PROMOTING MEDICAL DEVICES WITHIN FDA LAW AND POLICY OUTLINE (March 2001) Dvorah A. Richman, Esq. Partner King & Spalding 1730 Pennsylvania Ave., N.W. Washington, D.C. 20006 202-626-2948 drichman@kslaw.com
PROMOTING MEDICAL DEVICES WITHIN FDA LAW AND POLICY OUTLINE 1 I. Background. A. May be divided into four categories for better understanding. 1. Cleared/approved products (510(k) and PMA). 2. Pending applications (510(k) and PMA). 3. Investigational devices (510(k) and PMA). 4. Uncleared/unapproved devices and uncleared/unapproved indications (510(k) and PMA). B. Word promote not defined in the statute or regulations. C. FDA regulates promotion and advertising mostly by statutory authority and policies (mostly unwritten) since there are very few regulations in this area. D. FDA s application of regulation/policy is very fact specific. II. Approved/Cleared Products. A. Can promote for cleared/approved use(s) by any medium e.g., trade shows, press releases, seminars, hands on demonstrations, distribution of articles, magazine ads, Internet. B. Materials must be balanced and avoid misleading representations or omissions, including subjective statements or opinions and misrepresentations of competitor products. C. Materials must not deviate from cleared or approved uses although don t have to follow cleared/approved language precisely. 1. Must keep meaning but can, for example, make understandable for patients. D. May be able to make claims relating to cleared uses of 510(k)-cleared device where claim itself has not been cleared or approved (e.g., lower incidence of certain adverse effects). 1. Must be able to substantiate (e.g., by valid scientific evidence). 2. Be prepared for possible FDA scrutiny. 3. Cannot do the same thing for PMA-approved device. 1 FDA s regulations and policies are subject to change and varying interpretations. Also, FDA s decisions regarding promotion and advertising issues are very fact specific. It is important, for any given question, to carefully assess the particular facts and whether there has been a change in FDA regulation or policy. This brief outline should not be relied on as legal advice, but as general background to assist in understanding certain FDA promotion and advertising issues. -2-
E. Can say you have an approved PMA. F. One bite of the apple policy for announcing 510(k) clearances in a press release. G. Some things to be careful about. 1. Promoting directly to consumers (statements that are appropriate for medical professionals may be considered misleading in a consumer context). 2. Comparative claims must be relevant and not make false or misleading representations. Risky unless use head to head studies. 3. Avoid comparisons that don t reflect primary end points or are not based on statistical significance. 4. Mixing approved/cleared indications with unapproved/uncleared indications in a confusing manner. 5. Promoting for a narrower indication than that cleared or approved by FDA. 6. Implied claims -- what do the images and graphics suggest? 7. What are you doing compared to your competitors? III. Pending Application (510(k) and PMA). A. For pending 510(k) cannot promote but can: 1. Show at trade show. a. Can display device, but cannot take orders or be prepared to take orders that might result in contracts for sale. b. Can accurately describe device and functions. c. Should not make claims or suggestions that device is safe or effective. d. Best to avoid comparisons to other companies devices. e. Risky if displaying new indication for FDA-cleared device. f. For 510(k)-pending device prominently include statement like: The [name of device] is currently undergoing premarket review by FDA for the [diagnosis/treatment] of [disorder]. 2. Disseminate brochures, handouts, etc. a. Apply same type considerations as for trade show. 3. Issue press release. a. Can t say too much. b. Be careful. Product-specific press releases may be subject to FDA scrutiny (e.g., as labeling, advertising for restricted devices, -3-
and/or material that demonstrates a manufacturer s intended use ). c. FDA may be more flexible if press release intended for investors only. B. For PMA-pending device. 1. No promotion is permitted, although many companies, nevertheless, do display these devices. 2. Brochures, handouts, press releases risky. C. For pending 510(k) and PMA applications 1. Can participate in continuing medical education (U.S. based). a. May be risky to use CME to promote cleared/approved products for unapproved/uncleared uses. b. CME may be risky unless independent of manufacturer s influence. 2. Off-Shore Seminars. a. Outside of FDA s jurisdiction. b. Can talk about and give hands-on training regarding off-label uses to U.S. physicians and physicians outside U.S. c. Can t distribute seminar materials that mention off-label seminar topics in the U.S. 3. Can safely distribute. a. Peer reviewed off-label information in response to unsolicited request; or b. Peer reviewed journal articles or reference publications consistent with FDAMA provisions. 4. May be risky to distribute off-label articles under other circumstances. (See Washington Legal Foundation case.) IV. Investigational Devices or Device Uses (510(k) and PMA). A. By regulation, cannot promote, test market, or commercialize an investigational device or represent that it is safe or effective. 1. Things to stay away from include: a. Statements/implied references suggesting safety or effectiveness; b. Excess investigators or patients in an investigational study; c. Undirected mass mailings; d. Volume discounts on investigational devices; -4-
e. Continuing a study for too long; f. Claims made by physician or other third party if there is a financial relationship with the company or statements are made at the request of the manufacturer. B. May be permissible to show investigational 510(k) device at a trade show to solicit investigators to participate in a clinical study. 1. However, the current FDA position seems to be that investigational 510(k) devices cannot be shown at a trade show for other purposes. a. Manufacturers who, nevertheless, do show such devices often include a prominent statement like: Caution - Investigational Device Limited by Federal (or United States) Law to Investigational Use while not making any implicit or explicit claims suggesting safety or effectiveness. This may not protect the company. 2. May be risky to distribute brochures, handouts, etc. even if there are no claims or other suggestions of safety and effectiveness a. May reduce risk to make investigational status clear by using statement like that above. b. May reduce risk to describe features and functions but include no claims or other suggestions of safety and effectiveness. C. For investigational PMA-pending devices. 1. Not supposed to show at trade shows. 2. Risky to distribute brochures, handouts, etc. D. For all investigational devices (510(k) and PMA). 1. Press releases. a. Can say that company has an approved IDE (for significant risk study). b. Safest to focus on company not investigational product. c. Don t provide too much information. More facts = more risk. d. Don t provide data or statistics. e. Don t make statements that can be interpreted as safety or effectiveness claims. 2. Continuing medical education (U.S. based). a. Same restrictions as noted above. 3. Off-shore seminars. -5-
a. Same restrictions as noted above (cannot be seen as promoting, commercializing or representing investigational device or investigational indication as safe or effective.) 4. Distribution of off-label peer review articles. a. Can safely do upon unsolicited request or consistent with FDAMA provisions as noted above. b. May be risky if distribute off-label articles under other circumstances. 5. Focus groups /Consumer preference testing. a. Should be carefully constructed to obtain input regarding device rather than being a promotional endeavor. (Devices cannot be used on subjects.) 6. Recruiting investigators for clinical studies. a. Guidance Preparing Notification of Availability of Investigational Medical Devices and for Recruiting Study Subjects (issued 1985 and revised 1999). (1) Notices limited to scientific and medical publications or medical or scientific conferences. (2) Notices limited to: proposed use of device; sponsor s name/address; how to apply as investigator; how to obtain investigational devices; and a list of investigator responsibilities. (3) Can t imply safety or effectiveness or superiority. (4) Observe other restrictions in Guidance. V. Uncleared/unapproved devices and uncleared/unapproved indications. A. Cardinal rules. 1. Can t promote devices prior to clearance or approval. 2. Can t promote approved/cleared products for unapproved/uncleared uses. B. What can be done? 1. Works in Progress. a. Can focus on new technologies in particular areas. b. No names or specific products. c. Statements like: Company is a leader ; Exciting breakthroughs are coming are acceptable. -6-
2. Provide peer reviewed scientific articles about off-label uses of legally marketed products in response to unsolicited requests from health care practitioners. 3. Provide scientific articles about off-label uses of a legally marketed product consistent with FDAMA provisions noted above. 4. May be risky to distribute off-label information under other circumstances. 5. Continuing medical education seminars in U.S. a. Same restrictions as noted above. 6. Off-shore seminars. a. Same restrictions as noted above. VI. VII. Internet A. Apply general policies noted above regarding promotion and advertising. B. Use of disclaimers (depending on how they are written, placement, etc.) may be helpful. C. Be careful about manner in which display information about uses approved in other countries but not U.S. Country flags or other separate icons may be appropriate. D. Be cautious about linking to third-party sites. May be appropriate if they don t focus on off-label uses. E. Be aware that FDA staff has made statements to the effect that Web page information should include prominent discussion of side effects and risks associated with devices and adhere strictly to agency-approved labeling when discussing risks and instructions for use. Conclusion. A. Recognize most decision making regarding the acceptability of promotional pieces is very factually based. B. Must carefully analyze. C. May still be difficult to know when the line has been crossed. D. Must pay attention to nuance. E. Important for companies to a have a review procedure in place prior to dissemination of promotional materials. -7-