FTC Archives - HEALTH & LIFE SCIENCES NEWS

Top Takeaways: Permissible Provider Collaborations During COVID-19 and Beyond

by Ashley Fischer, Katharine M. O'Connor and Stephen Wu | May 21, 2020 | Health Antitrust, Health M&A

As the healthcare industry continues to cope with the Coronavirus (COVID-19) and form strategic and short- and long-term plans, providers are faced with numerous decisions that have critical antitrust implications. Whether seeking to collaborate with competitors for pandemic response or exploring potential transactional opportunities, there are both traditional antitrust guidelines and COVID-specific developments applicable to these business decisions. We discussed these important issues on our May 20 webinar. Below are top takeaways from the program. For a deeper dive into these issues, listen to our webinar recording.

Competitor collaborations

Antitrust compliance remains an important priority in the US. While companies have been engaged in finding creative solutions to COVID-19 challenges and regulators are expressing a willingness to be more flexible in interpreting and enforcing the law, the pandemic is not a carte blanche to engage in anti-competitive activity.
Regulators are more prone to accept collaborations limited in scope to respond to COVID-19 and its aftermath, and arrangements undertaken at the behest of or in partnership with government actors. Companies should avoid high-risk conduct such as direct exchanges of competitively sensitive information.
Procompetitive agreements not relating to price, wages or market/product allocations remain possible. Companies should conduct an antitrust analysis before entering new collaborations and consider whether it would be helpful or advisable to engage with federal antitrust authorities or state governments to receive feedback.

Avoiding antitrust violations in labor markets

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Anticompetitive Conduct in Biologics – An Enforcement Priority with FTC and FDA

by Lisa P. Rumin, Jon B. Dubrow and McDermott Will & Emery | Feb 5, 2020 | FDA, Life Sciences

This blog was originally published on McDermott’s Antitrust Alert Blog.

On February 4, 2020, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) released joint guidance concerning competition for biologics, including biosimilars. The joint guidance seeks to enhance competition for biologics and reduce manufacturers’ use of false or misleading statements or promotional communications concerning the efficacy or safety of biosimilars and other biologics. This guidance appears to be part of the Trump administration’s effort to reduce the cost of medications for consumers, as it is aimed at increasing the level of competition biosimilars can offer and raising awareness of the safety and efficacy of biosimilars.

The fast-growing biologics market has become an important sector of the healthcare and pharmaceutical industry. According to the joint guidance, private insurers spent over $125 billion on biologics in 2018 alone. Biologics treat many serious conditions that often lack alternative treatment options. Although Congress enacted an abbreviated FDA-approval process for biosimilars nearly a decade ago, adoption of biosimilars has been relatively slow. The FTC and the FDA will focus on competition for biologics in hopes of improving patient access to important treatment options and curbing costs. The joint guidance highlights the agencies’ efforts to transfer recent investigatory and enforcement efforts to biologics markets.

The joint guidance sets forth goals for which the FTC and the FDA will agree to collaborate in their efforts to support adoption of biosimilars and enhance competition in biologics markets. These goals build on [...]

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FTC to Look Closely at Competition between Biologics and Biosimilars and Patent Protection Strategies of Branded Manufacturers

by Louise Aberg and McDermott Will & Emery | Jul 24, 2018 | FDA, Health Antitrust

WHAT HAPPENED

On July 18, 2018, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb delivered a speech at The Brookings Institution in Washington, DC, discussing how to bolster competition from biosimilars while maintaining innovation.

The Commissioner noted the absence of true competition among biologics from biosimilar products in the United States, similarly to what the country experienced 30 years ago with respect to generics. The Commissioner said that this situation is caused, in part, by what he views as anticompetitive practices implemented by branded manufacturers, such as:

Rebating schemes in which drug manufacturers bundle discounts to health insurers and employers across different pharmaceutical products;
Multi-year contracts granting important rebates to payors, often entered into right before the entry of a biosimilar on the market;
Volume-based rebates;
Tying rebates, i.e., when rebates are offered if a product is bought together with a biologic;
Patent thickets, i.e., when branded manufacturers’ own dense portfolios of overlapping intellectual property rights cover biologics; and
Bundling biologics with other products, i.e., when a product is sold together with a biologic.

The Commissioner then introduced a plan (Biosimilars Action Plan) intended to apply some of the lessons learned by the FDA with respect to generic drugs to accelerate competition from biosimilars. He presented the four core action items of the Plan:

Improve the efficiency of biosimilars and of the approval process;
Maximize scientific and regulatory clarity for companies developing biosimilars;
Develop communications to improve understanding of biosimilars among [...]

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