As the beginning of a new administration nears, politicians and pundits have been floating many ideas for regulating the cost and availability of pharmaceuticals and other medical treatments. One of the worst ideas being discussed is the judicial creation of a common-law duty to manufacture. Thankfully, there are significant Constitutional and judicial hurdles preventing this duty from materializing.
In order to develop and produce innovative, life-saving drugs, pharmaceutical manufacturers must go through incredibly expensive and time-consuming clinical trials required by the rigid guidelines of the Food and Drug Administration (FDA). As an incentive to go through this process, these companies receive patents to help them recoup the costs of the clinical trials. In some instances, however, even with market exclusivity, manufacturers are unwilling to continue producing these drugs, often because production ceases to be economically feasible. Continue reading
Featured Expert Contributor — Antitrust & Competition, U.S. Department of Justice
Anthony W. Swisher, a Partner in the Washington, DC office of Squire Patton Boggs (US) LLP
In April of this year President Obama issued an executive order designed to “protect American consumers and workers and encourage competition in the U.S. economy … .” The order aimed to expand competition policy beyond just the Justice Department Antitrust Division (DOJ) and the Federal Trade Commission (FTC), and encouraged every federal agency to consider ways to enhance competition when drafting and enforcing each given agency’s regulations. A notable element of the President’s executive order was the promotion of competition in labor markets. The order asserted that the economic growth that flows from competitive markets “creates opportunity for American workers,” and that anticompetitive practices can reduce those opportunities. Continue reading
This Monday the U.S. Supreme Court will conduct its Long Conference, so named for the larger than usual number of certiorari petitions it considers there. With the fate of so many cert petitions hanging in the balance—and the overwhelming majority of them about to be denied—now is an opportune time to look back at the top 10 cases that were wrongly denied cert in the Court’s last term.
As with the previous installments of my “Not Top 10” list (see here and here), no more than half the cases discussed below will be ones in which Washington Legal Foundation filed a brief in support of certiorari. Also, the cases will once again be limited to those that affect economic liberty, including the need for legal certainty around key legal policies and regulatory regimes. From WLF’s free-enterprise perspective, those cases that implicate competition in the marketplace, limited and accountable government, individual and business civil liberties, or rule of law concerns matter the most. Continue reading
Last term, in the now-infamous Yates case, the U.S. Supreme Court rejected the Department of Justice’s outrageous contention that an undersized Red Grouper thrown overboard by a commercial fisherman in the Gulf of Mexico was a “record, document, or tangible object” under the “anti-shredding” provision of the Sarbanes-Oxley Act. By so doing, the Court prevented a law passed in the wake of corporate accounting scandals at Enron and WorldCom from becoming an all-purpose hammer for prosecutors. Yates quickly became the poster child for the “overcriminalization” phenomenon.
Unfortunately, it appears that DOJ has not learned its lesson. Although the phrase “tangible object” at issue in Yates was overbroad and ambiguous, in other cases the problem of overcriminalization arises when the government seeks to attribute a new, nonobvious meaning to long-understood, perfectly plain statutory language. Nowhere is that problem better epitomized than in the federal government’s utterly bizarre ongoing criminal prosecution of FedEx, which is slated for trial next month in federal court in San Francisco. Continue reading
On Monday, May 2, 2016, Washington Legal Foundation hosted a program in its Media Briefing series entitled Freeing Off-Label Use Information: Three Lingering Questions for Medical-Product Innovators and Regulators. The recording of that program is available below. Also below are links to related materials, including an April 29, 2016 WLF Legal Backgrounder that draws lessons from a medical-device company’s successful defense of a criminal prosecution for alleged off-label promotion.
- Edward Berg, Sanofi US
- John Osborn, Hogan Lovells LLP
- Coleen Klasmeier, Sidley Austin LLP
- Eric Grannon, White & Case LLP (moderator)
The program can also be viewed through WLF’s website—with a higher-quality video and integrated slides—by clicking here.
John Osborn’s Yale Journal article, “Can I Tell You the Truth?”, cited by the U.S. Court of Appeals for the Second Circuit in U.S. v. Caronia, is available here.
WLF’s Legal Backgrounder, “The US v. Vascular Solutions Acquittal: Three Lessons for Targets of ‘Off-Label Promotion’ Enforcement,” is available here.