Biden administration’s antitrust campaign a concern for pharma

Last year, the Biden administration drafted an executive order that promoted competition in the U.S. economy across several industries, including pharma and biotech. The focus on the pharma industry was not surprising, given Biden’s campaign pledge to curb drug pricing. To that end, the Biden administration has explored a variety of approaches, Robin Adelstein, the global head of antitrust and competition and co-head of commercial litigation, U.S. at Norton Rose Fulbright.

In November, the FTC signaled its intent to provide guidance for enforcement of the FTC Act, passed in 1914, to regulate monopolies and eliminate unfair competition and deceptive business practices.

Robin Adelstein

“For a long time, the FTC Act has been interpreted as being coextensive with the antitrust laws,” Adelstein said.

In 2015, FTC released the Statement of Enforcement Principles Regarding ‘Unf…

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FTC and DOJ staff eyes new ways to enforce antitrust laws in pharma

A two-day virtual workshop from the Federal Trade Commission (FTC) and the U.S. Department of Justice (DOJ) mulled the current state of antitrust law enforcement in the pharmaceutical industry, discussing the role of pharmacy benefit managers (PBMs) in driving up prices for consumers.

“A competitively vibrant market protects access to existing drugs and promotes new innovation, but access to medicine is already in peril by untenable costs,” said Rebecca Kelly Slaughter, an FDA commissioner in the workshop, which was held June 14–15.

M&A plays a role in driving up costs, Slaughter argued. “When mergers diminish competition in pharmaceutical markets, the result is higher prices, which can have a devastating effect for patients,” she said. “Enforcement action is necessary to prevent such harms.”

The workshop was organized by the Multilateral Pharmaceutical Merger Task Force, formed in March 2021 by then-Acting FTC Cha…

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 Department of Justice accuses Xlear of deceptive advertising; Xlear responds

Last month, the Federal Trade Commission (FTC) sued nasal spray company Xlear for claiming that its xylitol-containing saline nasal spray could help fight COVID-19. Specifically, the FTC alleged that Xlear had violated the COVID-19 Consumer Protection Act.

The Department of Justice also accused the company of violating the Federal Trade Commission Act.

American Fork, Utah–based Xlear released a statement denying the charges, arguing that federal authorities have violated its First Amendment right to free speech.

“Xlear’s response [to the allegations] outlines a series of studies, including two randomized clinical trials (RCTs) and other clinical and lab data, that more than substantiate Xlear’s statements regarding COVID-19,” said Nathan Jones, Xlear’s CEO, in a press release.

Jones cited an RCT that found that the Xlear nasal spray reduced the risk of hospitalization from COVID-19 by a factor of eight.

Xlear has also asserted that its nasa…

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Biden and Pelosi pursuing plans to cap drug prices

Joe Biden and Nancy Pelosi images from Wikipedia

President Biden has instructed FDA to develop a plan to import prescription drugs from Canada while asking federal officials to create a “comprehensive plan” to cut drug prices within 45 days.

Biden has also recommended that FTC block “pay for delay” agreements from pharma companies paying generic drug makers to hold off on introducing competitive products.

The proposals are included in a far-reaching executive order with several healthcare provisions. The main thrust of the order, however, is stimulating competition in the economy.

Earlier this year, Biden asked Congress to allow Medicare to negotiate drug prices, which was also a goal spelled out in the 2019 House Bill H.R. 3 that Democrats reintroduced in April.

Biden included the recent effort to give Medicare drug negotiation powers in an executive order intended to spur economic comp…

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