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Growing Litigation and Regulatory Burdens have U.S. Pharma Companies searching for Tech Solutions

Melissa Singleton

Aug 29 2017

Executives within the U.S. pharmaceutical industry often find themselves in a unique position when it comes to the way they view the intensive government regulation of their industry.

On the one hand, they tend to favor the rollback of some corporate compliance requirements that add cost to the routine operations of their businesses. On the other hand, they generally support certain regulatory enhancements—such as the FDA’s new drug development model and regulatory review process—because it gives insurance companies the confidence they need to cover the cost of prescription drugs prescribed by physicians.

And while it’s certain that the U.S. pharmaceutical industry will continue to be one of the most heavily regulated sectors in the American economy, it’s less clear exactly what that regulatory framework will look like in the coming years.

Meanwhile, the volume of pharma-related litigation shows no signs of slowing down. One of the high-profile flash points in the litigation tide confronting the pharmaceutical industry includes the recent surge in lawsuits related to prescription painkillers. Within the past year, at least 25 states, cities and counties have filed civil cases against various companies in the drug supply chain, including some of the largest manufacturers in the industry.

Another key moment in the rise of pharma litigation this year was the recent conclusion of a two-year investigation into the generic-drug industry. The antitrust investigation into generics reportedly includes “more than a dozen companies and about two dozen drugs” manufactured in the U.S. In addition, failed pharmaceutical trials have sparked recent class-action securities lawsuits filed in federal courts, according to the Stanford Law School Securities Class Action Clearinghouse.

This growing regulatory and litigation pressure on pharma companies raises the stakes on how corporate executive teams manage electronic data that resides on email servers and other data repositories. In the heat of a government investigation or a legal battle, it’s likely that a company will be called upon to conduct e-discovery—review vast troves of electronic data and produce responsive evidence—under incredibly tight deadlines. Savvy pharma executives are managing this surge in electronic data management pressure by leveraging software that helps them deal with huge amounts of data and extracts relevant information.

A new white paper from AccessData explores the latest regulatory and litigation challenges facing pharmaceutical companies today, and offers strategies and best practices to help pharma executives better manage their e-discovery responsibilities. You can download your copy of the white paper here.

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