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Lee Rosebush Quoted Regarding FDA Policies Regarding Compounded Drugs

News / January 31, 2018

Partner Lee Rosebush is quoted in an article published by The Boston Globe on Jan. 31, 2018. The article, “FDA Wades Into Battles between Drug Makes and Compounders,” reports on new policies issued by the Food and Drug Administration (FDA) that seek to strengthen manufacturing standards for compounded medicines. The FDA has specified that compounders should not make exact copies of FDA-approved drugs, except when shortages exist. Two drug makers – Allergan and Endo International – have sued drug compounders alleging that they are unfairly making copies of their medicines.

Rosebush said the cases are important because they “could have a major impact on the future of both compounding and its impact on drug pricing.” He also noted that Allergan is accusing compounders of falsely advertising its medicines, which is a novel argument for thwarting compounding competition.

Read the article (registration required).

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