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Minority groups raise concerns around FDA’s Proposed Rule on Generic Labeling

BY Michael Johnsen

 

WASHINGTON — Twenty African-American and Hispanic community and health care organizations earlier this month submitted a letter to the Food and Drug Administration raising concerns that its Proposed Rule on Generic Labeling could jeopardize patient safety and access to affordable medicines. This is the second such letter sent to the agency by various institutions representing minority constituencies, including healthcare providers, bringing the total number to 34.The letter focuses on the adverse consequences of the proposed rule on patients, on costs and on vulnerable populations.
 
“The questions continue to mount, with more groups speaking out about the negative impact of the FDA Proposed Rule,” stated Ralph Neas, president and CEO of the Generic Pharmaceutical Association. “Now we are hearing from leading minority academic, medical and community organizations that are rightly worried about the impact on patient populations historically and currently underserved by our nation’s health care system. Because they speak for millions of Americans who rely on generic drugs,” Neas continued, “these groups are asking for inclusivity. They are asking to be heard in the FDA decision-making process.”
 
“Healthcare is paramount to the well-being of our communities, and proposed regulations like this one can have unintended consequences. Vulnerable patients — and the doctors, pharmacists and other health professionals who serve them — should be ensured that the rule change does not make decision-making more confusing,” stated Melanie Campbell, president and CEO of the National Coalition on Black Civic Participation.
 
The signatories include the Meharry Medical College, the NAACP, the National Hispanic Medical Association, and the National Medical Association. The letter cites specific challenges the rule presents for providers, noting that a recent survey showing that they favor a policy wherein FDA approval would precede any changes to generic drug labels.
 
“Recently,” the letter reads, “a Farleigh Dickinson University’s Public Mind survey found that health professionals were overwhelmingly in favor of making sure that generic drug safety labels are not changed without FDA approval. The survey results show that the Proposed Rule would cause confusion for both health care providers and patients."
 
According to the survey:
 
  • More than three-quarters (76%) of those surveyed say their patients would be at least somewhat confused by multiple labels for the same medicine;
  • Eight in 10 (88%) say multiple labels would be very confusing (53%) or somewhat confusing (35%) for themselves; and
  • Among prescribers, 60% said the change would have an impact on their willingness to recommend generic drugs in the future.
 
The letter also highlights the reliance of lower-income patients on the savings from generics, stating: “Recent studies have continued to raise serious concerns about the level of generic utilization among lower-income patients. The research suggests that there are cultural barriers to understanding of generic efficacy that can lead patients to miss out on the cost-savings generic medications offer. Even more worrying, this research shows it can lead to dangerous non-compliance. The Food and Drug Administration’s Proposed Rule on Generic Labeling, as drafted, likely will only add to these challenges.”
 
Finally, the letter calls for FDA to “fully explore the potential unintended and harmful consequences that the Proposed Rule may have on patient access and national health care costs before proceeding further with its finalization. 
 
This is the latest in a series of joint letters to the agency raising questions about the Proposed Rule, which were signed by more than 50 groups, including associations that represent more than 100,000 pharmacists and more than 40,000 pharmacies. In addition to virtually every member of the healthcare supply chain and providers, the FDA has received letters on behalf of patient advocacy, disability, veterans and minority organizations.
 
“Generic drug access is a critical part of keeping healthcare affordable and in reach for all Americans,” said Neas. “This letter underscores once more the imperative that during the FDA’s deliberations around its Proposed Rule on Generic Drug Labeling, racial and ethnic minority populations have a seat at the table to be able to discuss and understand the issue. Before finalizing this rule, the FDA must hear from these voices.”
 

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Ulta Beauty announces addition to board

BY Antoinette Alexander

BOLINGBROOK, Ill. — Ulta Beauty has announced that Michelle Collins, president of business and financial advisory firm Cambium, has been appointed to its board, and as a member of its nominating and corporate governance and audit committees.

“We are delighted to welcome Michelle to Ulta Beauty’s board of directors. Michelle brings extensive experience in corporate finance and deep corporate governance expertise, having served as a member of the board of directors for many public and private companies. I am confident she will make tremendous contributions to Ulta,” said Mary Dillon, Ulta Beauty’s CEO.

Collins joins the board with 28 years of experience in corporate finance and business consulting. She has been the president of Cambium since 2007. Previously, she was managing director and co-founder of Svoboda Capital Partners, a private equity firm, from 1998 to 2007. She began her career in 1986 at William Blair & Co., an investment banking firm, where she held the position of principal, corporate finance from 1992 to 1997, focusing on specialty retail, catalog and distribution businesses in corporate finance.

Collins has been a member of the board of Integrys Energy Group since 2011, and currently serves as the chair of its governance committee and as member of its audit committee. Collins was a director of CDW, a provider of integrated IT solutions, from 1996 to 2007 and served as the chair of the audit committee and, for a period, as a member of the compensation committee. She was a board member of Coldwater Creek, a specialty retailer of women’s apparel, accessories, jewelry and gift items, from 1997 to 2004. Collins also served on the board of Molex, a global manufacturer of electronics, electrical and fiber optic interconnection products and systems, from 2003 to 2013, as well as a member of its audit committee and nominating and corporate governance committee. She served as a board member of Bucyrus International from 2009 to 2011, including as a member of its audit committee.

Collins serves on the boards of several civic organizations and private companies. She has been a member of the advisory board of Svoboda Capital Partners since 2007.
 

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New ‘Buck Balm’ positioned as the first beard balm designed for hunters

BY Antoinette Alexander

PASADENA, Md. — Beard balm for deer hunters? Yep.

BeardBrothers, a U.S. army veteran-owned company based out of Pasadena, Md., has created Buck Balm, a new type of beard care product developed specifically for deer hunters.

According to the company, Buck Balm provides UV protection, attracts deer, covers the hunter's scent, can act as an insect repellent and is long lasting to keep the hunter’s facial hair from drying out.

Buck Balm's scent is strong enough for the deer to smell but not so strong that it would be overbearing, the company stated. As an added bonus, Buck Balm is a deterrent to insects and can also be used for bear and raccoon hunting.

Available at BeardBrothersLLC.com, the products are made in the United States with organic and all-natural ingredients.

The price? “Less than a tank of gas,” according to the company.
 

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