Too High a Price for Some Drugs?: The FDA Burdens Reproductive Choice

The U.S. Food and Drug Administration has imposed increasingly restrictive conditions on access to pharmaceutical products such as isotretinoin (Accutance) and thalidomide that carry a serious risk of birth defects. This Article focuses on the requirement that female patients agree to use two forms of contraception, drawing parallels to suggestions that similar conditions apply to certain persons on welfare or probation, and posing hypothetical variations of the FDA\u27s access restriction. If anyone ever challenged this aspect of the agency\u27s risk management strategy, a court would have to decide whether the policy (1) grew out of state action (complicated by the fact that the FDA did not technically mandate it and could not sanction patients who failed to comply); (2) affected the exercise of a fundamental right (e.g., procreative liberty (declining contraception), free exercise/speech); (3) inappropriately conditioned access to a benefit on the waiver of one of these rights; and (4) failed strict scrutiny (in light of the argument made in other contexts that, even though the government may seek to minimize the risk of in utero exposure to teratogens, it lacks a compelling interest in preventing the birth of a child so exposed)

State Affronts to Federal Primacy in the Licensure of Pharmaceutical Products

Article published in the Michigan State Law Review

Platitudes about Product Stewardship in Torts: Continuing Drug Research and Education

This Article focuses on one emerging aspect of tort litigation against pharmaceutical manufacturers that, if it gained traction, portends a dramatic (and potentially counterproductive) expansion in the prescription drug industry\u27s exposure to liability. The traditional theories of products liability--mismanufacture, defective design, and inadequate warnings--no longer exhaust the potential obligations of sellers. In addition to increasingly popular claims of misrepresentation and negligent marketing, which seem more like extensions of the three defect categories than entirely novel theories, a growing chorus of commentators would impose on pharmaceutical manufacturers a broader duty to test and educate (aspects of what they call an obligation of product stewardship ). Frustrated by the inherent limitations of preapproval clinical trials, the failure of the Food and Drug Administration (FDA) to demand rigorous postapproval testing, and the minimal information communicated directly to patients, these commentators have urged judges to draw on the common law tradition in order to remedy these and other alleged failings of the regulatory system

Federal Regulatory Responses to the Prescription Opioid Crisis: Too Little, Too Late?

Part I of this Article suggests that the medical establishment shares more blame for the crisis than many commentators seem to appreciate. Part II canvasses a variety of ways in which the federal government has responded to the opioid problem during the last few years before delving more deeply into the FDA’s role in the mess, assessing the different tools that it has tried to use as well as some that it failed to employ. This Article concludes that the agency should have allowed only a narrowly defined subset of physicians to prescribe opioid analgesics, even though the medical community would have pitched a fit about any such an intrusion on its prerogatives, to say nothing of the drug manufacturers aghast at the prospect of far more modest sales. Greater use of such restrictions on distribution might have worked to nip this disaster in the bud, and it needs more serious consideration by the FDA before the next one comes down the pike

Whatever Happened to the Frankenfish ?: The FDA\u27s Foot-Dragging on Transgenic Salmon

AquaBounty Technologies has genetically modified the Atlantic salmon through the introduction of a growth hormone gene from the Chinook salmon, which allows the fish to reach market size almost twice as quickly as its farmed counterparts. The research began more than two decades ago. The company secured licenses for the patents that emerged out of this research, and its plans to commercialize the transgenic salmons (branded “AquAdvantage”) took shape more than a decade ago. In late 2010, the U.S. Food and Drug Administration (FDA) appeared to be on the verge of authorizing production, but, more than two years later, the company continues to await the agency’s blessing. With AquaBounty facing bankruptcy, a group of biotechnology researchers and entrepreneurs wrote President Obama to denounce the political meddling that apparently had stalled the review process. Shortly thereafter, the FDA took a tentative further step toward approval, issuing a draft environmental assessment (EA) at the end of 2012. In explaining why it would allow no more than sixty days for the submission of written comments, the agency noted that its draft EA different little from the one that it had made available more than two years earlier, which makes one wonder what exactly it had done during the interim. If history is any guide, this next step in what has become a tortuous review process does not portend imminent approval: the FDA again will receive thousands of largely duplicative adverse public comments, and members of Congress representing constituents threatened economically by approval of the AquAdvantage salmon again will pressure the agency. Will regulatory officials manage to ignore the static this time around when they seemed incapable of doing so just two years earlier