Pharmacists’ Group Pushes Fundamental Change In Supplement Regulation
This article was originally published in The Tan Sheet
Executive Summary
Concern about possibly harmful interactions between dietary supplements and drugs has prompted the American Society of Health-System Pharmacists to recommend that Congress fundamentally change the regulation of supplements by requiring pre-market approval of the products
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Concern about possibly harmful interactions between dietary supplements and drugs has prompted the American Society of Health-System Pharmacists to recommend that Congress fundamentally change the regulation of supplements by requiring pre-market approval of the products. The society's House of Delegates, while meeting in Seattle in early June, adopted "policy actions" including lobbying Congress to enact legislation that would require dietary supplements to "undergo FDA approval for evidence of safety and efficacy," according to ASHP. The proposal appears in ASHP's list of 2008 lobbying goals published June 20. Brian Meyer, ASHP's government relations director, said conversations with pharmacy customers prompted society members to advocate pre-market approval for supplements as a lobbying goal. Meyer said ASHP members are concerned by patients' statements about interactions between medications and supplements. Members also say many patients assume supplements are regulated similarly to prescription drugs, he said. The patients expect supplements "are tested for safety and efficacy before they are approved or marketed." "Our members realize that it's not the same thing, but we're talking about essentially a patient perception," Meyer said. Some researchers have emphasized that consumers should identify the vitamins and supplements they use when they are prescribed medicines. ASHP has published survey data showing the prevalence of consumers using both supplements and Rx or OTC drugs (1 (Also see "Rx, OTC, Supplement Concurrent Use Reported By Half Of Survey Respondents" - Pink Sheet, 22 Jan, 2001.), p. 9). The National Center for Complementary and Alternative Medicine has launched a campaign to encourage patients and health care providers to discuss CAM use to minimize the risk of adverse interactions with conventional care (2 'The Tan Sheet' June 23, 2008, In Brief). The Natural Products Association contends ASHP's policy decisions do not consider the full regulatory impact on the industry from the Dietary Supplement Health and Education Act. Dietary ingredients introduced to the market after the law's enactment in October 1994 must be submitted to FDA, NPA says. Further, health care providers are expected to inquire about a patient's use of supplements as well as drug products before prescribing medications, NPA Executive Director David Seckman said. "That's always been the responsibility of the physicians and the patients to have conversations about what the patients are taking," Seckman said. ASHP also seeks to require supplements to bear FDA-approved labeling "that includes disclosure of excipients" and instructions for safe use "in a clear, standardized format, including the potential for interaction with medications and cautions for special populations." The society's delegates also voted to continue lobbying for restrictions on supplement product advertising. They say supplement ads should be banned unless a product is marketed with "evidence-based information regarding safety and efficacy ... in a format that allows for informed decision-making by the consumer." ASHP also wants ads to include "any known warnings or precautions" on supplements' interactions with drugs or diseases and recommendations to consult with health care professionals before using a product. Moreover, the society says supplement ads should be "educational in nature and include pharmacists as a source of information." While this is the first time ASHP has made a call for FDA to require pre-market approval of supplement products a lobbying priority, the group has raised the issue before. In a March 2006 statement submitted to the House Government Reform Committee for a hearing on supplement regulation, ASHP recommended Congress amend DSHEA to require FDA approval of supplement products based on evidence of their safety and efficacy. ASHP cited the FDA's ban of ephedra, noting that under the current system, the burden falls on FDA to prove a substance is unsafe by establishing "a significant risk of illness or injury by a preponderance of the evidence." - Malcolm Spicer ([email protected]) |