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Study: Healthcare providers concerned about proposed FDA rule on generic drug labeling

BY Antoinette Alexander

WASHINGTON, D.C. — A survey co-released on Wednesday by the Generic Pharmaceutical Association and the National Coalition on Healthcare reveals that the healthcare providers patients rely on most to explain safety information about their prescription drugs have serious concerns about a proposed FDA rule on generic drug labeling.  



A random phone survey of 150 physicians, 150 physician assistants and 150 pharmacists conducted by Fairleigh Dickinson University’s PublicMind on behalf of GPhA, found strong reservations about many of the rule’s key provisions among all three groups.



The study comes as FDA considers more than 100 responses to its proposed rule, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products,” which would alter the current regulations to allow generic medicine manufacturers to change their safety labels without prior FDA review and without immediate access to the drug’s complete safety data.



“Doctors, physician assistants and pharmacists are on the frontlines of health care in America, and large majorities said that provisions of the proposed rule would create confusion, take up essential time and impact their likelihood to prescribe generic drugs. And most importantly, 81% of those surveyed believe FDA approval should be required prior to generic drug safety label changes. Their voices need to be heard,” stated Ralph G. Neas, president and CEO of GPhA.



“The proposed rule raises significant concerns for practicing pharmacists, particularly in regard to patient confusion and effective risk counseling,” added Thomas E. Menighan, EVP and CEO of the APhA. “Pharmacists devote a great deal of time to counseling patients on appropriate medication use, and as the survey indicates, 67% of pharmacists asked are concerned that they will not have sufficient time to effectively address issues created by this proposed regulation.”

 

“This new research indicates that physician and health professionals concerns about the proposed rule could significantly increase healthcare costs,” stated John Rother, National Coalition on Health Care president and CEO.  “For instance, 60% say the proposed rule would have at least ‘some’ impact on their willingness to recommend generic drugs in the future.  Given that generic drug use has generated more than $1.2 trillion in savings to the U.S. healthcare system over the past decade, and saved $217 billion in 2012 alone, this could undermine the sustainability of our healthcare system.”



Other key findings of the study include:

  • News of the proposed new generic drug labeling rule has not yet reached physicians, pharmacists or physician assistants; in fact, 79% say they have heard “nothing” about this rule;
  • Prescribers and dispensers both expressed the belief that by allowing multiple versions of labeling for the same drug, the proposed new rule would lead to confusion in the marketplace.  Most (76%) say their patients would be at least somewhat confused, while more than half (53%) say having multiple safety labels would be “very” confusing for themselves;
  • Most believe the new rule would have a negative impact on their time.
  • 71% anticipate the new rule would increase the amount of time they need to spend with their patients reviewing patient history and the new labels;
  • 74% believe it would have at least some impact on the time they will need to spend researching labeling differences;
  • In addition, 68% believe they would not have the time required to keep current with the labeling changes; and
  • Concerns regarding liabilities also are an issue, as 77% are at least somewhat concerned the proposed new rule could impact their legal liabilities. This concern is even more pronounced among pharmacists (85%).

Click here to access the full study.

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Dannon unveils decadent new brand

BY Ryan Chavis

WHITE PLAINS, N.Y. — Dannon introduced Dannon creamery, a new brand of dairy desserts that takes inspiration from pudding and cheesecake. There will be five cheesecake-inspired options, which incorporate Greek yogurt with fruit sauces. The three pudding offerings are made with Grade A milk.

“This is another example of Dannon leading category growth, and it’s not just another flavor or line extension. Dannon Creamery is the launch of a new category within dairy,” said Sergio Fuster, CMO of the Dannon Co. “Living well means enjoying the simple things, like a great dessert, and Dannon Creamery re-imagines what indulgence in the dairy aisle can mean. Dessert is about never compromising on taste, and we have created a smart option for indulgence."

Dannon Creamery will be available this July in 5.3-oz. cups for a manufacturer’s suggested retail price of $1.69. The three puddings varieties are milk chocolate, dark chocolate and vanilla. The cheesecake-inspired flavors will be available in strawberry, blueberry, cherry, lemon and caramel.

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Pantene urges women to stop over-apologizing with new ‘Not Sorry’ video

BY Antoinette Alexander

CINCINNATI — Procter & Gamble’s Pantene hair care brand is further evolving its global Shine Strong campaign with the launch of the global Shine Strong Fund and a new video that tackles a common but unconscious behavior many women engage in everyday: over-apologizing.

Pantene’s Shine Strong campaign first took shape in December 2013 following the worldwide success of a viral video titled “Labels,” originating from the Philippines, depicting gender labels in the workplace (more than 46 million YouTube views to date). Pantene’s latest video titled “Not Sorry” is designed to spark a dialogue about how women unknowingly minimize their strength with the subtle, yet powerful behavior of unnecessarily saying “sorry,” when there is no reason to apologize.

“Pantene is committed to helping women across the globe be strong and shine both inside and out,” stated Colleen Jay, president, P&G global hair care and color. “We are certain this evolution of the Shine Strong campaign and roll-out of the global Shine Strong Fund will inspire action and change. We believe the message of the “Not Sorry” video will resonate with women, encouraging them to be more aware of this diminishing behavior and, in turn, prevent any bias they may be unconsciously creating.”

The overwhelmingly positive response to the Shine Strong campaign inspired Pantene to continue the conversation, ignite change and help more women in more ways through the creation of a new global Shine Strong Fund. The mission of the Shine Strong Fund is to educate and enable women to overcome bias and/or societal expectations so they may reach their full potential, as well as celebrate the many strong women in the world who exemplify the essence of Shine Strong.

In the United States, Pantene’s Shine Strong Fund will kick-off with a collaboration with the American Association of University Women, a charity that has been empowering women on campus and in the workplace since 1881. The fund will underwrite monetary grants and give access to influential leaders to enable women to be strong and shine, whether on college campuses, in the workplace or in the community.

In the United States, the Pantene Shine Strong Fund will provide women with resources in several areas:

College Grants Program: Beginning in August 2014, students will apply for the AAUW and Pantene Shine Strong Campus Action Project grant program. The program is designed to challenge women student leaders on college campuses throughout the country to initiate change and tackle harmful gender biases and stereotypes that permeate our culture. Grants will be awarded spring in the semester and Grantees will present their work at AAUW and NASPA’s National Conference for College Women Student Leaders in June 2015.

Professional Training Programs: Pantene will provide professional women with various tools and resources for bias awareness and prevention, including a monthly web chat series, hosted by female leaders from across several industries, to help them succeed in the workplace.

Giving Back in the Community: The Pantene Beautiful Lengths program is one way the brand will connect with women in the community. Pantene provides free, real-hair wigs to women undergoing cancer treatment to help them feel and look like themselves and overcome some of the biases associated with cancer.

 

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