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Innovative antiretroviral HIV drugs may qualify for PDUFA fee waivers or refunds if the fee would be a significant barrier to development, according to new FDA draft guidance aimed at implementing the President’s Emergency Plan for AIDS Relief. Read More
The FDA estimates that its generic drug approval pathway — which led to a record-setting year of generic drug approvals in 2017 — helped consumers save $11.8 billion in drug costs through February 2018. Read More
The Trump administration has formally delayed implementing an Obama-era rule that would have set a ceiling on drug prices for 340B hospital discount programs and fine those drug makers who violate the rules. Read More
A Florida doctor is the latest to plead guilty in connection with an Insys scheme to pay kickbacks in exchange for prescribing its opioid drug Subsys. Read More
FDA Commissioner Scott Gottlieb urged internet stakeholders to help the agency crack down on illicit online opioid sales Tuesday as the FDA posted warnings sent to nine online operators of 53 websites for illegal marketing and sale of opioids including tramadol and oxycodone. Read More
Gottlieb said before the law’s passage that if additional patient protections did not make it into the final bill they could be passed “administratively” without compromising the intent of the law. Read More
Sen. Ron Johnson (R-Wis.) requested a meeting with FDA Commissioner Scott Gottlieb to clear up “misconceptions” about the agency’s role in implementing the newly signed right-to-try legislation. Read More