Rx Drugs

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FDA’s declaration Wednesday (Jan. 22) that Chiesi’s hypertension drug Cardene (nicardipine hydrochloride) was not withdrawn for safety and efficacy reasons opens the door for generic manufacturers, such as Baxter, to make the drug and may help resolve current shortages of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

FDA Deputy Director of Regulatory Programs Doug Throckmorton assured lawmakers during a recent hearing that the agency doesn’t need more authority from Congress to regulate cannabidiol (CBD) products.

FDA plans to study how proprietary drug names affect public perception and how they can sometimes be misleadingly overstate the safety or efficacy of the drug, expand drug indications or suggest superiority, the agency told the White House budget office on Friday (Jan. 17).

Eli Lilly is halving the list price on two more of its insulin products for consumers who either are uninsured or choose to buy the products without insurance, the company announced Tuesday (Jan. 14).