FTC Pharma Workshop Focuses on Supply Chain Issues and “Gamesmanship” of FDA Regulation

Featured Expert Column: Antitrust & Competition Policy — Federal Trade Commission

06633 - Royall, M. Sean ( Dallas )By M. Sean Royall, a Partner with Gibson, Dunn & Crutcher LLP, with Richard H. Cunningham, Of Counsel in the firm’s Denver, CO office, and Abiel Garcia, an Associate Attorney in the firm’s Los Angeles, CA office.

On November 8, 2017, the Federal Trade Commission hosted a workshop examining competitive dynamics in the pharmaceutical sector.  Participants in the workshop included professors Michael A. Carrier, Aaron Kesselheim, Stephen Schondelmeyer, Neeraj Sood, Erin Fox, and Rena Conti; representatives from industry interest groups Mark Merritt and Todd Ebert; consumer advocate David Mitchell; economists Adam Fein and Hal Singer; FDA Commissioner Dr. Scott Gottlieb; and FTC Acting Chairman Maureen Ohlhausen.

While FTC workshops are informal and have no binding effect on the policies of the agency, they frequently foreshadow areas of future investigative or enforcement focus.  Participants’ comments generally affirmed that areas of long-standing FTC activity in the pharmaceutical sector, including reverse payments and merger enforcement, are likely to remain areas of ongoing focus.  Two notable new issues also emerged:  scrutiny of the industry’s distribution system and potential abuse of FDA regulatory processes to inhibit generic entry.  In addition, Dr. Gottlieb announced three new FDA initiatives to facilitate generic entry into pharmaceutical markets. Continue reading “FTC Pharma Workshop Focuses on Supply Chain Issues and “Gamesmanship” of FDA Regulation”

Third Circuit Antitrust Decision Makes Pharmaceutical Patent Disputes Nearly Impossible to Settle

FTC_Man_Controlling_TradeThe U.S. Supreme Court’s 2013 FTC v. Actavis, Inc. decision held that “reverse payment” settlement agreements—in which a drug company suing a generic competitor for patent infringement pays the alleged infringer a substantial amount of cash to settle the litigation—are subject to antitrust scrutiny.  The Court reasoned that such reverse payments are unusual and may indicate that the generic company is really being paid not to compete.

An August 21, 2017 decision from the U.S. Court of Appeals for the Third Circuit has stretched the Actavis holding far beyond anything intended by the Supreme Court.  If the appeals court’s decision in In re: Lipitor Antitrust Litigation is allowed to stand, it may become virtually impossible for drug companies to settle patent-infringement litigation. Continue reading “Third Circuit Antitrust Decision Makes Pharmaceutical Patent Disputes Nearly Impossible to Settle”

FTC’s Action against “Repetitive” Filing of Citizen Petitions Reflects Expanding Pharma-Sector Enforcement Program

Featured Expert Column: Antitrust & Competition Policy — Federal Trade Commission

06633 - Royall, M. Sean ( Dallas )By M. Sean Royall, a Partner with Gibson, Dunn & Crutcher LLP, with Richard H. Cunningham, Of Counsel in the firm’s Denver, CO office, and Andrew B. Blumberg, an Associate Attorney in the firm’s Dallas, TX office.

On February 7th, 2017, the Federal Trade Commission (FTC) filed a complaint alleging that Shire ViroPharma Inc. (Shire) violated the antitrust laws by filing sham citizen petitions in an effort to forestall generic competition for its branded prescription drug, Vancocin.  The case is another stepping stone in the agency’s steadily expanding efforts to police what it views as potential antitrust abuses in the pharmaceutical sector. Continue reading “FTC’s Action against “Repetitive” Filing of Citizen Petitions Reflects Expanding Pharma-Sector Enforcement Program”

SCOTUS Seeks Solicitor General’s Views on Apple’s Cert. Petition in Antitrust Suit

app storeIn an orders list issued today, the U.S Supreme Court invited the Solicitor General of the United States to file a brief expressing the federal government’s views on the petition for certiorari in Apple, Inc. v. Pepper. The case, in which Washington Legal Foundation filed an amicus brief supporting Apple’s request for review, involves a forty-year old Supreme Court doctrine dictating that only direct purchasers of good or services may file private enforcement actions under federal antitrust laws.

The Court occasionally seeks the federal government’s views on a petition for certiorari in cases in which the government is not directly involved, but that implicate significant federal interests. In Supreme Court-speak, this is known as a CVSG: Calling for the Views of the Solicitor General. Continue reading “SCOTUS Seeks Solicitor General’s Views on Apple’s Cert. Petition in Antitrust Suit”

“U.S. v. Anthem/Cigna” and Regrettable Skepticism of Procompetitive Efficiencies

Antitrust & Competition — US Department of Justice

swisherAnthony W. Swisher, a Partner in the Washington, DC office of Squire Patton Boggs (US) LLP.

One of the principles underlying merger analysis has always been that mergers provide value to society. Historically, this idea has seen practical expression in a degree of humility on the part of the antitrust enforcement agencies, and a reluctance to intervene too hastily in a deal, lest they disrupt the benefits that might flow from it. Another practical expression of the recognition of merger-specific benefits is the availability of the efficiencies defense. Under the Horizontal Merger Guidelines, the Department of Justice’s Antitrust Division and the Federal Trade Commission will consider the degree to which a deal will permit the merging parties to obtain efficiencies that would not be available to them individually. Continue reading ““U.S. v. Anthem/Cigna” and Regrettable Skepticism of Procompetitive Efficiencies”

FTC Must Refocus on Harm to Consumers and Competition

FTC_Man_Controlling_Trade

Federal agencies regularly use statistics to demonstrate their relevance and justify their exorbitant budgets. The Justice Department, for instance, boasts about the billions it brought in from False Claims Act lawsuits last year. The Environmental Protection Agency brags about the amount of fines and years in jail resulting from its enforcement actions in 2016. But the public is rarely provided concrete evidence of how those incarcerations and billions in fines, say, actually reduce contracting fraud or improve the environment.

So, too, with the Federal Trade Commission. In recent years, FTC hasn’t missed an opportunity to tout its statistical successes to the public and congressional appropriators. In the process of piling up the number of cases brought and fines extracted trumpeted by Chairwoman Edith Ramirez in her resignation press release, however, a critical limitation on FTC’s mission and authority has taken a backseat: the need to prove consumer harm. Continue reading “FTC Must Refocus on Harm to Consumers and Competition”

DOJ Announces Intent to Go Criminal in Wage-Fixing and No-Poaching Antitrust Cases

swisherFeatured 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 “DOJ Announces Intent to Go Criminal in Wage-Fixing and No-Poaching Antitrust Cases”