Online Graduate Certificate Program in Pharmaceutical & Medical Device Law & Compliance, ‘Bringing Products to Market,’ to Start on Oct. 7, 2012
Filed under: Compliance, Health Law, Medical Device, Pharma
Through its Center for Health & Pharmaceutical Law & Policy, Seton Hall Law School offers 3 graduate certificate programs in Pharmaceutical & Medical Device Law & Compliance. These flexible, 8-week certificate programs are designed for professionals seeking to enhance their knowledge about legal, regulatory, and ethical issues within the pharmaceutical and medical device industries. Featuring intensive, individualized feedback, the programs provide both an immersion in key substantive issues and an opportunity to develop the practical skills necessary to research and communicate effectively about the law. Online classes for the Bringing Products to Market Certificate start on October 7, 2012.
Bringing Products to Market Certificate
The Pharmaceutical & Medical Device Law & Compliance Certificate: Bringing Products to Market covers the following topics:
- The FDA approval process
- Products liability and FDA preemption
- Advertising and promotion
- Life science companies and the First Amendment
It takes 8 weeks to complete the certificate program. All coursework must be completed in the sequence in which it is offered. Students should plan to spend 6-8 hours per week on online coursework, including reading assignments, research and writing projects, and online discussions.
Seton Hall Law School’s online Graduate Certificate Programs are offered during our Spring, Summer, and Fall semesters. Start dates for upcoming offerings of the Bring Products to Market certificate and are indicated in the Certificates At-A-Glance section.
Do I need to be in a certain profession to be admitted?
No. While the program is specifically designed to meet the needs of mid- to senior-level professionals in the pharmaceutical and medical device industries, it is also open to qualified students from other backgrounds.
Applicants must submit the following:
- Online application
- Application fee of $50
- Official baccalaureate degree transcript from an accredited college or university
- Current resume
- A 500-word statement explaining why you want to study Pharmaceutical & Medical Device Law & Compliance with a focus on Bringing Products to Market
No entrance exam is required for admission. However, international applicants who are not native speakers of English must submit a TOEFL score.
Paradigms are made to be broken– like hearts, artificial or otherwise. And some solutions seem so simple in retrospect, yet unthinkable prior. Incapable, at times, of seeing that which sits right in front of our eyes, we marvel when someone brings it to our attention: “Oh yes, of course!”
Two surgeons from Texas, Dr. Billy Cohn and Dr. Bud Frazier, of the Texas Heart Institute, have hooked together what amounts to a tandem of centrifugal pumps–and have used it to replace the heart. No pulse, no rhythm, just pumping– a continuous flow. You can see the press conference here, along with an image of the pumps– installed.
Cohn and Frazier did not start totally from scratch. They took two medical implants known as ventricular assist devices and hooked them together.
A ventricular assist device has a screwlike rotor of blades, which pushes the blood forward in a continuous flow.
Thousands of people have one of these implanted close to their hearts, including former Vice President Dick Cheney. By using two, the doctors replaced both the right and left ventricles — the entire heart.
Important conceptually to the beatless heart is the purpose, in the first place, of the beat. NPR notes:
the only reason blood must be pumped rhythmically instead of continuously is the heart tissue itself.
“The pulsatility of the flow is essential for the heart, because it can only get nourishment in between heartbeats,” Cohn says. “If you remove that from the system, none of the other organs seem to care much.”
They’ve implanted the device successfully in a number of animals and one human being– the human being a man named Craig Lewis, a 55-year-old who was dying from amyloidosis, a disease which causes abnormal protein buildup on the organs which ultimately causes the cessation of those organs. Mr. Lewis’ heart was said to have been down to 12 hours of working time when it was replaced with the surgeons’ whirring pumps. It worked, though the amyloidosis afterwards fatally attacked his other organs.
NPR reports: “Craig Lewis lived for more than a month with the pulseless heart. He died in April, due to the underlying disease. His doctors say the pumps themselves worked flawlessly.”
And there it is, that which we have thought the quintessence of existence, the pulse, the rhythm of life, perhaps not essential– and perhaps that which attempts to recreate that rhythm is simply less efficient.
Doctor Cohn has what I think is a good grasp of the nature of his innovation– the sort of flash, recurrent through human history, which makes one question what else it is they thought they knew.
Biomedical companies worldwide are still trying to perfect a pulsing artificial heart.
But Cohn says those companies are like the last buggy-whip manufacturers: fine-tuning a product that will soon become obsolete.
He is sympathetic to their efforts, though. He points out that the history of invention is full of dead ends.
“When man first tried to come up with machines that flew, he looked around and saw bats and birds and butterflies and mosquitoes,” Cohn says. “Everything had wings that flapped.”
But what works in nature is often not the only mechanical solution, or even the best one.
“When they saw that you could create wind, and that wind over a fixed wing was a great way to provide lift, then the whole field shifted,” Cohn says. “There are very few flying machines in modern times that have flapping wings. And I think this is the same intellectual leap in pumping blood or pumping fluids.”
Filed under: Medical Device, Prescription Drugs, preventive care
Having previously described my diet, proclivities, and the thoroughly reasonable fear I had regarding the battery of tests I would have to undergo this week at the Cardiologist’s, I am pleased to say that I did so well that my doctor no longer thinks I will need to take Lipitor. My valves seem to all flap when they’re supposed to (echocardiogram), and the nuclear stress test showed no obstructions whatsoever. But the clincher was that the calcium scan showed zero calcium. Yes, zero.
Given the high correlation between the presence of arterial calcium and propensity for heart disease in a country where heart disease is the number one killer (about every 25 seconds an American will have a coronary event) and a major medical expense, I wrote previously how it seemed penny wise and pound foolish for health insurers to not pay for calcium deposit screening. This test can offer actionable insight years prior to the onset of ultimately costly symptoms. There is, reasonably speaking, savings of more than one kind to be had in this kind of knowledge: if one knows, one can act in accord. I paid the $318 out of pocket. Now, it seems, despite the ostensible risk factors which may have counseled otherwise, I have spared my insurer the cost of a lifetime’s worth of Lipitor. And myself the burden of a lifetime’s worth of pharmaceutical dependence.
There’s a J.D. at the end of my name, not an MD, so I do not give medical advice. But I will say that the whole battery of tests was painless, congenial, and took about 4 1/2 hours spread over two visits– which is not a lot of time to invest in dispensing with the ominous unknown. Of those one every 25 seconds in America who have a coronary event, one every minute will die. Testing will help tell you where you stand, and you never know, you just might get some peace of mind.
Filed under: Health Reform, HHS, Medical Device, Medicare, Medicare & Medicaid
Health care finance is always going to be a contentious topic. Two recent stories about devices in health care show the unexpected ways in which technological innovation can generate new burdens, worries, and ethical dilemmas for patients and their families.
Katy Butler authored a heart-rending account of her father’s decline (and her mother’s near-exhaustion as a caregiver) in the NYT last week. Her father’s stroke changed both his and Butler’s mother’s lives:
The day before [the stroke], my mother was an upper-middle-class housewife who practiced calligraphy in her spare time. Afterward, she was one of tens of millions of people in America, most of them women, who help care for an older family member.
The story of what happens next is long and complex, but for health policy makers the nub comes down to a decision the family must make about whether to implant a permanent pacemaker when her father needs surgery to repair a hernia:
[T]he cardiologist, John Rogan, refused to clear my dad for surgery unless he received a pacemaker. . .. The decision fell to my mother — anxious to relieve my father’s pain, exhausted with caregiving, deferential to doctors and no expert on high-tech medicine. She said yes. One of the most important medical decisions of my father’s life was over in minutes. . . .
[If my father's primary care physician had] had the chance to sit down with my parents, he could have explained that the pacemaker’s battery would last 10 years and asked whether my father wanted to live to be 89 in his nearly mute and dependent state. He could have discussed the option of using a temporary external pacemaker that, I later learned, could have seen my dad safely through surgery. But my mother never consulted Fales. And the system would have effectively penalized him if she had. Medicare would have paid him a standard office-visit rate of $54 for what would undoubtedly have been a long meeting — and nothing for phone calls to work out a plan with Rogan and the surgeon.
Medicare has made minor improvements since then, and in the House version of the health care reform bill debated last year, much better payments for such conversations were included. But after the provision was distorted as reimbursement for “death panels,” it was dropped. In my father’s case, there was only a brief informed-consent process, covering the boilerplate risks of minor surgery, handled by the general surgeon.
Butler’s family’s situation was clearly a troubling one. I do not agree with her harsher critics, who charge the New York Times has used her story to promote its political agenda:
The New York Times is continuing its promotion of the Obama administration’s cost-cutting health care legislation three months after it was signed into law. Central to the newspaper’s support for the bill is its drive to cut back on “unnecessary” treatments and procedures and to target for elimination “overly generous” insurance benefits. . . . The article is a cynical attempt to utilize the author’s family’s personal story—unarguably tragic and heartrending—to make the case that artificial pacemakers are being widely over-utilized.
But I was also troubled by Butler’s quoting the following studies:
In a 1997 study in The Journal of the American Geriatrics Society, 30 percent of seriously ill people surveyed in a hospital said they would “rather die” than live permanently in a nursing home. In a 2008 study in The Journal of the American College of Cardiology, 28 percent of patients with advanced heart failure said they would trade one day of excellent health for another two years in their current state.
I have not experienced “advanced heart failure,” but I know people who do, and it’s inconceivable to me that they would trade a day of “perfect health” for two months, much less two years, of stasis. Moreover, as Alasdair MacIntyre argues in his book Dependent Rational Animals, caring for others and being dependent are essential, important human experiences.
As I read Butler’s piece, I kept wishing that society had done more (perhaps along the lines of Britain’s Social Care programs) to help her family.
But even some forms of aid for the cared for (and their caregivers) are filled with philosophical complexities. Consider the Paro, a robotic seal I blogged about in last month and back in 2006. The Paro has been approved as “a Class 2 medical device (a category that includes powered wheelchairs)” to help soothe elderly patients. Here is one example of its powers:
One recent morning, staff at Marian Manor in Pittsburgh, one of Vincentian Collaborative’s homes, circulated three Paros among residents gathered for a sing-a-long. As 77-year-old Anita Biro sat down at a table, she berated two fellow residents and told them to leave, recalls Beth Kuenzi, activities manager for the home’s dementia unit. But when Ms. Kuenzi put Paro in front of Ms. Biro, her mood changed. As Ms. Biro stroked the robot’s synthetic fur, the machine batted its eyelashes and tracked movement with its head and eyes.
“I love this baby,” Ms. Biro cooed. Aides also take Paro to residents’ rooms to get them to socialize. At another Vincentian home, Lois Simmeth, 73, doesn’t always participate in group activities, but she ventures into the hall when she hears Paro’s sounds.
“I love animals,” explains Ms. Simmeth. She whispered to the robot in her lap: “I know you’re not real, but somehow, I don’t know, I love you.”
MIT Professor Sherry Turkle concedes that the Paro has some very good effects, but wonders “Why are we so willing to provide our parents, then ourselves, with faux relationships?” Another article explores advances in “building a machine that fills the basic human need for companionship.” Turkle, again, questions the larger social context:
[S]ome social critics see the use of robots with such patients as a sign of the low status of the elderly, especially those with dementia. As the technology improves . . . it will only grow more tempting to substitute Paro and its ilk for a family member, friend — or actual pet — in an ever-widening number of situations.
“Paro is the beginning,” she said. “It’s allowing us to say, ‘A robot makes sense in this situation.’ But does it really? And then what? What about a robot that reads to your kid? A robot you tell your troubles to? Who among us will eventually be deserving enough to deserve people?”
These are all fantastic questions, all-too-ready to be answered by techno-libertarian fantasists. I look forward to tracing the degree to which the decision to approve Paro as a covered device could reflect the larger ethical concerns explored by Dov Fox in his piece on the “gap between ethics and law” in other health decisionmaking.
Filed under: FDA, FDA Center for Devices and Radiological Health, Medical Device, Physician Compensation
The New York Times reports that New Jersey Attorney General Anne Milgram announced a settlement agreement with medical device maker, Synthes, for failing to disclose the financial conflicts of interest of doctors researching its products. Synthes is the maker of the ProDisc, an artificial spinal disk.
The settlement agreement with Synthes was described in the AG’s press release, which quoted Ms. Milgram, as “the first of its kind because of its disclosure provisions, as well as its ban on compensating clinical researchers with company stock. She said the latter provision runs counter to widespread industry practice — a practice she called unacceptable.” Notably, the state pursued the case as a matter of consumer fraud. The premise being that the failure to fully disclose such conflicts constituted such for both human trial subjects and the purchasing public.
In a letter to the FDA, critical of the FDA and cc’d to key members of Congress, Ms. Milgram described the results of the AG’s investigation into the business and research practices of Synthes. The letter states:
The investigation revealed that a majority of the physicians who participated in these clinical trials had significant investments in the products -investments that would have been worthless had the product failed to obtain regulatory approval from the FDA. And, the investigation revealed that Synthes, which acquired ProDisc while the clinical trials were underway, failed to disclose these financial conflicts of interest to the FDA.
Yet, despite the fact that Synthes’ failure to adequately disclose these interests should have been obvious from even a cursory review of its FDA submissions, the FDA did nothing to regulate these conflicts. A number of the disclosure forms were signed and dated, but were otherwise left blank. Others indicated that the clinical investigator had a significant equity interest in the product, but did not attach the requisite details. But the FDA approved Synthes’ applications for premarket approval without any delay or further inquiry into this issue.
Leaving aside for the moment the criticism of the FDA (the State of New Jersey joins a long list of increasingly vocal complainants, including the Program on Government Oversight (citing “dramatically reduced inspections of ‘good laboratory practices’ at facilities that do the earliest testing of medical devices. Such inspections declined from 33 in 2005, to seven in 2007, to just one last year”), and FDA scientists from the Center for Devices and Radiological Health, who have openly proclaimed that the FDA “is fundamentally broken.”), it’s worth a moment to consider that Synthes has agreed to “stop paying doctors who are conducting clinical trials of its products with stock or stock options,” and that AG Milgram described the compensation of research doctors with stock as being “apparently common” and a “widespread industry practice.”
Compensating a doctor with stock or stock options financially tied to the results of his research may well be the antithesis of an impetus for objective clinical research.
The basic proposition is this: you, doctor, are charged with investigating whether or not this medical device is safe and fit and shows efficacy for human use. For doing so, we will give you a portion of the company (stock or stock options) which owns the medical device. If the medical device is efficacious and fit for human use, the company will stand to profit. As a holder of stock and/or stock options in the company, you will be paid a portion of that profit and/or the value of your holdings in the company will increase correspondent to your determination of safety for human use and efficacy. If you determine that the device is not safe for human use and/or not efficacious, your holdings in the company will be worth much less, if not worthless. “Is the device safe for human use and efficacious?” Does an answer of “Yes” surprise anyone?
It is also not an answer to say that the doctors may have merely been compensated in cash and then later converted that cash into stock or stock options independently. My guess is that in constructing these compensation packages, as with most securities matters, timing and knowledge is important. That the stock or stock options must be issued or at least contracted for by the researcher simultaneous with the hiring so as to avoid SEC difficulty regarding the particulars of the researchers’ “inside” and “confidential” knowledge regarding the device and the research itself. Researchers who have purchased interested stock (or who have had stock purchased by others) before news of their research has been made public have often paid a price.
And obviously, once the doctor’s research has been made public, any positive results will have been already reflected in the market price of the stock, all but foreclosing the research doctor from reaping profits tied directly to his research determinations.
As part of A.G. Milgram’s “Assurance of Voluntary Compliance agreement (the Synthes case was handled by Deputy Attorney General Megan Lewis, Chief of the Division of Law’s Affirmative Litigation Section, and Deputy Attorney General Michelle T. Weiner) Synthes must disclose any future payments made by the company to physicians conducting clinical trials on its devices, as well as any investments held by such physicians in the devices they test. A $3 billion global company, Synthes has also agreed to stop paying clinical trial physicians with company stock or stock options.”
Attorney General Milgram said that “the Synthes agreement should serve as a template for the entire industry,” and in her letter to the FDA remarked that she was “hopeful the Synthes terms will become “best practices” for disclosure among medical device makers.”
In addition to signifying her hope, Ms. Milgram announced that her office issued subpoenas “to five major medical device manufacturing companies seeking information about their business practices.”