Seton Hall Law Alum David Gibbons on Hospira v. Burwell and FDA’s Authority to Order Drug Recalls

Last week, Seton Hall Law alum David Gibbons of Hyman, Phelps & McNamara published a blog post at the firm’s FDA Law Blog on a very interesting legal question, whether a court can order the FDA to order a drug manufacturer to recall a drug. In a suit brought by Hospira challenging the FDA’s approval of generic versions of one of Hospira’s drugs, a federal district court in Maryland recently reversed itself on this point. The court vacated its earlier–unprecedented–ruling that would have required the FDA to order the generic drug manufacturers to recall the generic versions of the drug at issue. As Gibbons explains:   

Generally speaking, FDA cannot compel a mandatory recall, except in very limited circumstances as authorized by statute, none of which apply to drugs…

FDA states clearly and succinctly in its Brief: “FDA cannot order recalls.”  The Agency goes on to argue that the recall ordered in the Hospira TRO could not even be requested by FDA because the basis for the recall was a patent dispute and not a matter of product safety or efficacy.  FDA says: “consumers should believe that recalled products present a risk to health or are grossly deceptive. That is decidedly not the case here.”  The Agency admitted that “[i]f a company chooses not to comply with an FDA request to recall, FDA has no mechanism to enforce its request because it does not have statutory authority to order drug recalls.”

Read the entire post here.

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Medicaid Expansion Under the ACA Just Makes Sense

Adam Mitchell

By Adam Mitchell

I am not a proponent of big government or social welfare programs. I did not vote for Obama or support the Affordable Care Act. However, after researching the current Medicaid expansion debate, I am having a hard time supporting the “opt out” point of view. Ultimately, opting out of Medicaid expansion is only going to further disadvantage the poor and keep them from receiving early and preventative care.

Originally the ACA called for a mandatory state Medicaid expansion. If a state refused to expand Medicaid, the federal government could withhold all federal Medicaid funding until the state complied. However, in NFIB v. Sebelius, the Supreme Court struck down this “gun to the head” provision when it held that the federal government could not rescind existing Medicaid funding as a consequence for a state’s failure to expand Medicaid.

In short, Sebelius gave states the choice to opt in or to opt out of the ACA’s Medicaid expansion.  As of June 10, 2014, as shown in this Kaiser Family Foundation graphic, 26 states plus Washington, D.C. have opted in and expanded Medicaid, leaving 3 states considering expansion, and 21 not expanding at the current time:

current-status-of-the-medicaid-expansion-decisions-healthreform1

The states opting out of the expansion have left many uninsured who would otherwise have qualified for Medicaid under the ACA. These “opt out” states cite future costs of expansion as their main objection. They argue that even though the federal government will cover 100% of the expansion costs up front and gradually step it down to 90% by 2022 ,  that even the 10% left to the states will not be financially sustainable. The opt-out states also argue that the government is unreliable and may not be able to fulfill its financial commitment in the future, leaving the states with the bill for the expanded coverage. For example, Florida Gov. Rick Scott has used this argument to defend his decision not to expand Medicaid in Florida. (Scott, of course, subsequently came to favor expansion.)

However, these arguments ignore the reality that medical bills for the uninsured are already being paid by the state and the taxpayer. The counter to the arguments of Rick Scott and other opt-out proponents follow a more logical form of thinking. The uninsured do not receive preventative care or regular check-ups. Furthermore, any ailment is not of concern until it reaches a point where it becomes an emergency room-worthy condition. The uninsured also utilize emergency room services in lieu of a primary care provider. Therefore, insuring these individuals so that they may be treated before they develop an emergency room worthy-condition would be the logical step in reducing health care related costs, not increasing them. This Kaiser Commission on Medicaid and the Uninsured graph analyzing 2011 NHIS data illustrates this point:

Capture

On the whole, those with health insurance (private or Medicaid) v.s. the uninsured are significantly more likely to have a usual source of care and significantly less likely to postpone or forgo care due to cost. This equates to the insured seeking and receiving early and preventative care which is far more effective and less expensive than ignoring the problem until emergency care becomes a necessity simply because you are uninsured. Insurance also allows individuals to seek medical care from a primary care provider rather than utilizing emergency room services for conditions that are not emergencies. The old adage, an ounce of prevention is worth a pound of cure, appropriately summarizes this position.

Furthermore, even if opt-out states refuse to change their position, their Medicaid enrollment is likely to grow nonetheless because of other ACA provisions. For example, as a result of the individual mandate, many signing up for health care on a state exchange will find that they are eligible and sign up for Medicaid. Also, Medicaid enrollment will climb due to an increase in part-time positions as a result of employers not wanting to offer health care to full-time workers as required under the ACA. Therefore Medicaid is going to grow from pre-ACA levels regardless of whether states opt in or out. How much it grows and the amount of federal funding for said growth remains the decision of the individual states but currently the smart move is to expand Medicaid.

Adam Mitchell is a Juris Doctorate student at Seton Hall University School of Law. We are very pleased to welcome him to the blog today.

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Averting Mental Health and Fiscal Crises: Crisis Intervention Teams and Access to Meaningful Treatment for Mental Illness

August 26, 2014 by · Leave a Comment
Filed under: Health Reform, Mental Health 

Tara Ragone

Cross-Posted at Bill of Health

Social media recently focused my attention on two very different law enforcement interactions with people with mental illness that reinforce the need for increased training of law enforcement in crisis intervention as well as the need for improved access to treatment for people with mental illness.

The first is a video of the fatal police shooting of Kajieme Powell in St. Louis, Missouri earlier this month.  Mr. Powell was twenty-five years old and suspected of shoplifting junk food from a convenience store.  The first eighty seconds of the video show Mr. Powell pacing and muttering on the sidewalk — with four pedestrians passing by without incident — before the police arrive.  The police then exited their vehicles with their guns drawn, shouted at Mr. Powell to drop his weapon, and fired about twelve shots fewer than twenty seconds after they arrived on the scene.

The second is an NPR story that included an audio recording of law enforcement officials in San Antonio, Texas responding to a 911 call about a twenty-four year old group home resident named Mason, who was off of his medications, had set his blanket on fire, and was a danger to himself and others.  When they arrived at the scene, the officers acknowledged that they did not use the “tough guy command voice” that they typically would in responding to a 911 call reporting suspected criminal activity.  Instead, in plain clothes and without their weapons drawn, they spoke calmly with Mason, reassuring him that they wanted to get him help.  They astutely noticed signs suggesting that Mason was experiencing tactile, auditory, and visual hallucinations, and with patience and skilled questioning, got him to acknowledge the hallucinations and seek psychiatric treatment.

The San Antonio officers were members of a six-person mental health squad that the city created to confront severe prison overcrowding.  As NPR correspondent Jenny Gold reported, the city and county have saved $5 million and eliminated prison overcrowding over the past five years by diverting people with mental illness out of prisons and overcrowded emergency rooms and into appropriate mental health treatment.  Officers must take forty hours of crisis intervention team (“CIT”) training to help them learn how to handle mental health crises.

By juxtaposing the St. Louis and San Antonio incidents, I am not suggesting that they necessarily can be fairly compared.  The facts that were available to the officers in each situation may have justified different law enforcement responses.   The San Antonio officers were warned in advance that Mason may have been experiencing increased symptoms of mental illness and, when they arrived, Mason was sitting by himself without any suspected weapon.  In contrast, the St. Louis 911 call reportedly did not raise any concerns that Mr. Powell was suffering from a mental illness.  In addition, the police claim that Mr. Powell was brandishing a knife as he approached the officers, and a knife reportedly was recovered at the scene.  Michael Woody, a CIT expert and former police trainer in Akron, Ohio, has opined that the St. Louis scene was not stable enough for the CIT protocol to be appropriate.  (But query whether other tactics short of lethal force could have controlled the situation and spared Mr. Powell’s life.)

The starkly different outcomes in these cases shine a spotlight on the potential for CIT training to arm officers with effective tools to help de-escalate mental health crises in appropriate cases.  In a December 2012 article in the Community Mental Health Journal, Kelli E. Canada, Beth Angell, and Amy C. Watson summarized some of the preliminary findings of CIT effectiveness, including:

  • “improved officer preparedness and improved disposition of mental health calls”
  • “improved attitudes, increased knowledge and patience, and an increase in support of local treatment programs”
  • “the potential to reduce stigma and alter beliefs about mental illness”
  • “increases in the number of identified mental health calls[,] . . . transports to treatment by CIT officers[,] . . ., and voluntary transports”
  • “increasing access to mental health services through linking individuals with community providers”

An analysis of interviews these researchers conducted of CIT and non-CIT trained officers in Chicago “uncovered three specific areas that CIT trained officers demonstrated specialized procedures in comparison to non-CIT trained officers: assessment, response tactics, and disposition.”

Here in New Jersey, Camden was the first city to use CIT training back in 2008, and eleven New Jersey counties currently have CIT programs.  A Union County officer reported that the training caused him to think twice before curtly shuffling a homeless man along.  Instead by talking with the man, the officer learned that he was suicidal and convinced him to seek treatment for his previously undiagnosed schizophrenia.  New Jersey should continue to expand CIT programs in law enforcement agencies throughout the state.

But, as the St. Louis incident reminds us, CIT training alone is not enough.  (Indeed, reportedly one of the officers involved in the shooting of Mr. Powell was CIT-trained.)  New Jersey also needs to invest in treatment services for patients with mental illness, both to help them avoid a crisis and to have appropriate and available treatment options when they reach a crisis.  Officers need places to bring or refer individuals in need of mental health treatment.  Yet patients often report difficulty trying to access appropriate mental health services in New Jersey as in other states.  We need to be sure there are adequate networks of providers to meet the needs of people with mental illness.

Given current fiscal realities, it is unclear how New Jersey will fund efforts to improve mental health access.  Gold reports that jails, hospitals, courts, police, and the mental health department in San Antonio banded together to build the Restoration Center, which offers an array of mental and physical health services, including “a 48-hour inpatient psychiatric unit; outpatient services for psychiatric and primary care; centers for drug or alcohol detox; a 90-day recovery program for substance abuse; plus housing for people with mental illnesses, and even job training.”

New Jersey agencies similarly should explore ways to coordinate.  Given the cost savings San Antonio has realized, perhaps New Jersey should revisit the role for social impact financing to improve mental health network adequacy.

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Monday Morning Recap: The Week (8.18.14-8.24.14) in Drug & Device Law & Policy

Picture3Well, another week has flown by and it’s once again time for the Monday Morning Recap, the post where we call out the recent drug and device law and policy developments that caught our eye and made us think.  We  are looking forward to a busy last week of summer on the blog, with posts from yours truly, from Seton Hall Law student Adam Mitchell, and from Tara Adams Ragone. We’ll take a break for Labor Day Weekend and then be back for the fall with lots of timely analysis and commentary from Seton Hall Law’s health law faculty.

1. This past week the ubiquitous ALS ice bucket challenge came to Seton Hall Law, with Professor Mark Alexander (video here) and Dean Patrick Hobbs (video here) taking part. For those interested in how the money raised will be spent, I recommend this post by Carey Goldberg at CommonHealth. Goldberg spoke with “Dr. Lucie Bruijn, chief scientist of the ALS Association that is reaping the ice-bucket windfall” who “describe[d] a field that is forging ahead in multiple directions.” To give just one example,  the Association might direct some of the money towards a clinical trial of “a compound that has been approved for people who have changing emotions in ALS — laughing and crying that’s exaggerated” to see if it might also, as anecdotal evidence suggests, improve swallowing. On a sobering note, Dr. Bruijn notes that “trials can be anywhere up from $25 million plus, just for perspective. So these are not small investments.”

2. This interview, by Geoff Colvin at Fortune, of Kathy Giusti, a former pharmaceutical executive who founded the Multiple Myeloma Research Foundation (MMRF), touches on similar themes. There are currently six drugs approved to treat multiple myeloma, “and the MMRF played a role in advancing all of them, with more in the pipeline. Life expectancy for many patients has doubled.” Giusti credits her foundation’s success to her decision to focus on funding research (to the exclusion of advocacy or public policy or healthcare), and, in particular, to focus on fixing a cancer research system that Giusti describes as “broken.”

3. This week also brought news of a recent development in Depomed’s struggle to protect its drug Gralise, a once-a-day version of gabapentin, from generic challengers.  As Arlene Weintraub reports at FiercePharma, “Judge Joel Pisano of the U.S. District Court in New Jersey ruled that Actavis’s filing for FDA approval of generic Gralise infringes all seven of Depomed’s patents on the product. With this ruling, Depomed’s market exclusivity will be protected until 2024.” Depomed continues to litigate on another front, however. As Weintraub explains: “Simultaneously, Depomed has been in a war with the FDA, which approved Gralise under its Orphan Drug program but did not grant the company the 7 years of market exclusivity that normally goes along with orphan designation. Depomed sued the FDA in September 2012 seeking that exclusivity and is still awaiting a decision from a federal district court judge, according to the company’s latest quarterly filing.

4. Also at FiercePharma, and also by Arlene Weintraub, this article about the Drug Enforcement Administration’s re-classification of “combination drugs containing hydrocodone . . . as Schedule II products, imposing on them the same restrictions that apply to pure hydrocodone, as well as oxycodone and morphine.” As Weintraub explains: “Vicodin and similar products used to be grouped in the less restrictive Schedule III, but recent DEA research showed that the drugs can be as addictive as pure opioids and “may lead to severe psychological or physical dependence,” a statement from the agency says. “Adding nonnarcotic substances like acetaminophen to hydrocodone does not diminish its abuse potential.”

5. Finally, at The Hill, Peter Schroeder reports that the Inspector General for Tax Administration has found a number of problems with the Internal Revenue Service’s implementation of the Affordable Care Act’s device tax. Among other things, “IRS agents were still having a hard time determining exactly which medical device manufacturers were subject to the tax” and “both the returns filed and revenue raised have come in well short of expectations.”

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Monday Morning Recap: The Week (8.11.14-8.17.14) in Drug & Device Law & Policy

August 19, 2014 by · Leave a Comment
Filed under: Monday Morning Recap 

Picture3The student’s are back here at Seton Hall Law and the Tuesday Monday Morning Recap is too, after a restful but all-too-brief vacation. Monday Morning Recap is the post where we call out the drug and device law and policy developments that caught our eye and made us think over the previous week.  You can see all of our previous Monday Morning Recap posts here.

1. The high-priced Hepatitis C drug Sovaldi continued to make headlines this past week. At Forbes, Yevginiy Feldman noted that “the UK’s National Institute for Health and Care Excellence (NICE) just approved the drug as being cost-effective, and recommended it for subgroups of patients.” Feldman suggests that, “given that a system with very tight price controls, and what can be described as a true single-payer system, decided to cover Sovaldi for some subgroup of patients, perhaps the mud-slinging against [Sovaldi's manufacturer] Gilead is a bit unwarranted. The evidence appears to be shifting in Sovaldi’s favor.

2. At Kaiser Health News, Jim Burress reported on the barriers that stand in the way of more widespread use of the anti-viral medication Truvada by individuals at risk of, but who do not have, HIV or AIDS. Burress quotes researcher Dr. Melanie Thompson who “says no doctor would refuse to prescribe cholesterol-lowering statins to patients because they’re overweight.  Somehow, the conversation around PrEP is different. ‘So I think it’s a very interesting moralistic attitude that soon will be outdated.  But I do think that this is a barrier for some patients,’ Thompson says. ‘They feel stigmatized. And honestly, health care providers need to step up their game and do better than that.‘”

3. AP Health Writer Matthew Perrone wrote about former AIDS activist Gregg Gonsalves, who “still travels to Washington, but with a different agenda: to defend the FDA.”  Perrone reports that “[s]ince May, three states – Colorado, Louisiana and Missouri – have passed laws designed to allow terminally ill patients to receive experimental drugs that have not been cleared by the FDA. Arizona will vote on its own so-called ‘right to try’ initiative in November and lawmakers in Florida, Oklahoma and Utah are set to introduce similar bills. All of these efforts are driven by lobbyists from the Goldwater Institute, a libertarian think tank. … In closing his talk on Capitol Hill earlier this summer, Gonsalves warned Senate staffers that a political shift to the right in coming elections could ‘change the game’ for drug safety and effectiveness. ‘We will have a different FDA than we have had for the last 30 years.’”

4. Charles Ornstein of Pro Publica broke the news that “[n]ext month, when the federal government releases data about payments to physicians from pharmaceutical and medical device makers, one-third of the records will be withheld because of data inconsistencies, an official told ProPublica. The issue is the latest hurdle for the federal government as it seeks to launch the already-delayed Open Payments database mandated under the Physician Payment Sunshine Act, a provision of the 2010 Affordable Care Act.” The data inconsistencies were uncovered after a physician in Kentucky named David E. Mann complained that some of the payments attributed to him were actually made to a David E. Mann in Florida. Even before he discovered the inconsistencies, Dr. Mann was frustrated. On August 1st, he Tweeted the following: “Just completed the application to view my #sunshine act data on CMS website. Applying for a visa to North Korea would be simpler.

5. Finally, at the Drug and Device Law blog, Jim Beck opines, with his usual entertaining irascibility, about the Alabama Supreme Court’s “re-decision” in Weeks v. Wyeth. In Weeks II, the Court held, as it did the first time around in Weeks I, that a plaintiff who was injured by a generic drug could bring suit against the manufacturer of the drug’s branded equivalent, to the extent that the plaintiff’s physician prescribed the generic drug in reliance on misrepresentations made by the branded manufacturer. Beck’s “[b]ottom line”: “Alabama has more home-grown plaintiff lawyers than pharmaceutical companies – and after Weeks II, it most assuredly always will.” (A video of (among other things) me giving my (contrary) take on Weeks I and innovator liability generally is here.)

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