Laura Helbling

Laura Helbling

Senior Writer-Pink Sheet

Washington, DC

Latest from Laura Helbling

Insurance CEOs In The Hot Seat: House Hearings Emphasize Rx Access, Not Prices

The grilling of several leading US insurance executives by two House committees suggested one benefit from the Most Favored Nation pricing deals is that for one day, someone else was on the hot seat.

CMS’ Literal Read Of Non-Opioid Pain Incentive Excludes Recently Approved Product

The FDA’s policies on analgesic labeling appear to be limiting the potential for novel non-opioid pain medicines to qualify for separate payments in Medicare after CMS said the indication must be for post-operative use.

Generic Drug Onshoring: Bipartisan Support For Federal Procurement Reforms

A Senate hearing on the medical product supply chain suggests there is bipartisan support for ‘buy American’ policies for federal Rx purchases, and for country-of-origin labeling to help those policies expand to the private sector.

Non-Opioid Analgesics Guidance On Chronic Pain: One Trial Plus Confirmatory Evidence May Be Enough

Alternative therapies designed to avoid, eliminate, or reduce the use of opioids may be eligible for Breakthrough Therapy Designation or Priority Review, the US FDA draft guidance says.

US Strategic Reserve Bulking Up: New Order Focuses On API Stockpile

The White House is directing the Health and Human Services Department to replenish stockpiles of active pharmaceutical ingredients for “especially critical” medicines.

BIOSECURE Act Returning, Privacy, Gain-of-Function Bills Coming, Senate Sponsor Says

Legislation prohibiting work with certain Chinese biopharma firms will be reintroduced soon, Democratic Sen. Gary Peters said. And it will not be the only bill tied to international biotech competition and security concerns that will be considered.