HEALTH

FDA to hold hearing on phenylephrine dosage efficacy

BY Michael Johnsen

ROCKVILLE, Md. According to documents posted on the Food and Drug Administration Web site in preparation for a public meeting to be held next week, FDA medical reviewers intimated they aren’t clear how well the over-the-counter decongestant phenylephrine works.

The assessment seems to support a citizen’s petition filed earlier this year by three professors from the University of Florida in Gainesville, who are petitioning the FDA to increase the effective dose of phenylephrine on the basis that the current 10 mg dose isn’t effective. The Florida professors claim a 25 mg dose may work better pending additional study.

Industry representative Consumer Healthcare Products Association stands opposed to the petition, suggesting that PE in its current approved dosage is both adequately safe and efficacious.

Phenylephrine became the decongestant of choice for many cough/cold manufacturers following the migration of pseudoephedrine from OTC aisles to behind the pharmacy counter last year.

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Dow’s foam-on-a-spoon may change the face of pediatric and geriatric drug delivery

BY Allison Cerra

SAN DIEGO Dow Chemical has announced a breakthrough in drug delivery technology, “foam on a spoon,” the first of its kind.

‘Foam-on-a-spoon’ may eliminate other medication hindrances (spills) and could make providing medication to the young and old quick and simple.

“A parent can deliver medicine to a child without worrying about spilling and staining associated with typical colored liquid medicines,” said Dow technical services leader Paul Sheskey in an interview. “The same is true for elderly patients and even pets that need medications.

“Foam-on-a-spoon was developed to aid the dispensing of liquid preparations. Dow scientists were looking for a fast dissolving drug delivery system that would be easier to administer to people with difficulty taking tablets and capsules.”

The foam-on-a-spoon—also known as FOAS—drug delivery technology works by incorporating air into a liquid formulation using a foam dispenser. “When a foamed formulation is dispensed onto a spoon, the yield stress imparts to the fluid a significant spill-resistance,” Sheskey said. “Typical uses would include analgesics, cough-cold preparations and allergy medications.”

The company uses a foam dispenser made by Rexam Airspray, which is currently used in many applications including hair, skin care, liquid soaps and sunscreens. Methylcellulose was used as the foaming agent, in-pharmatechnologist.com reported.

The U.S.-based company presented its findings at the American Association of Pharmaceutical Scientists conference in San Diego last month.

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FDA advocacy coalitions claim regulatory agency lacks adequate funding

BY Michael Johnsen

WASHINGTON Two coalitions that include several former Food-and-Drug-Administration commissioners announced the planned presentation of a 300-page report Dec. 3 that, in part, questions the FDA’s ability to execute against its mission—to safeguard and regulate the nation’s food, cosmetics and drug supply—given the lack of adequate funding, the coalitions announced Friday.

“The nation’s food supply is at risk, as are the regulatory systems that oversee the nation’s drug and device supplies,” stated a subcommittee of the FDA’s Science Board—a board established in 1992 by FDA to advise the agency on keeping pace with technical and scientific evolutions in the fields of regulatory science; on formulating an appropriate research agenda; and on upgrading its scientific and research facilities to keep pace with these changes—in a report it will present Monday.

The subcommittee attributed the deficiencies to soaring demands on the FDA; and resources that have not increased in proportion to those demands. They conclude that “this imbalance is imposing a significant risk to the integrity of the food, drug, cosmetic and device regulatory system, and hence the safety of the public.”

“Over the last decade, complex scientific advances, globalization and challenging new safety issues have combined to multiply the responsibilities of the FDA. As this new report makes clear: our expectations cannot exceed the resources we give FDA to accomplish its mission. In this regard, more is definitely better,” commented Mark McClellan, former FDA commissioner and chairman of the new Reagan-Udall Institute designed to enhance FDA’s readiness for future scientific challenges.

“That FDA needs more resources should be obvious,” added Jane Henney, former FDA commissioner and current senior vice president and provost for health affairs at the University of Cincinnati. “What makes this report so extraordinary is the qualifications of the individuals who wrote it, the year-long process to put it together, and the depth of analysis that supports its conclusion: FDA’s mission is at risk for lack of support for its scientific capabilities.”

The result of a year-long review by the Science Board subcommittee, the report concludes that the state of FDA’s scientific and regulatory programs could not be separated from the lack of resources available to support the agency’s scientific base, hire and train a broadly-capable scientific workforce, and build a sophisticated and modern information technology infrastructure.

“FDA can’t improve its science, prepare for the future, or protect American consumers without significant additional resources,” stated Don Kennedy former FDA commissioner and editor-in-chief of Science. “Congress is negotiating FDA’s FY 2008 [the current year] budget right now and can start to fix this critical problem.”

The two coalitions—the FDA Alliance and the Coalition for a Stronger FDA—formed in 2006 in response to the unmet resource needs of the FDA and the potential threat that poses to America’s health, safety and commerce. Both the FDA Alliance and the Coalition for a Stronger FDA bring together consumer and patient groups, professional organizations, trade associations, companies and individuals. More about each group can be found on their respective websites: www.StrengthenFDA.org (FDA Alliance) and www.FDACoalition.org (Coalition for a Stronger FDA).

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