Administrative Law Prof Blog

Voluntary industry codes

The FDA Law Blog has posted a note, "PhRMA Releases Revised 'Code on Interactions with Healthcare Professionals' that is More Restrictive than the July 2002 Version", on this voluntary industry code intended to govern marketing of drugs to health care professionals.  These industry codes are important for two reasons.  First, they can be incorporated by reference into statutes, regulations, and contracts.  A memorandum to which this post refers points out in its last paragraph that "It is important to note that, although the PhRMA Code is a voluntary industry code, it is currently incorporated into the laws governing marketing compliance in two states."  Second, they can become de facto standards for torts, contract performance, and administrative compliance, even if not incorporated explicitly.

EMM

Sued by Public Citizen, FDA Finally Imposes Urgent Warning on Cipro

Almost two years ago Public Citizen petitioned the FDA to improve warnings for Cipro, Levaquin and similar antibiotics because these drugs have caused hundreds of serious tendon injuries.  The FDA did not respond to the petition.  Public Citizen filed suit in January 2008, seeking an order compelling the FDA to improve the warnings.

The L.A. Times reports the FDA finally acted last week.  The FDA imposed the government's most urgent safety warning on Cipro, Levaquin and similar antibiotics citing evidence that they might lead to serious tendon ruptures that could leave patients incapacitated and needing extensive surgery. 

The FDA's decision to give Cipro, Levaquin and the like the "black box" warning has caused a rather heated debate among doctors.

AAJ Seeks Help to Fight FDA Rule Preempting Pregnant Womens' Claims

FDA Pregnancy and Lactation Labeling Rule

The FDA recently released a new system for labels to notify when certain prescription drugs could be harmful to women who are pregnant or breastfeeding.  In the preamble to this rule, the agency also claims that this new system will preempt any claims brought by women who are injured by these products or who claim they were not adequately warned about the dangers of these products.

AAJ will file comments.  It would be helpful to include examples of other instances where pregnant or lactating women sustained injuries caused by inadequate warnings on drugs, or examples where the FDA first said it was safe for pregnancy and later admitted that it was not.

If you have come across any such examples in your practice, please contact Gerie Voss, AAJ Director of Regulatory Affairs, at (202) 944-2847 or via email to Gerie.Voss@justice.org. 

LT
 

Why all lawyers - even criminal law types - need to understand administrative law

Courtesy of the CrimProf Blog: National Sex Offender Guidelines Released.

EMM

Workers' Comp Reform in CA Affects National Numbers

This article describes how California's recent reform of its workers' comp system caused a dramatic reduction in payments to workers.  The drop was enough to reduce the overall stats nationwide for 2005, even though the rest of the country - if California's numbers were excluded - would appear to have an increase for the same period.

-D.S.

State AG vs. County: New Settlement in Global Warming Case

This article reports an interesting regulatory twist: a state Attorney General coercing a county government into regulation of greenhouse gas emissions.  From the article:

California Attorney General Jerry Brown settled his global warming lawsuit Tuesday against San Bernardino County, working out an agreement on what had been a stumbling block to obtaining a deal on the state budget. Under the terms of the deal announced by Brown in a Los Angeles news conference, the fast-growing county in the heart of the Inland Empire of Southern California will amend its general plan within 30 months to include a greenhouse gas reduction policy. The process will include an inventory of all "known, or reasonably discoverable, sources of greenhouse gases" in the county.

In addition, the county will conduct an inventory on its 1990 emission levels and make projections for 2020. Then, the county will create a target for the reduction of emissions from discretionary land use by 2020.

-Dru Stevenson

New Regulatory Issues with Chocolate

The regulatory definition of chocolate is in dispute - read the Bookings-AEI story, or the (more pop-culture) CNN version.  Admin classes may find this entertaining - perhaps right after covering the Mead case, which is in many casebooks.

-Dru Stevenson

Abusing the Agency: "Underwear for the Undersecretary"

This column from the Washington Post describes the YouTube video campaign by anti-regulatory activists over a new regulation by the Dept. of Energy - the reg apparently makes affordable washing machines (under $900) too wimpy to get clothes clean.  In protest, the video encourages viewers to send their dirty underwear to the Undersecretary of Energy (just to make a statement; there is no promise that the Undersecretary is going to clean them for you)

From the article:

"Send your underwear to the undersecretary'' urges the actress in the Competitive Enterprise Institute's stinging 66-second anti-regulatory video posted on YouTube, a free video-sharing site that is a subsidiary of Google. The video blames a 2001 Energy Department rule for an energy-efficiency standard that it says has made new models of washing machines more expensive while getting laundry less clean.

The article concludes by saying that the office of "Undersecretary" Dennis R. Spurgeon has not yet received any underwear. I'm a little confused about whether he is the right recipient. This agency org chart does portray Spurgeon as the Undersecretary of Energy and puts the "Assistant Secretary for Energy Efficiency" beneath him.  But his main govt. bio page dubs him the "Assistant Secretary for Nuclear Energy," which presumably has little to do with consumer laundry machines.

E.politics seems skeptical  about the video's effectiveness, and also understood the video to say "clean" underwear, which I must have misunderstood when I watched it.  And this review has some production suggestions to make the video more interesting.  The original article mentions attempts by regulatory agencies to use online videos to promote safety awareness, etc.

-Dru Stevenson

OMB Addresses Recurring Problem of Data Being Lost or Stolen

This article from the Chicago Tribune describes the OMB's new internal demands on federal agencies that they curb their unnecessary use of Social Security numbers in databases, as a way to reduce the fallout when laptops and hard drives go missing.

-D.S.

New Reg for VA Atty Certification & Fees

This new reg finished its 12,866 review a few days ago, and affects attorney doing Veteran's Benefits hearings, etc.

In the Background of the Immigration Debate...

This new Labor regulation attempts to rectify the perverse incentives employers have in dealing with the labor certification requirements for alien workers - recently completed its 12,866 review.

-D.S.

Exec Order 12,866 & 13,422

Executive Order 13,422, amending and updating the famous EO 12,866 covered in most Admin Law casebooks, now has a lengthy implementation manual from OIRA.

-Dru Stevenson