Rx Drugs

The Pew Charitable Trusts says ensuring Medicare and Medicaid programs cover all approved medication-assisted treatment (MAT) and levels of care as laid out by the American Society for Addiction Medicine (ASAM) is one way Congress could help improve access to opioid use disorder treatment.

FDA has launched a pilot program aimed at streamlining the process for requesting orphan drug designation, and has scheduled a public meeting on regulatory issues associated with granting orphan drug designation -- and possibly applying orphan drug incentives -- to tissue-agnostic therapies, the agency announced Monday (Feb. 26).

State officials and the National Academy for State Health Policy compiled policies to help states negotiate cheaper drug prices that include closed formularies, specialty pharmacy networks and a joint federal-state Medicaid Technical Advisory Group.

The Biotechnology Innovation Organization (BIO) in a newly released report found that development of and investment in novel pain medicines has been sorely lacking over the past decade, with only two novel chemical entities -- those with no prior approval history -- entering the market since 2007.

Patients for Biologics Safety & Access is calling on FDA to rework portions of its newly released web page meant to educate prescribers about biosimilars, with the group suggesting changes aimed at downplaying the agency's safety assurances.

Should the president's budget hike for FDA get ratified, the agency would spend the extra $400 million dollars on: creating Centers of Excellence for compounding and digital health, researching continuous manufacturing, standing up third-party certification of medical device quality, advancing near-real-time evaluation of real-world evidence, expanding the digital health precertification program, conducting natural history studies for rare disease, and creating new internal agency systems for knowledge management and generic drug submission, according to FDA Commissioner Scott Gottlieb.

The Trump administration's fiscal 2019 budget allocates $20 million to FDA's Oncology Center of Excellence, a pleasant surprise for Friends of Cancer Research (Friends), the organization that has been involved with OCE from its inception.

Advocates for robust funding of FDA were pleased the president's fiscal 2019 budget released Monday (Feb. 12) calls for a 13 percent increase over fiscal 2018 continuing resolution levels.

A newly released Council of Economic Advisors report on drug pricing, which is expected to inform HHS' fiscal 2019 budget request, is angering both public health advocates and those favoring sweeping drug pricing reforms, given it suggests FDA can lower drug prices by speeding FDA approvals of brand drugs and making FDA's approval standards easy to comply with, all while making no mention of brand industry-opposed reforms, including those that have been floated by FDA Commissioner Scott Gottlieb, such as cracking down on abuses of FDA-mandated safety programs.