The Center for Health & Pharmaceutical Law & Policy
investigational new drugs provides that the ban on promoting such drugs “is not intended to restrict the full exchange of scientific information concerning the drug[s], including dissemination of scientific findings in scientific or lay media.”81 Manufacturers may disseminate information on unapproved drugs and unapproved new uses of approved drugs to the physician investigators participating in clinical trials.82 Information can also be disclosed as required by securities and other laws, including, for example, the law requiring disclosure to www.clinicaltrials.gov.83 Manufacturers can disseminate off-label information “through the submission of original research to peer-reviewed publications[,]”84 and by distributing peer-reviewed medical journal articles and other materials about off-label uses directly to prescribers.85 Manufacturers can also respond to unsolicited requests for off-label information.86 Subject to certain limitations, manufacturers are also permitted to fund off-label continuing medical education programs for practicing physicians.87 There is also a provision of the FDCA that governing the presentation of “healthcare economic information” by a manufacturer “to a formulary committee, or other similar entity, in the course of the committee or the entity carrying out its responsibilities for the selection of drugs for managed care or other similar organizations.”88 Known as “Section 114” because of its numeration in the Food and Drug Administration Modernization Act (FDAMA), the statutory provision defines health care economic information as “[a]ny analysis that identifies, measures, or 81
21 C.F.R. § 312.7(a). Ralph F. Hall & Elizabeth S. Sobotka, Inconsistent Government Policies: Why FDA Off-Label Regulation Cannot Survive First Amendment Review Under Greater New Orleans, 62 FOOD DRUG L.J. 1, 9 (2007) (“FDA permits dissemination of information about investigational uses in order to recruit or educate investigators or clinical trial subjects.”). 83 Id. at 32-33. 84 Citizen Petition Regarding the Food and Drug Administration's Policy on Promotion of Unapproved Uses of Approved Drugs and Devices; Request for Comments, 59 Fed. Reg. 59,820, 59,823 (Nov. 18, 1994) (providing that "information on unapproved uses may be disseminated through the submission of original research to peer-reviewed publications"). 85 U.S. Food and Drug Admin., Revised Draft Guidance for Industry Distributing Scientific and Medical Publications on Unapproved New Uses—Recommended Practices (Feb. 2014), available at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm387652.pdf. and U.S. Food and Drug Admin., Draft Guidance for Industry Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices (June 2014), available at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm400104.pdf. 86 U.S. Food and Drug Admin., Draft Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (Dec. 2011), available at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm285145.pdf. 87 Final Guidance on Industry-Supported Scientific and Educational Activities, 62 Fed. Reg. 64,074, 64,093-100 (Dec. 3, 1997). 88 21 U.S.C. § 352(a). 82
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