FDA Law: More Statutes Than Regulations?

By Katie Booth

The FDA Law Blog has just published a semi-serious study by Kurt Karst on the growth of Title 21 of the United States Code (“USC”) compared to Title 21 of the Code of Federal Regulations (“CFR”) over the past twelve years. Title 21 governs food and drug law. Karst used the PDFs of the USC and CFR available on the Government Printing Office website to compare the number of pages in the USC and CFR from year-to-year. A graph of his results is available on Karst’s post, “The Obesity Epidemic: FDA’s Growing Waistline!

Unsurprisingly, Title 21 of both the USC and the CFR grew in length between 1999 and 2011. More interestingly, however, the USC grew by 50% while the CFR grew by only 10%. If the purpose of regulations is to interpret and flesh out statutes, common sense would suggest that food and drug regulations would grow at a greater rate than food and drug laws (or at least at the same rate). Karst’s explanation for his findings is that the “FDA has been issuing far fewer regulations, and instead, has been implementing the law through guidance and other policy documents.”

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The Evolution of Public Health Law Research

By: Scott Burris, JD

Law has been used to protect and promote public health from the early days of European colonization of North America. Quarantine statutes and orders are reported from the mid-17th century. The 1793 yellow fever epidemic in Philadelphia, where our office is based, inspired the federal government’s first public health statute, authorizing relocation of the capital in the event of an outbreak.

By the mid-19th century, sanitarians like Boston’s own Lemuel Shattuck were articulating the idea that a considerable proportion of death and illness was preventable, and arguing that it was moral, feasible, and economical for the state to do the preventing. Law was a primary tool for prevention, and throughout the 19th century, and into the early twentieth, the extent and limitations of federal, state and local public health authority was litigated, debated in legislatures and defined in voluminous treatises by scholars like Freund, Tiedeman and Tobey.

And then, it got quiet.

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Discrimination in the Doctor-Patient Relationship

By Holly Fernandez Lynch

Nir Eyal’s post below has teed up the issue of doctors refusing to accept patients for reasons that seem to be pretty questionable.  The latest example has to do with obesity, but there are plenty of others having to do with vaccination status, sexual orientation, and the like.  Sometimes these refusals can be clearly categorized as conscientious objections (religious or otherwise).  And other times they are  a bit fuzzier, such as when the refusals are rooted in attempts to drive changes in behavior  (e.g., “get vaccinated or you can’t be my patient”) or when they stem from having inadequate staffing or equipment.  But for the patient, all of these refusals can feel discriminatory.   And that raises the obvious question: can doctors legally discriminate against patients?  The answer: it depends.  Sometimes yes, and sometimes no.

First, bear with me while I make the obligatory pitch for my book, Conflicts of Conscience in Health Care, which is now a few years old, but the issues are still very much live.  In that book, I delve deeply into the question of how to balance provider conscience and patient access.  In general, I argue that it is important to protect provider conscience, to a point (or points) – and those points have to do with burden on the patient and avoidance of invidious discrimination.   Read More

Conference Announcement: Connected Health Symposium 2012

We got an email today announcing the Connected Health Symposium in Boston this October 25-26.  Check out the agenda here.  Elliott Fisher, Professor at The Dartmouth Institute and one of the architects of the concept of “accountable care organizations,” will be discussing why the principles underlying accountable care should help to address the problems confronting US health care.

 

Call for Abstracts: ACA Book

We’ll occasionally be posting event announcements here, as well as calls for papers, etc. that are likely to be of interest to our readership.  Speaking of which, one such announcement came in today (from Fritz Allhoff in the Philosophy Department at Western Michigan University):

A few months ago, we put out a call for a special issue of Public Affair Quarterly focusing on the Affordable Care Act decision.  The response was overwhelming, and we received far more submissions than we could accommodate in a single journal issue.  We’re now expanding the project to include–in addition to the special issue of the journal–an edited volume.  If anyone is interested in participating, please submit a 500-750 word abstract to Fritz Allhoff (fallhoff@umich.edu) directly. The coverage will still be the same as the earlier call, available here: http://www.wmich.edu/medicalhumanities/files/ACA_CfA.pdf

 

Generic Drugs: Grabbing a Bigger Slice

by Jonathan J. Darrow

The expiration of the patent on $11-billion-per-year Lipitor® (atorvastatin calcium) last November received wide media attention and was eagerly greeted by consumers, reflecting public excitement that seems to have not yet dissipated.  In the following months, prices “plunged from about $175 a month for Lipitor to about $15 for generics,” according to a recent article in the New York Times. At times it felt as if legions of consumer Davids had triumphed over a corporate Goliath.

Although the public’s euphoria over the availability of cheaper generic versions of drugs is an understandable cause for celebration, price decreases in themselves should not be mistaken for net gains to society.  The societal gains represented by new drugs, to the extent there are any gains at all, come from the new therapeutic benefits that those drugs offer to patients. The entrance of generic competition, on the other hand, merely represents a shift of wealth from one unit of society (originator manufacturers) to another (patients, and also generic drug companies and insurers).

While individual consumers may care little about “net gains to society,” policy-makers should care: If there are no net gains to society from the high prices preceding patent expiration, then perhaps the patent system should be abolished entirely.  That option, however, has not been a serious topic of discussion in the United States since the 1870s. Instead of debating the underlying issues, however, the public’s attention is focused on what is easiest to see: When can I pay less?  One has to wonder, however, what the innovative landscape would look like if more attention were paid to baking a bigger pie, rather than celebrating the newfound ability to grab a bigger slice.

When Common Ground Becomes a Healthcare Battleground

By Cassie Chambers

The addition of Paul Ryan to the Republican presidential ticket has brought the healthcare proposals of both parties to the forefront. To listen to the Sunday morning talk shows, you’d think the platforms were definitively and irreconcilably split on every health-related issue. Examining healthcare proposals from both sides, however, shows that they have more in common than you might realize.  Yet we seem to have reached a point where this common ground isn’t something to celebrate, but rather a reality to retreat from as quickly and decisively as possible.

Let’s start by rewinding a few years.

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Broadening “Innovation Law & Policy” (and “Human Subjects Research”)

By Michelle Meyer

In legal scholarship and education, innovation law and policy is virtually synonymous with intellectual property in general, and with patent law in particular. This is curious and, I think, misguided. We expend considerable effort designing optimal incentives for innovation. We expend similar effort ensuring that socially useful knowledge, once produced, is widely and accurately disseminated. But if knowledge-producing activities themselves are suboptimally regulated, neither upstream incentives to engage in them nor downstream mechanisms to disseminate their fruits will much matter.

In Regulating the Production of Knowledge: Research Risk-Benefit Analysis and the Heterogeneity Problem, I

critically examine[] that regulatory framework, adopted by more than one dozen federal agencies in the U.S. and many other countries, which governs the vast majority of those knowledge-producing activities that have the greatest potential to affect human welfare: research involving human beings, or “human subjects research” (HSR). [The Article] focuses on the primary actors in the regulation of HSR — licensing committees called Institutional Review Boards (IRBs) which, before each study may proceed, must find that its risks to participants are “reasonable in relation to” its expected benefits for both participants and society. It argues for a particular interpretation of this risk-benefit standard and, drawing on scholarship in psychology, economics, neuroscience and other fields, argues that participant heterogeneity prevents IRBs from carrying out their regulatory duty. Instead, the regulatory system implicitly responds to the heterogeneity problem with risk aversion that is costly not only to researchers and society but, critically, to would-be research participants. The Article concludes by laying out the policy options that remain in the wake of the heterogeneity problem’s intractability: continuing the legal fiction of risk-benefit analysis, honestly embracing the heterogeneity problem and its costs, or jettisoning IRB risk-benefit analysis. A companion Article develops the possibility of the third option.

HSR is not, of course, unknown to the legal academy. Read More

No Doctor for the Obese?

by Nir Eyal

Yesterday, Boston public radio station WBUR interviewed a Massachusetts primary care physician who refuses to admit new obese patients. She claims that it’s because she lacks proper equipment, but she seems to have mixed motives. Earlier she had admitted that it’s rather because she feels that if they don’t lose the weight, “I’m paying the cost of other people’s choices.” I bet if she lacked the equipment for wheelchair-bound patients, she would go buy it.

In an upcoming post (09/07: update here), Holly Fernandez Lynch, who, along with Glenn Cohen, gets kudus for kicking off this blog, will explain whether it’s legal for doctors to reject obese patients. But before rejecting them becomes the next trend, is it right?

A whopping 35.7% of Americans are obese, and the trend continues upwards. Obesity increases risk for heart disease, stroke, type II diabetes, and various cancers. It costs the system a fortune. We must tackle this problem head on. But conditioning physician access on weight loss is not the way. Read More