Drugs

Ways to Overcome Drug Company Regulatory System Abuse

Researchers from the University of Michigan and Harvard Medical School say that Reckitt Benckiser earned at least $1 billion in extra profits by exploiting various FDA regulatory procedures to impede the entry of generic competitors and maintain elevated prices for its Suboxone (buprenorphine), used to treat opioid use disorder. Writing in the New England Journal of Medicine, the researchers say the company (now known as Indivior) secured potentially undeserved orphan drug status for its buprenorphine products, filed questionable citizen petitions, and engaged in abuses of the REMS plan to attenuate safety risks associated with buprenorphine products.

The article lists several steps that Congress could take to reduce abuses in the prescription drug market:

modify regulatory procedures;
reform the Orphan Drug Act to prohibit “grandfathering” of orphan drugs and require FDA to base qualifying economic-recoupment determinations for orphan drugs on unbiased sales projections and to revoke designations if revenues exceed projected sales;
modernize the Waxman-Hatch Act to define a period before the loss of product exclusivity (such as one year) and a similar period after generic entry during which new formulations of the existing product would not be granted market exclusivity; and
modify procedures for citizen petitions to empower FDA to penalize sham filings under an objective standard, require that petitions be filed within a year after a generic manufacturer files a new drug application, prohibit companies from marketing products they have questioned in a citizen petition, and lower the statutory threshold required for FDA to summarily deny a citizen petition filed to delay entry of generic competitors.

The authors demonstrate how such changes would have deterred Reckitt Benckiser from filing its initial citizen petition shortly before the exclusivity period for its tablet formulations expired and from questioning the safety of products akin to its own. They say the changes might also have empowered FDA to deny the petitions more rapidly.

“Although these policy actions alone wouldn’t completely solve the problem of high drug prices and other access barriers,” the article concludes, “they could contribute meaningfully toward making generic versions of lifesaving drugs more quickly available at affordable prices.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome