Mist’s commercialization of products that provide unique and meaningful clinical advantages improves the lives of patients who are suffering from cardiovascular and metabolic disease as well acute and chronic pain.
Mist acquires under-promoted, under-utilized products and those in late stage clinical development, in order to enhance their market acceptance via reformulation or revitalized promotion. The end result is newer therapeutic options for providers and patients.
A fully integrated specialty pharmaceutical company, Mist’s commercialization team covers all key commercial and scientific disciplines including:
Regulatory and Medical Affairs
Sales and Marketing
Managed Markets and Trade Relations
The core leadership at Mist is comprised of individuals who have more than 100 years of collective experience building and operating successful companies in the healthcare industry.
Joseph J. Krivulka, Founder and Chairman
Mr. Krivulka has more than 30 years of pharmaceutical management and product experience. He has founded a number of successful companies, including Reliant Pharmaceuticals and Triax Pharmaceuticals. He has also served as president of Bertek Pharmaceuticals, Inc., (a subsidiary of Mylan Laboratories).
Mr. Krivulka has also held management positions in marketing, product strategy, clinical development and manufacturing at several major pharmaceutical companies, including Janssen Pharmaceuticals (a Johnson & Johnson company), Sandoz Pharmaceuticals, and Lederle Labs.
Keith Rotenberg, Ph.D., Founder and President
Dr. Rotenberg has close to 25 years experience in various clinical and regulatory settings within global pharmaceutical companies. Early in his career, he led the Regulatory Affairs and Quality Operations for Forest Laboratories, worked as a Senior Licensing Executive for G.D. Searle, and led Regulatory Affairs for Lorex Pharmaceuticals. He also was a Technical Supervisor and Pharmacologists with the FDA where he developed expertise on various regulatory and quality assurance issues. Dr. Rotenberg founded Rotenberg Consultants, LLC, where he advised clients on FDA interaction with respect to regulatory and quality assurance issues. In 2003 he became Vice President, Regulatory Affairs with Reliant Pharmaceuticals, Inc. where he was later promoted to Senior Vice President, Research & Development.
Timothy J. Soule, Founder and Corporate Secretary
Mr. Soule has over 20 years of business development and management experience in the pharmaceutical industry and government. Prior to Mist Pharmaceuticals he served as Senior Director, Human Resources with Reliant Pharmaceuticals. From 1986 to 2000, he served as President of Franklin County Industrial Development Corporation where he managed numerous industrial expansion and business development projects. Mr. Soule earned his BA degree in economics and political science from Middlebury College.
Todd K. Noe, Vice President of Sales
Mr. Noe has over 15 years of experience in pharmaceuticals sales management. He began his career with Abbott Laboratories as sales representative, quickly rising through the ranks as a sales specialist, district sales manager and national sales trainer. Mr. Noe also served as a district sales manager with Ferndale Laboratories before moving on to become a Regional Manager with Triax Pharmaceuticals during a critical period of growth for the company. Mr. Noe spent 3 years with Akrimax Pharmaceuticals where he developed and managed a large sales region for the company through its inception and subsequent growth, highlighted by a series of product launches that took place on very aggressive timelines. In addition to his experience in pharmaceutical sales management, Mr. Noe is a veteran of the United States Marine Corps where he taught leadership, team building and discipline.
At Mist Pharmaceuticals, our expertise allows us to provide innovative solutions for patients suffering from cardiovascular or metabolic disease or from conditions causing significant pain. Our portfolio currently includes the following prescription drug therapies:
Stendra ® (avanafil) tablets, a co-promotional effort with Akrimax Pharmaceuticals and TIMM Medical. For more information about Stendra, please visit www.stendra.com. Please click here to see Full Prescribing Information.
NitroMist ® (nitroglycerin lingual aerosol). For more information about NitroMist, including Full Prescribing Information, please visit www.NitroMist.com. Please click here to see Full Prescribing Information including Black Box Warning.
Primlev ™ (oxycodone HCl/acetaminophen) CII. For more information about Primlev including Full Prescribing Information, please, go to www.Primlev.com. Please click here to see Full Prescribing Information including Black Box Warning.
Tirosint ® levothyroxine sodium) capsules, a co-promotion with Akrimax Pharmaceuticals. For more information about Tirosint including Black Box Warning, please visit www.Tirosint.com. Please click here to see Full Prescribing Information including Black Box Warning.
At Mist Pharmaceuticals, we constantly look to expand our product offering with the goal of becoming a company that is recognized for its ability to aid health care professionals and patients with best in class therapies.
If you would like more information about Mist Pharmaceuticals or would like to discuss business development or partnering opportunities, please contact:
Mist Pharmaceuticals Business Development Dept.
At Mist Pharmaceuticals, we offer entrepreneurially-minded employees the opportunity to work collaboratively in a small team of highly-skilled and motivated professionals dedicated to improving the lives of patients suffering from cardiovascular and metabolic disease and acute pain.
We believe that our employees are our biggest asset and are at the core of our company. That’s why at Mist we work to create an environment in which smart, compassionate and knowledgeable employees can work in a fast-paced and supportive environment. If you’re a seasoned pharmaceutical pro who might like the challenge of helping to build a new best-in-class pharmaceutical company, Mist may be right for you.
Applying for a job at Mist is easy. Simply send a copy of your most recent resume to careers@MistPharma.com. We’ll review your credentials and will respond quickly if we think there’s an opportunity.
Last Updated: 5/2/2017
THE SITES DO NOT PROVIDE MEDICAL ADVICE. The Sites, and the Content are provided for informational purposes only, and are not intended as a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something made available to you on the Sites, or the Content. If you think you may have a medical emergency, call your doctor or 911 immediately. Reliance on the Sites, and the Content is solely at your own risk.
USE OF PERSONAL DATA
Our Sites contain descriptions of various Products. We attempt to be as accurate as possible with the descriptions of the Products that are made available to you through the Sites. However, we make no warranties that the Product descriptions and any other content are accurate, complete, reliable, current, or error-free. We reserve the right, at any time, to modify, suspend, or discontinue the sale of any Product with or without notice and we will not incur any obligation as a result of such change.
LINKS TO THIRD PARTY SITES
The Sites may contain links to other websites (“Linked Sites”). The Linked Sites are not under the control of Mist Pharmaceuticals and Mist Pharmaceuticals is not responsible for the contents of any Linked Site, including without limitation any link contained in a Linked Site, or any changes or updates to a Linked Site. Mist Pharmaceuticals is not responsible for webcasting or any other form of transmission received from any Linked Site. Mist Pharmaceuticals is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement by Mist Pharmaceuticals of the site or any association with its operators.
Mist Pharmaceutical’s community, like any community, functions best when its people follow a few simple rules. By accessing and/or using the Sites, you hereby agree to comply with these community rules and that:
You will comply with all applicable laws in your use of the Sites and will not use the Sites for any unlawful purpose;
You will not access or use the Sites to collect any market research for a competing business;
You will not upload, post, e-mail, transmit, or otherwise make available any content that:
infringes any copyright, trademark, right of publicity, or other proprietary rights of any person or entity; or
is threatening, tortious, defamatory, libelous, indecent, obscene, pornographic, invasive of another’s privacy, or promotes violence; or
discloses any sensitive information about another person, including that person’s e-mail address, postal address, phone number, credit card information, or any similar information;
You will not “stalk” or otherwise harass another;
You will not impersonate any person or entity or falsely state or otherwise misrepresent your affiliation with a person or entity;
You will not decompile, reverse engineer, or disassemble any software or other products or processes accessible through the Sites;
You will not circumvent, remove, alter, deactivate, degrade, or thwart any of the protections in the Sites;
You will not use automated means, including spiders, robots, crawlers, data mining tools, or the like to download or scrape data from the Sites, directly or indirectly, except for Internet search engines (e.g., Google) and non-commercial public archives (e.g., archive.org) that comply with our robots.txt file;
You will not use, frame, or utilize framing techniques to enclose any Mist Pharmaceuticals’ trademark, logo, or other proprietary information (including the images found on the Sites, the content of any text, or the layout/design of any page or form contained on a page) without Mist Pharmaceuticals’ express written consent;
You will not use meta tags or any other "hidden text" utilizing a Mist Pharmaceuticals’ name, trademark, or Product name without Mist Pharmaceuticals’ express written consent;
You will not take any action that imposes or may impose (in our sole discretion) an unreasonable or disproportionately large load on our technical infrastructure;
You will not interfere with or attempt to interrupt the proper operation of the Sites through the use of any virus, device, information collection or transmission mechanism, software or routine, or access or attempt to gain access to any data, files, or passwords related to the Sites through hacking, password or data mining, or any other means; and
If you find something that violates our Community Guidelines, please let us know, and we’ll review it.
We reserve the right, in our sole and absolute discretion, to deny you access to the Sites, or any portion of the Sites, without notice, and to remove any comments that do not adhere to these guidelines.
The Sites contain materials, such as software, text, graphics, images, sound recordings, audiovisual works, and other material provided by or on behalf of Mist Pharmaceuticals (collectively referred to as the “Content”). The Content may be owned by us or by third parties. The Content is protected under both United States and foreign laws. Unauthorized use of the Content may violate copyright, trademark, and other laws. You have no rights in or to the Content, and you will not use the Content except as permitted under this Agreement. No other use is permitted without prior written consent from us. You must retain all copyright and other proprietary notices contained in the original Content on any copy you make of the Content. You may not sell, transfer, assign, license, sublicense, or modify the Content or reproduce, display, publicly perform, make a derivative version of, distribute, or otherwise use the Content in any way for any public or commercial purpose. The use or posting of the Content on any other website or in a networked computer environment for any purpose is expressly prohibited.
If you violate any part of this Agreement, your permission to access and/or use the Content and the Services automatically terminates and you must immediately destroy any copies you have made of the Content.
The trademarks, service marks, and logos of Mist Pharmaceuticals (“Mist Pharmaceuticals Trademarks”) used and displayed on the Sites are registered and unregistered trademarks or service marks of Mist Pharmaceuticals. Other company, product, and service names located on the Sites may be trademarks or service marks owned by others (the “Third-Party Trademarks”, and, collectively with the Mist Pharmaceuticals Trademarks, the “Trademarks”). Nothing on the Sites should be construed as granting, by implication, estoppel, or otherwise, any license or right to use the Trademarks, without our prior written permission specific for each such use. Use of the Trademarks as part of a link to or from any site is prohibited unless establishment of such a link is approved in advance by us in writing. All goodwill generated from the use of the Mist Pharmaceuticals Trademarks inures to our benefit.
Elements of the Sites are protected by trade dress, trademark, unfair competition, and other state and federal laws and may not be copied or imitated in whole or in part, by any means, including but not limited to the use of framing or mirrors. None of the Content may be retransmitted without our express, written consent for each and every instance.
COMMUNICATIONS WITH US
Although we encourage you to e-mail us, we do not want you to, and you should not, e-mail us any content that contains confidential information. With respect to all e-mails you send to us, including but not limited to, feedback, questions, comments, suggestions, and the like, we shall be free to use any ideas, concepts, know-how, or techniques contained in your communications for any purpose whatsoever, including but not limited to, the development, production and marketing of products and services that incorporate such information.
DISCLAIMER OF WARRANTIES; LIMITATION OF LIABILITY
THE INFORMATION, CONTENT, SOFTWARE, PRODUCTS, AND SERVICES INCLUDED IN OR AVAILABLE THROUGH OUR SITES MAY INCLUDE INACCURACIES OR TYPOGRAPHICAL ERRORS. CHANGES ARE PERIODICALLY ADDED TO THE INFORMATION HEREIN. MIST PHARMACEUTICALS AND/OR ITS SUPPLIERS MAY MAKE IMPROVEMENTS AND/OR CHANGES IN THE SITES AT ANY TIME. ADVICE RECEIVED VIA THE SITES SHOULD NOT BE RELIED UPON FOR PERSONAL, MEDICAL, LEGAL OR FINANCIAL DECISIONS AND YOU SHOULD CONSULT AN APPROPRIATE PROFESSIONAL FOR SPECIFIC ADVICE TAILORED TO YOUR SITUATION.
MIST PHARMACEUTICALS AND/OR ITS SUPPLIERS MAKE NO REPRESENTATIONS ABOUT THE SUITABILITY, RELIABILITY, AVAILABILITY, TIMELINESS, AND ACCURACY OF THE INFORMATION, CONTENT, SOFTWARE, PRODUCTS, SERVICES AND RELATED GRAPHICS CONTAINED ON SITES FOR ANY PURPOSE. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, ALL SUCH INFORMATION, CONTENT, SOFTWARE, PRODUCTS, SERVICES AND RELATED GRAPHICS ARE PROVIDED “AS IS” WITHOUT WARRANTY OR CONDITION OF ANY KIND. MIST PHARMACEUTICALS AND/OR ITS SUPPLIERS HEREBY DISCLAIM ALL WARRANTIES AND CONDITIONS WITH REGARD TO THIS INFORMATION, CONTENT, SOFTWARE, PRODUCTS, SERVICES AND RELATED GRAPHICS, INCLUDING ALL IMPLIED WARRANTIES OR CONDITIONS OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NON- INFRINGEMENT.
IN CONNECTION WITH ANY WARRANTY, CONTRACT, OR COMMON LAW TORT CLAIMS: (I) WE SHALL NOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES, LOST PROFITS, OR DAMAGES RESULTING FROM LOST DATA OR BUSINESS INTERRUPTION RESULTING FROM THE USE OR INABILITY TO ACCESS AND USE THE SITES, OR THE CONTENT, EVEN IF WE HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES; AND (II) ANY DIRECT DAMAGES THAT YOU MAY SUFFER AS A RESULT OF YOUR USE OF THE SITES, OR THE CONTENT SHALL BE LIMITED TO ONE HUNDRED DOLLARS ($100).
SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OF CERTAIN WARRANTIES. THEREFORE, SOME OF THE ABOVE LIMITATIONS ON WARRANTIES IN THIS SECTION MAY NOT APPLY TO YOU.
You agree to defend, indemnify, and hold us and our officers, directors, employees, successors, licensees and assigns harmless from and against any claims, actions, or demands, including, without limitation, reasonable legal and accounting fees, arising or resulting from: (i) your breach of this Agreement; (ii) your misuse of the Sites and/or the Content, and (iii) your violation of any intellectual property or other right of any third party.
TERMINATION OF THIS AGREEMENT
Mist Pharmaceuticals reserves the right, in its sole discretion, to terminate your access to the Sites and the related services or any portion thereof at any time, without notice.
COMPLIANCE WITH APPLICABLE LAWS
The Sites are intended to be used only by residents of the United States. We make no claims concerning whether any Content may be downloaded, viewed, or be appropriate for use outside of the United States. If you access the Sites from outside of the United States, you do so at your own risk. Whether inside or outside of the United States, you are solely responsible for ensuring compliance with the laws of your specific jurisdiction.
DIGITAL MILLENNIUM COPYRIGHT ACT
Mist Pharmaceuticals respects the intellectual property rights of others and attempts to comply with all relevant laws. We will review all claims of copyright infringement received and remove any Content or user submissions deemed to have been posted or distributed in violation of any such laws.
Our designated agent under the Digital Millennium Copyright Act (the “Act”) for the receipt of any Notification of Claimed Infringement which may be given under that Act is as follows:
Mist Pharmaceuticals, LLC
11 Commerce Dr, 1st Floor
Cranford, NJ 07016
If you believe that your work has been copied on the Site(s) in a way that constitutes copyright infringement, please provide our agent with notice in accordance with the requirements of the Act, including (i) a description of the copyrighted work that has been infringed and the specific location on the Site(s) where such work is located; (ii) a description of the location of the original or an authorized copy of the copyrighted work; (iii) your address, telephone number and e-mail address; (iv) a statement by you that you have a good faith belief that the disputed use is not authorized by the copyright owner, its agent or the law; (v) a statement by you, made under penalty of perjury, that the information in your notice is accurate and that you are the copyright owner or authorized to act on the copyright owner’s behalf; and (vi) an electronic or physical signature of the owner of the copyright or the person authorized to act on behalf of the owner of the copyright interest.
To the maximum extent permitted by law, this Agreement is governed by the laws of the State of New Jersey, U.S.A. and you hereby consent to the exclusive jurisdiction and venue of courts in Union County, New Jersey, U.S.A. in all disputes arising out of or relating to the use of the Sites. Use of the Sites is unauthorized in any jurisdiction that does not give effect to all provisions of these terms and conditions, including without limitation this paragraph. You agree that no joint venture, partnership, employment, or agency relationship exists between you and Mist Pharmaceuticals as a result of this Agreement or use of the Sites. Mist Pharmaceuticals’ performance of this Agreement is subject to existing laws and legal process, and nothing contained in this Agreement is in derogation of Mist Pharmaceuticals’ right to comply with governmental, court and law enforcement requests or requirements relating to your use of the Sites or information provided to or gathered by Mist Pharmaceuticals with respect to such use. If this Agreement is terminated in accordance with the Termination provision above, such termination shall not affect the validity of the following provisions of this Agreement, which shall remain in full force and effect: “Intellectual Property,” “Disclaimer of Warranties; Limitation of Liability,” “Indemnification,” “Termination of the Agreement,” “and “General.” Unless otherwise specified herein, this Agreement constitutes the entire agreement between you and Mist Pharmaceuticals with respect to the Sites and it supersedes all prior or contemporaneous communications and proposals, whether electronic, oral or written, between you and Mist Pharmaceuticals with respect to the Sites. A printed version of this Agreement and of any notice given in electronic form shall be admissible in judicial or administrative proceedings based upon or relating to this Agreement to the same extent and subject to the same conditions as other business documents and records originally generated and maintained in printed form.
© 2017 Mist Pharmaceuticals, LLC.
Last Updated: 5/2/2017
The Information We Collect and/or Receive
In the course of operating the Sites, we will collect (and/or receive) the following types of information. You authorize us to collect and/or receive such information.
If you contact us via the Contact Us page or by any other means through the Site(s), you will be asked to provide certain information which may include your name, e-mail address, phone number, and company name. If you would like to participate in our patient savings program for the Product(s), you will be asked to provide certain information about yourself which may include your name, address, date of birth, zip code, social security number, phone number, gender, physician’s name, physician’s phone number, physician’s zip code, and insurance/payer information.
All information we collect and/or receive under this section is collectively called “Personal Information.”
In addition to the Personal Information we may collect additional information (the “Other Information”). Such Other Information may include:
From Your Activity. In an ongoing effort to improve the Sites and to determine which Mist Pharmaceuticals services are popular, we automatically collect certain information when you visit the Sites. Such information includes, without limitation, your IP address, browser type and language, domain names, referring and exit pages and URLs, date and time, amount of time spent on particular pages, what sections of the Sites visitors visit, and similar information concerning your use of the Sites.
From Cookies. The Sites use “cookies” to help us personalize your online experience. A cookie is a text file that is placed on your hard disk by a web page server. Cookies cannot be used to run programs or deliver viruses to your computer. Cookies are uniquely assigned to you, and can only be read by a web server in the domain that issued the cookie to you. One of the primary purposes of cookies is to provide a convenience feature to save you time. The purpose of a cookie is to tell the web server that you have returned to a specific page. For example, if you personalize Mist Pharmaceuticals pages, or register with Sites or services, a cookie helps Mist Pharmaceuticals to recall your specific information on subsequent visits. When you return to the same Site, the information you previously provided can be retrieved, so you can easily use the Mist Pharmaceuticals features that you customized. You have the ability to accept or decline cookies. Most web browsers automatically accept cookies, but you can usually modify your browser setting to decline cookies if you prefer. If you choose to decline cookies, you may not be able to fully experience the interactive features of the Sites.
Please be advised that if you opt out of any service, you may not be able to use the full functionality of the Site(s).
Information Collected by or Through Third-Party Advertising Companies
How We Use and Share the Information
You authorize us to use your Personal Information, and Other Information (collectively, the “Information”) to provide and improve our Sites; to maintain quality of the service; to solicit your feedback; to inform you about our company, products and services; to contact you via surveys to conduct research about your opinion of current services or of potential new services that may be offered; and to contact you on behalf of external business partners about a particular offering that may be of interest to you.
We do not collect or ask you to provide any sensitive personal information, such as race, religion or political affiliations. But if you provide any such sensitive personal information to us, Mist Pharmaceuticals will not use or disclose any such sensitive personal information, without your explicit consent.
You also authorize us to use and/or share your Information as described below.
Agents, Providers and Related Third Parties. We may engage other companies and individuals to perform certain business-related functions on our behalf. Examples may include providing technical assistance, order fulfillment, customer service, and marketing assistance. These other companies will have access to the Information only as necessary to perform their functions and to the extent permitted by law. We may also share your Information with any of our parent companies, subsidiaries, or other companies under common control with us.
Aggregated Information. In an ongoing effort to better understand our users and the Sites, we might analyze your Information in aggregate form in order to operate, maintain, manage, and improve the Sites. This aggregate information does not identify you personally. We may share this aggregate data with our affiliates, agents, and business partners. We may also disclose aggregated user statistics in order to describe the Sites to current and prospective business partners and to other third parties for other lawful purposes.
Business Transfers. As we develop our businesses, we might sell or buy businesses or assets. In the event of a corporate sale, merger, reorganization, sale of assets, dissolution, or similar event, your Information may be part of the transferred assets.
Legal Requirements. To the extent permitted by law, we may also disclose your Information: (i) when required by law, court order, or other government or law enforcement authority or regulatory agency; or (ii) whenever we believe that disclosing such information is necessary or advisable, for example, to protect the rights, property, or safety of Mist Pharmaceuticals or others.
Accessing and Modifying Information and Communication Preferences
If you have provided us any Personal Information, you may access, remove, review, and/or make changes to the same by contacting us at email@example.com. In addition, you may manage your receipt of marketing and non-transactional communications by clicking on the “unsubscribe” link located on the bottom of any Mist Pharmaceuticals marketing e-mail. We will use commercially reasonable efforts to process such requests in a timely manner. You should be aware, however, that it is not always possible to completely remove or modify information in our subscription databases.
Security of your Personal Information
Mist Pharmaceuticals takes commercially reasonable steps to protect your Personal Information from unauthorized access, use, disclosure, loss, misuse, alteration, or destruction. Please understand, however, that no security system is impenetrable. We cannot guarantee the security of our databases or the databases of the third parties with which we may share such information, nor can we guarantee that the information you supply will not be intercepted while being transmitted over the Internet. In particular, e-mail sent to us may not be secure, and you should therefore take special care in deciding what information you send to us via e-mail.
Important Notice to Non-U.S. Residents
The Sites and the servers are operated in the United States. If you are located outside of the United States, please be aware that any information you provide to us maybe transferred to, processed, maintained, and used on computers, servers, and systems located outside of your state, province, country, or other governmental jurisdiction where the privacy laws may not be as protective as those in your jurisdiction. If you are located outside the United States and choose to use the Sites, you hereby irrevocably and unconditionally consent to such transfer, processing, and use in the United States and elsewhere.
Mist Pharmaceuticals, LLC
11 Commerce Dr, 1st Floor
Cranford, NJ 07016
In addition, Mist Pharmaceuticals does not monitor, recognize, or honor any opt-out or do not track mechanisms, including general web browser “Do Not Track” settings and/or signals.
Compliance Policy Summary
It is the policy of Mist Pharmaceutical, LLC (“Mist”) to comply with all applicable laws and regulations and industry standards, including the PhRMA Code on Interactions with Healthcare Professionals and the Compliance Program Guidance for Pharmaceutical Manufacturers developed by the U.S. Department of Health and Human Services Office of the Inspector General (the “OIG Guidance”). Our Comprehensive Compliance Program incorporates the following elements from the OIG Guidance:
Written Policies and Procedures
Effective Training and Education
Effective Lines of Communication
Internal Monitoring and Auditing
Enforcement Through Discipline Pursuant to Published Guidelines; and
Prompt Response and Corrective Action for Detected Problems
Mist sales and marketing personnel interact with healthcare professionals to provide them with information about Mist products and other relevant educational or scientific topics. Mist believes that these interactions provide educational value to healthcare professionals and help benefit patients. In connection with certain of these interactions, Mist may provide promotional materials, or educational items intended to benefit a patient or related to a healthcare professionals’ practice. Mist may also on occasion offer modest meals to healthcare professionals in connection with educational presentations. The PhRMA Code allows pharmaceutical companies to provide “items designed primarily for the education of patients or healthcare professionals if the items are not of substantial value ($100 or less) and do not have value to healthcare professionals outside of his or her professional responsibilities.” On occasion Mist may approve the distribution of an educational item to a healthcare professional in accordance with the PhRMA Code standards. Mist’s Comprehensive Compliance Program is designed to ensure that these activities are conducted in lawful manner.
California Health and Safety Code §§ 119400-119402 requires pharmaceutical companies to make available their Comprehensive Compliance Program and to set an annual aggregate limit on certain promotional expenditures provide to a healthcare professional as defined under the California law.
Annual Spend Limit
Subject to this California law, Mist has determined that the annual aggregate limit on covered promotional expenditures in California is set at $500.00 per covered healthcare professional for each calendar year. This limit may be revised by Mist from time to time. It is important to note that this annual dollar limit is an upper limit. It is not an accurate representation of the average value of gifts, promotional materials, items or activities that Mist may provide generally to a healthcare professional. The average could be a lower amount. In accordance with the law, certain items and payments are excluded in determining whether the annual limit has been met. The annual limit does not include the value of:
Drug samples provided to healthcare professionals intended for free distribution to patients;
Financial support for continuing medical education forums;
Financial support for health educational scholarships; and
Payments for legitimate professional services, including professional speaking, advising, consulting, training or market research services, that are based on the fair market value of the services provided.
Declaration of Compliance
Mist declares, in good faith, that Mist is in substantial compliance with its Comprehensive Compliance Program and the requirements of California Health and Safety Code §§ 119400-119402. Our declaration is based upon information available during the twelve month period from January 1, 2016 through December 31, 2016. The next declaration will be based upon information captured beginning January 1, 2017.
As appropriate and consistent with applicable law, Mist will amend and make conforming changes to its Comprehensive Compliance Program. Mist is committed to assessing ongoing compliance with its Comprehensive Compliance Program. A copy of the Comprehensive Compliance Program and this written declaration can be requested by calling 973-597-6202.