First Edition: May 6, 2016
Today's early morning highlights from the major news organizations.
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)
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)
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)
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 Wall Street Journal:
Knockoffs Of Biotech Drugs Bring Paltry Savings
Generic drugs have long delivered huge savings over their brand-name counterparts. That isn’t likely to happen, though, with knockoff versions of some of the expensive drugs on the market today. Rival versions of so-called biotech drugs, called biosimilars, are just starting to be released, and health insurers and drug-benefit managers say they expect them to cost nearly as much as the brand-name originals did for years. (Rockoff, 5/5)
The Associated Press:
Merck Beats 1Q Profit Views With Tight Cost Controls
Merck posted an 18 percent jump in first-quarter income, beating Wall Street expectations, as reduced spending on marketing, administration and research easily offset lower medicine sales outside the U.S. The second-biggest U.S. drugmaker on Thursday raised its 2016 financial forecasts. "We are off to a promising start this year," CEO Kenneth Frazier told analysts on a conference call. (5/5)
The Wall Street Journal:
Valeant Forms Committee To Determine Drug Prices
Valeant Pharmaceuticals International Inc., which has come under heavy fire from politicians because of dramatic price increases for its drugs, said it had formed a committee that will be responsible for those prices going forward. “Valeant has made mistakes in how it priced its drugs in the past, and we are committed to ensuring those mistakes are not repeated,” said new Valeant Chief Executive Joseph Papa, who took the reins of the company from Michael Pearson. (Becker, 5/5)
The Associated Press:
Questions Arise About California Doctor's Response To Prince
Was a California doctor acting legally when he sent his son to Prince's home with a drug often used to treat people addicted to opiates such as prescription painkillers? Dr. Howard Kornfeld may have been trying to help, but he was not licensed to practice medicine in Minnesota and was not registered to care for patients there via telemedicine, as the state requires. His son, Andrew Kornfeld, who has been described as a pre-med student, was not a licensed prescriber. (5/5)
The Associated Press:
Cayman Islands To Deploy Genetically Modified Mosquitoes
British biotech company Oxitec and the Cayman Islands government announced plans Thursday to release millions of genetically modified mosquitoes in the fight against a species that spreads Zika and other diseases. Deployment of the mosquitoes against the Aedes aegypti species in the Cayman Islands is a major advance for Oxitec, which has promoted the method heavily as an environmentally safe way to combat the vectors of mosquito-borne illnesses while confronting public concerns about the technology. (Kay and Fox, 5/5)
The Washington Post:
D.C. Department Of Health Plans To Distribute Zika Virus Prevention Kits
There’s a donut-shaped disk filled with bacteria that’s toxic to mosquito larvae. Then there’s bug spray and condoms. After three people who traveled to the District were diagnosed with the Zika virus, officials plan to hand out kits filled with these special items to educate and stop the spread of the disease. The D.C. Department of Health will host community outreach sessions in all eight wards on Saturday (May 14) and July 16 about the virus, which can spread via mosquitoes or through sexual contact. Officials said during the sessions, residents will receive Zika prevention kits, learn about the proper use of insecticides and how to reduce mosquito breeding sites in the community. (St. Martin, 5/5)
The Washington Post:
Report: 1 In 6 Hospital Beds In U.S. Is In A Catholic Institution, Restricting Reproductive Care
One in every 6 hospital beds in the country is in a Catholic hospital system, according to a report released Thursday that suggests the consolidation of health-care systems puts more patients than ever in hospitals where the medical procedures available to them may be dictated by faith. The U.S. Conference of Catholic Bishops advises that Catholic hospitals should not perform abortions or sterilizations and should not promote contraception to patients. Although hospitals vary in how closely they follow the Catholic directives, the American Civil Liberties Union and MergerWatch, which drafted the new report together, expressed concern that patients in many areas of the country find it difficult to access certain forms of care. (Somashekhar and Zauzmer, 5/5)
The Associated Press:
Feds: NYC To Pay $4.3M To Settle FDNY Medicare Billing Case
Prosecutors say New York City will pay $4.3 million to settle claims that its fire department improperly received reimbursement from Medicare for ambulance calls that didn't meet the federal requirement for medical necessity. The settlement was announced Thursday by the U.S. attorney's office in Manhattan. (5/5)