A half-day open meeting intended to examine “how the public perceives and values pharmaceutical quality,” convened by the Robert J. Margolis Center for Health Policy at Duke University in cooperation with the FDA, included a rundown of the agency’s oversight program, results of surveys to measure viewpoints of patients and providers – and tart commentary from a two-member “reactant panel.”
With four gene therapies already approved and more than 900 in development, the FDA has finalized six guidances and issued a draft guidance to clarify the rules of the road for developing and manufacturing the treatments.
As the industry looks forward to 2020 at the 38th Annual J.P. Morgan Healthcare Conference next week, BioWorld is looking backward to those we lost in the past year.
For the first time since Congress opened the door to biosimilars in 2010, the FDA approved nearly as many biosimilars in 2019 as it did new biologics. As the first decade of biosimilars came to a close, the agency’s Center for Drug Evaluation and Research (CDER) approved 10 biosimilars referencing seven blockbuster biologics, bringing the total number of approved biosimilars to 26.
The FDA took concrete steps Wednesday in mapping out import routes for prescription drugs by issuing a notice of proposed rulemaking and a draft guidance. If finalized, the proposed rule, for the first time, would implement a 20-year-old provision of the Federal Food, Drug and Cosmetics Act that gives the Health and Human Services (HHS) secretary the authority to authorize the import of certain small molecule drugs from Canada. However, the proposal is getting pushback from Canada.
The FDA’s proposed rule would, for the first time, implement Section 804 of the Federal Food, Drug and Cosmetics Act (FDCA), which allows certain small-molecule drugs approved in Canada to enter the U.S. market – if the Health and Human Services secretary certifies that the drugs would pose no additional risk to public health and safety and that they would result in a significant reduction in cost.
Vancouver, British Columbia-based Correvio Pharma Corp. is hoping that it will receive a positive response from the FDA’s Cardiovascular and Renal Drugs Advisory Committee, which meets tomorrow to consider the U.S. approvability of Brinavess (vernakalant hydrochloride, I.V.), its antiarrhythmic drug for the rapid conversion of adult patients with recent onset atrial fibrillation (AF).
Commissioner of the FDA for five years starting in 1984, Frank Young relished his position “at the vortex of controversy” as he sought to deal with the AIDS crisis and public furor over drug tampering, said his son, Jonathan Young, co-founder and chief operating officer of South San Francisco-based Akero Therapeutics Inc. Post-FDA, Frank Young would help grapple with the opioid epidemic as well – a scourge that began with the passage of the Compassionate Pain Relief Act (CPRA), passed the year he was appointed. Young, 88, died Nov. 24 of B-cell lymphoma.
Stephen Hahn, of the MD Anderson Cancer Center, generally managed to avoid any controversy in today’s Senate confirmation hearing for the FDA commissioner’s job, stating for instance that he is “open to all science and data that could potentially support” drug reimportation as a solution to the drug pricing problem.
The FDA has typically used real-world evidence (RWE) as a way of monitoring safety issues post-approval, especially through the Sentinel Initiative, which started in response to the FDA Amendments Act of 2007.
