Re: Annual Licensure of Wholesale Distributors, 204 of Public Law No , the Drug Supply Chain Security Act (DSCSA), 21 U.S.C.

Transcription

1 BY ELECTORNIC MAIL Connie T. Jung, RPh, PhD Associate Director for Policy and Communication Office of Compliance Food and Drug Administration Room 2242, White Oak Office Building New Hampshire Avenue Silver Spring, MD Re:, 204 of Public Law No , the Drug Supply Chain Security Act (DSCSA), 21 U.S.C. 353(e)(2) Dear Dr. Jung: The Healthcare Distribution Management Association (HDMA) thanks you and the Food and Drug Administration (FDA) for the collective efforts to begin implementation of Title II of Public Law No , the Drug Supply Chain Security Act (DSCSA). One of the early requirements of the DSCSA is for FDA to begin accepting reports from wholesale distributors about their state licenses. Pursuant to amended 503(e)(2) of the Federal Food, Drug and Cosmetic Act (FDC Act), 21 U.S.C. 353(e)(2), beginning January 1, 2015, any person who engages in wholesale distribution must, among other things, report to FDA each state in which it is licensed. The Guidance Agenda published by the Center for Drug Evaluation and Research (CDER) states that the agency intends to issue guidance in calendar year 2014 regarding Reporting Licensure by Wholesale Drug Distributor and Third-Party Logistic Providers. In anticipation of FDA issuing guidance and the fast-approaching licensure submission requirements, HDMA offers the following brief comments. HDMA is the national association representing primary wholesale distributors, the vital link between the nation s pharmaceutical manufacturers and healthcare providers. Each business day, HDMA member companies ensure that 15 million prescription medicines and healthcare products are delivered safely and efficiently to nearly 200,000 pharmacies, hospitals, long-term care facilities, clinics and others nationwide. HDMA and its members work daily to provide value and achieve cost savings, an estimated $42 billion each year to our nation s healthcare system. For more information, visit AFDOCS/

2 Letter to Connie T. Jung, RPh, PhD Page 2 of 6 1. Annual Wholesale Distributor Licensure Reporting Requirements The DSCSA provides as follows: (A) REPORTING. Beginning January 1, 2015, any person who owns or operates an establishment that engages in wholesale distribution shall (i) report to the Secretary, on an annual basis pursuant to a schedule determined by the Secretary (I) each state by which the person is licensed and the appropriate identification number of each such license; and (II) the name, address and contact information of each facility at which, and all trade names under which, the person conducts business; and (ii) report to the Secretary within a reasonable period of time and in a reasonable manner, as determined by the Secretary, any significant disciplinary actions, such as the revocation or suspension of a wholesale distributor license, taken by a state or the Federal Government during the reporting period against the wholesale distributor. 503(e)(2)(A), 21 U.S.C. 353(e)(2)(A). 2. Submitting State Licensure Information to FDA HDMA recommends that wholesale distributors submit state licensure information electronically, in a standardized template. We attach a sample EXCEL spreadsheet as an example of the desired format. HDMA urges FDA to make the submission of information to the agency as easy and straightforward as possible. We attach, in an EXCEL format, a template that satisfies this need for simplicity and includes all the information the DSCSA requires: each state in which the wholesale distributor is licensed; the state license number; the name, address and contact information for each facility at which the wholesale distributor conducts business; and all trade names. The spreadsheet is deliberately organized first by facility address to reflect the fact that a single wholesale distribution facility, although situated in one state, may hold licenses to distribute in many or even in a majority or all of the states. We believe that organizing the data collection so that it leads by facility address is the most sensible way to collect and present the information to FDA. Wholesale distributors have a very strong preference for submission of state licensure information electronically, via this type of standardized template, which FDA can then internally upload to a database. We do not believe that other information submission portals/mechanisms that FDA currently hosts and implements are suited to the submission of wholesale distributor state licensure information because of the unique structure of distributor operations and the information that the DSCSA mandates must be submitted. A single wholesale distribution center

3 Letter to Connie T. Jung, RPh, PhD Page 3 of 6 might be licensed to distribute in all 50 states, with each state having a unique license number, and wholesale distributors have multiple, licensed physical locations. A mid-sized or large wholesale distributor could easily be reporting thousands of individual state license numbers to FDA. As such, we believe it will be very difficult to make this information submission if FDA uses a reporting mechanism that requires an individual to log into an FDA portal and type into the website one state license after another, after another, after another, for each of the wholesale distributor s many licensed distribution centers. Using this type of submission system will be very error prone as an individual must manually enter long alphanumeric strings of state license numbers and there could be up to 50 state licenses to be reported for each distribution facility. The length of time involved which could be hours and even days will be very slow and cumbersome. We believe time outs, transcription errors and lost data entries are very likely. We, therefore, recommend that wholesale distributors submit their state licensure information in an electronic file in a format such as the spreadsheet attached. If FDA intends to implement a different submission system, we ask that the agency consult with wholesale distributors on its design to assure that DSCSA reporting requirements are met in a manner that facilitates efficient submission of the required information to the agency. 3. Reporting Interval HDMA recommends that wholesale distributors report by the last business day in January their state licenses that are in effect as of January 1. The DSCSA requires wholesale distributors to report their state licenses to FDA on an annual basis pursuant to a schedule determined by [FDA] beginning on January 1, (e)(2)(A)(i), 21 U.S.C. 353(e)(2)(A)(i). Given that reporting begins on January 1, 2015, HDMA recommends that, going forward, FDA adopt reporting requirements that have wholesale distributors report by the last business day in January of each year, their state licenses that are in effect as of January 1 for the same year. There are numerous reasons to follow this type of submission schedule. Wholesale distributors, like other businesses, are very busy at the end of the calendar year closing out financial and other commercial activities. Making the submission as of January 1 may be difficult operationally to accomplish, particularly if FDA adopts a reporting system that is very manual and labor-intensive. Further, state licensing bodies, to the extent they renew wholesale distribution licenses effective January 1 (and not all do so), may wait days or weeks to mail out renewed licenses. Even though a license is renewed, the wholesale distributor may not receive the actual, written, renewal notification from the state licensing authority for several weeks after it submits its renewal application. Reporting by the last business day in January all licenses in

4 Letter to Connie T. Jung, RPh, PhD Page 4 of 6 effect on January 1 will afford wholesale distributors the time to assure that licensure submissions are as accurate as possible. 4. Public Availability of Wholesale Distributor State Licensure Information HDMA recommends, and the DSCSA requires only, FDA s public database of wholesale distributors state licenses identify the distributor s name, contact information and the states in which it is licensed to engage in wholesale distribution. FDA must create a publicly available database of registered wholesale distributors and their state licensure status. Such database shall (i) identify each authorized wholesale distributor by name, contact information and each state where such wholesale distributor is appropriately licensed to engage in wholesale distribution; (ii) be available to the public on the Internet website of the Food and DrugAdministration; and (iii) be regularly updated on a schedule determined by the Secretary. 503(e)(2)(B), 21 U.S.C. 353(e)(2)(B). The DSCSA specifically recognizes that some of the information that wholesale distributors submit to FDA may be confidential: Nothing in this paragraph shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information 503(e)(2)(D), 21 U.S.C. 353(e)(2)(D). Wholesale distributors are particularly concerned that the publicly available database not contain the physical addresses of their warehouse locations listed with FDA. Distribution centers are large, secured and very anonymous to avoid attracting the attention of would-be thieves. While individual facility addresses are likely available in local telephone directories, all wholesale distributor addresses are not, currently, easily accessible in a single place. Including physical address information in the FDA database that would be available on the agency website and be easily searchable could increase the risk that those intent on theft or diversion will target distributions centers. This raises serious concerns about employee and product safety, since physical violence and disregard for appropriate product handling can be associated with, for example, burglary. Costs may also increase as a result of public disclosure to cover such additional expenses as increases in insurance rates.

5 Letter to Connie T. Jung, RPh, PhD Page 5 of 6 We note that the DSCSA does not require the identification of distribution center addresses. Wholesale distributors must provide the addresses of their facilities to FDA. 503(e)(2)(A)(i)(II), 21 U.S.C. 353(e)(2)(A) )(i)(ii)). However, new 503(e)(2)(B), 21 U.S.C. 353(e)(2)(B), expressly requires publication in the database only of the identity of each wholesale distributor by name, contact information and each state in which the distributor is licensed; the DSCSA does not require publication of addresses. The inclusion of broader language in new subsection 503(e)(2)(A)(i)(II) (registration information provided to FDA) and the narrower language in new subsection 503(e)(2)(B) (information available in public database) strongly suggests that address of each facility is not required to be included in the public database. As noted above, the DSCSA does not require disclosure of physical addresses, and we cannot think of another reason for disclosing this information that would override the highly compelling security considerations. Thus, we urge FDA not to display the physical addresses of wholesale distributors warehouse locations on the publicly available database. 5. Time and Manner For Reporting Significant Disciplinary Actions HDMA recommends that wholesale distributors report to FDA any significant disciplinary action within 30 days of when the action is final and do so via the same mechanism that state licensure information is submitted. The DSCSA requires a wholesale distributor to report to FDA certain disciplinary actions within a reasonable period of time and in a reasonable manner, as determined by the Secretary (e)(2)(A)(ii), 21 U.S.C. 353(e)(2)(A)(ii). a. Reasonable Period of Time Many state licensing bodies already require reporting of disciplinary actions. While the timeframes vary, HDMA believes that in most states the most common requirement is for a wholesale distributor to report final disciplinary actions to a state licensing board within 30 or more days, or at time of renewal. 1 A few states have shorter reporting intervals. 2 1 See e.g., Alaska Board of Pharmacy, 12 AAC (30 days); Colorado Board of Pharmacy, (q) (30 days); Delaware Board of Pharmacy, 8.2.1(30 days); Iowa State Board of Pharmacy, IA BReg (4) (30 days); New Jersey Department of Health, NJ Practice Act 24:6B-15. C (30 days); Washington State Board of Pharmacy, WA BReg (30 days); Wyoming Board of Pharmacy, WY BReg Chapter 8 Section 5.(f) (30 days); Idaho State Board of Pharmacy (7) (at time of renewal); Illinois Board of Pharmacy, IL BReg (45 days); Kentucky Board of Pharmacy, KY BReg 902 KAR 55:010.(4) (30 days or time of renewal, whichever comes first); West Virginia Board of Pharmacy, WV Practice Act 60A-8-7 (at renewal or 12 months, whichever occurs first). 2 See e.g., Oregon State Board of Pharmacy, (10) (15 days); Oklahoma State Board of Pharmacy (10 days).

6 Letter to Connie T. Jung, RPh, PhD Page 6 of 6 HDMA recommends that FDA s reporting requirements align with those that currently exist in most states and that wholesale distributors report any significant disciplinary action within 30 days of when the action is final. We recommend reporting of only final actions to allow for those circumstances in which the wholesale distributor is contesting, disputing or otherwise appealing a disciplinary action. b. Reasonable Manner HDMA recommends that significant disciplinary actions be reported to FDA via whatever mechanism the agency elects for receipt of licensure information. A dedicated address or portal should be sufficient for submission of this information. Whatever the reporting mechanism, it should allow for verification of the submission so that the wholesale distributor can demonstrate that it met its reporting obligations. * * * HDMA thanks you for this opportunity to provide initial suggestions on wholesale distributor licensure. If you have any questions, please contact me at or at aducca@hdmanet.org. Sincerely, Anita T. Ducca Vice President, Regulatory Affairs Attachment: EXCEL Spreadsheet - Example for Reporting Licensure Information

7 Report to FDA by any person who owns or operates an establishment engaged in wholesale prescription drug distribution 21 U.S.C. 353(e)(2)(A)(i) Example - Not for Official Use Name of facility Address Contact information Other trade names State State Lic. Number Facility name Facility street address, city, state, zip code Contact information Trade Name 1 State 1 License #1 Trade Name 2 State 2 License #2 Trade Name 3 State 3 License #3 State 4 License #4 State 5 License #5 EXAMPLE: 123 Distributor 123 Main St., Sacramento, CA License Department XYZ Distributor AK 1 ATD Distributor CA Model Healthcare OR xy12345 WA wa NV xyz Attachment Letter to Connie T. Jung, RPh, PhD From the Healthcare Distribution Management Assocaiton ;