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NEJM Perspective: Congress Needs to Help FDA Combat Procedural Abuses

Posted 09 January 2020 | By Zachary Brennan 

NEJM Perspective: Congress Needs to Help FDA Combat Procedural Abuses

Congressional action is necessary stop pharmaceutical companies from abusing the Orphan Drug Act, filing sham citizen petitions and extending the market exclusivity for products that are reformulated, Rebecca Haffajee, assistant professor of health management and policy at the University of Michigan, and Richard Frank, professor of health economics at Harvard Medical School, write in a New England Journal of Medicine perspective.

Haffajee and Frank offer the example of Reckitt Benckiser’s Suboxone, a patent-protected buprenorphine-naloxone sublingual film, which has seen limited competition because the firm exploited various US Food and Drug Administration (FDA) regulatory procedures.

They explain how Reckitt, which is now operating as Indivior, earned at least $1 billion in extra profits by securing orphan drug status for its buprenorphine products (although that orphan status is in the process of being revoked by FDA), manipulated the availability of such products, filed questionable citizen petitions and abused FDA’s Risk Evaluation and Mitigation Strategy (REMS) plan by not working with generic manufacturers.

The company also “product hopped” from its tablet formulations to its new film formulation, which involved raising the tablet prices and then removing them from the market.

Jeffrey Francer, SVP and general counsel of the Association for Accessible Medicines, explained at a House subcommittee hearing in September how the promotional claims that the new film version was safer than the tablet were later determined to be false.

Reckitt also used the delaying tactic of filing a citizen petition to formally request that FDA take action against manufacturers of generic buprenorphine. Over the years, FDA has raised concerns with the use of such petitions to delay generic competition, and the agency denied Reckitt’s petition and referred it to the Federal Trade Commission as an anticompetitive action.

Within a year after a generic buprenorphine tablet entering the market, the authors note how the price was estimated to be 37% lower than the price of Subutex at the time the generic was launched.

“So the introduction of a generic buprenorphine–naloxone film in 2017 to compete with Suboxone film, which garnered $1.90 billion in sales that year, might have saved approximately $703 million overall and $203 million for Medicaid alone,” they add.

Potential Solutions

Although Haffajee and Frank praise the recent passage of the CREATES Act, which they call “one meaningful step toward curbing abuse,” they also say it’s not enough to combat a range of abuses. The new law enables generic drugmakers to sue a patent holder that fails to provide enough brand-name product for bioequivalence testing and it clarifies that providing such samples does not violate REMS requirements.

“Congress could also reform the Orphan Drug Act to prohibit ‘grandfathering’ of orphan drugs and require the FDA to base qualifying economic-recoupment determinations for orphan drugs on unbiased sales projections and to revoke designations if revenues exceed projected sales,” they note.

Congress could further alter the filing procedures for citizen petitions.

“Modifications could include empowering the FDA to penalize sham filings under an objective standard, rather than having to refer these cases to the Federal Trade Commission; requiring that petitions be filed within a year after a generics manufacturer files a new drug application, which would reduce the number of petitions filed just before a generic is eligible for approval; prohibiting companies from marketing products they have questioned in a citizen petition; and lowering the statutory threshold required for the FDA to summarily deny citizen petitions filed for the purpose of delaying entry of generic competitors,” they note.

NEJM Perspective

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