10/20/14: Emerging Issues and New Frontiers for FDA Regulation

lab_colored_beakers_slideEmerging Issues and New Frontiers for FDA Regulation

October 20, 2014 8:00 AM – 5:00 PM

Alston & Bird, The Atlantic Building, 950 F Street, NW, Washington, DC 20004-1404

Symposium co-sponsored by the Food and Drug Law Institute (FDLI) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Please join the Food and Drug Law Institute and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School for an academic symposium on cutting-edge legal and regulatory issues facing FDA.  Leading academics will present papers on mobile health, stem cells, personalized medicine, and other novel medical product issues, as well as food regulation.  Papers will be available to registered attendees in advance, and will be published in an upcoming issue of the Food and Drug Law Journal.

Registration is now open online. A limited number of free seats are available to Harvard affiliates. For more information or to request a seat, please email us at petrie-flom@law.harvard.edu.

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bioIP Workshop – Deadline for Abstracts Approaching

Call for Abstracts: 2015 bioIP Faculty Workshop

The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the first annual bioIP Faculty Workshop on May 7, 2015 at Boston University School of Law.

The Workshop will offer a unique opportunity for three junior scholars (in their first decade of teaching) to present their work in progress for in-depth critique and commentary by respected senior scholars in the field.

Topics for the workshop are at the intersection of biotechnology/life sciences/FDA and IP (hence, bioIP), broadly defined. A Review Committee will select papers for the Workshop in a blind process. Papers should present an original thesis and contribute to scholarly literature. The Workshop will not review published work.

Scholars with less than ten years of teaching experience interested in having their papers reviewed should submit an abstract (up to 750 words) of the proposed paper (without identifying details) along with a c.v. to Ted Hutchinson, Executive Director of the ASMLE at  thutchinson at aslme.org by Oct 1, 2014. Selected abstracts will be announced later in Fall 2014 with the full draft papers due by April 1, 2015. The organizers will cover reasonable travel and lodging expenses. VAPs and Fellows are eligible for the Workshop.

The Workshop Committee consists of faculty from: The Boston University School of Law; Georgia State University College of Law; Indiana University Robert H. McKinney School of Law; and the Loyola University Chicago School of Law.

For questions, please email Kevin Outterson,   Posted in Call for Abstracts, Kevin Outterson | Tagged , | Leave a reply

So Much, But Yet Not Enough—The Administration’s Plan to Combat Antibiotic Resistance

By Diana R. H. Winters
[Cross-posted at HealthLawProf blog.]

Yesterday was a big day in the fight against antibiotic resistance. The White House released an Executive Order and a National Strategy document on Combating Antibiotic-Resistant Bacteria, the President’s Council of Advisors on Science and Technology (PCAST) released a report on antibiotic resistance, and the National Institutes of Health and the Biomedical Advanced Research and Development Authority announced a $20 million prize for developing tests to identify highly resistant infections. Kevin Outterson at The Incidental Economist, Food Safety News, and the New York Times provide a good summary of these developments.

It is clear that the administration recognizes the grave threat posed by antibiotic resistance and that it intends to make combating this danger a national priority. Its approach is broad—the National Strategy includes a “Guiding Principle” that “[d]etecting and controlling antibiotic resistance requires the adoption of a ‘One-Health’ approach to disease surveillance that recognizes that resistance can arise in humans, animals, and the environment,” and the strategy pays much attention to the role of antibiotics in food production. One main objective of the strategy is to eliminate the use of medically important antibiotics at subtherapeutic levels for growth promotion (the practice of feeding animals antibiotics to make them fatter, not to make them well).

But in regards to the use of antibiotics for growth promotion in animals, the strategy does not provide the tools, or even the rhetoric, to support meaningful movement towards decreasing their use. The strategy calls for FDA to implement Guidance #213, to enhance its data collection capabilities, and to increase educational outreach on the appropriate use of antibiotics. Guidance #213, issued in December 2013, is intended to provide drug sponsors with information as to how they can “modify the use conditions” of medically important antimicrobial drug products to limit use to that “necessary for assuring animal health,” and only under veterinary supervision. Not only do guidance documents not establish legally enforceable duties, the recommendations in Guidance #213 are characterized as voluntary. FDA, moreover, has known the dangers of using antibiotics in animal feed at subtherapeutic levels for four decades, and has been sitting on the information. Swift and strong action is needed now.

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9/22/14: HLS Health Law Workshop with Thomas McGuire

HLS Health Law Workshop: Thomas McGuire
September 22, 2014 5:00 PM
Griswold Hall, Room 110 (Harvard Law School)
1525 Massachusetts Ave., Cambridge, MA [Map here.]

Download the Paper: Do ‘Reverse Payment’ Settlements of Brand-Generic Patent Disputes in the Pharmaceutical Industry Constitute an Anticompetitve Pay for Delay?

Thomas G. McGuire, PhD, is a professor of health economics in the Department of Health Care Policy at Harvard Medical School. His research focuses on the design and impact of health care payment systems, the economics of health care disparities, and the economics of mental health policy. Dr. McGuire has contributed to the theory of physician, hospital, and health plan payment. His research on health care disparities includes developing approaches to defining and measuring disparities, and study of the theory and measurement of provider discrimination. For more than 30 years, Dr. McGuire has conducted academic and policy research on the economics of mental health.

House Hearing on Regulation of Laboratory-Developed Tests Displays More Consensus Than Disagreement

The Health Subcommittee of the House Energy & Commerce Committee held a hearing last week on the FDA’s proposed draft guidance regarding laboratory-developed tests (LDTs), as part of its “21st Century Cures” initiative. The hearing, which can be viewed online (here and here), featured representatives from the FDA, industry, and research organizations. And although the various panelists offered differing views on the propriety of the FDA’s decision to begin exercising its regulatory authority over LDTs, there seemed to be more agreement than disagreement among the panelists.

Most interestingly, as Representative Henry Waxman pointed out toward the end of the hearing, “[no]body on the panel [is] arguing that there shouldn’t be a very careful scrutiny of these tests. It seems like the question is who should do it: CLIA or the FDA.” Representative Waxman’s subsequent colloquy with Harvard Medical School Professor Christopher Newton-Cheh on this point particularly helped to differentiate the historical roles of CMS and the FDA in this space. But even those panelists who opposed the FDA’s involvement seemed supportive of expanding CMS’ authority under CLIA to conduct clinical validity analyses. (Anyone interested in the administrative law aspects of this issue should know that problems of shared regulatory jurisdiction have recently received increased scholarly attention, with Jody Freeman and Jim Rossi providing a particularly thorough treatment of the issue in their recent article, Agency Coordination in Shared Regulatory Space.)  Continue reading

Research Assistant III: Work with Professors Eyal, Hammitt, Freedberg, Kuritzkes, and collaborators on HIV cure studies’ risks, risk perceptions, and ethics

The research assistant will work with the principal investigator Nir Eyal and collaborators from the Harvard TH Chan School of Public Health, Duke University, Massachusetts General Hospital, and the Brigham and Women’s Hospital as well as the ACTG HIV trial site network. The multidisciplinary team uses methods of clinical epidemiology, economics, simulation modeling, and normative theory to predict risks in early-phase HIV cure studies, assess how much likely candidates for participation understand those risks, and make ethical recommendations on the conduct of HIV cure studies.

The research assistant will help prepare, conduct and analyze a pilot survey expected to take place in a US site of the AIDS Clinical Trials Group (ACTG). The survey will assess perceptions of HIV cure and of cure study risks. The research assistant will also promote other research and grant-related activities, through literature reviews and assistance in the preparation of abstract, poster, and manuscripts for publication, grant applications, a simple project website (using Harvard’s user-friendly OpenScholar platform), and slides for lectures and seminars. The research assistant will be in touch with top researchers in HIV cure, medical decision making, and ethics from around the country, to facilitate our meetings, a workshop, and regular conversations to plan the research and debate ethical issues around early-phase HIV cure studies.

For the full job ad:
https://jobs.brassring.com/1033/asp/tg/cim_jobdetail.asp?partnerID=25240&siteID=5341&AReq=33776BR

Live Blogging: Post-Trial Responsibilities Conference, Session 4

Panel Discussion: Christine Grady, Mitchell Warren, Richard Saver, Luann van Campen; Moderator: Mark Barnes

Session four of the Post-Trial Responsibilities conference featured a panel discussion of a complex hypothetical scenario. The hypothetical used in this session (available here) was made complex by design, to avoid the easy answers and to force readers to make difficult choices regarding both people and institutions.

In this hypothetical, the Ministry of Health in Angola begins a collaboration with a Belgian biotech company, BelgiqueTec. BelgiqueTec is not an established multinational pharmaceutical company, but is instead more like a start-up that’s been funded by some investment capital but which lacks deep pockets. BelgiqueTec has the rights to a diabetes drug and is interested in testing it in clinical trials. The Angolan government contributes $25 million to finance trials of the drug in Angola, due to the population’s burgeoning diabetes problem and concomitant development of wait times for treatment in the government’s diabetes clinics. In return, the Angolan government will take some ownership stake in the company and therefore in the outcome. There is an in-kind commitment of resources from Angola in terms of the study sites, which will be hospitals or clinics owned by the Angolan government or ministry of health (MOH). The agreement between BelgiqueTec and the government establishes that Phase I and II trials will be done in Angola, and any Phase III trials would feature a site in Angola (as well as elsewhere).

In the hypothetical, the Phase I trial was completed and showed no adverse effects. Now, a Phase II study has enrolled 200 treatment-naïve Angolan citizens with moderate to severe diabetes. Half showed improvement in the control of their diabetes, but three patients showed decreased cardiac function associated in time with drug administration, suggesting a potential causal link between administration of the drug and the observed cardiac side effect.

The first set of key questions for discussion was as follows: if drug development is halted at Phase II based on the adverse events, what are the obligations of BelgiqueTec and the MOH to continue to deliver diabetes treatments of any kind to the 200 Phase II subjects? Since a number of the patients showed improvement on the experimental drug, should the treatment be the experimental drug or the standard of care? For how long must the treatment continue? Continue reading

Live Blogging: Post-Trial Responsibilities Conference, Session 3

By Robin Pierce

Session 3 of the Post Trial Responsibilities Conference, Lessons Learned, featured four speakers who have been involved in the conduct of trials for which post trial access was an issue. Moderated by Petrie-Flom Executive Director, Holly Fernandez Lynch, the session aimed to better understand real world experiences implementing post-trial responsibilities, including both successes and failures, and to more clearly articulate and assess the complexities involved. To do this, the speakers used case studies drawn from actual trials conducted around the world.

The first case study, presented by Joseph Millum of NIH, dealt with NIH-funded global HIV research, covered by the NIH policy on post-trial access to ARVs. Confronting the tough issues at the outset, Millum stated plainly that if there were no post trial access in the study at hand, which aimed to evaluate third line treatment options for HIV patients failing other regimens, there would be no way for affected participants to obtain the drugs that they needed to stay alive after the study. Here, Millum identified two key challenges – 1) access to drugs and 2) obtaining clinical care.

Millum devoted the rest of the discussion to describing the creation and implementation of a two part solution in which the manufacturers negotiated an agreement to provide darunavir, etravirine, and raltegravir free of charge for two years after study participation. Another element of the solution was created out of a recognition that in order for drugs to be administered at study sites, they had to be part of a study. Therefore, a final step was added to the study in which participants taking the drugs were given the option of staying in the study for an additional 96 weeks. For this, researchers tailored the consent process to state that after the study, the participant and his or her doctor will decide what treatment the participant should have and that study staff would discuss how the participants may be able to obtain the drugs post-trial. Continue reading

Live Blogging: Post-Trial Responsibilities Conference, Session 2

By Zachary Shapiro

Hello from the Post-Trial Responsibilities conference! I will be live blogging session 2: where speakers will be providing important perspectives on PTA. Barbra Bierer is monitoring the discussion.

We started with Richard Klein calling in from FDA:

Richard is talking about post-trial responsibilities. He points out that there is a justice issue here with ensuring access to health care and up to date interventions. He points out that while the FDA can encourage Post-Trial Access (PTA), it has no authority to require or ensure it. He points to moral authority, rather than legal. Foreign trials, however, are a different story, as the FDA has sway over protocol applications that are submitted in the US. Richard begins highlighting some specific considerations for protocol drafters and IRBs: particularly focusing on determining monitoring plans, as well as figuring out financial responsibilities for the provision of PTA.

He moves on to highlight that there is more of a moral obligation than a legal obligation. FDA is supportive of the provision of PTA. He believes that enthusiasm must be tempered, as there are situations when PTA is not appropriate. These include studies that have significant safety concerns, studies of bio-markers as well as validation studies that do not specifically examine safety and effectiveness. There are also situations where PTA is simply not feasible, particularly if additional drugs do not exist (one thinks of the recent Ebola treatment), if there is insufficient safety data, or if there is no practical capacity or resources to provide safety monitoring. We must also be aware of financial limitations, especially for start-up biotech firms that might not have deep pockets. Continue reading

Live Blogging: Post-Trial Responsibilities Conference, Session 1

By Holly Fernandez Lynch

Today, the Multi-Regional Clinical Trials Center (MRCT) at Harvard University and the Petrie-Flom Center at Harvard Law School are co-hosting a daylong conference on “Post-Trial Responsibilities: Ethics and Implementation.”  We’ll be live blogging the conference here at Bill of Health, and video/slides from the conference will be available soon.

The conference was kicked off by Mark Barnes, co-director of MRCT, who pointed to two key statements of ethics that refer to post-trial responsibilities, the Declaration of Helsinki’s Paragraph 34 (DoH) – which Mark referred to as “mysterious,” as it could not in practice mean what it literally says – and the Council for International Organizations of Medical Sciences Guideline 10 (CIOMS).

Mark went on to describe the wide spectrum of issues that may be encapsulated in the simple phrase “post-trial access” – for example, over what period of time is access provided, is it provided for chronic diseases or only transient conditions, is it necessary only till a patient is stabilized or for longer, is it a lifetime commitment, does it apply only to research subjects themselves or broader research communities?  How much evidence should we demand of benefit before imposing post-trial responsibilities?  Exactly what should be provided – only the study drug, whatever was offered to the control group, other supportive care?  Must post-trial access be free of charge?  What about improved infrastructure, knowledge, and other benefits as components of post-trial access?  Our goal for the day will be to clarify the ways in which the Declaration of Helsinki, the CIOMS guidelines, and other ethical standards and regulatory requirements require additional guidance for practical application to the complex real-life circumstances of clinical trials.

The conference’s first panel – “Setting the Stage” – had the objective of introducing current ethical and regulatory approaches, as well as key controversies.  The panel was kicked off by Christine Grady (NIH), who gave a talk on the ethics of post-trial responsibilities, including history, models, agreements, and controversies.  Christine explained that compared to the very clear articulation of researchers’ responsibilities before and during a trial, they have very little guidance on what should happen when a trial is over.  Indeed, they had no guidance whatsoever until the 1990s, when there was both an upsurge in international collaborative research, and HIV research more specifically.  In that context, new efforts cropped up to minimize the possibility of exploitation in international research, including development of the concepts of responsiveness to local needs and reasonable availability of research benefits, as well as capacity building, collaboration, and community engagement. Continue reading

Fall Facebook/OKCupid and Future of Research Tour

Sept. 18 Tweet ChatI’m participating in several public events this fall pertaining to research ethics and regulation, most of them arising out of my recent work (in Wired and in Nature and elsewhere) on how to think about corporations conducting behavioral testing (in collaboration with academic researchers or not) on users and their online environments (think the recent Facebook and OKCupid experiments). These issues raise legal and ethical questions at the intersection of research, business, informational privacy, and innovation policy, and the mix of speakers in most of these events reflect that.  Continue reading

Upcoming Event: Cutting-Edge Issues in the Ethics of Conducting Biomedical Research

DNAcode_slideCutting-Edge Issues in the Ethics of Conducting Biomedical Research

Thursday, October 9, 2014, 7:45 AM – 2:15 PM

Saul Farber Auditorium, Bellevue Hospital, 27th Street and First Ave (462 First Ave.), New York City

Registration is required for the conference.

Informed consent and Institutional Review Boards (IRBs) are the cornerstones of modern bioethical research but they do not solve all of the complicated issues of science, justice, and coercion that such studies raise.  The NYULMC Division of Medical Ethics invites you to a provocative program on cutting-edge issues in the ethics of conducting biomedical research.  Attendees will learn from leading experts and engage in discussions of current controversies, ranging from understanding ‘minimal risk’ in studies that involve socially vulnerable populations to the ethics of randomized controlled trials without consent.  Other topics to be covered include the contemporary implications of the U.S.-led sexually transmitted disease research conducted on Guatemalans during the 1940s; new strategies and technologies for improving informed consent; and the vexing issue of compassionate use.

For a list of speakers and conference agenda, click here [PDF].

NYULMC: Compassionate Use Could Impact Long-Term Medical Benefits

A new working group at the NYU Langone Medical Center has issued preliminary findings from their studies on the research ethics of compassionate use. Among their findings include:

  • Biotechnology companies have no legal or regulatory obligation to provide access to unapproved treatments on the grounds of compassionate use. Some companies allow access under the guidance of well thought out policies; some companies decline to allow access; some companies grant access but have no set guidelines; and some companies change their practices midstream as a result of public pressure. This lack of uniform policy is confusing to those seeking unapproved treatments.
  • Contrary to widespread perception, the U.S. Food and Drug Administration (FDA) is not an obstacle to those seeking compassionate use. In fact, the FDA almost always defers to the company that is developing the unapproved treatment to decide whether to grant compassionate use acces.
  • The “human impulse” to help patients facing insurmountable odds motivates both the general public’s support for compassionate use and so-called “right to try” laws to help gain access to unapproved treatments. However, increasing access to unapproved therapies may prove detrimental in the long run to longstanding and effective research and clinical trial systems through which interventions are proven effective and safe, and given regulatory approval.

You can learn more about the working group and read more of their findings here.

King v. Governor of the State of New Jersey: Applying the First Amendment to Laws Regulating Physician Speech

[Cross-posted from HealthLawProf Blog.]

Last week’s decision by the U.S. Court of Appeals for the Third Circuit in King v. Governor of the State of New Jersey, provides an insightful addition to the growing body of case law examining the clash between the state’s power to regulate clinical practice andfree speech.

Although the common law of informed consent arguably implicates the First Amendment rights of physicians and other health professionals, the conflict between the state’s power to regulate health care and free speech has become more apparent in recent years as state legislatures have increasingly enacted laws prescribing what physicians and other clinicians can and cannot say. Such laws are especially common with respect to abortion, but state legislatures have also required physicians to provide specific information about breast cancer treatments, or refrain from asking patients about gun ownership.

Not surprisingly, these laws are frequently challenged on First Amendment grounds. Some courts, relying on the Supreme Court’s cursory treatment of a First Amendment claim in Planned Parenthood v. Casey, have held that laws pertaining to what is said in the course of treatment regulate clinical practice rather than speech, and are, therefore, not subject to heightened review under the First Amendment. That was essentially the approach followed by the Ninth Circuit in Pickup v. Brown, which upheld a California law banning sexual orientation change efforts (SOCE) for minors, and the Eleventh Circuit in Wollschlaeger v. Governor of the State of Florida, which upheld a Florida law limiting physicians’ ability to inquire about their patients’ gun ownership.  As a result of these decisions, it became easier for states to regulate the speech of physicians than the speech of commercial purveyors of deadly products.  Continue reading

Clinicians, Care, and Conflicts of Interest in the Sports Medicine Environment

By Christine Baugh

A recent British Medical Journal blog post by Dr. Michael Stone sheds insight into the professional trials and tribulations of physicians working with professional soccer teams in England. As described, it is not uncommon that the team physician is recommended by a team manager and hired by the team’s executive board without thorough review. This hiring process, in turn, leads to the implicit expectation that the physician answers to the manager rather than the entire team, making the physician’s employment with the team insecure and the need for him to appease the manager a required condition of his employment. Beyond leading to an uncomfortable and potentially ineffective working environment, it is possible that this type of relationship could compromise care. These types of conflicts of interest within the sports medicine environment have been documented elsewhere.

A 2013 article in the Chronicle of Higher Education written by Brad Wolverton detailed a similar phenomenon in American collegiate sports. According to their survey of collegiate sports medicine clinicians, approximately one-third of clinicians indicated that members of the football coaching staff had influence over their employment and about half of clinicians reported having felt pressure from coaches to prematurely return athletes to play. Wolverton was able to provide striking examples of professional relationships between coaches and clinicians that led to compromised care. He also indicated that the topic was so sensitive that very few of the athletic trainers contacted were willing to talk about the issue for fear of losing their jobs.

Both the Stone and Wolverton articles highlight the complexity of sports medicine as a field and the specific conflicts that can arise when competing interests from multiple stakeholders are in play. However, critical to both authors’ conclusions, is that seemingly simple structural changes could play a major role in positively affecting health outcomes. Namely, to ensure quality of care, it is critical that the clinician’s employment is based upon the care he gives to his patients, not the team manager or team coach’s opinions of him. This is not a novel assertion. For example, the National Athletic Trainers’ Association, the National Collegiate Athletic Association (page 65), and others have put forth guidelines and recommendations indicating that having the coach serve as a primary supervisor for a clinician is inappropriate. However, it is not clear that these best practices are being implemented uniformly across sports, leagues, and teams. Given the health risks faced by athletes, and the role that sports medicine clinicians can play in mediating those risks, taking steps such as implementing an appropriate supervisory structure for sports medicine clinicians is imperative.

[This post reflects my own views only.  It does not necessarily represent the views of the Petrie-Flom Center or the Football Players Health Study at Harvard University.]

Tomorrow: Post-Trial Responsibilities Conference

pills_genericvariety_slidePost-Trial Responsibilities: Ethics and Implementation

Thursday, September 18, 2014 7:30 AM – 5:30 PM

Wasserstein Hall, Milstein East AB, Harvard Law School, 1585 Massachusetts Ave.

The conference is free and open to the public, but due to limited seating, registration is required to attend. Please register here.

The term “post-trial access” is used broadly to connote a wide range of possibilities for providing continued access to study interventions (and potentially other care) once a trial is over, or a subject’s participation has ended.  For the purposes of this conference, we will focus discussions on the following:

  1. Continued access to study intervention(s) and/or other care for people who were enrolled in the clinical trial and were benefiting (whether between the end of the trial and product approval or indefinitely)
  2. Provision of the study intervention(s) and/or other care to people who were enrolled in the clinical trial but did not get the intervention and would like to try it (whether between the end of the trial and product approval or indefinitely)
  3. Provision of the study intervention, other care, or other resources to the community in which the trial was conducted

The full background, conference objectives, and agenda are now available on our website

Cosponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Multi-Regional Clinical Trials Center at Harvard University. This event is also supported by the Oswald DeN. Cammann Fund.

Gilead Announces Access Program for Hepatitis C Drug

For all those who are interested in issues of global health, access to medicines, and drug pricing, yesterday Gilead formally announced its access program for enabling many developing countries to purchase its new Hepatitis C drug, Sovaldi, at low prices. This announcement is particularly noteworthy because Sovaldi represents a significant improvement over the current standard of care for Hepatitis C, as it can cure a much greater percentage of sufferers than could standard therapies, and it does so with many fewer negative side effects. Gilead’s partnership-based program will permit seven Indian generic drug companies to produce and sell the drug in 91 developing countries. The discounts are significant: although Gilead formally charges $1,000 a pill (or $84,000 for a course of treatment) for Sovaldi in the United States, it will charge just 1% of that, or $10 a pill, in India (the total cost there is estimated at $1,800, given the difference in strain prevalence).

The global health community has reacted to the announcement with mixed reviews. The 91 countries in the program include more than half of the world’s Hepatitis C patients. But tens of millions of other patients in large nations like China, Brazil, Mexico, and Thailand are left out of the program. Going forward, some of the excluded nations may seek to issue compulsory licenses in an effort to expand access to Sovaldi.

Gilead has also drawn fire in the United States for Sovaldi’s $84,000 sticker price (which, for various reasons, very few if any will actually pay), to the degree that members of both houses of Congress have asked Gilead to justify the price of the drug. Those opposing Sovaldi’s price have generally not come out publicly against the high price of many orphan drugs, which can cost $250,000-$350,000 per year. But because Hepatitis C afflicts about 2.7 million people in the US, as compared to the few thousand people with one of the relevant orphan diseases, its impact on insurers (both public and private) is likely to be much larger (as this very blog has previously noted).  Continue reading

Upcoming Event: A Conversation with the HHS Office of the Inspector General

pills_white_closeup_slideA Conversation with the HHS Office of the Inspector General

Tuesday, September 30, 2014 12:00 PM – 1:00 PM

Wasserstein Hall, Room 3018, Harvard Law School, 1585 Massachusetts Ave.

Please join the Petrie-Flom Center for a conversation with the Boston office of the U.S. Department of Health and Human Services Office of the Inspector General (OIG), Office of Evaluation and Inspections.  OIG has for decades served as the foremost government watchdog of federal healthcare programs, overseeing Medicare, Medicaid, the Food and Drug Administration, the National Institutes of Health, and the Centers for Disease Control and Prevention.  Among other topics, the Boston office’s recent work has focused on the labeling of dietary supplements and human subjects protections, including the informational risks associated with biospecimen research and other topics.

Come hear about the work of the OIG, its role in the Department of Health and Human Services, and some of its current and past projects.  We will be joined by Joyce Greenleaf, MBA, Regional Inspector General, and Jessica Fargnoli, MPH, Program Analyst (biographical details below).  Matthew Lawrence will moderate.

Lunch and refreshments will be served.  Co-sponsored by the Petrie-Flom Center and Harvard Catalyst.