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Life Sciences Dilemma: Limiting Liability without Stifling Innovation

Life Sciences Dilemma: Limiting Liability without Stifling Innovation

Two opening keynote speakers at the Meeting Management and Speaker Programs Life Sciences Forum, held last week at the Coronado Island Marriott Resort and Spa near San Diego, Calif., explored two sides of the same regulation coin.

Laura Duffy, an attorney with the U.S. Attorney’s Office for the Southern District of California, began by laying out enforcement trends and observations. Among them:

• The government is focused on making healthcare regulation violators pay the cost until it hurts, including holding execs and board members personally accountable.

• Whistleblower cases have spiked recently.

• There is more focus on the Foreign Corruption Act, False Claims Act, and anti-fraud measures in the Affordable Care Act.

• The government is finding new and interesting ways to use today’s advances in data-mining to catch pharma wrongdoers.

She urged those in the room to examine their organizations’ cultures toward risk and fraud: Is it specific to your organization? Is your staff trained regularly? Are your communication channels effective? How often is your risk management program reviewed? How does your organization respond to noncompliance? How are complaints handled? “Creating the culture of compliance is hard. But if you do foster a culture that is valued and viewed as part of everyone’s jobs, it will be a lot easier to stay in compliance.”

Mary Grealy, president, Healthcare Leadership Council, said that, as important as it is to comply with the rules and regulations that govern pharmaceutical, medical device, and other life sciences companies’ interactions with healthcare professionals, we must take care not to stifle the innovation that collaborations between HCPs and industry can give rise to.


The Healthcare Leadership Council she heads includes leaders representing the full spectrum of healthcare stakeholders. “We have a shared vision of affordable, accessible healthcare that is driven by innovation,” she said. Physicians should be involved in innovations, she said, citing the fruits of past collaborations that include implantable cardioverter-defibrillators, pacemakers, coronary stents, and penicillin.

The Danger of Data Without Context
While some believe it’s inherently wrong for pharma companies to have financial relationships with physicians, without those relationships, healthcare advances may not happen. “We need to root out the bad actors without precluding future positive collaboration,” Grealy said. The Sunshine Act requirements to publicly post all transfers of value between HCPs and pharma could have a chilling effect on innovation if the American public doesn’t also receive information about the context in which those TOVs are made.

Data without context can create negative presumptions that don’t serve society’s interests, and could cause some physicians to not want to collaborate with industry. “We need to keep asking, ‘What is in the patient’s best interest?’”

Her organization developed the National Dialogue for Healthcare Innovation to bring together thought leaders who have diverse points of view but the same goal—encouraging innovations that help people live longer, healthier lives. The members have developed a consensus on four key principles for appropriate collaboration that include benefiting patients, keeping HCPs autonomous, and ensuring that relationships are transparent and each party is held accountable for its actions. The plan going forward is to reach out to Congress, federal agencies, and the media to explain the principles and the context in which it is not only proper, but advantageous, for those collaborations to happen.

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