Regulatory and Compliance Implications of Orphan Drugs


Providing incentives to spur the development of new and novel drugs to combat rare diseases has historically posed a challenge to drug manufacturers, the FDA, the medical community, and—most important—patients afflicted with these diseases. Given the high and ever-increasing costs and challenges of drug development, combined with the relatively small number of patients that would be eligible to receive such treatments—which limits a company’s ability to recoup its R&D investment—pharmaceutical manufacturers have struggled with the economics of rare-disease drug development. The Orphan Drug Act, passed in 1983, was designed to address these concerns by providing incentives for pharmaceutical companies to develop drugs for uses for rare disorders or conditions. While the act was well intended, its application in practice has generated speed bumps as companies try to navigate through the waters of government reimbursement programs applicable to these drugs, as well as an unpredictable and often inconsistent DOJ enforcement pattern.
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Our Technology Continues to Evolve – So Why Hasn’t our Security?


When you think about the ways in which technology has evolved over the last 20 years, it’s not difficult to imagine how much is left to explore and discover. It’s estimated that by 2020, there will be approximately 50 billion Internet-connected devices across the globe, compared to the 6 billion in existence today. This means that many of the future categories of Internet of Things (IoT) devices have yet to be thought of. In the next several years, we can expect exponential growth and innovation within this new realm of ‘things’ that work together to make our lives easier, but with this growth comes vulnerability and insecurity.
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The Role of Compliance in Launch Strategy


Rules and regulations govern every aspect of a drug’s life cycle, but the early days of approval have unique risks that come with heavy pressure for a successful launch. With studies demonstrating the importance of the first six months on the market to a drug’s long-term sales potential, not to mention the high and rising cost of drug development and commercialization, ensuring the success of drug launches is a critical strategic priority for every CEO and closely watched by every industry analyst. During this critical pre- and post-launch window, decisions must be made about the best strategies for positioning the product and gaining market access. The historical launch playbook no longer works in today’s hypercompetitive and cost-sensitive market. More innovative customer engagement approaches and value propositions are needed. However, new strategies – and heightened organizational pressures – also often mean increased risk, thus increasing the need for companies to partner with compliance experts early in the launch planning stage. Considering compliance on the front end not only minimizes risk, but it can also prevent costly and time consuming investments into developing marketing campaigns and sales strategies that eventually have to be rethought following regulatory review.
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Labogen First to be Charged in Brazil Under New Anti-Corruption Law. Who will be Next?


In Brazil, a recent case highlighted the need for pharmaceutical and medical device companies to improve their local business-to-government compliance policies, as well as echoed requests for transparency and objectiveness in certain Government-funded projects. Up to 20% of a company’s annual gross revenues may be at stake.
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Best Practices for Handling FDA Inspections


Like death and taxes, FDA inspections are inevitable. The agency conducted at least 40,000 inspections in 2012, according the FDAZilla blog. While the FDA is required to inspect drug manufacturing facilities every two years, the agency can conduct additional inspections such as for Pre-Approval Inspections (PAIs) and “For-cause” inspections in case of a drug recall, adverse event, etc.
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Medical Device and Healthcare Cybersecurity


In a now famous 2012 episode of Showtime’s award-winning series, Homeland, the cross-section of medical devices and cybersecurity was presented to viewers in stark relief when terrorists hacked into the vice president’s pacemaker and brought on a fatal heart attack. The possibility (and ramifications) of such an attack may have been new to the viewing public, but to those in the cybersecurity industry it was simply the cinematic realization of a risk that had been known for some time. In the months and years preceding the episode, cybersecurity experts had both raised the issue in papers, and demonstrated how one could use a laptop to wirelessly (1) hack into a pacemaker and deliver a 830-volt shock, and (2) hack into an insulin pump and deliver unregulated does of insulin.
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