Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
Polsinelli Podcast - Generic Drugs to Market - What's the Climate in 2014?
It is seen as the cost of doing business. It may be illegal, but is also highly profitable, so why stop?
That seems to be the attitude of many pharmaceutical companies – and the latest proof of that comes in the form...more
The recent investigations into two pharmaceutical companies active in the ophthalmic drugs market in Italy and France serve as a reminder of the cooperation that takes place between national competition authorities....more
What is the “country of origin” for the drugs you manufacture? This question arises every time a pharmaceutical company labels a drug, imports it, exports it, markets it, or sells it to the U.S. government. Unfortunately, the...more
Last year continued the trend of robust False Claims Act (FCA) enforcement by the U.S. Department of Justice (DOJ) and proliferating qui tam lawsuits brought by whistleblowers on behalf of the United States. In 2012, DOJ...more
In an article, entitled “GSK China probe flags up wider worries”, in the Wednesday edition of the Financial Times (FT) reporters Andrew Jack and Patti Waldmeir discussed the ongoing bribery and corruption scandal involving...more
On November 18, 2013, the Senate, by voice vote, approved the Drug Quality and Security Act (DQSA), intended to bolster the Food and Drug Administration's (FDA) oversight of compounding pharmacies in light of last year's...more
A new law, the Internet System for Tracking Over-Prescribing (I-STOP) Law (§3343-a of the NYS Public Health Law) enacted one year ago, will go into effect on August 27, 2013, requiring practitioners who prescribe controlled...more
As the Healthcare Landscape Shifts, Four Issues Are Critical to Build Effective Market Access Strategies -
In this time of high growth and fast change for the healthcare industry, pharmaceutical, biotechnology and...more
As part of its expanded authority resulting from the Patient Protection and Affordable Care Act (PPACA), the Health Resources and Services Administration (HRSA) is continuing its efforts to ensure compliance with 340B Drug...more
On February 15, the Centers for Medicare & Medicaid Services (CMS) released its Proposed Rule, effective calendar year (CY) 2014, implementing the Medical Loss Ratio (MLR) requirements for Medicare Advantage (MA)...more
The government may be coming up with a new cost-effective measure to help balance the federal budget – enlisting private companies to do their policing. A 2011 settlement between the Justice Department and Google for $500...more
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