Rx Drugs

The prospect of Congress passing drug pricing legislation may depend in large part on the outcome of Texas v Azar, the GOP lawsuit to repeal the Affordable Care Act, according to former congressional and administration staff.

In a few weeks, FDA will announce plans to update its technology infrastructure, Acting FDA Commissioner Ned Sharpless told stakeholders at a Research!America event Thursday (Sept. 5).

Four former FDA commissioners and a host of patient advocacy, research and physician groups on Tuesday (Sept. 3) called on President Donald Trump and HHS Secretary Alex Azar to nominate Acting FDA Commissioner Ned Sharpless as the agency’s permanent chief.

EPA staff have clarified that under the agency’s new pharmaceutical waste rule, healthcare facilities can manage over-the-counter (OTC) medications as hazardous waste and send them to a reverse distributor, easing significant logistics issues that otherwise would likely have arisen for the facilities, according to an attorney tracking the issue.

Senior FDA officials on Tuesday (Aug. 27) took on critics who say the agency’s increased use of expedited approval pathways is a move toward more lax approval standards.

Several Republican senators in tough re-election races haven’t been playing up the upper chamber’s accomplishments on drug-pricing over lawmakers’ August recess, analysts say, though the most impactful bill would save taxpayers more than $100 billion.

The Drug Enforcement Administration (DEA) will review more than 30 pending applications from entities interested in growing marijuana for research purposes, the agency announced Monday (Aug. 26).

Large employers are increasingly open to the government negotiating prices of high-cost drugs, a notable change from previous years that reflects ongoing concern over skyrocketing costs, according to a new survey by the National Business Group on Health (NBGH).

House Ways & Means Democrats are scheduled to meet Sept. 10 and 11 to talk about drug pricing and surprise billing legislation, and the committee might even mark up a bill mid-month, but it’s unclear which measures might be marked up or what they might entail.