May 18, 2015 Food and Drug Administration Division of Dockets

May 18, 2015 Food and Drug Administration Division of Dockets Management (HFA-305) 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: Proposed Rule to Require the Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products [Docket No. FDA–2007– N–0363] Dear Sir or Madam: The National Community Pharmacists Association (NCPA) represents the interests of America's community pharmacists, including the owners of nearly 23,000 independent community pharmacies. As small business owners and healthcare providers, our members have a vested interest in this proposed rule and appreciate the opportunity to submit our comments on this important topic. The Food and Drug Administration (FDA) has formally proposed to amend its prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or within the package from which the product is dispensed. NCPA has a long history of working with industry stakeholders on this issue however, to date, a system whereby costs would not be shifted to community pharmacies has yet to be realized. As a point of reference, NCPA formally corresponded with both the FDA Commissioner and Director of the Office of Management and Budget (OMB) on April 4, 2014, respectfully requesting that OMB and FDA suspend plans to issue the pending proposed regulation “Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products”, which was received by the Office of Information and Regulatory Affairs (OIRA) at OMB on August, 3, 2013. NCPA Overall Concerns with the Proposed Rule In the proposed rule, the FDA makes it clear that pharmacies will incur net costs due to initial capital costs to access the information, increased search time when accessing the information and the printing cost when a request is received for the information in printed form. The FDA estimates the annualized costs range from $47 million to $89 million and are a shift from manufacturers to pharmacies. As small business owners, NCPA members are not in a position to absorb these costs. NCPA is opposed to the changes proposed in the rule until reliable systems are in place that will allow pharmacists to access electronic professional package inserts (PI) in a timely, efficient and cost neutral manner. We would like to point to the July 2013 Government Accountability Office (GAO) report entitled Electronic Drug Labeling: No Consensus on the Advantages and Disadvantages of its Exclusive Use as support for our position. This report concludes that relying on electronic labeling as a complete substitute for paper labeling could adversely impact public health by limiting the availability of drug labeling for some physicians, pharmacists, and patients by requiring them to access drug labeling through a medium with which they might be uncomfortable, that they might find inconvenient, or that might be unavailable.1 NCPA’s primary recommendation for any move to electronic labeling is that costs not be shifted to small business community pharmacies. If paper drug labeling ceases to exist, costs will undoubtedly shift to the pharmacies to obtain and/or provide this information to patients who ask for it. The GAO report noted that if patients want to continue receiving drug labeling in paper form and pharmacies are expected to print drug labeling for distribution, it would shift the costs of printing to the pharmacies.2 Please note that it is common practice in community pharmacies for pharmacists to utilize the manufacturer-provided paper insert, which patients often request. A survey of pharmacists conducted recently found that pharmacists who prefer professional prescription labeling “indicate that these inserts are fast and easy to access, are familiar and allow pharmacists to readily search for needed information. Pharmacists also state that familiarity with the professional PIs allow them [to] access information reliably, with minimal interruption to work flow, and without errors.” Moreover, 27 percent of pharmacists polled indicated “that their pharmacy either does not have Internet access or that they cannot browse the internet.”3 Small business community pharmacies are unable to bear the costs of providing this information on their own, which would include additional computer terminals, printers and other office supplies such as paper, ink and toner. The GAO report also rightly noted that disruption to pharmacy workflow that would ensue from having to access the labeling electronically reduces the time available to counsel patients and has been shown to increase the risk for errors made when dispensing a drug.4 In addition, the FDA has not provided adequate evidence to support its assertion that the regulation would improve health benefits to patients. While the health benefits are unknown, the FDA cost benefit analysis shows minimal monetary benefits. In fact, the cost savings would merely be a financial shift from drug manufacturers to pharmacists. Also, there is cause for concern that the proposed changes to the current labeling framework would lead to unintended public health negative consequences, including a risk that healthcare practitioners may not always have access to PI when it’s needed. 1United States Government Accountability Office Report to Congressional Committees; Electronic Drug Labeling No Consensus on the Advantages and Disadvantages of Its Exclusive Use; GAO-13-592; July 2013 2 Id. 3 NERA Economic Consulting, “Pharmacy Practice: A Report on Pharmacists’ Use of Printed Package Inserts” (Jan. 2015) at 7 (hereinafter, “NERA survey”). http://www.nera.com/publications/archive/2015/pharmacy-practice--a-report-on-pharmacists--use-of-printed-packa.html 4 Id. at 1. 2 NCPA Concerns with Shifting Financial Burden on Pharmacies and FDA’s Underestimation of Projected Costs The proposed regulation would shift the financial burden from a higher gross margin industry (pharmaceutical manufacturing) to a lower gross margin industry (pharmacies), inevitably creating economic hardship for pharmacies. The negative economic impacts of the proposed regulation affect pharmacies disproportionally. The FDA expects the cost effects would be similar between independent pharmacies and chain pharmacies (between $565 and $1,014 per affected pharmacy per year) and about 30% of expected costs to hospital pharmacies (between $1,436 and $2,684 per affected pharmacy per year).5 FDA’s assumption, however, is inaccurate. Since average annual revenues of independent pharmacies are less than chain and hospital pharmacies, additional annual costs as percentage of revenues are higher in independent pharmacies than other pharmacies. Additionally, the FDA cost benefit analysis monetizes the time lost by pharmacists using the proposed system at between $31.9 million and $39.8 million annually6, but this estimate underestimates these costs because it fails to include time lost from using the automated phone line for prescribing information. Creating more work for pharmacists could exacerbate the issue of medication errors instead of reducing them. NCPA is concerned that FDA’s Regulatory Impact Analysis7 regarding the Proposed Rule does not accurately weigh the rule’s proposed benefits against its likely costs. These issues are also addressed in detail in an independent, economic-focused assessment of FDA’s Regulatory Impact Analysis conducted by NDP Analytics (hereinafter “NDP Assessment”).8 According to the NDP Assessment, erroneous or unrealistic assumptions include the following: Internet Access: The FDA cost benefit analysis assumes that all pharmacies including independent pharmacies have Internet access, but that some retail chains and hospitals partially or totally block employee access.9 The assumption is wrong. Inadequate or no Internet access is a reality in some parts of the United States. In its 2015 report, the FCC estimates that 54.6 million people and 17% of population in the U.S. in 2013 did not have access to the Internet.10. More than 32.6 million people in the rural and about 53% of population in the rural areas in 2013 did not have Internet access The FDA’s optimistic assumption underestimated the projected costs as well as unintended negative impacts on pharmacies and, by extension, patients. 5 Proposed Regulatory Impact Analysis, FDA, Table 17. 6 Proposed Regulatory Impact Analysis, FDA (pp. 26-27). 7 See “Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products: Proposed Regulatory Impact Analysis, Proposed Regulatory Flexibility Analysis, Unfunded Mandates Reform Act Analysis” available at: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM431225.pdf and FDA Docket FDA-2007-N-0363-0047. 8 See “Assessment of FDA’s Regulatory Impact Analysis Related to the FDA’s Proposed Regulation to Change the Prescription Information from Printed Materials to Electronic Version on the FDA Website” NDP Analytics (May 2015). This report is attached hereto as Attachment A. 9 Proposed Regulatory Impact Analysis, FDA (pp 25). 10 GAO’s report states: “Federal Communications Commission, approximately 14 million Americans have inadequate access or no access to adequate broadband capabilities.” GAO’s findings are based on a 2010 FCC report. 3 Computer Availability: The FDA assumes that only 1% of pharmacies would need to buy additional computers.11

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