HEALTH

American Diabetes Association teams up with HearPO

BY Allison Cerra

PLYMOUTH, Minn. A national strategic partnership between the American Diabetes Association and HearPO will provide additional resources to educate people with diabetes, medical practitioners and the general public about the connection between diabetes and hearing loss.

HearPO, one of the largest distributors of hearing aids and hearing services in the world, is working together with the American Diabetes Association to locate and treat diabetic patients who have not been diagnosed or treated for existing hearing loss. The organizations are offering testing sites and seminars, as well as booklets and other educational supplements to raise awareness about the relationship between diabetes and hearing loss.

 

"We are pleased HearPO is joining with us to spread the word that there is a direct correlation between diabetes and hearing loss," said Nash Childs, American Diabetes Association board chairman. "More specifically, we’d like to educate older adults with diabetes, as this population faces many issues in managing their disease, and through this relationship we’ll be able to provide additional tools and resources."

 

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House committee to hold hearing over J&J recall

BY Michael Johnsen

WASHINGTON House Committee on Oversight and Government Reform chairman Ed Towns, D-N.Y., on Thursday announced that the committee will hold a hearing Sept. 30 at 10 a.m. to examine the circumstances surrounding Johnson & Johnson’s recall of more than 135 million bottles of infant and children’s medicines produced by Johnson & Johnson/McNeil Consumer Healthcare, including children’s Tylenol, infant’s Tylenol, children’s Motrin and children’s Benadryl.

 

The hearing also will examine the circumstances surrounding a “phantom recall” of a particular Motrin product, which became public as a result of the committee’s hearing on May 27.

 

 

“This is about the safety of trusted medication that our children and grandchildren use,” Towns stated. “The evidence we have uncovered since our first hearing is extremely troubling.” 

 

 

Witnesses invited to testify include Bill Weldon, J&J chairman and CEO, and Colleen Goggins, J&J worldwide chairman, consumer group.

 

 

The hearing will be webcast on the committee’s website, Oversight.house.gov. 

 

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Forest Pharmaceuticals pays $313 million in settlement deal

BY Alaric DeArment

SILVER SPRING, Md. Drug maker Forest Pharmaceuticals will pay more than $300 million to the federal government as part of a plea agreement over alleged improper drug distribution and obstructing a Food and Drug Administration inspection.

The FDA said Wednesday that Forest Pharmaceuticals, a subsidiary of New York-based Forest Labs, had entered a plea agreement whereby it would accept criminal responsibility for distribution of an unapproved drug, distribution of a misbranded drug and obstruction of an FDA inspection. The total payment of $313 million includes $164 million in criminal penalties.

One charge centered around the marketing of Levothroid (levothyroxine sodium), an unapproved drug used to treat hypothyroidism. A 1997 Federal Register notice announced that Levothroid is a “new drug,” and that manufacturers who wish to continue marketing it would have to obtain approval from the FDA by August 2000.

 

The company also is charged with alleged off-label promotion of the antidepressant Celexa (citalopram) for use in children; the drug is only approved for use in adults. The charge of obstructing an FDA inspection relates to an alleged 2003 incident in which Forest employees made false statements to the agency.

 

 

“We are pleased to bring closure to this long-running investigation,” Forest chairman and CEO Howard Solomon said. “We remain dedicated to ensuring that we operate in full compliance with all laws and regulations and that our employees uphold the highest principles of integrity, honesty and ethics.”

 

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