Regulation and patent reform needed for asthma and COPD inhalers – Consumer Health News

FRIDAY, May 20, 2022 (HealthDay News) — Of the 62 inhalers approved by the U.S. Food and Drug Administration since 1986, few have offered new drug innovations, according to a study published online May 17 in Health Affairs.

Noting that inhalers face limited generic competition in the United States, William B. Feldman, MD, D.Phil., of Brigham and Women’s Hospital in Boston, and his colleagues analyzed all patents and regulatory exclusivities granted to inhalers for asthma and chronic obstructive pulmonary disorders. approved by the FDA between 1986 and 2020.

Overall, 53 of the 62 approved inhalers were branded products, and these had a median protection of 16 years against generic competition. Researchers found that a single inhaler contained an ingredient with a new mechanism of action. Of the patents, more than half related to the inhaler device and not to the active ingredients or other aspects of drug-device combinations. By transferring active ingredients from one inhaler to another, manufacturers have extended the brands’ market exclusivity periods (“device hops”). There was a median of 28 years between approval of an original product and the last patent to expire or regulatory exclusivity for branded products.

“Drugmakers have used a variety of strategies over the past thirty-five years to obtain regulatory exclusivities and patents on branded inhalers to limit generic competition,” the authors write. “Regulatory and patent reforms are essential to ensure that rewards given to branded manufacturers better reflect the additional clinical benefits of new products.”

One author disclosed financial ties to the health insurance industry; a second author disclosed ties to Arnold Ventures and served as an expert witness against Gilead.

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