Epidemic of Skin Cancer Threatens Americans this Summer.

sun

May is Melanoma Awareness Month

WASHINGTON, DC – With more than 2 million cases of skin cancer diagnosed each year, U.S. Senator Kelly Ayotte (R-NH) announced  that she is cosponsoring the Sunscreen Innovation Act – bipartisan legislation that aims to streamline the approval process to bring safe and effective sunscreens to consumers as quickly as possible. The bill seeks to break a logjam at the Food and Drug Administration (FDA), where some sunscreen ingredients that are widely used in foreign markets – such as Canada and Europe – have been stuck in the approval process for 12 years.

“The fight against skin cancer starts with using the best available sunscreen, and this bipartisan legislation will help ensure that Americans have access to the highest quality sunscreen products,” said Senator Ayotte. “As we observe national Melanoma Awareness Month, Congress should take up and pass this commonsense bill right away. There’s no reason why bureaucratic federal regulations should prevent safe and effective products from reaching the marketplace.”

Ingredients in over-the-counter sunscreens must be approved by the FDA, which hasn’t added to its list of approved sunscreen ingredients since 1999 – even though sunscreen with new ingredients has been available in foreign markets including Europe, Canada, Asia and South America for 15 years.

The Sunscreen Innovation Act aims to ensure that sunscreen ingredients going through the FDA approval process receive a transparent review within a predictable timeframe – 11 months or less, depending on whether it is a new or existing submission. As it stands now, there is no mandatory timeline for this process. Existing FDA eligibility requirements would be maintained – an ingredient must be used extensively and safely for at least five years in at least one country.

The Sunscreen Innovation Act (S. 2141) was introduced in the Senate by Senator Jack Reed (D-RI) and Senator Johnny Isakson (R-GA). Companion legislation (H.R. 4250) was introduced in the House by Congressman Ed Whitfield (R-KY) and Congressman John Dingell (D-MI).

The legislation is supported by: the American Cancer Society Cancer Action Network, the Melanoma Research Foundation, the Prevent Cancer Foundation, and the Skin Cancer Foundation.

coppertone

 

Senate Acts Quickly on Nicotine Poisoning Threat Posed by E-Cigarettes.

The technology may be safe; but the poison it delivers is still deadly.
The technology may be safe; but the poison it delivers is still deadly.
Call Follows New York Times Report on Dramatic Rise in Accidental Nicotine Poisonings

Washington, D.C. – In light of mounting evidence that the emerging market of new nicotine delivery products poses serious public health and consumer protection issues, six U.S. Senators have called on the Food and Drug Administration (FDA) to move quickly to regulate the rapidly evolving market of e-cigarettes and other nicotine products saying: “It’s time for the FDA to stop the sale of these candy-flavored poisons to our children.”

U.S. Senators Barbara Boxer (D-CA), Dick Durbin (D-IL), Tom Harkin (D-IA), Richard Blumenthal (D-CT), Ed Markey (D-MA), Jack Reed (D-RI) and Jeff Merkley (D-OR) signed on to today’s letter.

New York Times report found a dramatic increase in accidental nicotine poisonings, notably among children. The article cited the National Poison Data Systems which recorded 1,351 accidental nicotine poisonings from electronic devices in 2013 – a 300% increase from 2012. Of the cases in 2013, 365 were referred to hospitals, triple the previous year’s number. In addition to health risk posed by the nicotine in these products, the New York Times article cites quality control and manufacturing dangers.

“Yesterday’s New York Times describes the dangerous emergence of liquid nicotine products, raising serious public health and consumer protection concerns about the rapidly evolving market for new and unregulated nicotine delivery products,” the Senators wrote. “These nicotine products are readily available in stores and online, where they can be sold to youth and adults who do not understand the associated health risks…As the [FDA] asserts regulatory authority over tobacco products, it is critical that the agency’s regulatory oversight keeps pace with these new nicotine delivery products.”

Electronic cigarettes, also called e-cigarettes and e-cigs, are battery-operated products that simulate traditional cigarettes by converting cartridges of liquid typically filled with addictive nicotine, other additives, and flavorings into vapor inhaled by the user. Currently, e-cigarettes, nicotine liquids, and nicotine dissolvable products are not subject to federal laws and regulations that apply to traditional cigarettes, including a ban on marketing to youth. Unlike traditional tobacco products, these nicotine products can be legally sold to children and are not subject to age verification laws.

The Senators wrote, “In spite of the growing popularity of nicotine delivery products, decades of research shows that exposure to nicotine increases risk of addiction and has adverse health consequences. Unlike traditional cigarettes and tobacco products, these novel nicotine products are not subject to federal regulations that prohibit sale to minors, restrict marketing to youth, ban products in candy and fruit flavors, and regulate manufacturing practices and ingredients. In the absence of federal oversight, these products are taking advantage of the regulatory vacuum to market nicotine products to youth and risk addicting a new generation to nicotine.”

Last month, Durbin, Harkin, Boxer, Blumenthal and Markey introduced the Protecting Children from Electronic Cigarette Advertising Act which would prohibit the marketing of e-cigarettes to children and teens. Despite claims from some e-cigarette makers that they do not market their products to children, e-cigarette manufacturers have adopted marketing practices similar to those long used by the tobacco industry to market regular cigarettes to youth – including flavoring their products in candy or fruit flavors that appeal to children, and sponsoring youth-oriented concerts and sporting events in order to market their products to teens.

The Protecting Children from Electronic Cigarette Advertising Act would permit the Federal Trade Commission (FTC) to determine what constitutes marketing e-cigarettes to children, and would allow the FTC to work with states attorneys general to enforce the ban.

According to the National Youth Tobacco Survey, 1.8 million middle and high school students said they tried e-cigarettes in 2012, and a study released by the Centers for Disease Control and Prevention found that the percentage of high school students who had tried them had more than doubled in just one year – indicating that e-cigarette companies could be targeting youth through advertisements. More than 76 percent of those users said they also smoked conventional cigarettes, suggesting that for many young people, e-cigarettes could be a gateway to nicotine addiction and smoking of conventional cigarettes.

In December, Senators Boxer, Durbin, Blumenthal, Harkin, Markey, and U.S. Senator Sherrod Brown (D-OH)sent a letter urging the FTC to investigate the marketing practices of e-cigarette manufacturers.

Text of today’s letter is below:

March 29, 2014

The Honorable Margaret Hamburg
Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Dear Commissioner Hamburg:

Yesterday’s New York Times describes the dangerous emergence of liquid nicotine products, raising serious public health and consumer protection concerns about the rapidly evolving market for new and unregulated nicotine delivery products. As the Food and Drug Administration (FDA) asserts regulatory authority over tobacco products, it is critical that the agency’s regulatory oversight keeps pace with these new nicotine delivery products.

As a result of the Family Smoking Prevention and Tobacco Control Act of 2009, the FDA has made commendable efforts to enhance the regulation of cigarettes and smokeless tobacco products. However, over the years we have seen the emergence of new nicotine products, such as e-cigarettes, hookah pens, dissolvable nicotine orbs and strips, and liquid nicotine products, also called e-liquids, which are marketed to appeal to children with bright colors and flavors like cherry and bubble gum. Unlike traditional cigarettes and tobacco products, these novel nicotine products are not subject to federal regulations that prohibit sale to minors, restrict marketing to youth, ban products in candy and fruit flavors, and regulate manufacturing practices and ingredients. In the absence of federal oversight, these products are taking advantage of the regulatory vacuum to market nicotine products to youth and risk addicting a new generation to nicotine.

In spite of the growing popularity of nicotine delivery products, decades of research shows that exposure to nicotine increases risk of addiction and has adverse health consequences. The 1988 U.S. Surgeon General’s Report, The Health Consequences of Smoking: Nicotine Addiction, states that “nicotine is a psychoactive drug with actions that reinforce the use of tobacco…and that causes addiction.” The report goes on to say that, “the pharmacologic and behavioral processes that determine tobacco addiction are similar to those that determine addiction to drugs such as heroin and cocaine.” Furthermore, nicotine exposure during adolescence can have important health consequences. The 2014 Surgeon General Report found that nicotine exposure during adolescence, a critical window for brain development, may have lasting adverse consequences.

These nicotine products are readily available in stores and online, where they can be sold to youth and adults who do not understand the associated health risks. The New York Times article reports that, “accidental poisonings, notably among children, are soaring.” According to National Poison Data Systems, accidental e-liquid poisonings in the U.S. have skyrocketed “to 1,351 in 2013, a 300 percent increase from 2012…. Of the cases in 2013, 365 were referred to hospitals, triple the previous year’s number.” According to Dr. Lee Cantrell, Director of the San Diego Division of the California Poison Control, the dose of nicotine in some e-liquids is lethal enough to kill, “Not just a kid. One tablespoon could kill an adult.”

In addition to health risk posed by the nicotine in these products, the New York Times article cites quality control and manufacturing dangers. The article reports that, “[e-liquids] are mixed on factory floors and in back room shops.” These concerns are supported by a 2009 analysis FDA conducted on a sample of e-cigarettes. The analysis found significant quality control issues, such as the presence of carcinogens and toxic chemicals, including diethylene glycol, an ingredient commonly found in antifreeze. FDA also found that different samples of the same product emitted markedly different nicotine levels, indicating that some manufacturers are using substandard or non-existent quality control measures. This analysis substantiates concerns regarding the safety of e-cigarettes, both for current users and for bystanders exposed to their vapor.

The emerging market of new nicotine delivery products raises serious public health and consumer protection concerns. It’s time for the FDA to stop the sale of these candy-flavored poisons to our children. We urge FDA to move quickly in developing a regulatory structure to minimize the harm to public health not only of traditional tobacco products, but also the rapidly evolving market of nicotine products.

Sincerely,

Richard J. Durbin
United States Senator

Tom Harkin
United States Senator

Barbara Boxer
United States Senator

Richard Blumenthal
United States Senator

Edward J Markey
United States Senator

Jeff Merkley
United States Senator

skull

Allegedly Defective Medical Device to be Subject of Senate Investigation.

Is the Myxo brand dangerous to heart patients?
Is the Myxo brand dangerous to heart patients?

WASHINGTON – Sen. Chuck Grassley of Iowa is asking Northwestern University for documents on a medical device implanted in patients for heart valve repair.  Grassley wrote to the university in 2008 and 2009 about the Myxo device over allegations that the device had not been cleared by the Food and Drug Administration (FDA) before it was implanted in patients as part of an outcomes study.

Since then, new allegations have come to light that Northwestern did not provide all of the documents to Grassley that were squarely within the scope of his request, and that Northwestern failed to provide any notice or explanation of why it was withholding certain documents.  In a letter this week to the presidents of Northwestern University and Northwestern Memorial Hospital, Grassley asks for the documents apparently withheld from him in response to his earlier inquiries.

The documents are important to reviewing whether Northwestern’s use of the devices was appropriate and whether notification to patients was adequate.

Grassley has a longstanding interest in FDA oversight and patient safety. 

The text of his letter is available here.

 

 

Federal Government Cover up: Whistleblowers Still Punished and Persecuted.

 

"I know nothing!"
“I know nothing!”

WASHINGTON –  House Oversight and Government Reform Committee Chairman Darrell Issa, R-Calif., and Senate Judiciary Committee Ranking Member Chuck Grassley, R-Iowa, released a joint report on the U.S. Food and Drug Administration (FDA)’s highly-invasive surveillance program that monitored employees who contacted Congress and the media with concerns about FDA’s medical device approval process.

In April 2010, the FDA initiated a surveillance program of unprecedented scope to monitor employees in the Center for Devices and Radiological Health.  The program allowed FDA managers to read communications between FDA employees and Congress, the U.S. Office of Special Counsel (OSC), and their personal attorneys.  The Joint Committee report, entitled “Limitless Surveillance at the FDA: Protecting the Rights of Federal Whistleblowers,” found the FDA acted without regard for employees’ whistleblower rights, which protect their communications to Congress and OSC.  The joint report also found that FDA conducted the program without adequate guidelines in place and made no effort to limit the scope of the program to exclude protected communications.

The Oversight Committee will hold a hearing on the FDA’s surveillance today at 10:00 a.m. in 2154 Rayburn House Office Building.

Key Findings:

•   Insufficient authorization and guidelines. The monitoring was implemented with insufficient written authorization, no policy in place and no legal guidance given to the contractors conducting the monitoring. As a result, FDA captured communications that are protected by law, including communications with Congress, the media, and watchdog groups like Project on Government Oversight.

•    Unlawful capturing of protected communications. Because no formal monitoring policy was in place, FDA managers did not understand the legal limits of employee monitoring. The FDA’s surveillance was not lawful, to the extent that it monitored communications with Congress and the Office of Special Counsel. Federal law protects disclosures to OSC and Congress.

•    Lack of explanation for capture of future communications. Instead of looking back at previous communications using available tools, the FDA captured real-time communications of current and future communications. When interviewed, FDA managers and IT professionals failed to explain clearly how the rationale offered to justify the monitoring (investigating a past leak) was consistent with the method used (monitoring current activity).

•    New policies do not offer sufficient whistleblower protections. In September 2013, the FDA issued interim policies that require written authorization prior to initiating employee monitoring. However, the policies do not offer sufficient protection for whistleblowers concerned about retaliation from agency officials.

 

Modern Rules for Modern Technology. By Senator Deb Fischer. Nebraska.

Sen. Deb Fischer. Nebraska.
Sen. Deb Fischer. Nebraska.

Almost forty years ago, few could have imagined how modern technology would change the way we live. Ground-breaking advancements have changed the way we do business, communicate with one another, and feed the world.
One rapidly-growing field is low-risk health information technology (health IT). These products, which pose little threat to human health, range from electronic health records and scheduling software to mobile wellness applications. Yet, they can greatly improve our quality of life.
Pioneers of low-risk health IT are engineering technologies that improve care, empower consumers with information, and save lives. Thanks to a $1.99 mobile app, an American basketball coach was able to download a refresher course on how to properly administer CPR. Thankfully, he was able to perform the procedure on a player who collapsed in practice the very next day.
In 2012, the Departments of Defense and Veterans Affairs partnered to release a free Apple and Android smartphone app called the Post-Traumatic Stress Disorder (PTSD) Coach. The app provides useful and reliable information on the disorder and its treatments. Since the app’s launch, it has been downloaded more than 100,000 times in 74 countries.
Yet, many of the current regulations governing these fields haven’t been appropriately updated to reflect modern developments. We need updated rules to help foster continued progress and ensure we stay competitive.
The current, overly broad definition of a medical device – written in 1976 – gives the Food and Drug Administration (FDA) authority to regulate a wide range of health information technologies entering the marketplace. The FDA claims it has discretion to regulate things like mobile wellness apps with the same rules it uses to review complex, invasive medical machines. This defies common sense.
As a result, many of the products posing little risk to human health fall victim to a long, costly regulatory process. This stalls progress and unnecessarily burdens inventors and entrepreneurs.
To address this problem, I teamed up with Senator Angus King (I-Maine) to introduce a bill that provides needed regulatory changes. Our legislation, the PROTECT Act of 2014, provides the industry certainty to promote innovation and encourage job creation all while protecting patient safety.
The PROTECT Act offers a more specific, risk-based framework for the FDA by drawing a line between low-risk and high-risk technologies. Our bill enables the FDA to focus its attention on devices that pose the greatest risk to human health. The agency’s work to protect people is important, and our bill makes sure that this oversight continues for dangerous medical devices.
Importantly, our legislation also cuts unnecessary red tape. Whenever I meet with business owners across Nebraska, I hear time and again that uncertainty, partly due to overregulation, remains an ongoing challenge. Lingering uncertainty holds back business expansion and prevents owners from hiring.
Health IT is a thriving sector of our economy. It is full of enormous growth potential, with opportunities for job creation. For example, the mobile health and mobile application market is expected to exceed $26 billion by 2017, and the mobile application economy is responsible for half a million new American jobs.
Congress should be working to help, not hinder, these successful job creators with pro-growth policies. The PROTECT Act provides regulatory certainty and gets government out of the way where it is not needed. Anyone with ambition and a dream should have a shot. Our legislation makes sure they do. We all benefit from more jobs, new technology, and innovative forms of healthcare.
I’m so pleased to work with Senator King and Senator Marco Rubio (R-FL) – an original cosponsor of our bipartisan bill – to remove bureaucratic hurdles stifling economic growth.

 

Food Safety Need Not Cripple Production. By Sen. Mike Crapo, Idaho.

Senator Mike Crapo
Senator Mike Crapo

 

The U.S. Food and Drug Administration (FDA) has taken a welcome step in announcing it would revise provisions of its proposed fresh produce rules that have been of concern due to the potential placement of unnecessary, costly burdens on certain farming operations, probable impacts on conservation efforts and more.  This provides an opportunity to go in a different direction and help ensure that new food safety measures fix problems without crippling production.

On January 4, 2013, the FDA issued a proposed rule for growing, harvesting, packing and holding fresh produce.  Among its requirements, the proposed rule would require weekly testing of all agricultural water at a cost of $35 to $40 per week.  The FDA estimates that the cost of implementing this rule would cost a producer approximately $5,000 to $30,600 per farm, depending on size, with a total industry cost of $460 million.  The rule was created pursuant to the 2011 enactment of the Food Safety Modernization Act, which was driven by concerns with high profile incidents of food contamination.

While I support ensuring the safety of our water and food supplies, we must also ensure that any needed changes reasonably address the problem without burdening producers with additional unnecessary paperwork and costs.  Unfortunately, the proposed rule did not achieve that goal.  Due to these concerns, I joined fellow Idaho Senator Jim Risch in introducing the Stopping Costly Regulations Against Produce (SCRAP) Act as an amendment to the Senate version of the 2013 Farm Bill.  This amendment would have defunded the FDA’s proposed rule.  Unfortunately, the amendment was not allowed a vote during consideration of the bill.  More recently, I wrote the FDA, urging them to release a second set of proposed rules before finalizing the current one.  Previously, the FDA extended the comment period on the proposed rules to November 15, 2013.

Now, in its most recent announcement, the FDA indicates that significant changes will be needed in key provisions, including water quality standards and testing, of the two proposed rules affecting small and large farmers.  FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor stated, “Based on our discussions with farmers, the research community and other input we have received, we have learned a great deal, and our thinking has evolved . . . We have heard the concern that these provisions, as proposed, would not fully achieve our goal of implementing the law in a way that improves public health protections while minimizing undue burden on farmers and other food producers.”  The FDA indicates that it plans to publish revised proposed rule language by early summer 2014, it will accept additional comment on the revised sections of the proposed rule, and there may be other revisions to the proposed rules.

This is an important and welcome step to correct the direction of the proposed rules, and we must remain engaged to ensure that any new regulations achieve food safety goals without hindering agricultural production.  I encourage all those affected by the proposed rules to continue to share your input and voice any concerns throughout the process.