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Biosimilars Debate

FDA Memo: Interchangeable Drug Makers Can’t Extend Exclusivity Periods

FDA’s biosimilars office issued an opinion in an internal memorandum that exclusivity periods for the first interchangeable drug in a class cannot be extended by the manufacturer’s decision not to bring the drug to market, including in cases where the interchangeable manufacturer has previously been sued by the maker of the reference product, overturning a Purple Book entry and providing insight into how FDA will address the issue in forthcoming guidance.

PBMs Oppose Formulary Levers, Favor Automatic Switch To All Biosimilars

Post-Pandemic News

Final FDA guidance on the development of drugs for the treatment and prevention of COVID-19 encourages sponsors to ensure they are including diverse populations in their clinical trials, including older populations in nursing homes that are most vulnerable to COVID-19, children, and pregnant or lactating patients.

Latest News

Several of FDA’s expert advisors raised concerns about an emerging class of blood tests designed to detect cancer, saying evaluation of the tests needs to include examining whether they are clinically useful and whether they could decrease rates of more established screenings, as well as consideration of the high imaging and treatment costs they’re likely to bring with them.

Republican critics of FDA’s controversial rule seeking to assert regulatory authority over laboratory developed tests potentially could try to block it through the Congressional Review Act (CRA), and lawyers say that FDA might have to finalize the rule as early as May 2024 to avoid a lookback period for so-called “midnight rules” under the CRA.

The Biden administration is appealing a district court ruling that vacated a provision in the 2021 exchange rule that let insurers use so-called co-pay accumulators and has also asked the court to confirm the ruling does not have an enforcement requirement -- upsetting patient groups that brought the suit and believe the ruling requires HHS to enforce the prior policy finalized in the 2020 exchange rule that required health plans to count the full value of a drug discount coupon toward a patient’s cost-sharing limitation in most circumstances.

Wednesday’s (Nov. 29) House Energy & Commerce health subcommittee hearing on the use of artificial intelligence in health care raised new issues on CMS’ reimbursement of the technology and possible new ways for lawmakers to wrap their heads around AI, while refining existing questions on the tech like the need for a national data privacy framework and ensuring demographic representation in the training of the models to promote health equity.

FDA Chief Scientist Namandjé Bumpus will replace Janet Woodcock as the agency’s principal deputy commissioner when Woodcock retires next year after spending decades at the agency and building a reputation as a medical regulation icon, Commissioner Robert Califf announced Wednesday (Nov. 29).


Fresh from the pre-Thanksgiving news that more than 4.5 million Americans have already signed up for Obamacare, the White House, the Biden re-election campaign and other Democratic stakeholders pounced on former President Donald Trump’s aim to once again try repealing the Affordable Care Act if he returns to office. The Democrats are highlighting surveys that list the various impacts of a repeal and show the law has widespread support among both parties.