Energy and Commerce Asks FDA Commissioner for Details on Complex Generic Drugs
On Jan. 17, the House Committee on Energy and Commerce Chairman Frank Pallone (D-NJ), ranking member Greg Walden (R-OR), health subcommittee Chairwoman Anna Eshoo (D-CA) and ranking member Michael Burgess (R-TX) as well as oversight subcommittee Chairwoman Diana DeGette (D-CO) and oversight ranking member Brett Guthrie (R-KY) sent a letter to FDA Commissioner Stephen Hahn to detail efforts to expand approval of complex generic drugs. The letter noted that despite record Food and Drug Administration (FDA) generic drug approvals, many expensive brand-name drugs lack substitutes. The members added that approvals for complex drugs for conditions like multiple sclerosis, schizophrenia, metastatic breast cancer, osteoporosis and chronic obstructive pulmonary disease were lagging. The primary purpose of the request is to figure out whether Congress needs to confer more authority to improve the approval process. Find the letter here.
Surgeon General: Unclear Whether E-Cigarettes Help Smokers Quit
On Jan. 23, U.S. Surgeon General Jerome Adams said in a report on smoking cessation that not enough evidence exists to determine whether e-cigarettes help smokers quit or ultimately improve public health. In the 34th report on the topic from the Office of the Surgeon General (OSG), it is noted that the increasing availability of e-cigarettes and their popularity among teens “raise questions about the potential impact that such products could have on efforts to eliminate disease and death caused by tobacco use.” In addition, because e-cigarettes are “a continually changing and diverse group of products,” it is also difficult to generalize about how useful they can be for smokers trying to quit traditional cigarettes. Find the full report here.
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