Administrative Law & Regulation
- Constitutional Structure
- Federal Regulatory Reform
- Judicial Review
- State Regulatory Reform
|Free To Choose Medicine|
The U.S. Food and Drug Administration approved 39 new medicines in 2012, the largest number in 16 years.1 Some, including the agency itself, are proclaiming a new era of cooperation and productivity for the pharmaceutical industry and the FDA.2 But a closer look at what’s happening in the industry reveals deep problems. Development costs are rising, research pipelines are drying up, and as medical science targets more complex diseases such as cancer and Alzheimer’s, it has become increasingly more difficult to translate basic scientific discoveries into marketable products that work well in the clinic....[Read More!]
|The Responsible Corporate Officer Doctrine and Regulatory Crimes - Podcast|
On July 10, 2012, the Consumer Product Safety Commission (CPSC) determined that Buckyballs and Buckycubes, executive office desk toys made for adults, were defective. The CPSC pressured retailers to stop selling these products, and on July 25, 2012, the CPSC’s staff brought an administrative action against Maxfield and Oberton Holdings LLC, the company that produced Buckyballs and Buckycubes, initiating a proceeding to order the company to stop selling all of its products and to conduct a total recall of all of its products already sold. On February 11, 2013, the CPSC amended its complaint to add Craig Zucker, the former General Manager of Maxfield and Oberton Holdings LLC, as a respondent, to hold him personally liable to conduct a CPSC-estimated $57 million recall of Buckyballs and Buckycubes. On November 12, 2013, Mr. Zucker fought back, claiming that the CPSC overreached by bringing an administrative remedial action against Maxfield and Oberton, a limited liability company, as well as him personally. Mr. Zucker challenges the CPSC’s personal jurisdiction over him, claiming he is neither a manufacturer nor a distributor of Buckyballs or Buckycubes and that, instead, the CPSC is exercising undelegated adjudicative authority over individual corporate officers. The CPSC justifies its authority under the Park doctrine, after United States v. Park, 421 U.S. 658 (1975), which has been applied to hold responsible corporate officers personally liable for criminal violations by the companies they oversee. The CPSC has made no findings of legal violations by Craig Zucker, nor has it sought to impose a criminal sentence, fine, or other monetary liability or penalty against him, instead using the responsible corporate officer doctrine for purposes of having him pay for a product recall. Here, the CPSC has asserted the responsible corporate officer doctrine without a predicate violation of the law by a corporate entity. Is the CPSC’s asserted authority justified? More broadly, the panelists sought to discuss the role and importance of the responsible corporate officer doctrine and whether the courts will recognize an expanding application of the responsible corporate officer doctrine in the future.
|Marijuana and the States: How Should Federalism Principles Inform the Federal Government’s Response to State Marijuana Initiatives? - Event Audio/Video|
In 2013 voters in Colorado and Washington legalized the possession of marijuana under state law. Several other states allow the possession and use of marijuana for medicinal purposes. Yet marijuana remains illegal under federal law. The Justice Department has not sought to preempt these decisions, and has outlined a new enforcement policy that largely defers to state law enforcement on the assumption that states will effectively regulate the sale and possession of marijuana. Are the Justice Department’s efforts to accommodate state decisions about marijuana policy prudent or irresponsible? Could it do more? Should the federal government defer to state voters on the desirability of marijuana prohibition? How should principles of federalism inform the federal government’s response to state initiatives on marijuana? Can the federal government allow states to decriminalize marijuana possession and sale without undermining the rule of law?
National Press Club
|The Electorate and the Courts - Event Audio/Video|
Closing Panel: The Electorate and the Courts