HealthLawProf Blog

FDA Regulation of E-Cigarettes—A Gateway to Teaching Administrative Law

 

It’s likely that most readers of this blog already know that the FDA just announced its intent to extend its regulatory powers to E-Cigarettes.   E-Cigarettes have proven to be a "high interest" topic in both my "Constitutional Issues in Health Law" and "Legal Issues in Human Subject Research Classes."  The struggle between the FDA and those it wishes to regulate raise questions about the powers of all three branches of Government.  It can serve as a proxy for all administrative agencies in an Admin Class or as a direct source of study in a public health, environmental or (of course) food & drug law class.

The FDA's current struggles include energy drinks, body building supplements and truth in calorie reporting (no more hiding calories by assuming unrealistic serving sizes).

But back to E-Cigarettes.  

Here is the text of the proposed rule.  And here is the Campaign for Tobacco-Free Kids’ list of reasons why the FDA is justified—and should—be able to do this.

The FDA’s relationship with regulating tobacco products has been a complicated one.  This book review by Margaret Gilhooley can bring you up to date on the history of FDA’s failed attempts to obtain jurisdiction.  It was not until June 22, 2009 that the FDA finally did get regulatory power when President Obama signed the Family Smoking Prevention and Tobacco Control Act (FSPTCA) that the FDA got any authority to regulate tobacco products—and that only through the filter (sorry) of protecting children.   And that still remains the outer limit—protecting children. 

So any regulation of E-Cigarettes has to be along the lines of making them less available to minors.  That’s why what sounds like a relatively weak reason—“even if they are harmless, they are a gateway for children to real cigarettes” is important because that is the statutory basis of the FDA’s power.  It’s not surprising that the FDA’s announcement has been met with immediate protest from Vapers.  New York’s ban (and remember, all the FDA’s done is to announce it intends to assert its authority to look into the product’s safety) has sparked considerable push-back based on issues of “personal liberty.” Apparently this anti-regulation movement is not restricted to the U.S.

   Vapers have had little success persuading cities to exempt e-cigarettes from public spaces, but they have been able to prevent outright bans and to allow the creation of “vaping lounges” –-the English majors among you know these better as modern day equivalent of a legal opium den—perhaps inhabited by today’s Keats, Shelleys and Coleridges.  We even have them in Lubbock.  

The FDA’s goal is to build on the actions of the cities that are equating e-cigarettes with “old style” tobacco to keep e-cigarettes as an “adults only” product.

 

Contraception, Corporations and Conscience

Do corporations have a right to religious expression? As the U.S. Supreme Court considers whether Hobby Lobby is exempted from the Affordable Care Act’s contraception mandate because of its religious beliefs, the Court first must decide whether for-profit corporations even have rights of religious freedom.

While the Supreme Court should impose appropriate limits on the First Amendment rights of corporations, there are important reasons to recognize corporate claims of religious freedom. We often call on corporations to act in ethically and socially responsible ways, and it is important that they do so. If we want corporations to inculcate an ethos of ethics, then we undercut that goal when we deny corporations their ability to act on the basis of conscience.

To be sure, there are nuances. It is much easier to speak of the religious freedom of a family-owned business such as Hobby Lobby than of a publicly-owned business such as General Electric. Moreover, we must draw a good balance between corporate rights and the public welfare (as I’ve argued about corporate speech and public health here).

Recognizing corporate rights of religious expression would not settle the Hobby Lobby case. We still would have to balance the public’s interest in access to contraception with the corporation’s interest in religious freedom. But that is where the debate should lie.

[cross-posted at orentlicher.tumblr.com]

Dartmouth Institute Publishes Atlas of Medicare Part D Areal Variations

The Dartmouth Institute has just published its Atlas of areal differences in utilization of prescription drugs by Medicare Part D recipients.  The Atlas--unsurprisingly but disturbingly--details significant differences.  Pharmaceutical interventions are classified as effective, discretionary (where there is diagnostic or therapeutic uncertainty), and likely to be harmful in the patient population at issue.  A caveat, however, is that the report measured prescriptions filled and thus may underestimate actual provider behavior.

An initial variation involved sheer numbers of prescriptions, with a high average of 63 per year in Miami and a low average of 39 per year in Colorado (overall, the average was 49 standardized 30 day prescriptions filled per year per Part D beneficiary).  In general, the Mountain West had the lowest prescription average and the Rust Belt and Appalachian states the highest.  These differences could not be explained primarily by overall burden of disease but instead appear to reflect variations in provider prescribing practices.  For example, the American Heart Association recommends use of beta blockers in heart attack patients for three years post-attack.  However, rates of prescriptions for these drugs in the first six months ranged from highs of 94% to lows of under 68%, and persistence in the next six months was only slightly lower, ranging from highs of 92% to lows of under 68%.  Variations in statin use were even greater, ranging from just over 91% in Ogden, Utah, to below 45% in Abilene, Texas.  Interestingly, there was little correlation between effective use of beta blockers and effective use of statins.

The other two therapies analyzed in the Atlas were treatment of diabetes and treatment of patients with fragility fractures.  Diabetic patients fared somewhat better than heart attack patients, albeit still with significant variations.  Osteoporotic patients, however, fared dismally, receiving a high of 28% and a low of 7% with filled prescriptions for drug to combat osteoporosis after fragility fractures in sites other than the hip (such treatment is recommended to decrease the risk of future hip fractures).

Most interesting of all, there was no correlation between drug expenditures and measures of effective care.  In other words, patients in some regions may be spending a great deal on their drugs (paid for under Part D), but receiving far less benefit that patients in other regions who spend a great deal less.

[LPF]