HEALTH

NPA to host Congressional lobbying day in April

BY Michael Johnsen

WASHINGTON The Natural Products Association plans to host its 11th annual lobbying effort, Natural Products Day, April 8, the association announced Monday.

“Natural Products Day is a fun and effective way for industry members to establish and strengthen personal relationships with members of Congress,” stated David Seckman, Natural Products Association executive director and chief executive officer. “It helps legislators stay aware of issues important to our industry and to their district, and is an essential tool in gaining support for our many important initiatives. We make it easy for anyone to participate by making appointments with legislators, providing educational reference materials and thoroughly briefing participants about the issues.”

Natural Products Day helps broaden the natural products industry’s base of political support by educating members of Congress about the important role natural products play in keeping Americans healthy, and the overwhelming public benefits of preventative care, the association stated.

This year, Natural Products Day will focus around the Child Nutrition Promotion and School Lunch Protection Act of 2007, proposed by Senator Tom Harkin, D-Iowa, to redefine what foods are considered healthy to be served in schools. Also featured will be the association’s opposition to legislation limiting the availability of the popular dietary supplement DHEA, used to aid with aspects of aging. According to the position of the Natural Products Association, DHEA has been inappropriately classified as an anabolic steroid, despite the fact that it has no proven athletic performance-enhancing attributes that would lead to abuse. 

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FDA issues nonapprovable letter over Merck’s Mevacor OTC

BY Michael Johnsen

WHITEHOUSE STATION, N.J. Merck may yet make a fourth attempt at switching its statin Mevacor over-the-counter, but the Food and Drug Administration officially declined its third attempt, the company reported Friday.

The FDA indicated in its letter that it would require a revised label and additional data from Merck in order to gain marketing approval. “We’re evaluating the conditions outlined in the agency’s response to determine a path forward for Mevacor OTC,” stated Edwin Hemwall, Merck president, global OTC regulatory and scientific affairs.

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CDC report finds few pediatric emergency visits due to OTC cough-cold medicines

BY Michael Johnsen

ELK GROVE VILLAGE, Ill. The journal Pediatrics, published by the American Academy of Pediatrics, on Monday afternoon released a Centers for Disease Control and Prevention report finding that a relatively low number of emergency department visits for children under 12 years of age are associated with prescription and over-the-counter cough and cold medicines; and of those, a majority of those visits is due to unsupervised or accidental ingestion by children between the ages of 2 and 5 years.

“This CDC review puts the overall discussion of pediatric cough and cold remedies into perspective by focusing on concrete data that address the real issue. These medicines are safe when used as directed, and this government review underscores the importance of educating consumers—especially those with small children—on the safe use and safekeeping of medicine,” stated Linda Suydam, president of the Consumer Healthcare Products Association. 

According to the report, an estimated 7,091 patients nationwide aged 12 years and younger were treated in emergency departments for adverse drug events from cough and cold medications, accounting for 5.7 percent of emergency department visits for all medications in this age group. Almost two-thirds, 64 percent, were for children aged 2 to 5 years. Unsupervised ingestions accounted for 66 percent of estimated emergency department visits, meaning that the child was not necessarily overdosed by their guardian, but happened upon the medicine and consumed it without supervision. “The other third were adults … in general giving an overdose due to a medication problem of some sort,” commented Richard Dart, director of the Rocky Mountain Poison and Drug Center, during a conference call hosted by CHPA at noon today.

“It’s very clear … these really are situations where parents were confused and [either] gave the wrong dosage,” commented Linda Suydam, CHPA president, or inadvertently left the medicines out where curious children could access them. The report underscores two important messages, Suydam said, the need for child-proof packaging and the need for education of appropriate OTC use among parents. The industry is committed to both initiatives, Suydam said. CHPA recently introduced www.otcsafety.org, designed to deliver “parents and healthcare professionals with one message—OTC medicines need to be respected.”

Even then, most children did not require admission or extended observation (93 percent). 

The ADA suggested that targeted education against caregivers may help reduce unsupervised ingestions.

The CDC, in the report, expressed concern that if cough/cold medicines for children younger than six were pulled off the market in an effort to reduce those adverse events, parents may be inclined to administer cough and cold medicines indicated for older children, or for adults, anyway. “Even after the recall of products for children aged 2 years, 64 percent of parents responding to a national survey still considered these medications very safe or somewhat safe and 20 percent plan to continue to use OTC cough and cold medication for their children 2 years,” the report read.

Indeed, it may have been this reason that the Food and Drug Administration earlier this month officially declared that cough and cold medicines were not appropriate to administer to children under the age of two, Suydam said.

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