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Walmart, other industry groups raise concerns on proposed generic labeling rule

BY Antoinette Alexander

WASHINGTON, D.C. — Walmart has joined almost two-dozen organizations from across the healthcare supply chain in a letter calling on the Food and Drug Administration to consider the public health impact of its Proposed Rule on pharmaceutical labeling.

“Walmart was a pioneer in promoting safe, affordable generic medicines for consumers and their families through its ground-breaking $4 generics program and continues to be a leader in ensuring access to life-saving medicines,” stated Ralph Neas, president and CEO of the Generic Pharmaceutical Association. “Today, they lend their voice to a chorus of healthcare companies concerned that the Proposed Rule creates a regulatory framework whereby multiple, different labeling, including different warnings, can simultaneously exist in the marketplace for multiple generic versions of a drug. This would cause dangerous confusion, increase costs, and reduce availability of generic medicines for patients who need them most.”



Walmart and Rite Aid add their names to a letter signed by 22 health industry groups and submitted to the FDA, raising concerns about the proposed regulation. The signatories call for FDA to “fully explore the potential unintended consequences that the rule may have on patient access and national health care costs. Permitting labeling changes for generic drugs without FDA approval counters 30 years of law requiring generic and brand medicines to have the same labels.”



The letter also pointed to the impact of the Proposed Rule on healthcare system costs, citing a recent study by Matrix Global Advisors. It showed that spending on generic drugs would increase by $4 billion per year (or 5.4% of generic retail prescription drug spending in 2012). Of this, government health programs would pay $1.5 billion, and private health insurance, $2.5 billion.

 

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Mondelez International reveals ‘Call for Well-Being’ strategy

BY Ryan Chavis

DEERFIELD, Ill. — Mondelez International, a snack industry leader whose portfolio includes such brands as Oreo and Nabisco, announced a plan to improve the well-being of our planet and people. The "Call for Well-Being" strategy seeks to broaden the reach and impact of the company’s programs. It will start with new global nutrition targets across its product mix, the company said.

"We know the health of people, communities, our business and the planet are inextricably linked," said Christine McGrath, VP external affairs and head of the company’s global well-being platform. "People around the world aspire to live healthier, better lives, but none of us can do it alone. We want to work with others to expand the conversation around well-being and bring an entrepreneurial approach to address the growing concerns around public health and the environment."

The "Call for Well-Being" focuses on four key areas:

Empowering consumers to snack mindfully. Mondelez International has set global nutrition targets to reach these goals by 2020: Grow "better choice" product to 25% of revenue, reduce sodium and saturated fat by 10%, increase whole grains by 25%, and increase individually wrapped options of 200 calories or less by 25%.

Partnering with communities. The company is investing $50 million in healthy-lifestyle community partnerships over the next several years, with a focus on nutrition education and the promotion of active lifestyles.

Securing sustainable agricultural supplies. The company will help farmers with a 10-year, $600 million investment in its Cocoa Life and Coffee Made Happy programs.

Reducing environmental footprint. The company will promote biodiversity and sound environmental practices. It also seeks to cut out energy and water use, waste and greenhouse gas emissions from manufacturing by 15% by 2015.

 

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FDA approves Upsher-Smith’s Qudexy XR extended-release capsules

BY Antoinette Alexander

MAPLE GROVE, Minn. — Upsher-Smith has received approval from the Food and Drug Administration for Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile.

Qudexy XR will be available to patients in second quarter 2014.

Qudexy XR is indicated as initial monotherapy in patients 10 years of age and older with partial-onset seizures or primary generalized tonic-clonic seizures. It also is approved as adjunctive therapy in patients 2 years of age and older with POS, primary generalized tonic-clonic seizures and seizures associated with Lennox-Gastaut syndrome.   

"Upsher-Smith is pleased by the FDA’s approval of Qudexy XR," stated Mark Evenstad, president and CEO of Upsher-Smith. "Today’s approval is a major milestone in Upsher-Smith’s history, as Qudexy XR is the first branded product in our central nervous system portfolio. At Upsher-Smith, our mission is to make a measurable improvement in people’s lives by focusing on the patient."

Qudexy XR is available in 25-mg, 50-mg, 100-mg, 150-mg, and 200-mg extended-release capsules.

 

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