Best Practices to Ensure Compliance with Scientific Exchange Dennis Raglin, Partner Life Sciences Practice Group SEDGWICK LLP San Francisco 2015
Scientific Exchange Unsolicited requests Unapproved use Scientific exchange can be powerful tool to get important and potentially life-saving information to physicians and health care providers
Scientific Exchange FDA estimates approximately 400 companies distribute scientific and medical publications that discuss unapproved new uses for FDA-cleared products FDA agrees that public health may benefit when health care professionals receive truthful and nonmisleading scientific or medical publications on unapproved new uses.
FDA s Views on Exchange The FDA has historically viewed off-label promotion of a device, or any medical product, as misbranding under the Food, Drug, & Cosmetics Act Companies can infer FDA s definition of scientific exchange through the safe harbors present in agency guidances: FDA permits manufacturers to disseminate off-label information as part of scientific exchange under prescribed circumstance
FDA Softens its Stance (a little) The FDA recently asserted in a draft guidance that, while it recognizes the value of truthful and nonmisleading scientific or medical publications on unapproved new uses, such information is in no way a substitute for FDA s premarket review process. It also has indicated a willingness to reconsider some of its off-label policies.
Promoting Off Label Use (Still) a No No Manufacturers must take FDA oversight on messaging seriously, creating separation between official, on-label promotional messages and scientific exchanges, which contain unapproved, off-label information. This separation results in separate policies, processes, approvals, and situational uses for promotional exchanges and scientific exchanges.
The 2014 FDA Guidance on Exchange Distributing Scientific and Medical Publications on Unapproved New use Recommended Practices Intended to clarify an earlier 2009 Guidance to incorporate medical reference texts and clinical practice guidelines (CPGs) Came about as a result of citizen s petition http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinf ormation/guidances/ucm387652.pdf
The Tricky Off-Label Landscape Only a health care provider can prescribe a drug or device for an off-label use A regulated company cannot actively promote an off-label use for a product FDA has issued warning letters (trade shows, websites, complaints by competitors)
No Off-Label Promotion Cannot make unsubstantiated claims Cannot omit or minimize risk information Cannot broaden indication for approved use of a product to include off label uses No right to commercial speech if it is false
The Risks of Off-Label Promotion FDA warning letter Product Liability Litigation Fraud claims under the False Claims Act Competitors focused on company SEC or FTC complaints/involvement
The Guidance The Do s Scientific publications (journal articles, reference texts and CPGs) should be: Distributed separately from the information that is promotional in nature Provided with the approved labeling for each product addressed in the publication (or, for 510(k) device, labeling re indications for cleared use)
The Guidance The Don ts Scientific or medical publications should not be: Funded in whole or part by the manufacturer Primarily distributed by the manufacturer Written, edited, excerpted or published specifically for, or at the request of, a manufacturer Edited or significantly influenced by the manufacturer
The Guidance Include a Statement Scientific or medical publications, or portions distributed, should be accompanied by an affixed, prominent statement disclosing: any drug or device in the publication in which the manufacturer has an interest That some or all of the uses of the manufacturer s products discussed in the publication have not been approved by the FDA Any author known to have a financial interest in the manufacturer Anyone known who has provided funding to the study All significant risks or safety concerns associated with the unapproved use
The Big Three
1. Scientific or Medical Journal Articles Published by organization with editorial board with independent and objective experts Article should describe controlled clinical observation (meta-analyses testing specific clinical hypotheses) When available, article should be sent with comprehensive bibliography of publications discussing clinical studies published in other scientific or medical publications about use
2. Scientific or Medical Reference Texts Based on systematic review of existing evidence Authored, edited and/or contributed to by experts who have demonstrated expertise in area Sold through usual or customary independent distribution channels (booksellers, subscription, Internet) Specific rules if only distributing one chapter of text
3. Clinical Practice Guidelines (CPGs) Systematic review of existing evidence Developed by multidisciplinary experts and representatives from key affected groups + transparent process that minimizes distortions, biases and conflicts of interest Consider important patient subgroups and preferences
Benefits from the Guidance Facilitates better communication between regulated companies and health care professionals Physicians need scientific information to help inform their decision-making around patient care, and the manufacturer of the product is probably most qualified to provide the correct information
Challenges from the Guidance FDA s recommended practice may prove too burdensome To comply, a company must provide a lot of information at the same time they provide the onpoint or relevant publication Will health care professionals have, or take, the time to wade through all of it? Is it easier just to opt out of providing publications on unapproved new uses?
Tips to Ensure Compliance Independence of Medical Affairs in structure and in finance Central place that distributes information Train employees on company policies & audit Don t send abbreviated or highlighted materials Don t promote off label uses Don t minimize risk Watch for misbranding issues Always have substantiation to back up the claims