Policy & Medicine Compliance Update
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AUGUST 2019 Issue
Issue Summary:
For August, our focus is once again on compliance in research, and we start with a look at the world of collaborative research. Maureen Lloyd and her fellow co-authors take an in-depth look at the current landscape of collaborative research and provide a practical suggestion for compliance to encourage consistency and transparency. Next, we have the second part of the series on real-world evidence and examine what the future may hold for its use in life sciences development and marketing. Rounding out the topic, David Vulcano discusses the FDA’s most recent attempt to improve patient access through Project Facilitate.
We then switch gears to examine the tapestry of regulations surrounding access to and use of medicinal cannabis. Darshan Kulkarni, Pharm.D, and Amy Urbine provide an overview of the current framework as a guide to compliance professionals. In a similar vein, Nicodemo Fiorentino examines the history and current landscape of state and local attempts to license pharmaceutical sales representatives.
FEATURE
Practical Considerations for Collaborative Research Between the Pharmaceutical Industry and External Investigators
By Maureen Lloyd, Cynthia Barbitsch, Mary Voehl Hirsch,Antonia Panayi, Eric Southam
Summary: Traditionally, clinical research has been conducted via either industry-sponsored studies or non-industry investigator-sponsored studies. Collaborative Research provides a relatively new mechanism for industry and non-industry partners to work together in the pursuit of effective and safe treatments for the patient. The aims of this article are to provide both industry and non-industry investigators with a greater insight into the complex processes that are currently employed by industry when entering into Collaborative Research agreements and to encourage consistency and transparency in approach across companies.
In Collaborative Research, instead of being limited to providing funding and/or product, the industry partner contributes expertise complementary to that of the non-industry partner, who is the sponsor of the study. Collaborative Research may be conducted before, during, or after regulatory approval of a drug or medical device, and maybe interventional, observational, or preclinical.
A collaboration requires appropriate process and governance frameworks to be established in order to be successful. Important considerations include the routes for submitting a request, the review and approval process, due diligence criteria, budgeting and contracting processes, permissible interactions during the execution of the research, the closing out of the research, and dispute resolution. It is also necessary to have in place an agreed communication strategy and a risk control framework. Clear and specific contract language around roles and responsibilities, intellectual property, rights to data, registration, and disclosure of publications, and an understanding of adverse event reporting procedures are other critical facets of Collaborative Research that are essential to avoid delays and disputes.
With no global standards for Collaborative Research, it is important that partners establish practical procedures, good ongoing communication, alignment of goals, and transparent interactions and disclosure to jointly advance the science of new, safe and effective therapies
TAGS: Collaborative Research, Research
Research
Data in the “Real World” – The Future?
By Dr. Seth B. Whitelaw and David Vulcano, LSCW, MBA, CIP, RAC
Summary: Real-world evidence is playing an increasing role in the development and marketing of pharmaceutical, medical devices. This is the second of the two-part series and examines what the future may hold and the implications for life science compliance professionals.
TAGS: Real-World Evidence, Real-World Data, Big Data, Research
Making Patient Access Better – FDA Launches Project Facilitate
by David Vulcano, LSCW, MBA, CIP, RAC
Summary: FDA has announced its newest initiative in the hopes of further streamlining preapproval access to investigational products outside of clinical trials under Single-Patient INDs. A pilot is underway for oncology drugs with plans to expand into other therapeutic areas if successful.
TAGS: FDA, Preapproval Access, Project Facilitate
Cannabis
Cannabidiol Confusion – A Brief Overview of Cannabis Laws for Compliance Professionals
by Darshan Kulkarni, Pharm.D, MS, Esq. and Amy Urbine, MS
Summary: The patchwork of laws surrounding the sale or use of cannabis has resulted in a confusing tapestry of state, federal, and local laws, as well as penalties for seemingly minor oversights. Since medical cannabis is still considered illegal by the federal government, it is important for compliance professionals to have a thorough understanding of the laws surrounding the substance to ensure that businesses are operating within legal parameters, which are discussed in this article.
TAGS: Cannabis, State Laws, Local Laws
Licensing
Pharmaceutical Representative Licensing: The Past, Present, and Future
By Nicodemo Fiorentino
Summary: The District of Columbia, the City of Chicago, and the state of Nevada all impose laws on pharmaceutical manufacturers’ employees, including their agents, to obtain a license or be registered prior to conducting certain activities within the respective jurisdiction. This article provides a refresher of those requirements and examines past and present legislation that has been introduced.
TAGS: Sales Representatives, State Laws, Local Laws
