Meeting+Minutes+Sep+2+2009+DL&ER+Workgroup

1. Export only issue: a. Issue: FDA/customs can’t connect the product being exported to a drug listing. i. When it may have to be reimported (for a return), there is no drug listing to refer to. ii. Issue: NDC number will not appear on the package, so how will customs know how to connect with the drug listing data? iii. Upon import, customs will communicate with the sponsor and sponsor can refer customs back to the drug listing. b. David Mazyak discussed this topic at DIA. FDA does expect industry to drug list products for export only ‐ using a more simplified SPL format i. If multiple countries, include 1 content of labeling and assign 1 set of NDCs. ii. Do not expect a translated COL. iii. COL would be similar to what we would include for an API. c. There will be a guidance out soon that will clarify this.
 * Topics from DIA meeting (Items 1 - 3):**

d. If we already market the product in the US and drug list, would we be considered drug listed? Reply: MF thinks this would be sufficient. e. Export letter explaining issues: Letter that Jean drafted has not yet been sent. Need to send this to David Mazyck soon ‐‐ to identify issues and so that he can involve pharma in the discussion before any decisions are made. i. Group wants to get out by the end of this week. ii. Jean can send this out under her signature as long as other pharma are represented in the letter. Let Jean/ MiChael know asap if you can be included/mentioned in the letter. 2. Submitting SPL: New guidance will be coming out soon that describes how to link the drug listing submission to the submission to the review division. 3. Project Pillbox: Project lead wanted to know if there were others that wanted to be involved in reviewing the project work – ie posting images of product to NLM, associated with the SPL. a. Let Michael know if you want to be involved, and he will pass along the information as to how to get involved. 4. Private Label Distributor: a. What is a private labeler distributor and. i. Per proposed rule to amend 207.1, published Aug 29, 2006. http://www.fda.gov/OHRMS/DOCKETS/98fr/06‐7172.pdf ii. Refer to page 5 of this pdf document, section II. B. 2. iii. “Private label distributors are owners or operators of establishments not otherwise required to register under section 510 of the act that distribute under their own label or trade name a drug manufactured or processed by a registered establishment.” iv. A private label distributor relationship can occue in many situations: • Walgreens/CVS type companies that market products (eg generics) under their brand ‐‐ manufactured by another company. • Large parent US companies for which the branded product is manufactured by one of their foreign subsidiaries. • Partnership arrangements where another company markets a product for the license holder/manufacturer. • Etc. b. Can a manufacturer drug list for a private label distributor? Yes. The drug listing SPL includes: i. The private labeler distributor requests a labeler code, using their corporate name and DUNS number. ii. The private label distributor is stated as the “Labeler” with their DUNS number iii. The manufacturer is listed as the “registrant” as well as one of the establishments. iv. The SPL uses the NDC number with the labeler code of the private labeler distributor 5. How would a repackager or relabeler create SPL for their products:? They would create new SPL by either (1) downloading it from Daily Med, or (2) getting the SPL from the manufacturer. Then, a. Change the set ID and change out the DPL and how supplied sections b. Put the NDC code of the original product in the DPL. ** Delisting Products: ** a. A process was outlined by FDA in last week’s SPL Process Meeting for situations where companies need to delist products that listed by a foreign manufacturing subsidiary. Lonnie Smith also sent out these instructions in an email (forwarded by Michael right before today’s meeting). i. Process: Copy the existing SPL, change the set ID, change the NDCs to the foreign manufacturer’s labeler code. Add a market start date (yesterday). Submit. Add a market end date (today). Submit. ii. One large pharma estimated that this process can be used on 90% of their products. iii. This process depends on the fact that SPL already exists for the product. iv. We think the percentage for most pharma is significantly below 90%. See other scenarios below. b. Key issues with problems/questions: i. Is there a requirement to delist products (ie ous mfg sites, old products, duplicate NDC numbers, discrepancies, etc.)? Yes, the CFR covers multiple reasons for delisting. ii. Process outlined above assumes SPL exists. There are many scenarios for which SPL doesn’t exist. In this case, complete SPL, including content of labeling, must be created – just of then delist the product. iii. This is a huge waste of time/effort/money. iv. SPL will exist on NLM, at least temporarily, and then in the archives. v. Risk re‐creating COL from paper files. QA nightmare. vi. Risk of getting bad information onto Daily Med for even a day….and having it archived as a presumably valid SPL/labeling file. vii. OTC products do not currently appear in the NDC directory even though they were drug listed in paper format. Do these need to be delisted? How do we know what was actually listed. Do we want to list these electronically…when we don’t know the exact data that is already listed….just to delist them? 7. Scenarios that cannot follow the proposed process outlined above because no SPL exists. Thus have to create SPL, just to delist: i. Products that are drug listed but (1) are not registered and (2) no SPL exists. Companies are stopping (or have stopped) marketing these. ii. Products that are currently being sold, but are living out their shelf life iii. OTC products – not electronically drug listed yet. So no SPL exists. Some companies have hundreds of products. iv. Outdated products (eg. foreign manufacturing sites for which products/licenses have been sold.) These products have not been marketed in years and should have been delisted years ago – but weren’t. • What COL to use? The COL that was effective for the company is not the same as the current COL – assuming that the product is still being marketed by someone. v. Company acquired products, but other companies didn’t delist their products. How to go about de‐listing for previous owners. vi. More to be identified. See below. 8. Proposals – since no SPL exists for these scenarios, can we have an abbreviated / minimalistic approach: i. Current SPL file with abbreviated COL in an SPL file—to minimize the burden to sponsors to create SPL for outdated products. ii. Abbreviated SPL file with minimal data: generic name, product codes, market start, market end, with no COL. Will this be allowed? Previous answer is “no”. iii. Would it be easier for FDA to mandate that all current products be listed electronically by a certain date….and delete everything in the paper listing system. iv. More to be identified. See below. 9. Michael Fahmy volunteered to pull a group together representing interested parties from the different subteams (to include Rx, OTC, generics, etc). The goal would be to identify scenarios and proposals, and then to discuss these with Lonnie Smith.
 * 6. Delisting products by Excel spreadsheets – FDA is no longer accepting Excel files to delist **.