The MoginRubin blog offers informative analysis and insightful commentary on timely issues related to competition and antitrust actions, mergers, acquisitions and associated regulatory and legislative activity.
The Federal Trade Commission recently filed an amicus brief in support of a generic drug maker’s antitrust case involving Apokyn®, a drug developed to treat late stages of Parkinson’s disease. The plaintiffs allege the makers and distributors of Apokyn have unlawfully maintained their monopoly by delaying FDA approval and then market entry of generic alternatives, which harms competition and consumers. According to the FTC, this case “may have significant implications for patients who rely on apomorphine to treat debilitating symptoms of ...
Citing “more than enough evidence," the U.S. Court of Appeals for the Fifth Circuit has upheld the Federal Trade Commission’s determination that Impax Laboratories, LLC engaged in an illegal pay-for-delay settlement to block consumers’ access to a lower-cost generic version of Endo Pharmaceuticals Inc.’s Opana ER, an extended-release opioid pain reliever. Entering into what is known as a “reverse payment” arrangement, Impax had agreed to accept funds from Endo to stay out of the market for two-and-a-half years. Judge Gregg Costa wrote in the ...
California Attorney General Xavier Becerra says the COVID-19 virus has “shone a light” on the impact consolidation in the healthcare market has had on Californians’ access to “affordable, quality healthcare.” A bill that would give the AG more power to oversee healthcare industry consolidation, monitor anticompetitive conduct, and enforce corresponding laws is getting closer to becoming law. A wave of scrutiny over the healthcare, pharmaceutical, and medical device industries is taking place at the national level as well, but industry ...
On May 5, 2020, U.S. Judge Nina Gershon of New York granted certification to a class of end-payor plaintiffs (EPPs) who purchased the successful dry-eye treatment Restasis, created and manufactured by Allergan, Inc. in In re: Restasis (Cyclosporine Ophthalmic Emulsion) Antitrust Litigation, 1:18-md-02819-NG-LB (E.D.N.Y 2018). The certified class includes individuals with and without health insurance, and third-party payors like union benefit funds that pay or provide reimbursement for drug costs for people they insure. The EPPs alleged that ...
Anticompetitive conduct and misleading advertising practices in the burgeoning biosimilars market – where nearly identical versions of bioilogics are made by different companies – have captured the attention of federal regulators. The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have announced their joint commitment to promoting competition and pursuing biologic product makers that make false statements. The agencies seek to improve patient access to biologics and to curb the prices consumers are charged for ...
The Federal Trade Commission and the New York Attorney General have sued Vyera Pharmaceuticals and two of its executives for antitrust law violations, saying the company illegally blocked generic drug makers from replicating its life-saving off-patent drug Daraprim, which has been on the market for 60 years. “This is just one example of the considerable hurdles companies face in trying to develop and market biosimilars,” said MoginRubin Senior Counsel Joy M. Sidhwa. When it acquired the drug in 2015, Vyera infamously hiked the price of ...
The Federal Trade Commission (FTC) is challenging Illumina Inc.'s $1.2 billion acquisition of Pacific Biosciences of California Inc. (PacBio), calling it an unlawful attempt by Illumina to maintain its monopoly over the U.S. market for next generation DNA sequencing (NGS). In their case, antitrust enforcers in the U.K. say the effects would be global; that the acquisition would increase prices and dampen competition and innovation. The U.K. action sparked a lengthy response from the companies which argue that the deal is good for the industry ...
You have to give Google credit. It’s no quitter. Despite pressure in the United States and Europe that might tell other companies to take a breath, Google took another in a series of steps to collect and leverage individuals’ healthcare data. In a deal valued at $2.1 billion, the company has entered into a definitive agreement to acquire Fitbit, Inc., the maker of popular health-tracking device wearables. This deal is yet another one that challenges the conventional analysis of what might constitute an anticompetitive merger in the context of ...
DNA sequencing giant Illumina, Inc.’s proposed $1.2 billion acquisition of Pacific Biosciences of California Inc. has drawn opposition in the U.K. and the attention of the U.S. Federal Trade Commission (FTC). The invaluable systems these and other companies provide are used to study genetics in order to develop crucial medicines and medical treatments. The serious headwinds greeting this merger make it clear that the life sciences industry has matured to the point where antitrust considerations are significant. The evolving technological ...
California Gov. Gavin Newsom has signed AB 824, known as the “Pay-for-Delay" bill, blocking pharmaceutical companies from paying generic drug makers to not develop and bring lower-cost medicines to market. The law makes these so-called “reverse payment” settlements of patent disputes – which the Federal Trade Commission says cost consumers $3.5 billion a year – “presumptively anticompetitive.” The new law provides that an agreement resolving a patent infringement claim is anticompetitive if the generic drug or biosimilar drug makers receive ...
Jennifer M. Oliver, Timothy Z. LaComb
October 17, 2019In a September 13, 2019 letter, seventeen consumer advocacy groups and unions (led by Public Citizen Inc.) sent a clear message to the Federal Trade Commission: investigate and, if necessary, terminate AbbVie Inc.’s acquisition of Allergan PLC or risk restricting consumers’ access to lower-priced pharmaceuticals, limiting innovation, and reducing competition. These groups explained their “hope” was that this investigation would be part “of a reinvigorated broader look at pharmaceutical drug mergers.” AbbVie announced in June that it would ...
Dan Mogin, Jennifer M. Oliver, Timothy Z. LaComb
September 18, 2019Democrats and Republicans in both chambers of Congress have come out against drug industry practices such as paying generic drug companies to delay the release of lower-priced versions of their products. The tactic drew criticism as anticompetitive at least and immoral at worst. Rep. David N. Cicilline (D-RI), for example, said the average hospital stay for a child with cancer is $40,000; organ transplants often cost more than $1 million; and drug costs have increased 200% in 10 years. Ten years is also the time it took for the FTC to settle ...
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