DOJ Gives Antitrust Shield To Big Pharma's Virus Info Sharing

By Mike LaSusa
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Law360 (July 23, 2020, 10:11 PM EDT) -- The Antitrust Division of the U.S. Department of Justice gave pharmaceutical giants including Eli Lilly & Co., Amgen Inc. and GlaxoSmithKline PLC a green light on Thursday for limited sharing of information about a possible treatment for COVID-19.

The companies, which also included AbCellera Biologics Inc., AstraZeneca PLC and Genentech Inc., had asked the Antitrust Division earlier this month for its view on potential information exchanges related to monoclonal antibodies, or mAbs, the active ingredients in many of the world's best-selling biologic drugs.

The head of the antitrust unit, Makan Delrahim, responded Thursday that the department doesn't plan to challenge the information sharing as it was described by the companies, pointing to the urgency of the need for drugs to fight the coronavirus pandemic and the safeguards the companies said they would put in place to prevent anti-competitive collusion.

"This critical collaboration will help Americans get access to potentially life-saving therapeutics sooner than otherwise would be possible," Delrahim said Thursday in a statement. "It also will help preserve Americans' ability to benefit from the free market competition that drives innovation and access to drugs in the biotech and pharmaceutical industry."

The DOJ said the guidance in its business review letter would be in effect for a year. The department added that while it has "no reason" to think the pharmaceutical giants aimed to engage in anti-competitive activities, it could change course if it suspects trouble.

"The department would be concerned ... if the collaboration jointly agreed to shift capacity away from non-COVID-19 mAb treatments in order to reduce output or raise prices for these treatments, or if the shifting of capacity away from non-COVID-19 treatments resulted in a market allocation among the requesting parties that compete to provide similar treatments for the same disease," the letter said.

The companies had told the DOJ in their July 15 request for the business review letter that they want to share technical information about the production of monoclonal antibodies, excluding details about pricing, marketing or other sensitive information relating to competition. And they said the exchanges would be restricted in scope.

"These efforts would be limited only to potential COVID-19 mAb treatments and would last only as long as necessary to accelerate production of treatments that can combat the detrimental effects of COVID-19 on the health and welfare of our country," the companies said.

The DOJ, along with the Federal Trade Commission, announced in March that it would offer an expedited process for requests for business review letters and FTC advisory opinions related to COVID-19.

That announcement came a day after European Union enforcers said that companies in the bloc will be able to coordinate the distribution of much-needed products without being brought up on cartel charges.

In early April, the DOJ said in another such business review letter that it will not challenge a plan for several medical supply companies, including McKesson Corp., Cardinal Health Inc. and Henry Schein Inc., to work together to speed up the distribution of supplies needed to combat the COVID-19 pandemic.

The department said later that month that it wouldn't use antitrust grounds to challenge AmerisourceBergen Corp.'s plans to coordinate with other health care suppliers to distribute pandemic medicines nationally.

And in May, the DOJ said it didn't foresee competitive problems associated with efforts from the nation's largest association of hog farmers to help coordinate the killing of unmarketable livestock accumulating in the wake of COVID-19 processing plant closures.

--Additional reporting by Jeff Overley, Matthew Perlman and Bryan Koenig. Editing by Bruce Goldman.

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