Media Mentions
2010
Michael Peregrine was quoted by BNA’s Health Law Reporter (February 11) concerning the impact that changes to the federal sentencing guidelines could have on the compliance programs of hospitals and health systems. Mr. Peregrine said the changes emphasize that “the definition of what constitutes an ‘effective compliance plan’ … remains living, breathing and subject to periodic modification.” He noted that some elements of effectiveness include a strong document retention program and a direct compliance officer reporting relationship to the board of directors. Mr. Peregrine added that the guidelines also cite self-reporting, cooperation with authorities and restitution of damages as desirable responses after an organization detects criminal conduct.
Michael W. Peregrine, Conflicts of Interest - Health, Corporate Responsibility and Governance, Health
Michael Peregrine was quoted in a January 18 Modern Healthcare article about a not-for-profit health system’s purchase of a stake in a health and wellness company whose CEO had sat on the health system’s board but resigned after the board voted to make the purchase. While not commenting on the transaction directly, Mr. Peregrine noted that not-for-profits must adhere strictly to conflict of interest policies in transactions involving board members’ companies, and that such transactions face greater scrutiny “regardless of whether it’s a ‘good deal’ or not.” He added that scrutiny by regulators and credit analysts is focusing on sophisticated private equity transactions by not-for-profit hospitals (such as in this case), because of doubts that the hospitals’ boards and executives have the ability to manage these investments.
Michael W. Peregrine, Conflicts of Interest - Health, Corporate Responsibility and Governance, Health, Nonprofit Organizations
2009
Bernadette Broccolo discussed conflict of interest (COI) concerns for university technology transfer offices (TTOs) in the September 2009 issue of Technology Transfer Tactics. She noted that, particularly in medical research, TTOs must integrate with university compliance officers to ensure that there is no appearance of financial conflicts from consulting arrangements, research grants, company interests, reimbursement, and similar issues. These are "looked at individually and in the aggregate" by regulators, industry associations and the media, Ms. Broccolo stated, "particularly when you're talking about several relationships in the same entity." COI concerns arising from any financial relationship are "variations on a common theme," she added, and COI programs "should not stop with reporting, as so many have done in practice," but instead should actively identify potential problems and monitor compliance throughout the life of a project.Bernadette M. Broccolo, Conflicts of Interest - Health, Health
Bernadette Broccolo discussed for Medical Research Law & Policy Report (June 9) a proposal by the National Institutes of Health to expand its management and oversight of conflict-of-interest policies for its grantees. Ms. Broccolo said that the proposal would identify conflict of interest by asking questions that “are very thorough and reflective of all the key considerations that have become part of the guidance we’ve been receiving from nongovernmental sources. And that’s important – very important....because the law has been perhaps at best a minimum standard.” Ms. Broccolo cited such points as the proposal’s focus on institutional conflicts of interest to demonstrate that it is “a really good effort to strike a balance between bringing things up to date but not being too prescriptive and recognizing that organizations need to have … flexibility for judgment.”
Bernadette M. Broccolo, Conflicts of Interest - Health, Health
Michael Peregrine was quoted by The Wall Street Journal on May 5 regarding more detailed disclosure on executive and trustee compensation that charities must make using new Form 990 annual reports to the Internal Revenue Service. Mr. Peregrine believes that the IRS intended the new form to involve board members more in the reporting process, stating that "The IRS feels the more the board is familiar with what's in the form, the more effective they will be in governance and oversight." He added that, for this reason, board members should be alert to and ask questions about potential conflicts of interest, excessive compensation or insider transactions revealed on the form.
Michael W. Peregrine, Conflicts of Interest - Health, Corporate Responsibility and Governance, Health
Jennifer Geetter was quoted by AISHealth.com on May 4 in a story about the Institute of Medicine's new recommended conflict of interest policies governing the relationships between health care institutions and pharmaceutical and medical device companies. "One of the challenges in management [of conflicts of interest] right now is most people recognize that they need to do it, but there are a lot of question marks around the how," Ms. Geetter said. "Now institutions are looking for matches between individual interests, imputed interests and institutional interests," which makes the process more inter-related and complex. She added concerning such relationships, "This is not just a compliance issue – it is a process issue. You [must] have a process in place that is flexible and elegant enough, that can handle all your problems, but is simple and transparent. And it has to be integrated into the other parts of your organization."
Jennifer S. Geetter, Conflicts of Interest - Health, Health
Bernadette Broccolo was quoted in an April 27 Modern Healthcare story about a healthcare communication systems company that formed an advisory board of seven nurse executives from hospitals that use the company's products. Ms. Broccolo believes that the advisors could still ethically discuss the company's products at their hospitals, but that they should disclose their advisory relationships and refrain from voting on product decisions to avoid any impression of bias. "What everyone is clamoring for first and foremost is . . . that any kind of participation in advisory groups of these kind[s] be made in the sunshine," she stated.
Bernadette M. Broccolo, Conflicts of Interest - Health, Health
2008
McDermott was mentioned in the October 2 issue of FDA's Webview in an article regarding the Firm's On the Subject discussing the letters issued by the U.S. Food and Drug Administration's (FDA) Division of Drug Marketing, Advertising, and Communications alleging that promotional material for certain products intended for use in treating attention deficit hyperactivity disorder (ADHD) made implied claims about an effect on ADHD "outcomes" that were not supported by "substantial evidence." FDA Webview notes, "Attorneys at McDermott...say FDA's Warning Letters and notices of violation to several manufacturers of ADHD drugs mean that drug companies wanting to avoid a challenge from CDER's Division of Drug Marketing, Advertising, and Communications (DDMAC) should review ad and promotional materials in all therapeutic categories to determine whether they make implied outcomes claims of the kind alleged by DDMAC in the ADHD letters."
Paul W. Radensky M.D., Conflicts of Interest - Health, Health, Life Sciences & Medical Products, Life Sciences - Health
