WALKING THE COMPLIANCE LINE: A REGULATORY LAWYER S PERSPECTIVE Presented By: Alan B. Minsk Partner and Chair, Food and Drug Practice Team Arnall Golden Gregory LLP alan.minsk@agg.com Presented To: ISMPP Baltimore, MD April 23, 2012 1
Before We Start Compliance is required by the law Compliance is good business Non-compliance is unlawful and bad for business The law is the law and applies to everyone 2
Renewed Government Interest Increase in FDA compliance personnel to review and enforce rules Justice Department and State scrutiny of product promotion is increasing Corporate Integrity Agreements, fines Bad Ad Program for Rx Drugs Do not have a false sense of security that the government won t review educational activities 3
Scientific Exchange vs. Promotion My Thoughts Education vs. spin Context and perception solicited vs. unsolicited request marketing vs. medical affairs greatest hits vs. entire reprint Relevance is the level of FDA regulation and oversight 4
Non-Promotional Information Some Examples Disease awareness communications Continuing Medical Education (CME) type activities Specific responses to unsolicited requests for information 5
Bottom Line (and to dispel misperception) Activities must be consistent with FDA guidelines regarding education and promotion e.g., no one at a company (or someone acting on behalf of the company) can promote off-label uses, suggest an investigational product is safe and effective, provide false or misleading information, or minimize risk FDA is more concerned about the content of the company s presentation of information than the title of the person providing the content 6
Off-Label Dissemination Off-label can result in misbranding, but misbranding (e.g., false or misleading information) and promoting an unapproved use can be separate violations FDA has issued guidance on proactive dissemination of off-label information (not promotion) in certain cases Good Reprint Practices guidance document (2009) www.fda.gov/regulatoryinformation/guidances/ucm125126.htm we ve prepared a Bulletin if you would like a courtesy copy FDA has recently issued guidance on responding to requests for off-label information we ve prepared a Bulletin if you would like a courtesy copy Remember there is no safe harbor for disseminating false or misleading information Be careful about oral or verbal statements that can change a product s intended use hush, hush voices carry 7
Misbranding In short and in simplistic terms, not telling a complete, truthful story Ambiguity, misdirection, false comparisons to other products, and creating a false impression are also ways to misbrand a product Some buzzwords that might raise FDA scrutiny (although not necessarily illegal) all none more than better never best most er -ending comparisons safe and effective for an investigational product Minimization of risk information is of significant concern to FDA 8
Untitled Letter or Warning Letter Source of violations competitor complaints (majority) FDA monitoring e.g., review of periodicals, attendance at trade shows, websites, Form FDA-2253 inspections (of manufacturing facilities) complaints FDA s Bad Ad Campaign other agencies 9
Untitled Letter or Warning Letter (cont d) Some trends promotion of unapproved uses i.e., off-label uses general use clearance but promoted for specific use failure or minimization of adequate risk information promotion of unsubstantiated or misleading comparative claims overstatement of effectiveness 10
White Paper Enforcement Example Untitled Letter (2011) FDA picked up a company-prepared paper at a promotional exhibit booth in a commercial exhibit hall paper promoted investigational new drug as safe and effective broadened indication of an approved product (i.e., off-label) unsubstantiated effectiveness and superiority claims omitted and minimized important risk information 11
White Paper Enforcement Example (cont d) The placement of the white paper on the counter top at the promotional exhibit booth in the commercial exhibit hall during open exhibit hours made it available to all conference attendees, including physicians and other healthcare providers involved in the decision process for treating patients The FDA representative was neither approached by a company representative when the white paper was obtained nor was a PI offered or attached to the piece FDA noted that the white paper bore a company material ID code, similar to those used as identifiers on promotional materials when they are submitted to FDA, which implied the paper was being used as a promotional piece 12
Another Enforcement Example Warning Letter (2010) white paper omitted important risk information, broadened the product s indication, and failed to provide adequate directions for use established name and brand name not used, but FDA concluded the piece was branded and promotional (e.g., company name and logo, only approved product for the indication, colors used that were similar to the other productpromotional pieces) 13
Other Possible Ramifications Corrective advertising Loss of credibility with FDA and the marketplace Diversion of $$$ from other projects to correct violative message 14
Some Key Takeaways From FDA Enforcement The agency has maintained (and the courts have upheld elsewhere) that false speech is not protected commercial speech Promotions that are highly visible increase risk e.g., national medical conference, TV Promotions that raise safety concerns are likely to trigger FDA action 15
Other Non-FDA Implications One Thing Leads to Another Bad publicity Whistleblower complaints Product liability State prosecution Fraud prosecution and abuse False Claims Act, Anti- Kickback (e.g., preceptorships, grants, publications, ghostwriting) Loss of good reputation in the medical and patient communities Other regulatory agencies e.g., SEC, FTC Competitor challenges Individual liability 16
Recommendations All materials disseminated should be reviewed internally accuracy and appropriateness of information balance of information and regulatory compliance Don t get hung up with titles, such as Medical Communications the government is more concerned with content and message educate internally about role difference and separate training for respective groups independence of Medical Affairs in both company structure and funding roles 17
Recommendations (cont'd) Make clear what s approved and what s investigational No homemade materials includes highlighting an article or spinning the information Promote only to audience that can lawfully prescribe/take product Be careful about symbols, logos, or graphics that can also get a company into trouble with intended use issues 18
Recommendations (cont'd) Did the company submit data during review process and what was FDA s response? If FDA rejected a claim during the regulatory review process, you would be ill-advised to promote that claim Always have substantiation for claims and tell the whole story Disclaimers or qualifying statements are helpful but won t eliminate risk if the whole promotion, when viewed in full and in context, is violative 19
Recommendations (cont'd) Items that are distributed should be recorded in case the company must take corrective action at a later date, which is one reason that there should be a central place that disseminates requested information Train employees and third parties you employ about company policies and monitor/audit them you don t want renegade individuals getting the company in trouble audit internally to make sure everyone is on the same page 20
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