Online Graduate Certificate Program in Pharmaceutical & Medical Device Law & Compliance, ‘Bringing Products to Market,’ to Start on Oct. 7, 2012

September 12, 2012 by · Leave a Comment
Filed under: Compliance, Health Law 

online-pharma-medical-device_31Through 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

Topics Covered

The Pharmaceutical & Medical Device Law & Compliance Certificate: Bringing Products to Market covers the following topics:

  1. The FDA approval process
  2. Pharmacovigilance
  3. Products liability and FDA preemption
  4. Advertising and promotion
  5. Life science companies and the First Amendment

Time Commitment

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.

Start Dates

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.

Application requirements

Applicants must submit the following:

  1. Online application
  2. Application fee of $50
  3. Official baccalaureate degree transcript from an accredited college or university
  4. Current resume
  5. 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.

Apply now. Click here.

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Another Multi-Billion-Dollar Settlement for Pharma

July 5, 2012 by · Leave a Comment
Filed under: Uncategorized 

zack-buck_4As reaction to the Supreme Court’s decision on the Affordable Care Act (“ACA”) continues to make headlines with mind-numbing political arguments surrounding the distinction (or lack thereof) between a “tax” and a “penalty,” healthcare fraud enforcement rolls on unchanged.  This week brought news of yet another pharmaceutical company entering into an eye-popping settlement following damning allegations that it fraudulently marketed their drugs and misled the FDA.

In another record-breaking settlement amount, GlaxoSmithKline agreed to pay the U.S. government $3 billion – a criminal fine of $1 billion and civil fine of $2 billion – for fraudulent promotion of Paxil, Wellbutrin, and six other drugs, and for failing to notify the FDA of safety information on Avandia, its blockbuster diabetes drug.

Particularly, GSK’s marketing staff is alleged to have illegally paid doctors in an effort to increase usage of its drugs.  This allegedly included speaking engagements, vacations (including hunting trips, spa vacations, and trips to Hawaii), and tickets to entertainment events – including a Madonna concert.  The government also alleged that GSK marketed Paxil for use in children, for which it was never approved, and marketed Wellbutrin for sexual dysfunction and weight loss, two conditions for which it was not approved.  Regarding Avandia, the Justice Department alleged that GSK did not notify the government of post-approval studies that indicated that taking the drug may result in heart disease and/or heart attacks.

However, as the New York Times reported, GSK made $10.4 billion on Avandia, $11.6 billion on Paxil, and $5.9 billion on Wellbutrin during the years covered by the settlement – totaling nearly $28 billion in profits on these three blockbuster drugs.  We’ve seen this before.

As Professor Katrice Bridges Copeland has impressively written in her article Enforcing Integrity in the Indiana Law Journal, and as this blog has noted in the past, corporate integrity agreements (“CIAs”) and large fines continue to hold questionable – if not very little – deterrent value.  As Copeland has argued, pharmaceutical companies continue to expect to be subject to fines and a new CIA following each new fraud offense.  As long as the company does not get excluded from any of the federal healthcare programs, none of its executives go to jail, and the monetary penalties make up only a fraction of the profits the pharmaceutical company makes on the drug, there are few incentives for companies to change their fraudulent practices.

Unfortunately, the ACA does relatively little to bring about change in healthcare fraud enforcement.  Sure, there are some statutory changes (e.g., now an Anti-Kickback statute violation explicitly constitutes a predicate offense for the False Claims Act), and it provides more funding for anti-fraud efforts, but the underlying structural problems that have failed to prevent or curtail healthcare fraud remain.  Put simply, the amount of offenders and settlement amounts continue to grow.  Indeed, the ACA may have altered the healthcare landscape, but the industry’s major enforcement challenges remain.

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Kate Greenwood on American Law Journal TV Regarding Off-Label Promotion

March 18, 2012 by · Leave a Comment
Filed under: Drugs & Devices 

greenwood-kate-sm_1_3In Case you missed it: Research Fellow & Lecturer in Law, Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy, Kate Greenwood, on American Law Journal TV regarding Pharmaceutical Off-Label Marketing and Free Speech. A regular blogger here at HRW, Kate Greenwood appeared along with attorneys Hope Freiwald of Dechert, LLP and Brian J. McCormick, Jr., of Sheller, P.C.

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Recommended Reading: Recent Scholarship on Drug and Device Regulation

December 1, 2011 by · Leave a Comment
Filed under: Recommended Reading 

Kate Greenwood_high res 2011In Patients Over Politics: Addressing Legislative Failure in the Regulation of Medical Products (forthcoming in the 2011 volume of the Wisconsin Law Review and available on SSRN), Efthimios Parasidis proposes a significant expansion of drug and device companies’ responsibility to engage in “active post-market analysis” of drugs and devices, to be coupled with a new rule that only companies that conducted such analysis would benefit from preemption of state tort claims.  Professor Parasidis’ article includes a nuanced and revealing analysis of the historical and other reasons for the Food and Drug Administration’s heavy focus on pre-market review of drugs at the expense of post-market surveillance, as well as useful updates on both the caselaw regarding the preemption of claims involving branded drugs, generic drugs, devices, and vaccines and the ongoing efforts to use health information technology to glean information about the safety and efficacy of marketed products.  Most notable, though, is the article’s thorough explication of Professor Parasidis’ interesting proposal that “preemption laws, which often are enacted pursuant to industry lobbying efforts [be linked to] protocols that further the public health.”

In Enforcing Integrity (forthcoming in the 2011 volume of the Indiana Law Journal and available on SSRN), Katrice Bridges Copeland makes a strong case for her conclusion that neither the exclusion of pharmaceutical manufacturers from Medicare and Medicaid — a punishment which the government is reluctant to impose because it would spell the end for the company — nor the use of corporate integrity agreements coupled with large fines — which manufacturers agree to in order to avoid exclusion — works to deter illegal marketing activities.  As Professor Copeland notes, numerous companies have learned that “the punishment for multiple offenses is simply another CIA and another fine.”  She recommends that the government consider a number of alternative penalties for repeat offenders, including (1) requiring that manufacturers fund clinical trials studying the off-label uses for which they promoted their products, (2) requiring that they license the product or products at issue to other manufacturers, (3) holding high-level individuals criminally liable under the responsible corporate officer doctrine, and (4) amending the Social Security Act to allow for the exclusion of particular drugs (as opposed to entire companies) from Medicare and Medicaid.

Finally, I recommend Seton Hall Law’s own Jordan Paradise’s fascinating article, Claiming Nanotechnology: Improving USPTO Efforts at Classification of Emerging Nano-Enabled Pharmaceutical Technologies (forthcoming in the 2011 volume of the Northwestern Journal of Technology and Intellectual Property and available on SSRN), in which she argues that the United States Patent and Trademark Office’s system for classifying patents on nanotechnology-related inventions, “[w]hile undoubtedly helpful for internal purposes,” cedes too much to the courts.  Reviewing the facts of the recent case Elan Pharma International v. Abraxis Bioscience, which involved a dispute over two patents describing nano or near-nano scale versions of the same existing cancer-fighting agent and was tried to a jury verdict, Professor Paradise points out several ways in which the patents’ claims potentially overlap.  She argues that the courts are “a clumsy forum” for sorting out the “complex patent law issues that arise based on scale, size, and interactions at the nanoscale that transcend previously envisioned physical and chemical boundaries[,]” and offers concrete recommendations for steps the USPTO can take to improve its classification efforts to reduce the number of patents with potentially overlapping claims thereby making court involvement less necessary.

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Does the Ban on Off-Label Promotion Bar On-Label Promotion?: The Case of Call Plans

November 6, 2011 by · 2 Comments
Filed under: Uncategorized 

kate-greenwood_high-res-2011As predicted, in the wake of the Supreme Court’s decision in Sorrell v. IMS Health pharmaceutical companies have raised First Amendment challenges to the ban on off-label promotion on a number of fronts.  Most recently, Par Pharmaceutical sued to invalidate the ban to the extent that it “criminalize[s] Par’s truthful and non-misleading speech to healthcare professionals concerning the FDA-approved use of its FDA-approved prescription drug.”  How is it that the ban on off-label promotion could be interpreted to bar the on-label promotion in which Par wishes to engage?  At the heart of Par’s dispute with the government are the “call plans” that pharmaceutical companies develop using the prescriber-specific prescription data at issue in Sorrell.

Call plans set forth which physicians pharmaceutical sales representatives should visit and how often.  In an article in the current issue of Next Generation Pharmaceutical magazine, Matthew Linkewich and Jay Margolis of IMS Health explain that a “properly conceived and configured … call plan directs reps to those physicians whose practice characteristics, constellation of prescribing behaviors and attitudes are conducive to supporting the brand goals.”  Because call plans embody “brand goals,” the government has focused on them as evidencing companies’ intent to engage in off-label promotion.

For example, in a December 15, 2010 press release announcing a $214.5 million settlement with Elan Corporation, the Department of Justice highlighted the fact that Elan’s “off-label marketing efforts” for its anti-epilepsy drug Zonegran “targeted non-epilepsy prescribers.”   A January 28, 2011 press release announcing the formal sentencing of Novartis in a case involving off-label promotion of its anti-epilepsy drug, Trileptal, similarly noted that the company “decided to market and promote Trileptal as a treatment for [two off-label indications, bipolar disease and neuropathic disease] and directed its sales force to visit doctors who would not normally prescribe Trileptal due to the nature of their practice.” Novartis’ plea agreement explains that while epilepsy is treated by epileptologists and neurologists, the company’s call plan included psychiatrists and pain doctors.

The corporate integrity agreement that Novartis entered into as part of the settlement of the Trileptal-related claims against it provides for independent review of “the bases upon which [health care providers] and [health care institutions] belonging to specified medical specialties are included in, or excluded from, the Call Plans based on, among other factors, expected utilization of Government Reimbursed Products for FDA-approved uses or non-FDA-approved uses[.]”  The corporate integrity agreement requires a similar review of the company’s sampling strategy and goes so far as to bar the company from delivering samples to health care providers identified by the company as “belong[ing] to a specialty group that is unlikely to prescribe” the sampled product on-label.

Currently, Par Pharmaceutical’s call plan for its appetite stimulant Megace, which is FDA-approved for the treatment of AIDS-related wasting, does not include oncology practices or long-term care facilities.  With the help of an outside consultant, Par determined that physicians in those settings “reasonably may encounter patients suffering from AIDS-related wasting, and thus may have occasion to prescribe [Megace] for its on-label use,” but all agree that they would be much more likely to prescribe the drug off-label to treat wasting in cancer and geriatric patients.  In the concluding paragraphs of Par’s complaint, it explains that the U.S. Attorney’s Office for the District of New Jersey, which is investigating the company’s marketing practices, has informed the company that before it promotes a drug for its on-label use to doctors who prescribe the drug off-label it must “confirm that there are presently a sufficient number of patients being treated for whom the drug could be prescribed on-label.”

As Par points out, the government has offered no guidance regarding the number of on-label patients that a doctor must treat before he or she can be included in a company’s call plan.  On the one hand, this is to be expected because the call plan is only one factor that the government considers in determining a company’s intent.  On the other hand, it leaves companies like Par without a clear course to follow and, after Sorrell, likely to sue.

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