Building a Drug or Device Sampling Program that is Compliant, Accountable, and Prepared for Federal and State Law


Within the Office of Inspector General’s Compliance Program Guidance for Pharmaceutical Manufacturers (OIG Guidance), three key risk areas are identified. One of the key risk areas is compliance with laws regulating drug sampling. With the enforcement of drug sample transparency spawned from implementation of §6004 of the Patient Projection and Affordable Care Act (PPACA), manufacturers are giving renewed attention to the Prescription Drug Marketing Act of 1987 (PDMA). This law, passed by Congress in 1988, is designed to discourage the sale of counterfeit, adulterated, misbranded, sub-potent, and expired drugs as a means to help ensure the safety and effectiveness of those drugs. The PDMA mandates that pharmaceutical companies implement specific accounting policies and procedures, auditing and monitoring protocols, and thresholds. Civil and criminal penalties are also established for individuals and corporations found guilty of noncompliance with the law.
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Embracing the Good and Avoiding the Bad and the Ugly in Pharma Manufacturing


Good manufacturing has always been about paying attention to the details. But now, thanks to competition, global sourcing, a higher compliance bar and increased regulatory scrutiny, there are more details to worry about than ever.
 
Some projects require thousands of steps towards completion. Under this new complexity, in which analyzing is as important as the manufacturing, the main manufacturing goal is to reduce the number of issues that can disrupt completion, which can range from major to minor. It’s important to realize that minor details, which once might not have represented issues before, can turn into a problem.
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The PDMA Alliance: Improving the Understanding of Drug Distribution Laws and Regulations

The annual Sharing Conference began over twenty years ago when a group of pharmaceutical executives came together to discuss the impact that the Prescription Drug Marketing Act of 1987 was having on their everyday responsibilities related to sample accountability. This group came to be known as The PDMA Alliance, a not-for-profit organization that presents an annual “Sharing” Conference for a diverse membership of industry executives and vendor partners. Conference registration is enhanced with the addition of year-round membership benefits for all participants, accessible through the Alliance website. Alliance membership and conference participation have been extended to include the medical device community, a sure sign of the organization’s ongoing outreach and continuing growth.
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New EU Clinical Trials Regulation


On 16 June 2014 a new Clinical Trial Regulation entered into force in Europe. It will apply no earlier than 28 May 2016.
 
The new regulation presents a major step forward in harmonizing clinical trial assessment process in the EU. For years, Europe was criticized for having too complicated, non-harmonized, nationally driven procedures for clinical trial assessment which often resulted in timely unpredictable and divergent assessment conclusions. Sponsors were faced with numerous country-specific protocol amendments as result of different opinions of one-country’s Competent Authority and Ethics Committee compared to opinions of other EU countries or even different opinions of Ethics Committee compared to national Competent Authority of the same country. In any case, Sponsors could expect any combination of decisions and close follow up by national experts was necessary.
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‘Long Arm of the Law’ Against Corruption Gets a Little Longer


Government’s reach extends to third party intermediaries when it comes to bribes, graft
 
Governments are broadening efforts to stamp out bribes, kickbacks, slush funds, and other forms of corruption. In particular, anti-bribery efforts are focusing upon prohibited cash payments, a lack of supporting documentation, and graft in the form of gifts, hospitality, and entertainment. Pharmaceutical, biotech, and medical device companies are particularly vulnerable because their supply chains, drug development programs and customer bases are expanding globally. The complexity, competitiveness, and highly regulated nature of these industries exert pressures that may lead some third party players to seek “shortcuts” that skirt the law or the manufacturer’s policies.
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Making Strategy Happen


The Pharmaceutical Industry continues to go through significant changes that present both challenges and opportunities. As a result, many companies are responding by developing bold and transformational strategies as they try to set the stage for future success. Setting the right strategy is not easy. It often means “placing bets” on which markets will enable growth, which therapeutic areas to focus on, what business segments to divest and invest, and how to transform business models. But the real challenge is not developing and setting the strategy. The real challenge is aligning the organization to effectively implement the strategy and “making strategy happen”.
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