Predictions for Pharmaceutical Compliance: Will They Come True?

It has been said for many years that philosophy and ethics need to keep up with technological progress else we will release advances that may hurt us rather than help us. Some have gone as far as saying that technological advancement should follow philosophy and ethics since this is the safest course to avoid possible mistakes. I can’t help but think of regulatory compliance in this context: How can we ensure that as advanced data-gathering technologies come to market, the lag in compliance regulations doesn’t slow down our ability to benefit from them?
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CEOs and Pharma Compliance: Tone is Set at the Top

CEOs help organizations establish the tone at the top for the role of compliance at drug and medical device companies. Traditionally, that tone has been one of mixed messages in the life sciences industry.
It’s understandable. CEOs at major life sciences companies mostly come from the ranks of clinicians, engineers, marketers or finance executives.   The top job is rarely given to someone from compliance, unless the board feels a need to address regulatory issues.
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Human Subjects Protections Proposed Rule Finally Released: Major Changes Loom Ahead for Industry

On September 8, after nearly four years in the making, the Department of Health and Human Services (HHS) released the notice of proposed rulemaking (NPRM) governing the protection of human subjects in research, also known as the “Common Rule.” This NPRM, entitled the “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” seeks to strengthen and expand the scope of human subject protections, while minimizing the regulatory and administrative burden on investigators. Stakeholders will debate whether this proposed rule is able to achieve these potentially conflicting goals. However, there is no argument that, on balance, this NPRM proposes changes that would have a significant impact on research and development by the pharmaceutical and biotechnology industry.
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What You Need To Know About the CEO-Employee Salary Ratio

With new salary reporting regulations on the horizon, financial executives throughout the pharmaceutical, biotechnology and medical device industries have a lot of work to do.
One looming issue is the recently announced Section 953(b) of the Dodd-Frank Wall Street Reform and Consumer Protection Act, which requires public companies to disclose the ratio of CEO compensation to the median compensation of the company’s employees. Right now, CEO and other executive pay is made available, but no salary information is required about employees. This ratio will be included in documents such as annual reports and registration statements. This rule goes into effect January 1, 2017.
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Capping Drug Prices Isn’t Cheap — In Dollars Or Lives

Some people seem to believe that a good alternative for a $1,000 breakthrough drug is a $100 breakthrough drug.
Unfortunate, the real alternative is no breakthrough drug at all.
Lawmakers in Massachusetts and Pennsylvania have recently proposed bills that would set price caps for new medications. It’s a terrible idea. Government price controls on medicines actually wind up costing citizens and patients more in terms of both dollars and lives.
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For Pharmaceutical Companies, Going Global Means both Opportunity and Risk

A pharmaceutical company decides to go global for a lot of reasons: Perhaps they want to expand into developing markets that are less saturated. Or they may need to conduct global clinical trials to get broader and more diverse participant base.
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