My Regulatory Grand Tour

By Peter J. Pitts

Like Johnny Cash said, “I’ve been everywhere” — or at least it seems that way. Over the past few months I’ve visited with government health officials in China, the Philippines, Malaysia, Egypt, Algeria, Saudi Arabia, Jordan, the United Arab Emirates, Russia, Brazil, Columbia, South Africa, Kenya, and many other points in-between. And the only thing that’s grown more than my frequent flyer miles is my respect and admiration for those over-worked and under-appreciated civil servants toiling on the front lines of medicines regulation.

It’s a global fraternity of dedicated (and generally under-paid) healthcare and health policy professionals devoted to ensuring timely access to innovative medicines and quality generics drugs.  Continue reading

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InSites: Accelerated Clinical Trial Agreements

InSites is a recurring commentary dedicated to clinical trial sites – including hospitals and academic medical centers – and their interaction with industry.

Albert Einstein proffered the notion that insanity is doing the same thing over and over again and expecting a different result. Yet all too often when it comes to clinical trial agreements (CTAs), this is how we operate: Hoping to best protect their own interests, sponsors and CROs offer a template CTA with terms and conditions unacceptable to the overwhelming majority of institutions (ie, research hospitals and academic medical centers). To gain the strongest legal protections for themselves, institutions counter with terms and conditions unacceptable to sponsors. Continue reading

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The Impact of Collaborative and Risk Sharing Innovation Approaches on Clinical and Regulatory Cycle Times

TIRS Editor-in-Chief Stephen Spielberg recently recorded a podcast with Joseph DiMasi and Kenneth Getz, both from the Tufts Center for the Study of Drug Development. The conversation focused on their paper, published in TIRS, entitle “The Impact of Collaborative and Risk-Sharing Innovation Approaches on Clinical and Regulatory Cycle Times.” To download and listen to this free podcast, click here.

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InSites: Medical costs for patients participating in clinical trials

InSites is a recurring commentary dedicated to clinical trial sites – including hospitals and academic medical centers – and their interaction with industry.

Patients are entitled to understand if their participation in a clinical trial will cost them money. The process of obtaining their informed consent must therefore include information relevant to subject costs and billing. Consider four categories of cost concern: treatment and diagnosis for research-related injury, lost wages, travel-related expenses, and healthcare items and services delivered during the trial. This last category can be an area of confusion for IRBs, investigators, and study teams, except in those cases when 100% of charges are either covered (or not) by the sponsor. I mentioned this topic in one sentence in the previous InSites blog, but it’s worth fleshing it out further. Continue reading

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Incidental data in pharmacovigilance

Drug regulations require that adverse event reports received by pharmaceutical companies must be entered into databases and analyzed for the detection of safety signals.  In a couple of scenarios, these strict regulations are leading us to add what has been called “incidental data” to our safety databases, which can actually make the identification of new safety issues more difficult, rather than easier.  Continue reading

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InSites: New FDA Guidance on Informed Consent

InSites is a recurring commentary dedicated to clinical trial sites – including hospitals and academic medical centers – and their interaction with industry.

On July 16th, FDA released its: Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and SponsorsWhen finalized it will replace the 14-year-old, A Guide to Informed Consent. At 42 pages, it is as long as some informed consent forms (ICFs). Continue reading

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Is There Room for Real Engagement Between Bioethicsts and the Pharmaceutical Industry?

There is currently a lot of tension between bioethicists and the pharmaceutical industry.

On the one hand, bioethicists have had much to say about the ways in which the pharmaceutical industry distorts biomedical research, publication, policymaking, and clinical practice. Bioethicists are also often critical of doctors and policymakers who engage with industry, with many critics viewing such interactions the source of unconscionable conflicts of interest[1].

Supporters of the pharmaceutical industry counter that many critics of the pharmaceutical industry are engaged in a “witch hunt”, based on a naïve, if not paranoid, idea about the complexities of commercial world and the motives of those who engage with it or work within it. It is also argued that bioethicists offer little in the way of meaningful remedies for the problems it they supposedly expose.[2]

To some degree, tensions of this kind are inevitable and healthy, producing the kinds of checks and balances that ultimately benefit everyone concerned. We would not want a world without whistleblowers—people who are prepared to put their own professional, and even personal, wellbeing on the line in order to expose what they perceive to be individual or systemic wrongdoing.

But it could also be argued that no one really benefits from sustained mistrust, suspicion, and reluctance or inability to engage in shared moral deliberation, and that more needs to be done to encourage collaboration between ethicists and industry.

This raises the question: how can bioethicists and the pharmaceutical industry engage in more fruitful debate about morally-charged issues?

One approach that has been increasingly championed in the United States is for companies to employ or contract with bioethicists, who can advise on the management of ethical dilemmas as they arise in practice. While there are good arguments for such arrangements, questions are inevitably raised about, for example, the objectivity of such ethicists, and their capacity to expose wrongdoing in the companies with which they are engaged[3].

Whether or not these perceptions are accurate, they exist, and they underscore the need for there to (also) be bioethicists who sit outside industry, but who understand the nuances of industry, and are able engage meaningfully with those who work within, or with, pharmaceutical companies.

This is not an easy position for a bioethicist to inhabit, but is one that an organisation such as DIA can facilitate*. As a bioethicist who wishes to occupy this “middle ground,” I invite DIA members to offer their ideas as to how we, as DIA members, might move beyond the “hostile interdependence” that characterizes many of the interactions between biomedicine, bioethics and the pharmaceutical industry and engage with one another in shared moral deliberation.

Please respond to this Blog with your ideas—skeptics are most welcome, but constructive suggestions would be much appreciated.

*With this in mind, DIA has established a new Community: “Ethics and the Medicines Lifecycle”

[1]See for example: Elliott C. (2010) White coat, black hat: Adventures on the dark side of medicine. Beacon Press.

[2] See for example:;;;

[3] See for example:

Author Wendy Lipworth is Section Editor for Ethics and Policy for Therapeutic Innovation & Regulatory Science. Dr. Lipworth is a medically trained bioethicist and qualitative social researcher from Sydney, Australia. She is based at the University of New South Wales (Australian Institute of Health Innovation) and Sydney University (Centre for Values, Ethics and the Law in Medicine). Over the course of her Masters degree, PhD and National Health and Medical Research Council (NH&MRC) Postdoctoral Fellowship, she has developed a program of research focused on the ethics of biomedical innovation, with a particular focus on the ethics of drug development, regulation, funding and prescribing. Methodologically, her work is best described as empirical bioethics in which empirical research (e.g. stakeholder analysis) is used in conjunction with theoretical analysis to address real-world problems. 


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InSites: Insurance Coverage Analysis in Clinical Trials

InSites is a recurring commentary dedicated to clinical trial sites – including hospitals and academic medical centers – and their interaction with industry.

As we approach the fourteenth anniversary of the effective day of the final rule for Medicare coverage of routine costs in qualified clinical trials (click here for more information),  it is useful to reflect at how little we have progressed toward a rational and efficient system of taking insurance coverage into account in budgets.

Although the stated purpose of the rule was to address under-enrollment of Medicare beneficiaries in clinical trials, it has evolved into a complex set of processes designed to avoid the legal and financial risks of inappropriately billing government  and commercial insurance payers. The process begins with an analysis of the protocol to determine which items and services can legitimately be billed to the payer. Medicare is the typical billing standard. At this first step – the so-called Coverage Analysis – inefficiency and inconsistency reign supreme. Continue reading

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Encouraging Adherence in Treatment

Adherence to medications is key to good outcomes in chronic illness.  Yet studies indicate no real breakthroughs in achieving better adherence.  In all the major conditions where adherence is critical, e.g. control of blood pressure in diabetics, prevention of asthma attacks, anti-platelet and hypolipidemic therapy post myocardial infarction, and adherence rates are dismal.   Continue reading

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First-ever FDA guidance on transferring research oversight from one IRB to another

On May 23, the US Food and Drug Agency (FDA) released its Guidance for IRBs, Clinical Investigators and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another IRB ( Despite newsworthy events involving transfer of IRB oversight based on research subject deaths and institutional decisions to outsource IRB review dating as far back as 1996, it seems that the highly-publicized shutdown of a commercial IRB in 2009 (, has driven this first such guidance. Note that FDA Guidance consists of suggestions on what should be done (but isn’t required). Continue reading

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