Rx Drugs

The medical device lobby is actively working with the Chinese and U.S. governments and stakeholders to ensure providers and patients have access to medical technologies that can help diagnose and prevent the spread of novel coronavirus, the group told Inside Health Policy on Thursday (Jan. 30), amid reports that China is experiencing shortages of masks, gowns and gloves.

CMS’ new policy that ties closed Medicaid drug formularies to block grants is a double whammy for the drug industry because sources say block grants amplify the negotiating power of closed formularies.

The over-the-counter drug lobby will broaden its focus to include consumer medical devices, and it plans to work with FDA to establish a definition and standards separate from those used to regulate more traditional medical devices, the Consumer Healthcare Products Association told Inside Health Policy.

FDA, the National Institutes of Health and the Office of the Assistant Secretary for Preparedness and Response are researching possibilities for vaccines, diagnostics and therapeutics to respond to the novel coronavirus, of which there are now five known cases in the United States, HHS Secretary Alex Azar said during a press briefing Tuesday (Jan. 28).

The House Energy & Commerce health panel will review legislative proposals that aim to end gaming of the Orphan Drug Act, improve generic drug labeling and foster continuous manufacturing at a legislative hearing Wednesday (Jan. 29).

Diagnostic test makers who want to pursue emergency use authorization for tests to detect novel coronavirus should contact FDA, the agency said in a press release Monday (Jan. 27) as part of an update on the agency’s response efforts.

House Speaker Nancy Pelosi’s (D-CA) top health aide Wendell Primus told lobbyists in closed-door meetings that he’s open to negotiating with Republicans on whether to let Medicare bargain with drug companies over prices, sources who recently met with Primus told Inside Health Policy.

FDA’s declaration Wednesday (Jan. 22) that Chiesi’s hypertension drug Cardene (nicardipine hydrochloride) was not withdrawn for safety and efficacy reasons opens the door for generic manufacturers, such as Baxter, to make the drug and may help resolve current shortages of nicardipine hydrochloride, a pharmacy group says.

New Mexico Gov. Michelle Lujan-Grisham (D) is proposing to create an office that would develop a plan to import Canadian drugs.