Monday Morning Recap: The Week (10.13.14-10.19.14) in Drug & Device Law & Policy

October 20, 2014 by · Leave a Comment
Filed under: Drugs & Devices, Monday Morning Recap 

Picture3It’s Monday morning, time for our Monday Morning Recap, the post where we call out recent drug and device law and policy developments that caught our eye and made us think…

1. Making the news this week was a release by WikiLeaks of “a second updated version of the Trans-Pacific Partnership (TPP) Intellectual Property Rights Chapter[,]” which will have significant implications for access to medicines. Public Citizen has released a detailed analysis of the pharmaceutical issues that remain under negotiation, here. Public Citizen notes that the negotiating countries are still wide apart on some issues and are, for example, “debating a range of possible monopoly periods for biotech drugs, ranging from zero years to twelve.”

2. Ebola drug development continued to make the news this week. This article by Peter Loftus and Betsy McKay at the Wall Street Journal provides a very helpful overview. Loftus and McKay quote Food and Drug Administration Commissioner Margaret Hamburg who “said the agency has shifted more employees to help speed the development of drugs, vaccines and diagnostics. ‘We’ve been up in the middle of the night in order to make product available’ on an emergency basis to infected patients in the U.S., she said in an interview this week.

3. Turning now to diseases for which safe and effective vaccines have been developed and are widely available, this week Karen Kaplan at the LA Times analyzes new Centers for Disease Control data on vaccine coverage among children in kindergarten. Kaplan highlights the fact that, “[a]cross the country, the median rate of MMR vaccination for kindergartners in the 2013-2014 school year was 94.7% for the MMR vaccine[,]” with “seven states and the District of Columbia [reporting] rates below 90%. At those rates, some communities are in danger of losing herd immunity – having enough people vaccinated to protect the small number of those who can’t get shots for medical reasons.”

4. At Forbes John Osborne reported that “Chairman Fred Upton (R-Michigan) and some of his colleagues on the House Energy & Commerce Committee want to talk about the off label issue.” Osborne notes that Congress could “direct the FDA to establish a new pathway under which truthful information outside the scope of the approved label would be able to be discussed with physicians. … Congress also could simply declare that the FDA may not regulate the communication of truthful information, and that may (or may not) limit the Justice Department’s determination to apply the False Claims Act to cases where off label prescribing is prevalent.” Osborne writes that “Chairman Upton plans to introduce an omnibus reform bill in the new Congress. If the off label issue is addressed, it would represent a historic change in attitude and behavior within the United States government that would clearly have significant implications for the way in which the FDA regulates drug, biotechnology and device company communications.

5. Finally, not this week but still worth noting, earlier this month the Office of Inspector General of the Department of Health and Human Services published a proposed rule which “would amend the safe harbors to the anti-kickback statute and the civil monetary penalty (CMP) rules under the authority of the Office of Inspector General (OIG).” The rule “would protect certain payment practices and business arrangements from criminal prosecution or civil sanctions under the anti-kickback statute[,]” “codify revisions to the definition of ‘remuneration,’” and “add a gainsharing CMP[.]“ This McDermott Will & Emery summary of the proposed rule provides helpful context. Comments on the rule are due December 2, 2014.


Seton Hall Law’s Sentinel Project in the News

October 15, 2014 by · Leave a Comment
Filed under: Uncategorized 

site3Journalist Beth Fitzgerald wrote an article about Seton Hall Law’s Sentinel Project that ran in yesterday’s NJ Biz. Fitzgerald writes:

Seton Hall Law School professor John Jacobi said the project is looking at ‘the extent to which people who get health insurance are actually successful in getting the care they need.’ He noted that ‘Health coverage is not the same as access, and we are hoping to learn how the insurance plans offering care in the individual and small group markets are doing when it comes to connecting people to appropriate care.’

He said the project began earlier this year and will continue through 2015. Tuesday, the Sentinel Project began publicizing its website and encouraging individuals and employers who have encountered problems with health care access to contact them.

Jacobi said that, so far, ‘The areas of concerns raised most often have to do with access to behavioral health services and to services for people with developmental disabilities.’ He said work on these areas is ongoing and ‘We are following up and hoping we get to the point where we understand where the problems are.’

Read the entire article here.


Seton Hall Law’s Sentinel Project: Help Us Help New Jerseyans with Insurance Issues

October 14, 2014 by · Leave a Comment
Filed under: Seton Hall Law 

Sentinel Project mailer v5


Monday Morning Recap: The Week (10.6.14-10.12.14) in Drug & Device Law & Policy

October 13, 2014 by · Leave a Comment
Filed under: Monday Morning Recap 

Picture3It’s Monday morning, time for what Ed Silverman calls a  “ritual cup of stimulation,” and time for our Monday Morning Recap, the post where we call out recent drug and device law and policy developments that caught our eye and made us think…

1. At USA Today, Peter Eisler and Christopher Schnaars report that “[t]wo years after contaminated drugs linked to a compounding pharmacy in Massachusetts killed 64 and sickened more than 750 with fungal meningitis, the industry still struggles with serious safety problems affecting thousands of patients … A regulatory crackdown by the U.S. Food and Drug Administration since the outbreak in October 2012 has led to an unprecedented spate of drug recalls by compounding pharmacies — and scores of citations for bad practices.

2. At the Food and Drug Administration’s FDAVoice blog, Jean Hu-Primmer discusses a new joint effort between FDA, the Biomedical Advanced Research and Development Authority (BARDA), and the United States Critical Illness and Injury Trials Group (USCIITG) “to gather important information about medical countermeasures used during public health emergencies.” Among other things, the project will work to “address challenges with collecting and sharing data rapidly in emergencies, including streamlining electronic case reporting for clinical trials and rapidly disseminating key findings to FDA and other stakeholders to support clinical decision-making. … USCIITG will also develop and pre-position a simple influenza treatment protocol in 10 hospitals throughout the U.S. during the 2015-2016 influenza season. The project will help doctors more easily use an investigational treatment protocol for patients with severe influenza, and test the data collection and reporting system during peak times. The goal is to help streamline the process during future influenza seasons and emergencies.”

3. At Bloomberg BNA’s Health Care blog, Alex Ruoff reports that “[n]early 60 health information technology groups and various industry associations are circulating a letter among member of Congress asking for legislation that clarifies the Food and Drug Administration’s authority to regulate health IT products. The letter was also sent to Health and Human Services Secretary Sylvia Mathews Burwell and called on lawmakers to pass legislation reflecting health IT oversight recommendations made earlier this year by three federal agencies, including the FDA and the Office of the National Coordinator for Health IT. The proposed legislation would ‘provide much needed statutory clarity and a stable foundation for continued innovation in health IT’ by establishing parameters, defined by the framework, for the FDA to oversee health IT products, the letter said.”

4. And at Bloomberg BNA’s Life Sciences Law & Industry Report, Nicole Ostrow summarizes the results of an analysis in the Annals of Internal Medicine that found that “[researchers] with financial ties to flu drug companies more often reported positive findings in their studies of the treatments… Christine Laine, editor in chief of the Annals and a senior vice president at the American College of Physicians in Philadelphia, said there’s a lot of confusion for doctors because of the conflicting findings among the studies of the flu medicines. Today’s results provide some insight into why the literature on this topic has been ‘inconsistent.’

5. Finally, I can’t recommend it yet, because I it hasn’t climbed to the top of the pile yet, but I am looking forward to reading this month’s Health Affairs, on Specialty Pharmaceutical Spending & Policy, cover to cover. (I did sneak a peak at the Narrative Matters piece, by Leana Wen, in which “[a] doctor who stutters confronts the stigma against patients—and providers—with disabilities.” It’s off the topic of drug and device law and policy, but of general interest and very thought-provoking.)


Monday Morning Recap: The Week (9.29.14-10.5.14) in Drug & Device Law & Policy

Picture3It’s October and it’s Monday, time for our  Monday Morning Recap, the post where we call out recent drug and device law and policy developments that caught our eye and made us think. And once again, there’s been a lot going on…

1. If the questions I have been fielding from friends and family this week are any indication, the development of vaccines to prevent, and anti-viral medications to treat, Ebola virus disease is on a lot of people’s minds. In an article in The New Yorker in August, James Surowiecki gave helpful background on “Ebolanomics”, here; Lecia Bushak provided an update in last week’s Newsweek, here. Our own Carl Coleman wrote about the Food and Drug Administration’s decision to allow compassionate use of the experimental treatment ZMapp, here; in early September, the Department of Health and Human Services announced that it was partnering with ZMapp’s manufacturer to develop the drug, here. The FDA has also granted permission to Tekmira Pharmaceuticals to provide its experimental drug TKM-Ebola to patients on a compassionate use basis, here. And just today, the biopharmaceutical company Chimerix announced that the FDA has authorized compassionate use of its experimental treatment, brincidofovir, here. And this is not all, e.g., here. The pace of development in recent months is both dizzyingly fast and much too slow. As much or more focus and funding must go to stopping the current epidemic using proven public health techniques. As Atul Gawande wrote in The New Yorker last week, “The diagnosis of the first U.S. case is not the sign that we need to shut patients out. It’s the sign that we need to bring more help in. The Ebola epidemic is stoppable.

2. Last week, the Open Payments website, which tracks payments drug and device companies make to doctors and teaching hospitals, finally went live. At Pro Publica, Charles Ornstein had this, highly critical, take: “If the federal government’s new Open Payments website were a consumer product, it would be returned to the manufacturer for a full refund. … As a health care journalist at ProPublica, I’m reasonably competent at analyzing data, plus I’m lucky to have another data reporter and a news application developer helping me. Still, it took us hours just to upload the data onto our servers so that we could dig into it.” Ornstein opines that “after the fumbled launch of, it might have been better if agency officials had pushed this off until it was in better shape.

3. At Sidley Austin’s Original Source blog, Jaime Jones and Brenna Jenny call attention to two recently-decided cases in which courts allowed the government, in one, and the relator, in the other, to establish liability using statistical inferences. Jones and Jenny write that, in U.S. ex rel. Martin v. Life Care Centers of America, “the court determined that the fraud-fighting goals of the FCA would be stymied if the court sided with the defendants and effectively required a ‘claim-by-claim review’ in every FCA suit.” These developments are no doubt being watched carefully by drug and device manufacturers, who frequently find themselves defending against FCA suits. In an article published earlier this year, I discuss (and endorse) a similar evolution towards the use of standard statistical methods to establish liability in economic injury cases brought by third-party payers against drug and device manufacturers.

4. At FiercePharma, Tracy Staton reports on a 60 Minutes segment on cancer drug pricing that aired on Sunday, October 5th. She concludes:

Over and over, experts have said that rising drug prices will eventually force a public debate. Perhaps “60 Minutes” will help touch that off. But one of the biggest obstacles to overhauling cancer costs will be Americans themselves. Everyone wants access to the latest treatments, no matter how expensive. No one wants to put a number on the value of longer life, no matter how brief.

So, while private insurers may be setting up their own barriers to expensive meds, allowing public programs to do the same is frightening. Letting payers restrict access behind closed doors is more comfortable than facing the issue in the open.

5. Finally, I enjoyed reading FierceBiotech’s brief profiles of their top fifteen women in biotech for 2014. Making the list is Amy Schulman, who joined Pfizer as General Counsel, but was running that company’s consumer healthcare business by the time she left. Schulman is now a Venture Partner at Polaris Partners where she currently serves as CEO of Polaris-funded start-up Arsia Therapeutics, which is “working on technology to make large-molecule biologics easier to administer.”  On the question of gender equity, Schulman comments: “We have to make sure we’re really being vigilant and look at, ‘Are we really gender neutral? Are we really color blind?’” she said. “… I’m hardly alone in the recognition that those of us who are here should be spending our political capital to open the doors to the next generation of women, and many of us are deeply committed to that.


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