In This Edition:
From Kaiser Health News:
After a wave of sometimes-deadly superbug infections, the agency last year ordered a recall of Custom Ultrasonics machines used to disinfect medical scopes. Now, with little explanation, it is backing off. (Chad Terhune, 5/6)
In 2013 and 2014, people ages 45 to 64 accounted for about half of all deaths from drug overdose, according to the CDC. (Kristin Espeland Gourlay, RINPR, 5/6)
A May Health Affairs study examines how Medicare’s eligibility age affects spending and prices, as well as the volume of services used by patients. (Michelle Andrews, 5/6)
The FDA expands its purview over all tobacco products -- including e-cigarettes, cigars, pipe tobacco -- but the new regulatory process could permit many products sold in the U.S. to remain so for up to three years. (Phil Galewitz, 5/6)
Kaiser Health News provides a fresh take on health policy developments with "Political Cartoon: 'Good Grief'" by John Deering.
Here's today's health policy haiku:
AFTER STAR WARS DAY (MAY 4) ...
My group was just bought.
I now work for Darth Vader.
Clipboard clones attack!
If you have a health policy haiku to share, please Contact Us and let us know if you want us to include your name. Keep in mind that we give extra points if you link back to a KHN original story.
Summaries Of The News:
The regulations ban the sale of e-cigarettes to anyone under the age of 18 and require manufacturers to submit their products for approval from the agency. Critics say many of the shops can't afford that process, and others worry that the new rules will push consumers back toward traditional cigarettes.
The New York Times: F.D.A. Imposes Rules For E-Cigarettes In A Landmark Move
After years of debate about the health risks of electronic cigarettes, the federal government on Thursday made it final: They need to be regulated and kept out of the hands of children. The Food and Drug Administration issued sweeping new rules that for the first time extend federal regulatory authority to e-cigarettes, banning their sale to anyone under 18 and requiring that adults under the age of 26 show a photo identification to buy them. The long-awaited regulations, 499 pages of them, shifted the terms of the public debate over e-cigarettes, putting the federal government’s heft behind a more restrictive approach to the devices. (Tavernise, 5/5)
The Wall Street Journal: FDA To Regulate E-Cigarettes, Ban Sales To Minors
In an action e-cigarette makers had been dreading, the Food and Drug Administration said it was assuming regulatory authority over e-cigarettes. Though the product-approval process will be phased in during three years, that will be little solace to the fledgling but fast-growing $3.5 billion industry that has, until Aug. 8 when the rules take effect, largely been unregulated and dominated by small manufacturers and vape shops. (Mickle, 5/5)
The Associated Press: FDA Will Require E-Cigarettes And Contents To Be Reviewed
"Millions of kids are being introduced to nicotine every year, a new generation hooked on a highly addictive chemical," Health and Human Services Secretary Sylvia Burwell said. "We cannot let the enormous progress we've made toward a tobacco-free generation be undermined by products that impact our health and economy in this way." (5/5)
The Washington Post: The Federal Government Is About To Begin Regulating The Booming E-Cigarette Market
The number of young people using e-cigarettes now exceeds the number who smoke traditional cigarettes, according to the Centers for Disease Control and Prevention. About 5.3 percent of middle school students reported in 2015 that they had used e-cigarettes in the previous 30 days. For high schoolers, the figure has risen to 16 percent. In 2015, 3 million middle- and high-school students reported using e-cigarettes, according to the FDA and the CDC. (McGinley and Dennis, 5/5)
NPR: FDA Acts To Regulate E-Cigarettes And Cigars For The First Time
The popularity of "vaping" has grown in recent years. The FDA says about 16 percent of high school students used e-cigarettes in 2015. Some have welcomed the devices as an alternative to traditional cigarettes, whose dangers are well-known, and as an aid to help smokers quit. (Kodjak, 5/5)
Los Angeles Times: FDA To Begin Regulating Electronic Cigarettes
Opponents said the FDA's product-review rules could harm the e-cigarette industry. Although the FDA contends that the cost of its approval process is less than $1 million per item, other estimates place the cost above $1 million. Either way, critics said the price would be too onerous for many of the small businesses that manufacture e-cigarettes, the vaping liquids and other related items. "This gigantic price tag is affordable to Big Tobacco companies but small- and medium-sized businesses will be crushed," said Gregory Conley, president of the American Vaping Assn. (Peltz and White, 5/5)
Marketplace: How The New E-Cigarette Regulations Will Impact Small Businesses
The implications for the growing electronic cigarette, or "vape," industry could be big. Industry insiders claim the new rules could force many shops, which often also manufacture e-cigarette products, and manufacturers to go out of business. In addition to requiring approval of products, the FDA's new mandates also prohibit sales to minors. At one 'vape' shop in New York City, the Henley Vaporium, owner Denholtz said he was concerned about the new rules. "They're 499 pages." he said. "It's going to take a while before we really understand what they mean." (Safo and Sharpe, 5/5)
The Associated Press: White House Calls FDA E-Cigarettes Move A 'Common Sense' Proposal
The White House called the Food and Drug Administration move on Thursday to ban the sale of e-cigarettes and cigars to anyone under age 18 and impose other regulations a "common sense proposal" that helps the public health and safety of Americans. (Mason, 5/5)
Reuters: FDA Says Eying Future Regulation On E-Cigarette Flavors
U.S. health officials ... said they will look at potential future regulations on flavors used in the products as more data becomes available. Mitch Zeller, head of the Food and Drug Administration's center for tobacco products, said the agency would review data on how many addicted smokers and tobacco users have actually been able to quit using e-cigarettes with flavors before making decisions on any flavor regulations. (Gershberg and Berkrot, 5/5)
Kaiser Health News: FAQ: How The FDA’s New Tobacco Rule Affects Consumers
Here are some questions and answers about how the Food and Drug Administration’s new rule will affect consumers. (Galewitz, 5/6)
Meanwhile, KQED examines how the new California tobacco laws play off the regulations —
KQED: How Tobacco Actions By California And FDA Reinforce Each Other
Last night, California’s governor signed into law a package of sweeping tobacco regulations. This morning, the federal Food and Drug Administration (FDA) handed down its own landmark regulations on e-cigarettes. (Aliferis, 5/5)
In a medical journal, the physicians say that even after the federal health law, there are "persistent shortcomings of the current health care system."
The Washington Post's Wonkblog: 2,000 Doctors Say Bernie Sanders Has The Right Approach To Health Care
More than 2,000 physicians announced their support Thursday for a single-payer national health care system, unveiling a proposal drafted by doctors that appears to resonate with Bernie Sanders' call for "Medicare for All." In an editorial and paper published in the American Journal of Public Health on Thursday, the doctors call out the "persistent shortcomings of the current health care system." They warn about the risks of continuing along the path laid out by the Affordable Care Act: "down this road, millions of Americans remain uninsured, underinsurance grows, costs rise, and inefficiency and the search for profits are abetted." (Johnson, 5/5)
The Hill: More Than 2,000 Doctors Join Call For Single-Payer Healthcare
The doctors backing the plan, like Sanders, say that ObamaCare has not gone far enough because millions remain uninsured. “Despite the passage of the Affordable Care Act six years ago, 30 million Americans remain uninsured, an even greater number are underinsured, financial barriers to care like co-pays and deductibles are rising, bureaucracy is growing, provider networks are narrowing, and medical costs are continuing to climb,” said Dr. Adam Gaffney, who co-chaired the working group that created the proposal. (Sullivan, 5/5)
Companies have been marking up the prices of their brand-name drugs before patents expire to eke out the most money they can. But this isn't just affecting those drugs: it is dragging the entire marketplace toward higher costs, because knock-offs set their value just below their brand-name counterparts.