Rx Drugs

HHS sent a draft guidance of its drug importation plan to the Office of Management and Budget on Monday (Oct. 7), the same day that both White House Domestic Policy Council head Joe Grogan and former FDA Commissioner Scott Gottlieb said they expect the administration to approve Florida’s Canadian importation plan.

Democratic presidential candidate Pete Buttigieg released Monday (Oct. 7) a plan to lower drug prices that resembles government price negotiation legislation orchestrated by House Speak Nancy Pelosi (D-CA), and the South Bend, IN, mayor included a measure that liberals back to let the government break patents.

FDA approved the second HIV prevention drug, Descovy, Gilead said Thursday (Oct. 3), setting the stage for difficult coverage decisions as Gilead touts Descovy as safer than its other HIV prevention drug, Truvada, a year before Truvada goes generic.

A prominent Canadian patient advocate alleged a U.S.-based biologics industry group is engaging in “fearmongering” in her country as part of a bid to reduce confidence in biosimilars, but the targeted group, the Alliance for Safe Biologic Medicines, told Inside Health Policy it is merely raising legitimate concerns over Canada’s new policy that requires biosimilar switching without the involvement of physicians.

FDA awarded a grant to the National Association of Boards of Pharmacy to set up an information-sharing system for drug compounding activities that are primarily overseen by states, the agency announced Wednesday (Oct. 2).

House Energy & Commerce Committee Democrats are considering changes to a measure in their drug pricing bill that would hurt many nonprofit hospitals by eliminating 340B discounts on drugs that are subject to government price negotiation.

FDA on Monday (Sept. 30) issued a draft guidance detailing the methods and best research practices stakeholders, especially drug makers, can use to find out what’s important to patients, including identifying the burdens of living with and treating a disease, as well as the benefits and risks in managing a disease.

FDA’s plan to streamline its reviews of new drugs through a major reorganization effort has been approved by Congress, agency drug center director Janet Woodcock announced Thursday (Sept. 26).

FDA on Tuesday (Sept. 24) announced the first FDA-approved vaccine for both monkeypox and smallpox, a disease that FDA biologics director Peter Marks said many Americans have no immunity to and that could pose a national security threat if it were released intentionally.