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In 2010, President Obama signed into law the Biologics Price Competition and Innovation Act, which created an abbreviated approval pathway for competing versions of previously-approved biologics. Passage of this legislation and the impending introduction of follow-on biologics, or biosimilars,...
Persistent link: https://www.econbiz.de/10014139888
There have been calls for the Federal Trade Commission and U.S. Department of Justice to consider the potential loss of consumer privacy as a factor in their merger reviews and to challenge mergers of firms with large stores of personal data that otherwise pose no competitive issues. I contend...
Persistent link: https://www.econbiz.de/10014135331
This paper examines the economics of litigation and settlement of patent disputes arising from Paragraph IV ANDA filings under the Drug Price Competition and Patent Term Restoration Act (“Hatch-Waxman Act”) within the framework set out in FTC v. Actavis. Recent economic analyses of reverse...
Persistent link: https://www.econbiz.de/10014141648
Under the Food and Drug Administration Amendments Act of 2007, the FDA can require the use of risk evaluation and mitigation strategies (REMS) over and above professional labeling, to ensure that a drug’s benefits outweigh its risks. The FTC and the generic drug industry have raised concerns...
Persistent link: https://www.econbiz.de/10014147492
Privacy has begun to creep into antitrust discussions. In some ways, this should not be surprising. Some of the largest and most ubiquitous companies, like Google and Facebook, give away their services in return for consumer data. If information about ourselves really is the price we pay for...
Persistent link: https://www.econbiz.de/10014038787
In this Article we focus upon an area in which greater convergence of U.S. policy with the practice of many foreign countries is long overdue: the treatment of public policies that suppress competition. Whereas the European Union (“EU”) and numerous other jurisdictions have taken strong...
Persistent link: https://www.econbiz.de/10014039873
One of the beneficial innovations for claimants introduced by the EU Competition Damages Directive is the rebuttable presumption of harm in cartel cases enshrined in Article 17(2). Especially for follow-on claimants, i.e. claimants who base their case on a cartel case that has already been...
Persistent link: https://www.econbiz.de/10014091393
One of the explicit aims of the Directive on competition damages actions (the Directive) is to make the quantification of harm resulting from violations of European Union (EU) competition rules easier for damages claimants. One of the several ways envisioned by the Directive to achieve that aim...
Persistent link: https://www.econbiz.de/10014091447
Netflix, Amazon, YouTube, and Apple have been joined by Disney+, Twitch, Facebook and others to supplant the broadcast industry. As the FCC, FTC, and other regulators struggle, a new digital divide has emerged. The current regulatory regime for television is built upon the government’s right...
Persistent link: https://www.econbiz.de/10014102715
Antitrust has been doubly disempowered: we can no longer effectively regulate corporate power and many forms of corporate power are now irrelevant to antitrust analysis. Drawing on the interconnected histories of antitrust and corporate law, this article makes the case for empowering corporate...
Persistent link: https://www.econbiz.de/10014103041