Cheesy distractions … – National Consumers League

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Amid all the craziness of the last few weeks – the hurricanes that destroyed so much of Puerto Rico and the islands, the earthquake in Mexico City, the horrific mass shooting in Las Vegas – I find myself gravitating to anodyne parts of the newspapers I love to read daily. Case in point, the Food Section of the Washington Post. 

And I happened to come upon a most interesting article on American cheeses – not the orange kind in cellophane wrapped slices, but intensely aged flavorful artisanal cheeses that are now competing with their European counterparts for the first time.

Why is this relevant to NCL? I’m getting there! The article appeared on the front page of the food section with the headline “All American contenders, At an International Cheese Festival, experts deem US-made varieties on par with Old World Stalwarts.” There they were in Bra, Italy with cheese aficionados from across the world touting the qualities of great new American cheeses. But when I looked inside for the jump page, all I could find was a headline that said “Raw milk producers look to make their case to wary American consumers.”  Wait, that wasn’t what I was reading about!

All of a sudden the article morphed into a discussion on the superiority of raw milk cheeses and the FDA’s rules about them, about which I know very little. Well, raw milk is important to NCL because, it’s dangerous to consume: it hasn’t been pasteurized. 

The American Cheese Society’s Nora Weiser was quoted: “ In the United States, we’re still in the phase where we’re trying to prove the safety of raw-milk cheese.”  NIH found that 90 outbreaks attributed to raw milk between 1998 and 2011 had caused 1,1882 illnesses, 230 hospitalizations, and six deaths. Forty-two percent of those were from raw milk cheese. And two people died eating cheese just this past March in New York, according to the article. That’s pretty scary! Ms. Weiser has an uphill battle, it appears. 

I learned that there’s a way to make raw cheeses safe to consume: age them for 60 days, per FDA rules. But then no soft, young raw milk cheeses allowed like those you find in Europe. Andy Hatch of Uplands Cheese in the United States complained that the FDA’s processes are opaque and not based on science. I don’t know if he’s right or not. I do know that for the consumers’ sake, anything made with raw milk should be made safe. Where the FDA is going to land on this is anyone’s guess. That said, this is why I LOVE newspapers, because at least for a few moments, this trip to an international cheese festival and celebration of new American artisanal cheeses – and discussion of raw milk  – took my mind off the depressing news of the week. 

Major consumer & passenger rights groups launch ad opposing air traffic privatization – National Consumers League

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October 6, 2017

Contact: NCL Vice President of Public Policy, Telecommunications, and Fraud, John Breyault, (202) 207-2819, johnb@nclnet.org

Washington DC—Today, leading airline passenger, consumer and rural organizations, including National Consumers League, FlyersRights.org, Consumer Action, the Alliance for Aviation Across America and In The Public Interest launched an ad to set the record straight on the airlines’ push to privatize the air traffic control system. The ad specifically aims to correct a number of misleading claims put forth by the airlines and their paid front groups that privatization would somehow benefit passengers or communities.

Under the airlines’ privatization plan, oversight of air traffic control would be transferred from the FAA to a corporate board essentially controlled by industry with zero seats for consumer or passenger rights organizations. This unaccountable body would have unlimited power to raise fees and taxes on passengers, cut critical access to community airports and make decisions based on their own business priorities instead of in the interest of safety and the public.

“From major computer meltdowns, lost luggage and children, and dragging their passengers through the aisles of aircraft, the airlines have repeatedly demonstrated an inability to manage their own operations, let alone oversee the world’s busiest air traffic control system. They point the fingers at air traffic control, but the DOT’s own data confirm that the airlines themselves are responsible for the vast majority of delays” said Paul Hudson, President of FlyersRights.org

Notwithstanding the efforts by airline-backed lobbying and PR groups to mislead the public, a wide range of consumer, business, labor stakeholders and notable experts strongly oppose privatization.

“Our air traffic control system is a public good that should not be gifted over to the same big airlines that assault and drag paying customers off flights, shrink seats to medically unsafe proportions and invent increasingly outrageous new fees”; said Linda Sherry, Director of National Priorities at Consumer Action.

John Breyault, Vice President of Public Policy at National Consumers League stated: “In just the past few weeks we’ve witnessed big airlines engaging in troubling hurricane-related price gouging to go along with the ongoing passenger abuses and unsavory marketing and pricing practices that harm consumers. This industry continues to put profits before passengers; based on their track record, they would likely do the same if handed control of our air traffic system.”

“Privatizing air traffic control system would allow the airlines to run it for their own benefit and further direct investment and infrastructure away from thousands of smaller communities around the country, including many towns that have already lost commercial air service,” said Selena Shilad, Executive Director of the Alliance for Aviation Across America.

“Why would we take a critical piece of our national, public infrastructure and turn it over to one, self-interested private interest in the system, without any oversight from Congress? The airlines continue to be the only ones pushing for this risky idea, because they are the only ones that would benefit.  =Our national airspace system should be operated in the public’s best interest, not any one customer’s private interest,” stated Donald Cohen, Executive Director of In the Public Interest.

To view the ad, click here.  

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

NCL applauds pro-consumer additions to autonomous vehicle (AV) legislation – National Consumers League

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October 4, 2017

Contact: NCL Communications, Cindy Hoang, (202) 207-2832, cindyh@nclnet.org

Washington, DC—The National Consumers League (NCL) is applauding a series of positive changes adopted by the Senate Commerce Committee today on a bill that will set the regulatory and legal framework for the deployment of autonomous vehicles in America in for years to come. The bill, the American Vision for Safer Transportation through Advancement of Revolutionary Technologies Act, or AV START Act (S. 1885), is still undergoing changes that the advocates hope will make the AV deployment safer and more consumer-friendly.

Sally Greenberg, NCL executive director said: “Thanks to robust consumer advocacy and the support of consumer champions on the Committee, including Ranking Member Nelson (D-FL), Senators Blumenthal (D-CT), Markey (D-MA), and Baldwin (D-WI) and many others, the bill is much improved, though we still have concerns about AV rollout’s impact on consumer safety protections. We are very pleased to finally have a provision that will address the problem of children dying in hot cars, and provisions giving consumers access to information about AVs.”

NCL, along with other consumer and auto safety organizations, raised concerns at a press conference on October 3 about the bill, including that it contained provisions that would weaken auto safety laws, preempt localities from protecting their own citizens, restrict the right of consumers to go to court if they are injured by faulty designs, and generally leave consumers at risk. NCL also worked with a coalition that included members of industry who share concerns about consumers controlling their data related to AVs and support a provision setting up a federal commission to study the issue. Such a commission would include consumer advocates with expertise on safety and privacy – and make recommendations to Congress on how best to protect the privacy of those data. Many – though not all – of those concerns were addressed at the Senate Commerce Committee markup today.

NCL noted that consumer advocates remained concerned by how the legislation would undermine some of the safeguards on which consumers rely and intend to work with senators to further improve the bill so that it sets up a safety framework that better protects consumers in AVs. “We are getting there,” said Greenberg. “All in all, the bill the Committee adopted today is a vast improvement over the initial drafts. We are grateful to members of the Committee who embraced the need for far greater consumer and privacy protections and supported these critical improvements to the bill.”

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

NCL: Hands-off approach to autonomous vehicles is ‘dangerous’ – National Consumers League

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October 2, 2017

Contact: NCL Communications, Cindy Hoang, (202) 207-2832, cindyh@nclnet.org

Washington, DC—In a letter to Congress, the National Consumers League (NCL) is expressing grave concerns about Senate legislation to promote the deployment of HAVs or “Highly Autonomous Vehicles.” The bill — S. 1885, the AV START Act — sponsored by Senate Commerce, Science and Transportation Committee Chair and Ranking members Senators John Thune (R-SD) and Gary Peters (D-MI), would alter existing consumer protection laws and regulatory authority for auto safety in favor of speeding the rollout of these autonomous vehicles.

NCL’s letter to the Committee outlines concerns that the bill does not adequately protect consumers or ensure that the self-driving cars of the future will be safe. The letter noted that Congress seems willing to allow massive deployment of this new and –in many ways untested -technology with no strong federal or state oversight.

On Wednesday, Oct. 3, NCL Executive Sally Greenberg will participate in a press conference with a coalition of leading safety and consumer advocates, and families of victims of deadly vehicle defects, to call on the U.S. Senate Committee on Commerce, Science and Transportation to stop and fix this dangerous bill.

NCL notes that this legislation would:

  • Allow untold millions of cars on the market that are exempt from federal safety standards and do not adequately protect occupants in a crash
  • Block states and local highway officials from enforcing their own laws through a sweeping provision – federal preemption – that prevents state and local entities from supervision and regulation of the safe operation of vehicles on their roadways
  • Ignore the auto industry’s long history of introducing dangerous and defective vehicles into the marketplace by taking a largely hands-off approach to the deployment of HAVs, which NCL notes, will undoubtedly have design flaws and be involved in fatal accidents.

NCL’s letter noted the auto industry’s long and unfortunate history of introducing dangerous automotive vehicle designs into the marketplace, including Ford Pinto’s exploding gas tank, the Chevy Corvair collapsing tires, the Ford Explorer tires detreading at high speeds, huge blind zones causing backovers of toddlers, ignition switch defects causing untold deaths, and defective airbags impaling drivers.

The letter sent by NCL on S 1885, the AV START Act,” NCL stated the following additional concerns:

  • The bill has no provisions for a public database – despite requests from consumer advocates – so the public can see impending hazards that will be identified when HAVs are deployed and track communications and responses about AVs between NHTSA and manufacturers. Other federal safety agencies, like the Consumer Product Safety Commission with *www.saferproducts.gov  and the Consumer Financial Protection Bureau, https://www.consumerfinance.gov/data-research/consumer-complaints/, make such information publicly available.
  • Safety exemptions for vehicle safety are far too numerous. They must be strictly limited in scope and any increases must be controlled based on real-world safety performance.
  • NHTSA must be given imminent hazard authority to protect against potentially catastrophic AV defects and the ability to institute recalls quickly.
  • NHTSA must be given adequate and sufficient resources to properly regulate AV technology and should establish an office dedicated to ensuring oversight and accountability.
  • NHTSA needs to be able to hire experts in automotive software technology who are independent from the industry to oversee the safe deployment of AVs
  • Consumers should have information about vehicles at point of sale or upon hiring the vehicle through ride sharing services

“While we are excited about the potential for autonomous vehicles to improve mobility and safety, it cannot be done in a vacuum. This is new and untested technology. Now more than ever, in these early stages, we need strong oversight and regulation to track problems and ensure consumers’ lives aren’t jeopardized when the inevitable happens: systems go down, hacking occurs, software malfunctions, crashes happen. Under S. 1885, the AV START Act, the protections aren’t there.  We are calling on Congress to address this problem, to give NHTSA authority to develop a safety net for this critical technology and provide the resources needed to take action quickly,” said NCL Executive Director Sally Greenberg.

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

 

*Links are no longer active as the original sources have removed the content, sometimes due to federal website changes or restructurings.

FDA agrees to enforce menu labeling rule in May 2018 – National Consumers League

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September 27, 2017

CSPI and National Consumers League Put Litigation on Hold After Reaching Agreement with Federal Government

Media contact: Jeff Cronin, CSPI: 202-777-8370; Cindy Hoang, NCL: 202-207-2832; Peter Lehner, Earthjustice: 212-845-7389

Washington, DC—U.S. District Court Judge Emmet Sullivan today approved an agreement that paves the way for the Food and Drug Administration to begin enforcing regulations requiring chain restaurants, grocery stores, and convenience stores to include calorie counts on menus in May 2018. The Center for Science in the Public Interest and the National Consumers League sued the FDA in June after the agency abandoned an earlier enforcement deadline only one day before enforcement was due to begin. The nonprofit law firm Earthjustice, which represents CSPI and NCL, and the Department of Justice agreed to stay further proceedings in that lawsuit following an August 25th statement from FDA Commissioner Scott Gottlieb providing assurance that there will be no further delay and no changes to the menu labeling requirements.

Longtime advocates for menu labeling say that the agreement gives much needed clarity both to consumers, who overwhelmingly want and use calorie and other nutrition information, and to companies, many of which are already making calorie counts available to the public on their menus or websites.

“Since Americans are getting more food outside the home than ever before, having access to calorie information at chain restaurants is important for consumers who want to maintain a healthy weight and reduce their risk of diet-related disease,” said CSPI vice president for nutrition Margo G. Wootan. Wootan was recently named by Eating Well magazine as one of the *2017 American Food Heroes for her work on menu labeling.

“Congress passed a law requiring menu labeling more than seven long years ago, and the FDA finalized its regulations almost three years ago,” said Sally Greenberg, executive director of the National Consumers League. “Responsible companies have already invested in compliance. As frustrating as this process has been, we’re glad that the end of the long campaign for menu labeling is now in sight.”

The FDA finalized the menu labeling rule in 2014, with compliance and enforcement due to begin before the end of 2015. The agency subsequently delayed enforcement until May 2017 and then, in the challenged rule, until May 2018. Today’s agreement provides that the lawsuit challenging the delay will proceed only if the FDA announces an additional delay of enforcement or fails to issue guidance to industry by the end of 2017. The guidance will clarify the menu labeling rule and aid implementation—but cannot weaken the rule’s requirements.

“Americans want and deserve to know what they’re eating,” said Earthjustice senior attorney Peter Lehner. “So it is good news that the FDA has affirmed its commitment to ensuring that chain restaurants, supermarkets, convenience stores, movie theaters, and similar food retail establishments provide calorie and other nutrition information to customers.”

Calorie labeling at restaurants isn’t entirely out of the woods, proponents caution. A bill pending in Congress, the so-called Common Sense Nutrition Disclosure Act, would undermine the Administration’s implementation of menu labeling by exempting take-out chains, including pizza restaurants, and others from some of the requirements, and by letting retailers use arbitrary serving sizes to mask total calorie content. The bill would also let supermarkets that sell restaurant-type food hide calorie information in less-visible locations.

“Most of the biggest chain restaurants are already providing calories on menus and menu boards,” Wootan said. “We hope Congress resists the efforts of outlier companies, notably Domino’s and other pizza chains, to weaken menu labeling.”

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The Center for Science in the Public Interest is a nonprofit health-advocacy group based in Washington, DC, that focuses on nutrition and food safety.  CSPI is supported largely by subscribers to its Nutrition Action Healthletter and by foundation grants.

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad.

Earthjustice is the premier nonprofit environmental law organization. We wield the power of law and the strength of partnership to protect people’s health, to preserve magnificent places and wildlife, to advance clean energy, and to combat climate change. We are here because the earth needs a good lawyer.

 

*Links are no longer active as the original sources have removed the content, sometimes due to federal website changes or restructurings.

The poultry industry wants to speed up production – but at what cost? – National Consumers League

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poultry_production-crop.jpgBeef consumption in the U.S is on the decline. The red meat that once played a central role in the American diet is disappearing off of consumers’ plates by the rate of about 20 pounds of beef per person, per year. Increased awareness of obesity and other weight-related diseases linked to red meat, and a public health push to persuade Americans to choose leaner options are likely some of the causes of this drop in demand. As beef consumption has decreased, poultry has steadily risen to become the most popular meat product in the U.S., and the poultry industry isn’t showing any signs of slowing down.

Earlier this month, the National Chicken Council (NCC) submitted a *petition to the Food Safety and Inspection Service (FSIS)–the food safety regulatory arm of USDA–requesting a lift on a *2014 Obama Administration rule that limits processing speeds to 140 birds per minute. In their petition, the NCC requests that FSIS initiate a waiver program allowing chicken slaughter establishments “to operate without the arbitrary line speed limitations.” This means processing speeds would likely increase to at least 175 birds per minute. The NCC argues that limiting processing rates is putting the U.S. chicken industry at a competitive disadvantage, as some countries are able to process over 200 birds per minute.

Despite their argument, it’s hard to feel sorry for the NCC when the U.S. is currently the world’s top producer of poultry meat. In fact, this year consumers are expected to consume a record amount of chicken, about 91.3 pounds per person. Not only is poultry production dominating nationally, but according to the USDA, the U.S. is also the second largest exporter of poultry meat in the world.

Since the NCC’s petition became public, animal rights groups, workers unions, and consumer advocacy groups (including NCL) have spoken up about the increased safety risks associated with faster processing. Removing speed line limits makes birds susceptible to harsher slaughtering conditions, including violent removal of limbs, drowning, scalding, and other egregious abuse. On top of inhumane slaughtering practices, the poultry industry is notorious for the poor treatment of their workers. Without processing rules, poultry workers are even more vulnerable. According to the director of Oxfam America’s U.S. Domestic Program, Minor Sinclair, “Bumping up the poultry processing line speed to 175 birds per minute – or striking 3 birds per second – will only invite more worker amputations, hospitalizations, and injuries – not to mention increasing the risk of meat contamination.”

The National Consumers League advocates for the health and safety of workers and consumers. We stand with the other consumer and worker rights organizations objecting a lift on speed line limits. The health and safety of workers and consumers is far more important than any potential economic gain for the poultry industry. Consumers should remain informed about the changes happening in food processing, and speak out against policies that put workers and public health at risk. There is already so much progress to be made in the poultry industry. If NCC’s petition is accepted, it will become even more difficult for the poultry industry to meet the needs of workers and consumers whose best interest they claim to serve.

*Links are no longer active as the original sources have removed the content, sometimes due to federal website changes or restructurings.

LifeSmarts enlists high school students as OTC medicine safety mentors – National Consumers League

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hertzberg-1.jpgThis blog was originally published on LifeSmarts.org.

We are excited to launch a new community service project today: the LifeSmarts OTC Medicine Safety Mentoring Project, which provides materials and curriculum that are bolstered by educational resources produced by Scholastic.

Studies have found that children as young as 10 and 11 begin self-administering OTC medicines. Our new outreach effort equips high school students with tools they can use to mentor younger children to be safe in their use and storage of OTC medicines.

  • High School focus: Classroom lessons, study materials for the 2017-18 competition, and resources to prepare high school students to educate 5th and 6th graders.
  • Middle School focus: Materials designed to be used with 5th and 6th graders and taught by LifeSmarts high school student mentors.
  • Community focus: Community-engagement activities offer fun, fast ways to engage with parents, children, and the community at large.

The LifeSmarts OTC Medicine Safety Mentoring Project represents strong partnerships, which drive everything we do here at LifeSmarts. We are gratified to work with dedicated educators seeking current consumer lessons for the classroom, competitive coaches looking for every advantage in preparing their teams for online and live competition, and enthusiastic student participants with a strong sense of community involvement. We are also gratified to have the support and encouragement of our funding partner, McNeil Consumer Healthcare.

We know LifeSmarts gives students the skills they need to succeed as adults, and we know students are eager to apply what they learn at home and in their communities. We have seen LifeSmarts students embrace the Safety Smart project, conduct food waste audits with gusto, and produce creative PSAs to educate their peers. We are excited to present students and coaches with this community outreach effort and see where they will take it!

As LifeSmarts celebrates “The Year of Health and Safety” in 2017-18 we will continue to give special focus throughout the year to health and safety lessons, learning activities, special projects, and new opportunities.

LifeSmarts announces ‘Year of Health and Safety’ for national consumer education / scholarship program – National Consumers League

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September 26, 2017

Contact: NCL Communications, Cindy Hoang, (202) 207-2832, cindyh@nclnet.org

Washington, DC–The 24th season of LifeSmarts, a national scholarship competition and educational program coordinated by the National Consumers League (NCL), kicked off earlier this month at LifeSmarts.org, where students learn about real-life consumer issues and compete to win prizes and scholarships. Today, NCL announced that the 2017-2018 LifeSmarts program year will be the “Year of Health and Safety,” with special emphasis on health-related curriculum and competitive opportunities, underwritten by a grant from McNeil Consumer Healthcare.

Today LifeSmarts is unveiling a new community service opportunity for high school students – the LifeSmarts OTC Medicine Safety Mentoring Project. LifeSmarts provides materials and curriculum, bolstered by educational resources produced by Scholastic, to enlist high school students to become mentors for middle school students to help them understand the wise use and safe storage of over-the-counter medicines.

“We are so excited to declare 2017-18 the ‘Year of Health and Safety,’” said national Program Director Lisa Hertzberg. “We know LifeSmarts gives students the skills they need to succeed as adults, and we see students applying what they learn immediately at home and in their communities. We are thrilled to be able to give special focus to this year on health and safety lessons and look forward to rolling out new resources for teachers and opportunities for student participants.”

Besides health and safety, LifeSmarts focuses on four other main content areas: consumer rights and responsibilities, personal finance, technology, and the environment. Students are quizzed on their knowledge of these subject areas during online competition. Top-performing teams then advance to statewide competitions, and state champion teams advance to the national championship held each year in a different American city. The 2018 National LifeSmarts Championship will take place April 21-24 in San Diego. Winning teams receive scholarships and other prizes.

Last year, students answered more than 3.5 million consumer questions about credit reports, recycling, nutrition, social media, state lemon laws, and everything in between. More than 100,000 students are expected to participate in the program in the 2017-18 season. LifeSmarts is active in all states and the District of Columbia, where NCL is headquartered.

“We are excited to have the opportunity to focus on health and safety for consumers at this age, when they are beginning to make decisions for themselves and influencing decisions made by their parents,” said Sally Greenberg, executive director of NCL. “Too often, traditional high school curriculum fails to teach students vital information to become successful adults, and LifeSmarts helps to close that gap.” 

“Johnson & Johnson Consumer Inc. is proud to be a long-standing supporter of the LifeSmarts program and thrilled about the OTC Medicine Safety Mentoring project. As a manufacturer of over-the-counter medicines, Johnson & Johnson Consumer Inc. believes that the LifeSmarts OTC Medicine Safety Mentoring Project can help instill a healthy respect for all medicines in adolescents by teaching core concepts on the responsible use and safe storage of medicines. In doing so, we are building a healthier future for our adolescents, and helping to prevent medicine misuse, errors, and adverse events,” said Ed Kuffner M.D., Chief Medical Officer, Johnson & Johnson Consumer.

In addition to hosting the official LifeSmarts competition, LifeSmarts.org provides resources for teachers to supplement existing lesson plans. These include daily quizzes, educational videos, social media competitions, focused study guides, and scholarship opportunities. LifeSmarts lessons closely align with courses taught in family and consumer sciences, business, technology, health, and vocational education.

Visit LifeSmarts.org for more information.

LifeSmarts: Learn it. Live it.

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About LifeSmarts

LifeSmarts is a program of the National Consumers League. State coordinators run the programs on a volunteer basis. For more information, visit: LifeSmarts.org, email lifesmarts@nclnet.org, or call the National Consumers League’s communications department at 202-835-3323.

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

NCL urges the Senate to reject the Graham-Cassidy bill – National Consumers League

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September 25, 2017

Contact: Cindy Hoang, (202) 207-2832, cindyh@nclnet.org

Washington, DC—The National Consumers League (NCL), which has been working to support health care for all Americans since our founding in 1899, is strongly opposed to the Graham-Cassidy bill to repeal and replace the Affordable Care Act (ACA). Like previous repeal bills rejected by the Senate, this proposed legislation will take health coverage away from an estimated 32 million Americans and decimate our health care system as we know it.

Graham-Cassidy is even more harmful than previous ACA repeal and replace bills. Provisions of the bill include the elimination of cost-sharing reductions that help low-income Americans pay for their coverage, and waivers of key consumer safeguards such as the essential health benefits, minimum coverage requirements, and the non-discrimination clause protecting Americans with pre-existing conditions.

Perhaps most egregious are the massive cuts to Medicaid, which covers 70 million Americans. Medicaid expansion is abruptly nixed, leaving millions of vulnerable patients and consumers without coverage. The shift to a per-capita cap will undoubtedly burden states with a huge financial liability, forcing them to choose between raising taxes to meet funding needs, cutting funding from critical programs such as infrastructure or education, or imposing devastating cuts to Medicaid eligibility, benefits, and coverage for millions. 

The Graham-Cassidy bill also represents yet another attempt to railroad legislation through Congress, absent bipartisanship and public discourse. A bill that would fundamentally change our health care system and affect one-sixth of our economy deserves transparency, and more than a few weeks of debate. NCL agrees with Senator John McCain’s opposition to the bill and his acknowledgment that “we could do better working together, Republicans and Democrats, and have not yet really tried.”  Truer words were never spoken. 

NCL joins with Senator McCain in urging the Senate to reject the Graham-Cassidy bill and instead explore bipartisan solutions to strengthen our healthcare system, and particularly support the constructive and bipartisan dialogue led by Chairman Lamar Alexander and Ranking Member Patty Murray in the Senate Health, Education, Labor, and Pensions Committee aimed at stabilizing the insurance market. We will continue to stand alongside our colleagues in the public health and patient advocacy communities to protect access to quality and affordable health care for every American.

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

 

NCL encouraged by FDA Commissioner Gottlieb’s comments on Alzheimer’s Disease guidance development – National Consumers League

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In August 2017, the National Consumers League, WomenAgainstAlzheimer’s, AARP, National Association of Nurse Practitioners in Women’s Health, and several other women’s health advocacy organizations met with Dr. Janet Woodcock, FDA’s Director of the Center for Drug Evaluation and Research (CDER), to discuss treatments for Alzheimer’s Disease (AD). 

 

We requested this meeting because of concerns about Alzheimer’s disproportionately affecting women, with two-thirds of the patients diagnosed and the vast majority of caregivers being female, and the unfortunate fact that no new treatments for this terrible disease have been developed and approved in the past 15 years.   

The group discussed the need for updating the agency’s Guidance on AD, and Dr. Woodcock indicated that this Guidance would be a good candidate for review. We were pleased that FDA Commissioner Scott Gottlieb, speaking at the September 13, 2017 Blueprint for Breakthroughs meeting sponsored by Friends of Cancer Research (FOCR) and Alexandria Real Estate Equities, confirmed the agency’s intent to revise the Guidance on AD.   

As reported in The Pink Sheet, the FDA Commissioner made the following observations at the FOCR meeting: 

  • We don’t have as many disease-specific guidelines as you would expect on the new drug side.
  • The FDA is planning a revised guidance on Alzheimer’s drug development, part of a broader reform of the Office of New Drugs (OND).
  • The OND development is being spearheaded by Center for Drug Evaluation and Research Director Dr. Janet Woodcock.  As Acting Director of OND, Dr. Woodcock is moving to implement policy and structural changes for OND, including re-evaluating the division-by-division staffing model to determine whether staff can be trained to move between review divisions as needs arise.  Dr. Woodcock has cited the need for more policy development, including guidance documents, to ensure that product sponsors receive the most up-to-date advice.
  • As part of the OND revamp, Gottlieb said, “we want to develop more time for reviewers to work on specific guidance documents that will help address certain aspects of the review process where we think that the science has evolved to a point where we want to create more modern standards.” 
  • The disease-specific guidance writing effort is an attempt to go back and look at diseases where there hasn’t been a lot of innovation in different aspects of clinical development, where the FDA  hasn’t articulated principles, with the forthcoming documents addressing issues such as use of different trial designs and endpoints. 
  • The guidance-writing initiative is intended to articulate modern evidentiary and clinical trial design expectations in specific disease areas where the science has evolved. 
  • The goal, Gottlieb said, is to “create more incentives for people to try to attack these unmet medical needs because we have clear direction that they can shoot against.”
  • Gottlieb explained: The new Alzheimer’s guidance will “look at some of the new modalities and points that could become maybe not a primary endpoint, but perhaps secondary and tertiary endpoints, or how you look at cognitive function versus performance as different endpoints. Those are now dual endpoints in a lot of clinical studies.”  With the guidance writing effort, “there’s going to be some things that we’re going to update because the science has changed.  In most cases, we’re doing these things anyway now in terms of how we’re thinking about these different therapeutic areas, but we just haven’t had the opportunity to articulate the standards in guidance, and that’s what this exercise is for.”

Our coalition is very appreciative of Dr. Woodcock’s time and accessibility for discussion of these issues. Her leadership is renowned. We also appreciate FDA Commissioner Gottlieb’s commitment to developing Guidances to ensure more clarity and direction as the medical and scientific community works to develop safe, effective, and affordable treatments for diseases like Alzheimer’s and so many others.