmic pharmaceuticals, surgical devices and instruments. For our Women’s Health business, I am responsible for the ADDYI team, which is solely focused on providing and delivering the first-ever treatment for premenopausal women with acquired, generalized Hypoactive Sexual Desire Disorder (HSDD).

Although the therapeutic areas differ, my management responsibilities are similar across the various businesses. The goal is to ensure each business offers innovative technologies, treatments, and resources that help meet the needs of healthcare practitioners and the patients they treat and to ensure patients have access to our broad portfolio of products.

Q. What do you think Council Members should know about Valeant?
A. Valeant Pharmaceuticals International, Inc. is a multinational, specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of women’s health, dermatology, eye health, GI, neurology and branded generics. Our products play a role in helping millions of people worldwide live healthier lives by providing treatment to those affected by debilitating diseases. As a company, we are committed to improving the health and well-being of people everywhere.

Q. What Valeant initiatives would you like to share with the Council?
A. As part of our Women’s Health initiatives, Valeant supports a program led by the American Sexual Health Association (ASHA) called Find My Spark that aims to provide facts about female sexual dysfunction (FSD), including its most common type, hypoactive sexual desire disorder (HSDD). Find My Spark encourages and empowers women to take charge of their sexual health and talk to a healthcare professional about any troubles they may be facing. You can find related information at FindMySpark.com.

Separately, ADDYI, indicated for the treatment of acquired, generalized HSDD in premenopausal women, is part of the Valeant Access Program. This program enables most commercially insured patients to pay no more than $25 for 12 refills; it also allows eligible patients to pay $150 for 6 refills if they are uninsured.

Bausch + Lomb is proud to have been dedicated to innovation in eye health for more than 164 years and is committed to providing affordable access to our large portfolio of products. The company’s pharmaceutical Rx eye care portfolio is part of the Valeant Access Program and enables most commercially insured patients to pay no more than $35 for their prescriptions of select drugs and $60 for eligible uninsured patients.

Q. What is Valeant doing to change the way people think about and approach healthcare?
A. Because we operate in many diversified businesses, we have an opportunity to collaborate across divisions to continually look for innovative solutions to healthcare issues including but not limited to building an innovative pipeline, educating consumers, and looking for innovative ways to ensure access. 

Q. What does Valeant value about membership in NCL’s Health Advisory Council?
A. We are honored to have the opportunity to become a Member of NCL’s Health Advisory Council. NCL is an organization that truly puts consumers first. Valeant is anchored by its 22,000 employees worldwide who come to work each day with a common goal of improving people’s lives through our healthcare products. We value NCL’s common goal of making a difference in people’s lives and providing education about healthcare.