2014 Health Law Student Scholarships for Healthcare Compliance Certification Program at Seton Hall

Healthcare Compliance Certification Program 

2014 Health Law Student Scholarships

Seton Hall University School of Law 

Center for Health & Pharmaceutical Law & Policy 

The Healthcare Compliance Certification Program is a multi-day educational program that addresses the myriad of legal and compliance issues faced by the pharmaceutical and medical device industries.

Purpose: This award recognizes promising health law students with an aptitude for and commitment to a career in health law with a focus on the legal and compliance issues within the pharmaceutical, biotech, and medical technology industries.

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Praise for Price’s “Making Do in Making Drugs”

Check out this nice write up of PFC Academic Fellow Nicholson Price‘s paper, Making Do in Making Drugs: Innovation Policy and Pharmaceutical Manufacturing, over at the Written Description IP blog.  Says blogger , “Price’s paper leads to a host of new and interesting questions, and his thorough research revealing potential shortcomings of the FDA approval process is likely to be very useful . . . .”

On Access and Accountability: Two Supreme Court Rulings on Generic Drugs

By Marcia Boumil and Gregory Curfman

In 2013 the U.S. Supreme Court issued two important rulings in cases involving the marketing of generic drugs. In Federal Trade Commission v. Actavis, the Court addressed the law governing a controversial pharmaceutical marketing practice known as reverse payment agreements, or pay for delay – a byproduct of the Hatch-Waxman Act.  This occurs when a generic drug company identifies a vulnerable patent held by a brand-name drug manufacturer and seeks Food and Drug Administration (FDA) approval for a generic version before the patent expires, provoking a lawsuit by the brand-name company for alleged infringement. A subsequent settlement involves the brand-name company paying the generic company to delay commercialization of its product (but not beyond the expiration of the patent). The FDA alleged that reverse payment agreements violate antitrust laws. The Supreme Court held that their validity would be evaluated on a case-by-case basis using the “rule of reason” standard. According to this standard, only those agreements that restrain trade will be viewed as violations of anti-trust law.

In the second case, Mutual Pharmaceutical v. Bartlett, the Court affirmed its 2011 ruling in Mensing v. PLIVA and held that generics manufacturers are substantially immune from civil claims regarding injuries caused by their products whether the tort claim be based upon failure to warn (Mensing) or design defect (Bartlett). The basis of the decision resides in the FDA requirement that generic drug labels be consistent with the label of the brand-name equivalent. Just days after the Bartlett decision issued, the FDA indicated its intent to propose a revision to the labeling requirements for generic drugs to create parity with branded drugs. If adopted, this revision could vitiate the law set forth in Mensing and Bartlett.

For more coverage of these cases, see the New England Journal of Medicine essay here.


Drug manufacturing’s innovation problem

By Nicholson Price

There’s a lot of talk and research about the drug industry, including its levels of innovation, its pricing patterns, transparency of clinical trials, industry changes over time, and how the industry is and should be regulated.  But one thing that usually flies way under the radar is the question of actually making drugs – cranking out capsules, tablets, aerosols, gels, and liquids day after day. We tend to think that manufacturing can be taken for granted, that it’s high quality, cheap, easy, high-tech, and unproblematic.

In a new paper up on SSRN and forthcoming in BC Law Review next year, I argue that these widely-held assumptions are wrong.  Drug companies tend to spend about twice as much on manufacturing as they do on R&D, and a lot of that is unnecessary.  Essentially, the industry wastes tens of billions of dollars per year on inefficient manufacturing techniques which have stayed largely unchanged for decades.  Increasing drug shortages, higher drug prices, and higher levels of drug recalls are the unfortunate result.  Read More

Intent, Legal Metaphysics, and the Regulation of Stuff

By Christopher Robertson

I recently posted my new article “When Truth Cannot Be Presumed: The Regulation of Drug Promotion Under an Expanding First Amendment“.  The article is forthcoming next year in Boston U. Law Review, but I have plenty of time to make revisions.  So I would love to get the feedback from BillofHealth readers.

Hamlin's Wizard Oil

One of the preliminary themes of the article is that the  Food, Drug, and Cosmetic Act is predicated on the drugmaker’s own intent that a substance be used to treat a disease.  The exact same chemical compound can be  sold for other purposes without any FDA oversight.  But once the drugmaker intends that the substance be used as a drug, it becomes a drug as a matter of law, and then each intended use must be proven as safe and effective to the FDA.  For example, turpentine has had this dual-life as a paint-thinner and as “Hamlin’s Wizard Oil,” for which “there is no sore it will not heal, no pain it will not subdue.”

This intent-based system of regulation sets up a confrontation with the First Amendment, since the drugmaker’s own speech is often the best evidence of its intent.  It is a pretty big confrontation too, since the intent concept is the very predicate for the entire FDA regulatory regime.  On the other hand, it is hard to conceive of an alternative threshold for what counts as a drug.  There was a time (e.g., the 1993 Mitchell case) when a ConLaw scholar could confidently say that such evidentiary use of speech presents no First Amendment problems at all, but the current Supreme Court has been eager to dispense with such formalisms (c.f., the 2012 Alvarez case).

In my research on this point, I found a few other intent-based regulations that metaphysically transform things into the objects of a regulatory regime.  For example, the distinction between whether the Federal Aviation Administration regulates your family station wagon depends on whether the carmaker intends it to fly.  (See note 20 of the paper.)  Perhaps a broader analysis is in order.  If the First Amendment undermines this mechanism of regulation, what other similar regulatory regimes may be threatened?

When Prescribing Gets in the Way

By Scott Burris

I am not disputing the value of properly trained health professionals acting as gate-keepers to potentially dangerous drugs. And I am not taking on here the question of which health care professionals should be allowed to prescribe which drugs, though that is an important question on which the states vary quite a bit. Right now, though, there are at least three examples of important, even life-saving medicine that is being kept from people who need it because of rigid (or rigid interpretations of) state prescribing law, and the inability of the FDA to move quickly when its labeling no longer seems to meet the public interest:

1)      Epinephrine (in epi-pens) to treat severe allergic reactions.  Here’s a good story about that, highlighting a tragic case in which a child died because a school nurse would not or could not use epinephrine that had been prescribed for a different child. The story reports that 30 states now allow “undesignated” epinephrine to be used in these cases, but only four require it – and 20 still prohibit it.

2)      Naloxone to prevent death from drug overdose.  Naloxone is the standard treatment to reverse opioid overdose.  People usually suffer OD far away from a doctor, but often in the presence of someone who could administer naloxone by simple intramuscular injection or intranasal spray.  This year there has been quite a bit of legislative activity to break down this barrier to life-saving treatment, including a new bill passing both houses in California this week.  But only 16 states and the District of Columbia have acted so far.

3)      Expedited partner therapy for treatment of STDs.  It takes at least two people to get an STD, or prevent one, but often only one partner is seeing the doctor.  EPT gives the patient an extra prescription or dose for the partner.  According to the CDC, this is still illegal in six states and not clearly legal in 9, the District of Columbia and Puerto Rico.

There is evidence for the safety and effectiveness of all these practices, and has been for years. Why does it have to take so long for state prescribing rules, or FDA labels, to change?  We need a faster mechanism for keeing prescribing rules consistent with current practice and evidence. This is, after all, a matter of everyday life and death.

Lethal Injection Drug Shortage Leads to Debate

By Nadia N. Sawicki

A recent article in the New York Times (“Death Row Improvises, Lacking Lethal Mix”) described the challenges that correctional departments in death penalty states face in obtaining the drugs needed for lethal injection. The manufacturers of pancuronium bromide and pentobarbital, for example, have refused to supply drugs for execution purposes, and the U.S. Court of Appeals for the District of the District of Columbia recently ruled that the FDA cannot approve importation of sodium thiopental. States such as Missouri, Arkansas, and California are now struggling to decide how to approach the issue.

The article quotes death penalty supporter Kent Scheidegger, of the Criminal Justice Legal Foundation, who describes the legal challenges to lethal injection drugs as a “conspiracy to choke off capital punishment by limiting the availability of drugs.”  Also quoted is Robert Blecker, a professor of criminal law at New York Law School, who refers to the drug challenges as “an abolitionist tactic to gum up the works … It’s just another tactic.”  Such comments do a disservice to those on both sides of the political spectrum who have legitimate concerns about the methods by which states execute death row prisoners.  Not every challenge to lethal injection techniques is a subversive tactic to overturn the death penalty.  In engaging in debate on this issue, commentators ought to look beyond their own political perspectives and consider that the arguments made by opponents are made in good faith and do not always reflect a predetermined political view.

While many opponents of lethal injection techniques are driven by a moral opposition to the death penalty, the arguments about the problems with these techniques are valid regardless of one’s political position. Surely, even a supporter of the death penalty can believe that the methods used to execute prisoners matter – that lethal injection techniques ought to be effective and efficient, and ought to be designed to avoid the types of errors that have caused complications in the past.  One’s support for the death penalty as a penal tool should not negate human compassion for even the most hardened criminal’s last moments on earth.  While death penalty states may be eager to move forward with executions as quickly as possible, it is foolish for this motivation to drive the adoption of untested and unproven drugs.

While there are very real logistical challenges to testing new execution techniques, death penalty supporters are wrong to describe the arguments presented by opponents of the current system of lethal injection as merely conspiratorial tactics to “gum up the works.” Rather, these arguments reflect legitimate concerns about the end-of-life experiences faced by the 40 to 60 prisoners who are executed every year.  Commentators such as Scheidegger and Blecker, if truly committed to the death penalty, ought to find ways to satisfy critics’ concerns about humane execution methods, rather than dismiss critics as politically-motivated obstructionists.

Symposium on Institutional Corruption and Pharmaceutical Policy

The Edmond J. Safra Center for Ethics at Harvard University has organized a symposium on Institutional Corruption and Pharmaceutical Policy that will be published in the forthcoming issue of the Journal of Law, Medicine & Ethics, 2013: Vol. 14 (3).  It will be published at the begining of September.

The goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption — that is, widespread or systemic practices, usually legal, that undermine an institution’s objectives or integrity. The pharmaceutical industry’s own purposes are often undermined.  In addition, pharmaceutical industry funding of election campaigns and lobbying skews the legislative process that sets pharmaceutical policy. Moreover, certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety, and the Food and Drug Administration’s oversight of pharmaceutical marketing.

Marc Rodwin invited a group of scholars to analyze these issues, with each author taking a different look at the sources of corruption, how it occurs and what is corrupted. The articles address five topics: (1) systemic problems, (2) medical research, (3) medical knowledge and practice, (4) marketing, and (5) patient advocacy organizations.

For more information on the symposium, including a full list of the articles, please visit the Safra Center’s website. You can also access advanced copies of the 16 symposium articles through SSRN online.

For a summary of each article and the key themes in the symposium see, Marc Rodwin, Institutional Corruption and Pharmaceutical Policy.


Importing unapproved drugs: lethal injections and shortages

By Nicholson Price

In a unanimous opinion (pdf) in Cook v. FDA, the DC Circuit just held that FDA must prohibit the importation of misbranded or unapproved new drugs, including those made by unapproved manufacturers abroad. In this case, a set of prisoners on death row sued FDA to require it to prohibit the importation of sodium thiopental, the first drug in the three-drug cocktail used in most states for lethal injection (and the only drug typically used in states with one-drug protocols).  Since 2009, no domestic company has made thiopental, and the foreign source used by most states is not registered with FDA, which makes it “misbranded” under 21 U.S.C. §§ 331(a), 352(o).  In 2011 FDA stated that it wouldn’t block importation of thiopental, using its enforcement discretion.  The DC Circuit rejected this approach, holding the statute compels FDA to inspect the drugs and prohibit their importation.  The opinion relates to both lethal injections and, less obviously, drug shortages – but though at first glance the implications look potentially significant, I have a hard time seeing how they’ll make much of a practical difference in either scenario. Read More

Shifting the burden of proof regarding placebo controls

By Annette Rid

Placebo controls usually get special treatment. Almost all ethical guidelines for research specify how to use placebo controls, in particular when an established or proven effective treatment exists. To list just a few: guidance issued by the World Medical Association, CIOMS and the Council of Europe all have provisions dedicated to the use of placebo controls. But is there any reason to consider placebo controls a special case? I believe there isn’t, and I also think the burden of proof is on those who hold that placebos should be evaluated differently from other research interventions.

Using a placebo when an established effective treatment exists deprives the control group of the benefits of that treatment. This poses relative net risks to participants – that is, risks from delaying or foregoing a treatment that participants may have received outside the trial. Some placebo interventions also pose risks themselves, but these risks are typically so low – taking a “sugar pill” or receiving a saline injection through an existing i.v. line, for example – that we rightly focus on the risks of foregoing or delaying treatment. (There are other cases, though, such as certain forms of sham surgery. I won’t consider these cases here.)

So how should we evaluate the risks of using a placebo when an established effective treatment exists? We have general criteria for evaluating the risks of research interventions, in particular:

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