Pharmaceutical Compliance Monitor
The help to keep in Compliance
We have seen a number of major mergers and acquisitions among pharmaceutical companies over the last few years. Is long term success in this industry an issue of size? And most importantly how do we mitigate the risk of large M&A transactions? This article will take a look at the reasons why mergers are so tempting and how to mitigate some of the inherent risks.
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In the multi-stakeholder, evidence-based healthcare environment of today, patient-reported outcomes (PRO) are becoming an increasingly important tool for drug developers to better demonstrate the real-world value of medications. As with nearly all other types of observational research, PRO provide clinicians, payers and regulators with additional data not only with regard to safety and effectiveness but also about outcomes that are most important to patients.
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Despite the 1988 enactment of the Prescription Drug Marketing Act (“PDMA”) 21 U.S.C. § 331, et seq., the drug supply chain remains vulnerable to diversion. Despite the PDMA’s goals to prevent the introduction and retail sale of substandard, ineffective, and counterfeit drugs, there are no regulations providing an industry-wide pedigree system to ensure compliance. As a result, the pharmaceutical industry has no consistent policy or means to prevent drugs from being diverted from authorized primary channels into unauthorized, but seemingly legitimate secondary market channels. These secondary channels are portals through which mislabeled, adulterated, expired, sub-potent, and counterfeit drugs enter the nation’s drug distribution system.[i]
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Any reports about contaminated, diverted or fake prescription drugs being taken by unsuspecting patients is a cause for concern. According to the latest figures from the National Community Pharmacists Association (NCPA), America’s independent community pharmacies dispense 1.5 billion prescriptions annually, and those sales represent over 92% of their business. These small business health care providers are committed to ensuring the pharmaceutical supply chain is safe and secure, which occasionally entails offering system-strengthening recommendations.
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