PHS/340B Audit Survival GuideEven the most disciplined and compliant companies dread receiving a letter or an email informing them of an impending audit. Nobody likes being put under the microscope. It doesn’t take a great deal of imagination to know what it feels...
Factors to Consider When Acquiring and Launching A Previously Marketed PharmaceuticalContemplating Acquiring An Existing Product?Be Sure to Do Your Homework!Any pharmaceutical manufacturer who has launched a new prescription drug understands the enormity of such an...
Another Update on Drug Price Disclosure LegislationMore tips for staying compliant with an accelerating trendStates Continue Their March Toward Prescription Drug Transparency Regulations. This paper, our fourth in a series that looks at the rising number of price...
Understanding Baseline AMP Rules Can Help You Avoid Pricing Decision DisastersWhat brand and generic drug manufacturers need to knowA lack of understanding respective to baseline Average Manufacturer Price (AMP) and how it can affect your Medicaid pricing can result...
Continued Emergence of Drug Price Disclosure LegislationTips for staying compliant with an accelerating trendStates Have Gotten Aggressive with Fines Against Pharma Companies for Price Reporting Noncompliance This paper, our third in a series that looks at the rising...
Avoiding Costly Government Pricing MistakesBasic steps pharmaceutical manufacturers should employ to avoid erroneous government pricing calculationsManaging Government Pricing (GP) computations can feel a bit like walking through a cave without a flashlight. Even an...
Continued Emergence of Drug Price Disclosure LegislationTips for staying compliant with an accelerating trendThe summer of 2019 saw an 86 percent increase in the number of states enacting pharmaceutical drug price disclosure laws. This paper, our second in a series...
Drug Price Disclosure LegislationFour steps to staying ahead and staying compliantMany states have moved to enact mandatory pharmaceutical price disclosure laws that would increase price transparency to address prescription drug costs (Fig. 1, pg. 3). In 2018, states...