Rx Drugs

A new group led by the Biotechnology Innovation Organization (BIO) is urging Congress to create additional incentives for drug and biologic makers to develop innovative antibiotics, starting with passage of the Medicare add-on payments included in the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019.

Senate Homeland Security & Government Affairs Committee ranking Democrat Gary Peters (MI) is concerned FDA doesn’t have the data it needs to mitigate drug shortages, which he says can drive up prices and hurt patients and hospitals.

The pharmaceutical industry, including GW Pharmaceuticals, the producer of cannabidiol-containing drug Epidiolex, warns FDA that allowing CBD in consumer products could freeze research and development on use of CBD in prescription drugs.

Women’s health experts, including former FDA chief Jane Henney and Planned Parenthood, argue FDA should drop its dispensing restrictions on “abortion pill” mifepristone as those restrictions continue to severely limit patient access to medication that health care provider groups already agree is safe.

FDA on Monday (Aug. 19) announced the approval of a first-in-class antibiotic to treat adults with community-acquired bacterial pneumonia, which means the pneumonia was acquired outside of a hospital.

White House budget officials and the Pharmaceutical Research and Manufacturers of America are scheduled to meet Aug. 26 to discuss the Trump administration’s plan to tie U.S. drug prices to those in foreign countries, according to the Office of Management and Budget website.

FDA on Thursday (Aug. 16) approved a third tissue-agnostic cancer treatment that targets biomarkers found in a multiple different tumor types rather than one specific location in the body.

FDA’s approval Wednesday (Aug. 14) of a new drug for treatment-resistant forms of tuberculosis developed by the nonprofit TB Alliance refueled debate on the role the government and nonprofits could play in spurring the development of new antibiotics.

Generic drug makers in the United States could experience an uptick in competition from China in the next 10 years, according to a non-profit think tank that focuses on public policy and innovation.