Could Obama end FDA preemption by executive order?
The Center for Progressive Reform < (CPR)issued this week a report called "Protecting Public Health and the Environment by the Stroke of a Presidential Pen: Seven Executive Orders for the President’s First 100 Days,”
As CPR’s Blog describes,
Through Executive Orders, a President exercises his broad authority over the executive branch; and in so doing can have a profound influence on how the federal government responds to important policy issues. By directing federal agencies to focus on particular priorities, and by reshaping the internal processes by which agencies do their business, President Obama can impose new policies, while at the same time sending a clear message to Americans and the world that change is under way.
Readers of this blog know that we frequently write about FDA preemption of consumer lawsuits against drug companies. The Supreme Court just heard on November 3 arguments in Wyeth v. Levine, a case that could very well shut the Courthouse doors across the U.S. to consumers who’ve been injured by unsafe drugs. Wyeth, the drug company defendant in the case, argued that the lawsuit against it for failing to warn musician Diana Levine and the medical staff that cared for her that a particular method of administering the anti-nausea drug Phenergan could cause gangrene should be preempted by the FDA’s authority to approve prescription drug labels. Most observers expect the Supreme Court to decide in Wyeth’s favor, and to say that consumers cannot file lawsuits alleging drug company “failures to warn.”
But the push for preemption in the past several years has not just been in the Courts. The FDA too has been aggressively arguing for preemption for the past 8 years. The FDA actively intervened in numerous lawsuits on unsafe drugs and medical devices to argue for preemption. In 2006, the FDA included a lengthy “preamble” in its revised rules on drug labelling requirements that argued that such lawsuits are/should be preempted. And the FDA’s new “Changes Being Effected” regulations, enacted in late August, (about when drugmakers can change the label of their drugs to include new information on risks) seems designed to preempt such suits as well.
This 8-year push for preemption is in stark contrast to the FDA’s previous approach to the subject for many years, which was to treat such suits as complementary to the FDA’s regulation of drugs and not antagonistic.
CPR proposes that the Obama administration adopt an Executive Order on preemption, or, specifically an order that would amend the existing Executive Order on Federalism. The main feature of their proposed Order would be to restore the traditional “presumption against preemption” (i.e. in order to preserve the powers that States are granted under the constitution — see, e.g. the Tenth Amendment— it should be presumed that state laws do NOT conflict with federal law unless shown otherwise.) They also propose a number of specific procedures that federal agencies like the FDA would need to follow to get White House approval before they take an action or position in favor of preemption.
Such an Executive Order would be a step in the right direction, at least in terms of halting the FDA’s (and other federal agencies) eight-year battle to limit the rights of states to protect public health and safety. But such an Order would not do anything to reverse a finding in favor of the pharmaceutical industry in Wyeth v. Levine (a decision is not expected from the Supreme Court until sometime in the first half of 2009).
To do that, Congress would have to step in and pass a law essentially reversing a Supreme Court decision in favor of preemption. Earlier this year, in Riegel v. Medtronic, the Supreme Court held that patient claims about unsafe medical devices are preempted, and more than 80 members of Congress and Senators are trying to restore patients’ rights to sue device companies in such cases with the Medical Device Safety Act. (H.R.6381 and S.3398). It is virtually certain that a similar bill will be filed if and when the Supreme Court decides in Wyeth’s favor.
An Executive Order also arguably wouldn’t do anything to affect the preemptive effect of the FDA’s Changes Being Effected regulations, which have already been promulgated and which stand as the “law of the land” for now. To undo the preemptive effect of those rules would most likely require that the FDA amend those regulations. Whether the new administration at the FDA will seek to tackle that remains to be seen — given the scandals that have rocked the FDA over the past few years, there may be bigger fish to fry (food safety, inspections of foreign drug manufacturing plants, etc.)
But an Executive Order would be important – not just to ensure that the Executive branch thinks long and hard before it tramples on the traditional powers of the States to protect public health and safety, but to change the tone and tenor of federal agencies’ approach to the issue. A restoration of the “presumption of preemption” in the FDA (and other federal agencies) would naturally affect what new regulations are promulgated, what old regulations are amended or scrapped, whether the FDA chooses to intervene in private lawsuits and what position it takes when it does so, what the FDA’s overall priorities are, and even what laws and regulations States pass – right now, the fear of preemption has a chilling effect on what measures States and state agencies will put into place to protect the public from unsafe drugs, food, and medical devices.