Drug Industry Avoids FDA's "Blunt Tools" With Safe Use Initiative Progress
This article was originally published in The Tan Sheet
Executive Summary
Efforts by firms and other pharmaceutical industry stakeholders to drive FDA's Safe Use Initiative agenda lower the likelihood of the agency intervening with enforcement action, according to Principal Deputy Commissioner Josh Sharfstein
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Efforts by firms and other pharmaceutical industry stakeholders to drive FDA's Safe Use Initiative agenda lower the likelihood of the agency intervening with enforcement action, according to Principal Deputy Commissioner Josh Sharfstein. At an April 27 Institute of Medicine roundtable in Washington, Sharfstein acknowledged the industry's ability - as well as incentive - to organize stakeholder coalitions and effect broad change, while FDA is forced to rely on "blunt tools" to regulate products and protect public health. Companies "have a vested interest ... in seeing their medicines used well to help people," he said. "I think that they would like, understandably, to avoid more restrictive or blunt instruments that would have to be used in the case that they're necessary." The workshop featured updates from industry stakeholders and academics on findings regarding consumer use and understanding of OTC drugs, as well as opportunities to revise labeling. Sharfstein discussed FDA's hopes for improving health literacy and drug awareness through the initiative launched in November 2009. He said pharmacies and health insurers might consider adopting new technologies to communicate with patients and consumers. For example, pharmacies could send mobile phone text messages reminding consumers to dispose of certain drugs with high potential for misuse or overdose. Such a communication strategy likely could be extrapolated to educate consumers on the proper use of OTCs in children - an area of interest for Sharfstein when he was Baltimore's health commissioner, prior to his FDA appointment (1 (Also see "Firms Consult FDA, Add “Do Not Use” For Under 4 To Pediatric Cold Products" - Pink Sheet, 13 Oct, 2008.)). Industry Strives For Safer Use Standardizing consumer medication information and improving dosing devices for Rx and OTC drugs were proposed as part of Safe Use, which FDA hopes will reduce preventable harm from medicine (2 (Also see "FDA Launches Safe Use Initiative; Details TBA Following Stakeholder Input" - Pink Sheet, 9 Nov, 2009.)). Research presented at the IoM event suggests OTC firms still have work ahead of them to reduce the risks associated with misuse of their products. Researchers looked at 200 pediatric oral liquid products across cough/cold, allergy, analgesic and gastrointestinal categories in what they called the first systematic review of OTC drug packaging and labeling variability. H. Shonna Yin, of the pediatrics department at New York University's Langone Medical Center, said many drugs failed to meet standards proposed by FDA's draft guidance on dosage delivery devices for liquid OTCs (3 (Also see "OTC Dosing Device Guidance Elicits Concern On Spoon Confusion, Added Cost" - Pink Sheet, 1 Feb, 2010.)). For example, 25 percent of the products evaluated did not include a dosing device, 67 percent used a nonstandard abbreviation for milliliter - not "mL" - and 64 percent used potentially misleading normal-sized font in measurement fractions. "We can do better than this, and I challenge you all to work on this issue and try to make things better," Yin said to industry representatives in the audience. Enhancing Acetaminophen Awareness Consumer confusion regarding acetaminophen has caused much hand-wringing in industry, especially since a June 2009 FDA advisory committee meeting recommended lower doses of the ingredient due to hepatotoxicity risks (4 (Also see "Lower Acetaminophen Doses Recommended Despite Cost Impact, Lack Of Data" - Pink Sheet, 6 Jul, 2009.)). Michael Wolf, director of the Center for Communication in Healthcare at Northwestern University's Feinberg School of Medicine, said an ongoing consumer use study conducted with McNeil Consumer Healthcare shows gaps in recognizing acetaminophen overdose risks. Thus far, 59 percent of participants said taking Tylenol and a generic acetaminophen product together is safe, even though both have the same active ingredient. Overcoming consumers' ingrained prior experience with OTCs - and frequent failure to read labeling - is a challenge for industry to overcome, Wolf said. McNeil, a Johnson & Johnson unit, is studying consumer responses to prototype acetaminophen icons, an executive said. The company hopes the ultimate design will become a universal labeling symbol for acetaminophen in Rx and OTC products. - Dan Schiff ( 5 [email protected] ) |