Pharmaceutical Commerce Legal / Regulatory RSS Feed http://pharmaceuticalcommerce.com/legalregulatoryrss.xml Pharmaceutical Commerce Legal / Regulatory RSS Feed en-us Lessons learned on bona fide service fees and fair market value-is there a 'right answer'? http://pharmaceuticalcommerce.com/legal_regulatory?articleid=26842 Recent regulatory actions and court cases highlight the importance of due diligence in reporting the value of service fees when federal reimbursements are concerned. The financial consequences can be substantial Criminal investigations for counterfeit, diverted drugs skyrocketed in 2012 http://pharmaceuticalcommerce.com/legal_regulatory?articleid=26812 Number of cases opened by FDA's Office of Criminal Investigations (OCI) triples to 170 Who will represent the specialty pharmacy business? http://pharmaceuticalcommerce.com/legal_regulatory?articleid=26813 As the business grows at double-digit rates, representing its interests becomes its own business opportunity VALID Compounding Act to regulate compounding pharmacies is introduced http://pharmaceuticalcommerce.com/legal_regulatory?articleid=26726 A new policy debate over drug regulation is emerging as the NECC scandal worsens In an EHR era, adverse event reporting takes on a new look http://pharmaceuticalcommerce.com/legal_regulatory?articleid=26717 As the number of adverse events (AEs) grows year by year, regulators and industry managers are looking at automated systems to handle the burden Analyzing drug-pricing mechanisms http://pharmaceuticalcommerce.com/legal_regulatory?articleid=26667 Pricing systems in US drug supply chain have many limitations; an analytics-based method might avoid some of them Medicare Star ratings: the billion-dollar opportunity for providers http://pharmaceuticalcommerce.com/legal_regulatory?articleid=26669 New incentives for health plans could alter the way payers review new drugs Ensuring the quality of comparative effectiveness research http://pharmaceuticalcommerce.com/legal_regulatory?articleid=26611 As payers seek higher-quality data from real-world treatment settings, the importance of reliable measures becomes critical 2012 PDMA Sharing Conference preview http://pharmaceuticalcommerce.com/legal_regulatory?articleid=26588 New sample reporting requirements will be a focus of this year's meeting Drug shortages 2012: a worsening situation, but movement on industry response http://pharmaceuticalcommerce.com/legal_regulatory?articleid=26589 Despite the lack of headlines today as compared to late last year, the drug-shortage situation has not improved. FDA, congressional and industry actions are beginning to change the dynamic Manufacturers are reviving their serialization plans http://pharmaceuticalcommerce.com/legal_regulatory?articleid=26485 The pioneering firms that installed serialization and track-and-trace systems are being joined by a fast follower crowd, but an industry-wide commitment is still in the future Aggregate Spending Rules Arrive, But Industry Is Still Gearing Up http://pharmaceuticalcommerce.com/legal_regulatory?articleid=2654 The 'Sunshine Act' provisions of the Affordable Care Act require records to be kept . . . Drug Shortages Continue To Rise, With No Near-Term Resolution http://pharmaceuticalcommerce.com/legal_regulatory?articleid=2608 A combination of regulatory processes and business practices are worsening an already-bad drug shortage situation . . . Google Prepares for a Possible $500-Million Penalty for Illegal Online Pharmacy Advertising, Says WSJ http://pharmaceuticalcommerce.com/legal_regulatory?articleid=2527 Dispute with US DoJ highlights role of NABP's Verified Internet Pharmacy Practice Sites (VIPPS) programs . . . Aggregate Spend Laws: Here Comes the Sun http://pharmaceuticalcommerce.com/legal_regulatory?articleid=2517 The industry is far from ready when it comes to collecting, aggregating, cleansing and disclosing data about regulated financial transactions with doctors and hospitals . . . How REMS Affect Pharmaceutical Distribution Processes and Partners http://pharmaceuticalcommerce.com/legal_regulatory?articleid=2462 First-ever study of the impact of REMS on supply chains finds that collaboration is a critical requirement . . . Google Prepares for a Possible $500-Million Penalty for Illegal Online Pharmacy Advertising, Says WSJ http://pharmaceuticalcommerce.com/legal_regulatory?articleid=2447 Dispute with US DoJ highlights role of NABP's Verified Internet Pharmacy Practice Sites (VIPPS) programs . . . FDA's Social Media Enforcement: Emerging Rules of Engagement http://pharmaceuticalcommerce.com/legal_regulatory?articleid=2394 The Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have signaled that social media marketing is a priority . . . FDA Opened 72 New Counterfeit Cases in 2010--a New Record http://pharmaceuticalcommerce.com/legal_regulatory?articleid=2398 Caseload reinforces concerns over illegal trade and distribution of pharmaceuticals . . . Adverse Event Reporting: At the Front Lines of Drug Safety http://pharmaceuticalcommerce.com/legal_regulatory?articleid=2349 Industry and regulators are taking steps to revolutionize the basic regulatory function of collecting and analyzing adverse medical events . . . 2010 Product Security Report http://pharmaceuticalcommerce.com/legal_regulatory?articleid=2278 More pieces for industry-wide track-and-trace are falling into place, but there's no rush to authenticate products . . . Consumer Survey Highlighting Drug-Safety Worries Accompanies Introduction of http://pharmaceuticalcommerce.com/legal_regulatory?articleid=2227 Senator Michael Bennet wants better FDA oversight of drug supply chain and material sourcing, as survey shows that 36% of Americans likely to vote have heard of unsafe ingredients . . . A Process-Based Approach To Aggregate Spend http://pharmaceuticalcommerce.com/legal_regulatory?articleid=2201 A Process-Based Assessment (PBA) is the first step to analyzing reporting needs . . . Smoothing the Path to Drug Safety http://pharmaceuticalcommerce.com/legal_regulatory?articleid=2156 In recent months, many healthcare stakeholders have expressed concern over Risk Evaluation and Mitigation Strategies (REMS) implementation Defending Fair Market Value (FMV) Assessments http://pharmaceuticalcommerce.com/legal_regulatory?articleid=2160 To avoid anti-kickback litigation with government, pharma companies need a defensible position on FMV assessments . . . With Healthcare Reform, Aggregate Spending Jumps as a Regulatory Priority http://pharmaceuticalcommerce.com/legal_regulatory?articleid=2090 The growing number of states with laws now are joined by the "51st state": the federal government . . . Medication adherence could get an EHR boost http://pharmaceuticalcommerce.com/legal_regulatory?articleid=1959 Growing digitization of patient data could break the threshold to better adherence to medication therapies Improving Outcomes Research Protocols http://pharmaceuticalcommerce.com/legal_regulatory?articleid=1952 Through its Sentinel Initiative program, FDA is planning to use data on 100 million patients to conduct all sorts of post-marketing surveillance, to proactively look for adverse events signals . . . Healthcare Provider Pushes Back on FDA's REMS Policies http://pharmaceuticalcommerce.com/legal_regulatory?articleid=1930 Kaiser Permanente files a citizen's petition to revise FDA's process of imposing REMS programs, also objects to restrictions on wholesale-distribution . . . Medical-Waste Processor Bids to Assist Manufacturers Who Distribute Injectables to the Home-Health Market http://pharmaceuticalcommerce.com/legal_regulatory?articleid=1922 Sharps Compliance Corp. lauds California law to raise the profile of proper consumer disposal of used sharps. Next up: unused pharmaceutical returns . . .