Compliance Due Diligence in an M&A Environment


In the pharmaceutical industry, mergers and acquisitions happen on a fairly frequent basis and as such, require due diligence across various business processes. While these mergers may have positive and negative effects on the industry as a whole, one of the most pressing issues is whether the compliance risk is raised as a result.
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They Ain’t Just Whistling Dixie: The Latest on Whistleblowing in America’s Drug Industry


The past three years have been tough on America’s drug industry. The entire chain of commerce from Manufacturer to wholesaler to pharmacy continues to defend accusations that their business dealings caused the federal and state governments to pay “false” claims at taxpayer expense.   Through a seemingly orchestrated campaign, the US Attorney General, the Office of Inspector General for HHS, and various state Attorneys General all tout the ongoing need for persons with knowledge of industry practices to “blow the whistle” on their employers. This campaign is impacting all levels of the drug industry and targeting an array of conduct.
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Recent Trends in Whistleblower Protection under Dodd–Frank


The enactment of the Dodd–Frank Act was intended to provide the SEC with an important weapon in its mission to seek and vigorously prosecute the commission of securities and other types of frauds domestically and overseas. By providing to whistleblowers monetary incentives ranging between 10 percent and 30 percent of fines assessed, the whistleblower program has gained an element of popularity—some would say notoriety—amongst would-be reporters of putative wrongdoing. Recent Federal Court decisions, however, have created significant roadblocks that could blunt the Dodd–Frank juggernaut.
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The Patent Use Code Conundrum – or Why FDA Can’t Read (Patents)


When Hatch-Waxman was adopted 30 years ago, Congress wanted to ensure that generic manufacturers could enter the market with low cost drugs just as soon as the initial protections on the brand drug had expired.  Specifically, Congress was concerned about “evergreening,” whereby new, protected indications might be added to the brand label to thwart generic entry and extend the life of the drug monopoly.  Congress said there was no reason why a generic drug could not be approved for older, unprotected uses at the same time the brand was being sold for newer uses protected by patent or exclusivity.
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The Gray Intersection of Pharma Patent and Reverse Payment Settlement Regulation


The Congress shall have Power To…promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries….
 
-U.S. Constitution Article I, Section 8, Clause 8
 
Ten pharmaceutical (“pharma”) titans support over one-third of the world’s pharma industry. Six of them are based in the United States. Pharma is a $300 billion global industry with figures expected to top $400 billion by 2016. The American legal system—particularly in the areas of intellectual property and antitrust—has scrambled to meaningfully regulate this sector to prevent marketplace collusion, protect pharma invention patent rights and, at the same time, encourage the pharma industry to grow for the public good. The unprecedented boom in pharma economics presents a unique policymaking challenge because Congress must balance pharma marketplace competition concerns with consumer demands for pharma products.
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Compliance – The Ultimate Team Sport


I come from a family obsessed with rowing. Okay may be obsessed is a little strong. Perhaps consumed with rowing is a more accurate description. My father was a rower, my brothers were rowers; and eventually, when I went to college, I was a rower. Even before I rowed, however, I was (and I still am) involved in rowing. From the time I was 5 years old, my spring weekends were spent on the banks of the Schuylkill River working at one regatta or another.
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