CBI Scene Blog

Unique Challenges When Commercializing Specialty Drugs & How to Mitigate Risk

Posted by Sarah S on Nov 12, 2014 10:09:42 AM

It is understandable that drug companies wish to extend the use of a product they spent considerable time and money developing. Similarly, patients who have been unable to find answers to their medical issues can hardly be blamed for championing off-label use of a medication to help alleviate a problem.

Opening up a drug to uses other than the one explicitly stated on its label, however, brings significant challenges. Regulators must ensure that drug manufacturers aren’t pushing product or advertising it in misleading or untruthful ways. Medical affairs departments and physicians must remain compliant but still do their utmost to help patients.

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Topics: Compliance

5 Best Practices to Secure Enterprise-Wide Buy-In for Master Data Management

Posted by Stephanie V on Oct 9, 2014 9:43:05 AM

 

The benefits of master data management in the life sciences industry cannot be understated; the enterprise-wide MDM approach allows for better communication across departments, ultimately leading to a reduction in overhead cost and significant improvements in overall business functioning. Unfortunately, in spite of the ample evidence suggesting that MDM is the way of the future in the world of life sciences, stakeholders may not be in favor of this approach. Convincing reluctant stakeholders is possible, but it requires thorough research and a compelling presentation littered with case studies and industry-wide analytics. The securing of an enterprise-wide buy-in may be a guaranteed challenge, but the following five best practices should make reluctant stakeholders more amenable to the idea of MDM.

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Topics: Compliance

Howard Doffman, VP & General Counsel at Ferring Pharmaceuticals on Social Media

Posted by Daria Binder on Aug 19, 2014 2:59:00 PM

 

Historically, the bio/pharmaceutical industry has been hesitant to adopt social media strategies, mainly due to the lack of regulatory guidance. The June 2014 FDA draft guidance on the Internet and social media has clarified some questions regarding what is considered to be appropriate messaging on social media sites, including patient/physician forums, Facebook, YouTube and Twitter (to name a few). Though the guidance is new, it has definitely helped to interpret regulatory stances on the topic.  I had the pleasure of discussing the social media draft guidance with Howard Dorfman, Vice President and General Counsel at Ferring Pharmaceuticals. He was able to shed some light on what the FDA guidance really means for industry, including how industry has and will continue to change, industry strategies, what is still unclear and what SOPs might be put in place to better utilize the social media world.

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Topics: Brand & Digital Strategy, Compliance

5 Tips to Manage Transparency & Aggregate Spend Dispute Resolution

Posted by Logan Fleck on Jul 8, 2014 1:18:00 PM

The medical sciences field comes with a wide range of uphill battles. There are about a million different issues and one major issue is open payment disputes. It is always helpful to identify those individuals in a company that are going to be able to help deal with open payments disputes. These individuals should be skilled in dealing with issues quickly and easily to help make the process run smoothly.

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Topics: Compliance

How to Establish Effective Global Transparency Reporting

Posted by Joseph D on Jun 27, 2014 11:36:00 AM

When it comes to exchanges of value with health care professionals and organizations, life science companies are faced with a myriad of transparency laws and industry codes. This complicated regulatory environment is predicted to become more extensive in 2014 and beyond, making it important for these companies to understand their reporting requirements and optimize their systems. Many life science companies are taking a global approach to compliance, which is prompting them to improve the efficiency of their data management systems.

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Topics: Compliance

Requirements for Open Payments Reporting for Clinical Research

Posted by Miranda B on Jun 19, 2014 10:00:00 AM

According to the Centers for Medicare and Medicaid Services, there has been a final ruling on the National Physician Payment Transparency Program: Open Payments, better known as the Sunshine Act. Under the Open Payments program, data collection of medical device and drug manufacturers who send gifts and payments to physicians and teaching hospitals is now mandatory. This applies to any manufacturer who receives government reimbursement, and collection data will be posted on a public website as of September 30, 2014.

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Topics: Clinical, Compliance

How to Prepare for Public Disclosure of Sunshine Data

Posted by Logan Fleck on Jun 9, 2014 10:14:00 AM

 

 

The March 31, 2014 deadline for submitting reports reflecting the financial relationships between biotech companies, group-purchasing organizations (GPOs), pharmaceutical companies and medical device manufacturers passed. Physicians now have 45-days to review the reports for errors before the Centers for the Medicare and Medicaid Services (CMS) database goes online.

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Topics: Compliance

Are Grey Areas In The Sunshine Act Leaving Manufacturers in a Fog?

Posted by Alice Dong on Apr 24, 2014 2:34:00 PM

While some areas of the U.S. Sunshine law are “clear as daylight," after a glance, and then a nice, long, hard stare, other areas of the law may leave manufacturers wandering in the dark. Through organizing teleconferences and issuing FAQs and updates, Centers for Medicare & Medicaid Services (CMS) has attempted to narrow the gaps between the law and real-life practices, but even with the combination of the statute, final regulation and its preamble, and CMS guidance (collectively, what we can term the “solid ground”), significant areas of vagueness remain, including the identification of teaching hospitals and whether to report certain indirect payments. These outstanding gaps seem hardly fair as manufacturers face significant monetary penalties for failure to report accurately. So, what are some methods for how manufacturers can leverage “solid ground” resources to develop a reasoned approach in addressing such gap areas?

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Topics: Compliance

Harry Potter’s Severus Snape & Big Pharma, a Comparison

Posted by Daria Binder on Sep 18, 2013 11:25:00 AM

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Topics: Brand & Digital Strategy, Medical Affairs, Patient Access, Distribution and Channel, Compliance, Finance

A Cautionary Tale as You Prepare for an FDA Advisory Committee Meeting

Posted by Scott Wallask on Sep 10, 2013 9:36:00 AM

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Topics: Compliance