Drugs

Lawmakers Question FDA on Canadian Drug Importation

Six Republican lawmakers are urging FDA commissioner Robert Califf to update them about an ongoing delay to review Florida’s proposed Canadian Prescription Drug Importation Program. A rule advanced by the Trump Administration allows states to implement import programs as long as FDA approves their programs. Florida’s Agency for Health Care Administration (AHCA) submitted its proposal 11/2020, and the state is awaiting a response from FDA on the proposal. The letter to Califf was signed by Senator Marco Rubio (R-FL) and U.S. representatives Mario Díaz Balart (R-FL), John Rutherford (R-FL), Gus Bilirakis (R-FL), Neal Dunn (R-FL), and Brian Mast (R-FL).

“The Biden Administration, which wants to lower drug costs for Americans, especially its older citizens, continues to delay the approval of Florida’s proposal intending to do exactly that,” their letter complains. “Florida is the first state to submit a [drug importation] proposal to the FDA and other states have followed suit. It is our understanding that the FDA was previously reviewing Florida’s proposal and even submitted two requests for information, to which AHCA promptly responded. However, the FDA has failed to provide a substantive update since November 2021. AHCA officials have attempted to reach out to the FDA for months but have received no additional requests for information or a timeline since a meeting in May 2022. This situation is particularly frustrating as information has come to light that the FDA is actively working with other states on developing their proposals while Florida’s program remains stalled.”

The letter is the latest chapter in FDA’s handling of drug importation proposals. In August, the state filed a lawsuit against the agemcy for failing to timely respond to a state-sought Freedom of Information Act (FOIA) request seeking information about why its and other states’ requests to begin importing prescription drugs from Canada have stalled at the agency. The Florida complaint contends the state is ready, willing, and able to begin operating the program immediately, having already built a refrigerated distribution facility and retained an approved importer and distributor that are being paid $1.2 million per month.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome