Impact of New Proposals on Name Creation for 87 th PTMG Conference Vienna, Austria

Transcription

1 Impact of New Proposals on Name Creation for 87 th PTMG Conference Vienna, Austria Susan M. Proulx, PharmD President, Med-ERRS A subsidiary of the Institute for Safe Medication Practices (ISMP)

2 Overview of Talk Latest guidances related to trademarks South Africa (Dec 2011) Health Canada (Feb 2013) EMA (June 2013) US FDA trademark guidance (awaiting its arrival Fall 2013?) Other US Proposals impacting TM s Risk Assessment Proposal (Dec 2012) P&L Proposal (April 2013) Comparison of guidances How to develop a trademark in this environment 2

3 Up to this point US FDA The last TM Guidance issued by FDA is Complete Submission, but it does not tell you how safety testing should be done, just what to submit to FDA. PDUFA IV was a failure due to lack of participation by sponsors. What s next? TM guidance allegedly coming out this fall. 3

4 What Should be Included in a Request for Proprietary Name Review? (FDA) Primary and alternate proprietary names Intended pronunciation of names Derivation of name Intended meaning of name modifiers Pharmacologic/therapeutic category Labeling Proposed labeling and container labels/labeling (if available) Established name and all clinical info such as dosage form, strength(s) (if labels are not available) Care environment for dispensing and use Delivery system/measuring device Testing is not required at this point 4

5 The FDA & Trademarks DMEPA is the division of FDA that reviews trademarks Currently reviews names for 45 new compounds per month Roughly 1/3 of the names submitted by companies are rejected 48% of the rejections are due to potential look-alike/sound-alike conflicts 25% of post-marketing errors are still due to trademark confusion FDA Vision Statement To increase the safe use of drug products by minimizing user error that is related to the labeling and/or packaging of the product Copyright Med-ERRS

6 The FDA & Trademarks The FDA will likely reject proposed brand names that: Imply a claim that is too promotional in nature Imply a benefit the data cannot support Sound or look like a currently marketed drug (Rx or OTC) Incorporate a USAN stem Incorporate a dosage regimen (BID, TID, etc.) in the name Copyright Med-ERRS

7 FDA review of proposed trademarks Initially, FDA will conduct a search of several standard reference texts: MICROMEDEX Facts and Comparisons New Drug Approvals Text and Image database American Drug Index Online version of FDA Orange Book USPTO (U.S. Patent and Trademark Office) After this initial review, DMEPA will then conduct primary market research with healthcare professionals to ascertain confusion or hyperbole Sample size of ~100 respondents used Group is made up of pharmacists (hospital or retail), physicians, nurses and all who could potentially prescribe or dispense the drug Copyright Med-ERRS

8 The FDA & Trademarks FDA uses a Murphy s law approach and assumes that anything that can go wrong, will go wrong FDA sets up their review process to simulate the real-world prescription environment Review process uses techniques such as interpreting written and phoned-in dummy scripts with the proposed brand name Besides the sound or look of a proposed name, other factors that the FDA will weigh before ultimately rejecting or accepting a name would be: Proximity of the name to another one in the same therapeutic category Dosing regimen Dosage strength Prescribing or dispensing environment Route of administration Duration of regimen Copyright Med-ERRS

9 Newest FDA Guidances FDA is releasing a series of 3 draft guidances over the course of ~1 year Purpose: To help minimize risks contributing to medication errors in the US Risk Assessment Draft Guidance Released: December 2012 Recommendations to minimize risk and improve drug product and container closure design at earliest stage in development Nomenclature Draft Guidance Anticipated: Fall 2013 Will include best practices for the development and testing of proposed proprietary names to minimize risks associated with drug product nomenclature, such as proprietary names that look or sound like the name of another product Package and Label Draft Guidance Released: April 2013 Recommendations for ensuring a product s container labels and carton labeling are designed to promote safe dispensing, administration, and use of product 9

10 Risk Assessment Draft Guidance: What you need to know When designing a product, sponsors should consider how the drug product will be used, the environments of use and how the end users will interact with the drug product design Sponsors should conduct proactive risk assessments before the initial approval of a medication, and also prior to subsequent product modifications such as: Additions to a product line (e.g., adding an extended-release formulation) Making changes to a currently marketed product (e.g., new strength, new dosage form, new packaging configuration, new indication of use, new delivery system) Prior to a revision made to address a known problem or error Sponsors are encouraged to conduct proactive risk assessments using: Failure Mode and Effects Analysis Simulated Use Testing 10

11 Risk Assessment Draft Guidance: What you need to know Many medication errors can be avoided by using proactive risk assessments Ultimately helps reduce risks associated with a drug product s overall design Risk assessments that employ analytical approaches (e.g., exploratory or formative evaluations and simulated use testing) should occur early in the design development process Taking into consideration the development and design of a drug product can reduce post approval safety issues Proactive risk assessments should: Consider human and environmental factors in drug product design to help manufacturers anticipate potential use errors Identify the need for implementing iterative design modifications Ensure that any design modification minimizes unintended consequences and the recurrence of use errors 11

12 Risk Assessment: Trademark Data Collection Project leader reviews the following information prior to the evaluation: Information provided by sponsor: Product information for other similar products, which focused on the nomenclature of ophthalmic products Examples of dual trademarks and modifiers for products currently on the market Select reports of actual or potential medication errors Summary is prepared using the gathered information for evaluation Each panel member independently reviews summary information Panel members are asked to consider potential error scenarios, pros and cons for each naming convention as well as other safety concerns Expert panel meets for discussion of the issues at hand, using the gathered information as references Potential error scenarios that could occur with each naming convention are determined Using the elements of FMEA, the panel assesses the potential failure mode(s), i.e., what can go wrong and what the outcome would be. Focus is on the following phases of the drug use process: procurement prescribing dispensing administration Focus on worst case scenarios Most common error expected Potential outcomes and risk of patient harm is recorded for each scenario Consensus decision is reached Panel determines which naming convention they would recommend from the safety standpoint Copyright 2013 Med-ERRS Friday, October 11,

13 Package & Label Draft Guidance: What you need to know The format and content of prescription drug and biological product labels and labeling must: Comply with FDA regulations in 21 CFR part 201 for drugs and 21 CFR part 610 Subpart G-Labeling Standards for biologics Conform with all labeling requirements required by the United States Pharmacopeia (USP) Principle display panel should include the following information: Proprietary name Established name or proper name Product strength Route(s) of administration Warnings (if any) or cautionary statements (if any) 13

14 Package & Label Draft Guidance: What you need to know Present key information such as the product name, strength, and dosage form in a clear, concise manner and display prominently. Sponsors should maximize the readability of proprietary, established, and proper names on the container label and carton labeling. We recommend capitalizing only the first letter in the proprietary name because words written in all-capital letters are less legible than words written in mixed case letters. The established name must be at least one-half the height of the proprietary name on the label...recommend not superimposing text over images or logos or placing a logo immediately before or after the proprietary name, because the logo can often look like an additional letter in the proprietary name. In addition, there should be no intervening written, printed, or graphic matter between the proprietary name, established name, and product strength (see (a)). 14

15 South Africa Very comprehensive guidance published by the Medicines Control Council in December 2011 Old drugs vs. new (pre-1965) Applicants may be requested to change an existing name Guidance issues opinions on: Family (umbrella) names INN requirements Incorporation of company identifiers Qualifiers and abbreviations Rx to OTC switches Reasons why a name may be rejected 15

16 South Africa some details The name of every registered product shall be unique and distinctive Could proprietary name pose public health risk and safety concerns, or is it misleading? Want to prevent potential medical errors or misadventures that may occur due to LA or SA proprietary names Names which imply an ingredient, benefit or use that may be misleading in nature or degree not acceptable Proposed proprietary name should not result in confusion in print, handwriting or speech with another proprietary name of another medicine Scheduling status of product will influence name evaluation (e.g., increased transparency of naming product for self-selected consumer products) Don t use: Ordinary words Personal names of people Abbreviations, or acronyms 1- or 2-letter names Phonemic and morphemic anagrams (e.g., COZAAR/ZOCOR) 16

17 Comparisons of Guidances Criteria US EMA Canada S. Africa Number of names submitted/approved What to submit (Mandatory/suggested) When to submit Additional names submitted? 1/1 2/2 1/1 1/1 Proposed name plus product characteristics Can submit with IND or NDA Use of qualifiers/modifiers Case by case basis perform risk assessment Testing methodology Proposed name(s) plus product characteristics 18 months 4 months prior to submission Proposed name plus brand name assessment (mandatory) N/A Provide motivations and supporting documentation as part of submission Y Y Y? Not specified since PDUFA IV concept paper Yes, but not single letters or numbers, and understandable across all EU languages Not specified May be acceptable if meets criteria Specified in guidance (search, simulate, synthesize) N/A Use one word, unless to differentiate strengths or route Not specified 17

18 Comparisons of Guidances (cont.) Criteria US EMA Canada S. Africa Approval by other regulatory authorities Reasons for rejection Use of INN/USAN stems Use of revoked/withdrawn names N/A N/A Sponsor may submit assessment that was sent to other regulatory authorities Confusability/ promotional issues USAN stems not accepted in stem position Generally not accepted Confusability/ promotional issues No similarity versus INN; not accepted in stem position +/- 5 years after withdrawal/ revocation Confusability/ misleading INN/USAN not allowed in trademark in any position Raises red flag If approved by more than one, then may accept name LA/SA issues plus misleading INN stems not accepted in stem position Generally not accepted Language English All 24 languages English/French 11 languages 18

19 What can sponsors do re: name creation? More questions than answers More difficult today to get a global name with the increase in rejections and increased scrutiny by regulatory authorities A global trademark can decrease the risk of wrong drug being dispensed to patient when traveling ROI: More time, money and effort for following the guidances (Health Canada) If testing is done according to a guidance, then will we see an increase in approvals? Should we develop/test more names? One report for all regulatory agencies? Probably not Should similar testing be performed in all countries where the name will be filed? 19

20 What can sponsors do re: name creation? More questions than answers Start name creation and initial testing earlier Name bank?? (with preliminary name clearance) Don t develop names that would be attached to a particular product Do safety testing even in countries without requirements Define a filing strategy of where to file first Country with most rejections/largest market? (US) Most comprehensive evaluation process? (Canada) Most name approvals? (EMA) 20

21 Thank you! Copyright Med-ERRS