PHARMACY

FDA unveils tighter rules on e-cigarettes, other products

BY Gina Acosta

WASHINGTON — The U.S. Food and Drug Administration announced Thursday that it will regulate all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others.

The industry’s first federal regulations call for requiring manufacturers to disclose ingredients, banning sales of e-cigarettes to minors and requiring proof of identification for sales.

“We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth. As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap. All of this is creating a new generation of Americans who are at risk of addiction,” said HHS Secretary Sylvia Burwell. “Today’s announcement is an important step in the fight for a tobacco-free generation – it will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions.”

Before Thursday, there was no federal law prohibiting retailers from selling e-cigarettes, hookah tobacco or cigars to people under age 18. Thursday's rule changes that with provisions aimed at restricting youth access, which go into effect in 90 days, including:

  • Not allowing products to be sold to persons under the age of 18 years (both in person and online)
  • Requiring age verification by photo ID
  • Not allowing the selling of covered tobacco products in vending machines (unless in an adult-only facility)
  • Not allowing the distribution of free samples

The new rule also requires manufacturers of all newly-regulated products to show that the products meet the applicable public health standard set forth in the law and receive marketing authorization from the FDA, unless the product was on the market as of Feb. 15, 2007. The tobacco product review process gives the agency the ability to evaluate important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users.

Under staggered timelines, the FDA expects that manufacturers will continue selling their products for up to two years while they submit – and an additional year while the FDA reviews – a new tobacco product application. The FDA will issue an order granting marketing authorization where appropriate; otherwise, the product will face FDA enforcement.

Today’s actions will subject all manufacturers, importers and/or retailers of newly- regulated tobacco products to any applicable provisions, bringing them in line with other tobacco products the FDA has regulated under the TCA since 2009.

These requirements include:

  • Registering manufacturing establishments and providing product listings to the FDA
  • Reporting ingredients, and harmful and potentially harmful constituents
  • Requiring premarket review and authorization of new tobacco products by the FDA
  • Placing health warnings on product packages and advertisements
  • Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA

 

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Mylan partners with Sarah Jessica Parker on anaphylaxis initiative

BY Gina Acosta

HERTFORDSHIRE, England and PITTSBURGH — Mylan is teaming up with actress and mom Sarah Jessica Parker on a national campaign to educate the public about the serious and unpredictable nature of anaphylaxis.

The company is unveiling an initiative called Anaphylaxis: For Reel. Through this initiative, Mylan, along with Parker and leading advocacy organizations, aims to inspire greater understanding about the risks of anaphylaxis. The campaign encourages young filmmakers and their families to make their voices heard by creating and submitting short, educational films about the realities of managing severe allergies. Parker, whose son has allergies to peanuts and hazelnuts, is joining this initiative to share her story and personal connection to this life-threatening health condition that affects families nationwide.

"With Anaphylaxis: For Reel, I hope to help empower other families affected by severe allergies to share their personal stories," Parker said. "Like every family, we have our own story. We learned about our son's food allergies only after he experienced anaphylaxis – and I still vividly remember how scary that day was for all of us. Since then, we've come to understand just how serious the risks of anaphylaxis are – and how crucial it is to take proactive steps to manage his severe allergies."

Anaphylaxis is a significant health issue in the U.S., with up to 43 million people at risk, including children affected by food allergies, estimated at one in 13. Every six minutes, on average, food-related anaphylaxis sends someone in the U.S. to the emergency department. 

"Anaphylaxis is very unpredictable – symptoms can vary from person to person, and reactions can be mild one time and life-threatening the next," said Dr. Hemant Sharma, clinical chief of the division of allergy and immunology at Children's National Health System in Washington, D.C. "Our goal with this initiative is to have the real-life, everyday stories of those who deal with life-threatening allergies firsthand shine a spotlight on the urgent need to increase education about the importance of being ready to respond if anaphylaxis occurs."

A panel, including Dr. Sharma and leading advocacy organization members, will come together to select up to five films to be featured at a premiere event in New York City this fall with Parker and posted on Anaphylaxis101.com. Films can be submitted on Anaphylaxis101.com through July 11. Films will be evaluated based upon creativity, originality and adherence to submission guidelines.

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CVS Health Research Institute: Home infusion both economically and clinically viable

BY Michael Johnsen
WOONSOCKET, R.I. – A new study by the CVS Health Research Institute found that home infusion care is safe, clinically effective and improves quality of life while reducing health care costs when compared to infusion care delivered in a hospital or clinic. 
 
The findings underscore the value of home infusion services – where medication is delivered intravenously in a patient's home – for the health care system, including patients and payers. The study was published in Healthcare: The Journal of Delivery Science and Innovation.
 
"As the U.S. health care payment system shifts from volume to value, we are focused on identifying new approaches to health service delivery that provide better care and improve patient outcomes while lowering costs," stated Troyen Brennan, study author and chief medical officer CVS Health. "Our research shows that home infusion care is a promising model that is both cost- and clinically-effective and is overwhelmingly preferred by patients when intravenous therapy is required." 
 
Researchers conducted a systematic review of existing peer-reviewed research evaluating infusion care for several conditions, including cystic fibrosis, antibiotics following orthopedic surgery and several cancers requiring infused chemotherapies. Researchers compared measures of quality, safety, clinical outcomes, quality of life and costs of home infusion services to those provided in medical settings. The research showed that patients receiving intravenous therapy at home had as good or better clinical outcomes as those patients who received the same therapy in a traditional health care setting. In addition, patients overwhelmingly preferred receiving their infusion therapies at home, reporting fewer disruptions in personal schedules and responsibilities. The costs associated with home infusion were also consistently lower than services provided in a health care facility, with savings ranging between $1,928 and $2,974 per course of treatment.  
 
"At CVS Health, we provide important home infusion services to patients through Coram, which is just one of the ways we are expanding our clinical delivery model and helping to move important health services to lower cost sites of care," added Alan Lotvin, EVP CVS Specialty. "In fact, our patients report high satisfaction with our Coram home infusion services, citing convenience and comfort as key elements that improved their overall experience."
 
 
 
 
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