WASHINGTON, D.C. — Today, just before the Memorial Day holiday that has traditionally kicked off the start of the summer beach and pool season, Senators Chris Dodd (D-CT) and Jack Reed (D-RI) sent a letter to U.S. Food and Drug Administration Commissioner Margaret Hamburg inquiring into the delay of a “meaningful, enforceable standard for sunscreen protection that includes both UVA and UVB protection.”
“At long last, the agency made an important step in 2007 when it released the proposed rule for sunscreen products. But too many questions have still not been answered – Why hasn’t the agency finalized this rule? What is the specific timetable for finalizing this rule? How long after the rule is finalized will consumers be able to purchase sunscreen products that meet the new standard for protection? ” Dodd and Reed wrote.
“Millions of Americans purchase and use over-the-counter sunscreen products every year thinking they are being protected from harmful UVA and UVB rays. In the time the agency has been considering a standard for UVA protection in sunscreen, the incidence of skin cancer has been on the rise,” the senators continued. “All Americans deserve equal access to clear, accurate and comprehensive sunscreen labeling, which includes informing them about UVA and UVB protection, as their first line of defense against skin cancer.”
In 2009, Dodd and Reed introduced legislation, the SUN Act, to help Americans better protect themselves from the sun’s harmful rays. The SUN Act would require the Food and Drug Administration (FDA) to strengthen labeling and testing standards for sunscreen products. Currently, FDA standards require that sunscreen protect against UVB rays, known for causing sunburns and increasing the chance of skin cancer. However, they do not require protection against UVA rays, which are a major cause of skin cancer and premature aging.
Dodd and Reed’s full letter to Commissioner Hamburg is below.
May 28, 2010
Margaret A. Hamburg, M.D.
Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Dear Dr. Hamburg:
As we head into another summer, we are writing to inquire about the status of the Food and Drug Administration (FDA)’s progress toward finalizing comprehensive labeling for sunscreen products that includes protection from UVA and UVB radiation. It has now been nearly three years since the FDA issued the proposed rule entitled Sunscreen Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph (72 Fed. Reg. 49070) and still Americans lack a meaningful, enforceable standard for sunscreen protection that includes both UVA and UVB protection. This year, there is a new sense of urgency to our inquiry since recent reports found that some sunscreen products may actually speed the onset of skin cancer.
As we have discussed with you on previous occasions, we are deeply concerned with how long it has taken the FDA to finalize a comprehensive standard for labeling, which the agency has reportedly been working on now for more than 30 years. At long last, the agency made an important step in 2007 when it released the proposed rule for sunscreen products. But too many questions have still not been answered – Why hasn’t the agency finalized this rule? What is the specific timetable for finalizing this rule? How long after the rule is finalized will consumers be able to purchase sunscreen products that meet the new standard for protection? Lastly, there has been a lot of attention paid to sunscreen products this week, especially in light of news that the use of vitamin A or its derivatives in sunscreen products may actually speed the onset of cancer. What is the agency doing to inform consumers that the products they are buying may not offer the level of protection advertised in the labeling or marketing materials?
In the past we have been told that a reason for the delay in finalizing the proposed rule is due to the number of written comments the agency received. How many comments did the agency receive? How does that compare to comments received for other proposed rules for over-the-counter products? How does the FDA’s timeline for responding to comments to this proposed rule compare to its response time for other proposed rules?
Millions of Americans purchase and use over-the-counter sunscreen products every year thinking they are being protected from harmful UVA and UVB rays. In the time the agency has been considering a standard for UVA protection in sunscreen, the incidence of skin cancer has been on the rise. In 2010, about 68,720 Americans will be diagnosed with melanoma, the most serious and most common form of skin cancer. This year alone, an estimated 11,590 Americans will die from skin cancer, 8,650 from melanoma and 2,940 from other non-epithelial skin cancers. As we head into Memorial Day weekend, the unofficial start of the summer season, it is even more important that consumers are educated about and protected from UVA rays that are as harmful, if not more harmful, than UVB rays.
All Americans deserve equal access to clear, accurate and comprehensive sunscreen labeling, which includes informing them about UVA and UVB protection, as their first line of defense against skin cancer. We look forward to hearing from you with information about when this proposed rule will be finalized and when consumers will be able to purchase sunscreen products
with the knowledge that they meet FDA’s enforceable standard.
Thank you for your consideration and we look forward to your reply.
Senator Chris Dodd (D-CT) has announced that individuals and households residing in Fairfield, New Haven, New London, Middlesex, and Windham counties that were affected by storms and heavy flooding in March, April and May are now eligible to apply for federal disaster assistance through the Federal Emergency Management Agency (FEMA).
“The heavy storms that struck our state in recent months have caused millions of dollars in damages not just to Connecticut’s highways, bridges and roads, but to people’s homes and belongings,” said Dodd. “Now, Connecticut residents will be able to apply for this vital federal funding that will help them make critical repairs to their houses and personal property. I encourage all those who were affected by the spring’s severe weather to apply as soon as possible by calling 800-621-3362 or logging onto DisasterAssistance.gov to file a claim.”
Last month, President Obama issued a major disaster declaration for the State of Connecticut, triggering the release of federal funds to help communities recover from severe storms that struck the area between March 12 and May 17. That disaster declaration was amended today to include individuals and households in the five previously listed counties. According to FEMA, constituents with disaster-related damages can apply for federal assistance by calling (800) 621-3362, TTY (800) 462-7585 for people with speech or hearing disabilities, or online at http://www.disasterassistance.gov.
Congresswoman Rosa L. DeLauro (CT-3) and Congressman Michael C. Burgess, M.D. (TX-26) introduced the Birth Defects Prevention, Risk Reduction, and Awareness Act of 2010 today, which will help provide accurate, evidence-based information to pregnant and breast-feeding women about medications, chemical exposures, foodborne illness and other exposures associated with birth defects or health risks to a breastfed infant.
Women who are pregnant or breast-feeding often have difficult questions, such as if they should continue taking medications for chronic diseases, or whether they should get vaccinated against H1N1 or the seasonal flu. The bill would establish a grant program to revitalize the national network of pregnancy risk information services (PRISs), more than half of which have closed over the last decade due to lack of funding. Over 70,000 women seek information from these essential services each year.
The legislation, which has been endorsed by the American Academy of Pediatrics, March of Dimes, the Organization of Teratology Information Specialists, Spina Bifida Association, American Academy of Allergy, Asthma and Immunology, and Allergy and Asthma Network/Mothers of Asthmatics, would also call for a national information campaign to help increase public awareness among health providers and at-risk populations.
“There is nothing more important than protecting our children, and this legislation will help expectant and breast-feeding mothers to obtain clear, accurate information about the potential risks of medications, illnesses, and other exposures during pregnancy and breastfeeding, helping them to both avoid risks and improve healthy behaviors like taking folic acid,” said Congresswoman DeLauro. “Unfortunately, research shows that up to half of pregnant women are not counseled by their health care providers about the potential risks of medications they may be taking, and programs to provide this information have been closing due to state and local budget cuts. This legislation will finally help mothers and health care professionals access critical information to help them ensure their babies are healthy, and I urge my colleagues to support our efforts.”
“During my 25-year medical practice as an obstetrician, I saw far too many expectant mothers and newborn babies affected negatively by a simple lack of education and information. It is so important that expectant mothers have all the information necessary, in consultation with their doctors, about how to ensure a safe and health pregnancy for both the woman and the child. This includes knowing if the medications the woman is taking are safe for the unborn baby, illnesses the mother may have come into contact with, and other factors that may pose a risk of birth defects,” said Congressman Michael C. Burgess, M.D. “Many of the issues that arise from this lack of information are preventable, so we must make sure pregnant women have access to services and education to ensure a healthy pregnancy and a healthy baby.”
Former Citizen’s Ethics Advisory Board (CEAB) Chairman G. Kenneth Bernhard, of Westport, CT, agreed to pay a $3,500 penalty for making three political contributions while serving as a CEAB member.
According to the attached complaint filed along with the consent order, from January 2008 to March 2010, Bernhard was a member of the Citizen’s Ethics Advisory Board, and therefore a public official under the Code of Ethics. In May and October of 2008, Bernhard made three political contributions. Two of these political contributions were to individuals who ran for state office in Connecticut. One of these political contributions was to Governor Rell’s exploratory committee. The amount of all three contributions combined totaled $250.
Connecticut law prohibits members of the CEAB as well as OSE employees from making a political contribution to any person subject to the Code of Ethics.
Bernhard settled without admission of guilt and states in the attached consent order that he had no knowledge that the contributions, made in his private capacity, might constitute a violation of the Ethics Code. He further states in the order that he received no personal gain from making the contributions. He resigned as a member of the CEAB on March 4, 2010.
The Office of State Ethics was represented through the process by Special Ethics Enforcement Officer Jill Hartley, a Hartford attorney, to preserve the impartiality of the investigation and resolution of this matter.
Under the American Recovery and Reinvestment Act of 2009 (ARRA), also known as the economic stimulus package, certain recipients of funds appropriated in ARRA (most grant and loan recipients, contractors, and subcontractors) are required to report the number of jobs they created or retained with ARRA funding after the end of each calendar quarter. The law also requires the Congressional Budget Office (CBO) to comment on those reported numbers. The CBO released a report to satisfy that requirement.
CBO’s Estimates of ARRA’s Impact on Employment and Economic Output
Looking at recorded spending to date as well as estimates of the other effects of ARRA on spending and revenues, CBO has estimated the law’s impact on employment and economic output using evidence about the effects of previous similar policies on the economy and using various mathematical models that represent the workings of the economy. On that basis, CBO estimates that in the first quarter of calendar year 2010, ARRA’s policies:
* Raised the level of real (inflation-adjusted) gross domestic product (GDP) by between 1.7 percent and 4.2 percent,
* Lowered the unemployment rate by between 0.7 percentage points and 1.5 percentage points,
* Increased the number of people employed by between 1.2 million and 2.8 million, and
* Increased the number of full-time-equivalent (FTE) jobs by 1.8 million to 4.1 million compared with what those amounts would have been otherwise. (Increases in FTE jobs include shifts from part-time to full-time work or overtime and are thus generally larger than increases in the number of employed workers.)
The effects of ARRA on output and employment are expected to increase further during calendar year 2010 but then diminish in 2011 and fade away by the end of 2012.
Safety Advocates Call on Congress to Pass Unfinished Highway and Auto Safety Agenda
Advocates for Highway and Auto Safety (Advocates) today released a new report showing that federal and state auto safety laws enacted over the past 20 years have saved over 85,000 lives and over $600 billion in costs. The auto safety group used the report, Advocacy for Safe Cars, Safe Driving and Safe Roads: 20 Years of Saving Lives and Reducing Costs from Traffic Crashes, to call on Congress to enact additional safety measures to reduce fatalities and bring costs down even further. The report was released at a news conference at the National Press Club and included participation by U.S. Secretary of Transportation Ray LaHood, business and government leaders, and individuals affected by car crashes.
“These dramatic findings, tens of thousands of American lives and hundreds of billions of U.S. dollars saved, serve to underscore the need to act and act now,” said Judith Lee Stone, president of Advocates. “We can’t rest until America’s roadways are as safe as the skies.”
The report, authored by Dr. Ted Miller at the Pacific Institute for Research and Evaluation, reviews a sample of federal and state laws enacted over the last 20 years with help from Advocates, and their impact on the reduction of highway deaths and injuries and mitigation of crash costs. Among the laws reviewed are airbags, primary enforcement of seat belts, booster seats, motorcycle helmets, .08 maximum Blood Alcohol Concentration (BAC) and graduated teen licensing requirements.
The report also describes several legislative and regulatory initiatives in the past 20 years that have resulted in life and cost savings, such as electronic stability control (reduces single vehicle fatal crashes by 56%), side impact (estimated $567 million annual benefit), and reflective tape for better visibility of large trucks at night (8,000 side and rear underride crashes prevented annually).
“Motor vehicle crashes are one of the most devastating public health problems our society has ever faced,” said Joan Claybrook, President Emeritus of Public Citizen and an Advocates Board Member. “When tens of thousands of people die every year and millions are injured in car and truck crashes, we have run out of excuses for not fixing the problem immediately.”
In recent years, an average of 5.8 million crashes has occurred on our nation’s highways each year resulting in almost 40,000 fatalities and 2.3 million injuries, at a cost to society of an estimated $230 billion per year. Every day 102 people are killed on America’s streets and highways, while more than 6,000 are injured, according to federal government statistics.
Bill Martin, Sr. Vice President of Farmers Insurance and an Advocates Board Member said, “Loss prevention is what we in the insurance community and the highway safety community, are all about. But we also have a moral responsibility to take aggressive action whenever and wherever possible to stem the decades-long tide of motor vehicle crash deaths and injuries that occur throughout the nation.”
Advocates’ unfinished auto and highway safety agenda includes the following:
• Close the gaps in state highway safety laws, making sure that every state enacts Advocates’ 15 basic laws (better seat belt use enforcement, all-rider motorcycle helmet laws, child booster seat laws, comprehensive graduated driver licensing (GDL) laws for teens, and impaired and distracted driving reforms);
• Improve teen driver safety by enacting the Safe Teen and Novice Driver Uniform Protection Act (STANDUP Act) setting minimum standards for all state GDL laws;
• Require DOT action on vehicle safety standards including vehicle crash compatibility, rollover crash dynamic test, better protection for pedestrians and children and improved seat belts;
• Provide safer interstate motorcoach transportation by enacting the Motorcoach Enhanced Safety Act ;
• Assure highway reauthorization legislation promotes tougher seat belt and impaired driving laws, and electronic on-board recorders on trucks and buses;
• Prevent distracted driving by enacting the Distracted Driver Prevention Act of 2009 and the Avoiding Life-Endangering and Reckless Texting by Drivers Act, to promote state laws that prohibit text messaging and restrict cell phone use;
• Enhance consumer protection by enacting the Motor Vehicle Safety Act of 2010 and a House companion measure, to address sudden unintended vehicle acceleration and strengthen the federal government’s ability to identify and address vehicle defects. Also enact the Consumer Auto Safety Enhancement Act of 2010 to improve collection of defect information and ensure privacy;
• Promote highway safety and infrastructure investment by enacting the Safe Highways and Infrastructure Preservation Act which will freeze the size and weight of large trucks on the National Highway System;
• Require new vehicle safety standards to protect children by enhancing rearward visibility, and preventing power windows from causing death or injury;
• Issue safer regulations for truck drivers to reduce fatigue and require behind-the-wheel training for new drivers; and
• Achieve long-term, significant, and sustained reductions in highway deaths and injuries.
Illinois State Senate President John Cullerton, sponsor of his state’s strong teen driving laws, said the enactment of the STANDUP Act in Congress would be helpful in those states which have not progressed sufficiently in adopting key GDL laws. “So we need to pass STANDUP, then stand back and watch all the states fall into line with excellent GDL laws,” he said. “We owe it to our children, their children, and everyone who gets behind the wheel of a car from now on. This is what I was elected to do.”
Terri Vaccher and her son Dominic from Fullerton, CA spoke at the National Press Club news conference. Ms. Vaccher survived a 1997 collision with a semi truck that pushed her SUV underneath the tractor trailer when she was eight months pregnant with Dominic. She and her baby were saved by the airbag. “It has been thirteen years since that terrible day, thirteen years since an airbag made all the difference between life and death for me and my son,” said Vaccher. “I think of that day so often, and I stand here today because so many in this room fought to make airbags standard equipment in all cars.”
Montgomery County (Maryland) Police Captain Tom Didone spoke of the crash in 2008 in which his 15-year-old son Ryan was killed in a crash with a high school classmate as the driver. Captain Didone has spent most of his career in traffic law enforcement and is now an advocate for federal teen licensing restrictions. “I know what a combustible situation it can be when you add newly-licensed teen drivers, and their passengers together,” said Captain Didone. “And, I know too what it is like to lose a child. Education and enforcement are key, but strong, uniform teen driving laws are the first step toward preventing crashes and saving lives.” Didone made a plea for Congress to pass HR 1895 and S.3269, the STANDUP Act.
Another business leader participating in the report release today was Alan Maness, Associate General Counsel, State Farm Insurance Companies who said, “We look forward to future safety victories to further improve vehicle safety design, reduce drunk and distracted driving and enhance roadway safety design.”
New Provisions Ensure Greater Transparency and More Robust Treatment Coverage
Anthem Blue Cross and Blue Shield, and its parent company, announced today it will unilaterally implement key provisions of the Breast Cancer Patient Protection Act introduced by U.S. Representative Rosa DeLauro. These new provisions include more transparent benefit language including clear explanations of benefits to members with breast cancer, and the provisions standardize minimum recovery times in the hospital for women recovering from mastectomy.
The adoption of these provisions builds on Anthem’s existing leadership in breast cancer treatment. While variability exists within clinical guidelines and state regulations, the vast majority of Anthem’s members already receive the standard of care indicated in the legislation. However, Anthem believes that applying this universal minimum standard will both benefit our members, as well as encourage others in the industry to follow and adopt this standard. Beginning July 1, 2010, Anthem will standardize clinical guidelines for women recovering from mastectomy to offer a voluntary 48-hour minimum in-hospital stay.
“Women recovering from breast cancer surgery, in consultation with their physicians, will decide whether hospitalization for 48 hours is required,” said Eina G. Fishman, MD, MS, CPE, Anthem Blue Cross and Blue Shield Medical Director. “We are committed to making medical coverage decisions for women with breast cancer that are in accord with the latest scientific evidence and clinical research. It’s important for us and our members that we continue to lead in this area,” she added.
“We continue to work with the American Cancer Society and academic thought leaders to gain real-world knowledge of breast cancer treatments to shape improvements in care for women with breast cancer,” said Fishman. “Our goal is to ensure that our members receive optimal care.”
Anthem also champions effective member communication and transparency regarding breast cancer diagnosis and treatment options. More than 3,000 nurses and clinical associates nationwide work with members daily, to encourage detection of breast cancer at its earliest stages and to ensure that members are receiving the best breast cancer treatments available. Toward that end, Anthem is taking steps to provide comprehensible, straight-forward explanations of benefits so that members more clearly understand their treatment options.
“I am proud of Anthem’s record in improving care for women with breast cancer in this state. Connecticut was a leader by being one of the first states to enact legislation in 1997 providing this benefit for women with breast cancer,” said David R. Fusco, president, Anthem Blue Cross and Blue Shield. “We commend Representative DeLauro and her fight to take the protection afforded to Connecticut residences to the rest of the nation.”
Sec. Gates: “I firmly believe that the interests of the taxpayers, our military, and the JSF program are best served by not pursuing an extra engine.”
Secretary of Defense Robert Gates reiterated his position against the F-35 extra engine program, calling it wasteful and unneeded in a letter to Congressman John B. Larson (CT-01). He wrote that he will advise President Obama to veto any legislation containing further funding to the program.
Secretary Gates wrote the following in his letter to Congressman Larson:
“I firmly believe that the interests of the taxpayers, our military, and the JSF program are best served by not pursuing an extra engine. Despite the continued opposition by the DoD (Department of Defense) under two Administrations, Congress has provided $1.3 billion in unrequested additional funding for continued development of this program. We have reached a critical point in this debate where spending more money on an extra engine simply makes no sense and diverts limited modernization funds from more pressing DOD priorities.
“Given the many pressing needs facing our military and the fiscal challenges facing our country, we cannot afford a business as usual approach to the defense budget. Tough choices must be made -by both the department and Congress -to ensure that current and future military capabilities can be sustained over time. This means programs and initiatives of marginal or no benefit -like the F136 engine -are unaffordable luxuries.
“Accordingly, as I have stated repeatedly, I will strongly recommend that the President veto any legislation that contains funding for an extra JSF an unneeded engine.”
The letter by Secretary Gates is in response to a letter written by Congressman Larson on May 21st 2010. In his letter, Congressman Larson asked that Secretary Gates provide his position on issues concerning the extra engine program, including whether to continue funding the program.
Congressman Larson stated,
“President Obama, Secretary Gates, and I are all of like minds when it comes to this issue. This letter proves that Secretary Gates is committed to ending this misguided program. In a time in which we are facing two wars and a budget deficit, we must make tough choices to reduce the waste in our spending. The Department of Defense has fully vetted the information, and has determined that the extra engine program is a prime example of wasteful spending that will not serve the best interests of our military or taxpayers. I am proud to call Secretary Gates a partner in this fight.”
Congressman Larson is leading the fight to end the F-35 extra engine. The House of Representatives is expected to vote on the Department of Defense authorization bill on Thursday.
