Drugs

Consider Impact of Increased FDA Foreign CGMP Inspections: Attorneys

Attorneys Neil O’Flaherty and Jur Strobos (Baker McKenzie) say that FDA has responded to congressional instructions by increasing its inspection focus on foreign drug production sites’ current good manufacturing practices (CGMP) and using its new tool of “refusing inspections” to shut down or impose import alerts on foreign drug production sites, particularly from Asia. Writing in an online blog post, the two say that the agency trend “suggests that U.S. companies that source product or raw materials from Asia or other low cost production sites may want to reconsider use, or be proactive in ensuring compliance of foreign suppliers.”

The post says the increased FDA action is demonstrated through a substantial increase in foreign Warning Letters, increased use of the new Section 501(j) “refusal to inspect” provision, and increased use of import alerts.

According to the attorneys, the trends in agency action suggest that many foreign manufacturers have not trained their personnel in preparing for an FDA inspection. “FDA has statutory authority to inspect at reasonable times, within reasonable limits and in a reasonable manner,” they say. “Education in the appropriate management of an FDA inspection is paramount to avoid the peril of losing the U.S. market until a resolution of problems is reached with FDA. The impact of a consequent ban on imports is a substantial risk to manufacturers who operate non-U.S. production sites. Drug manufacturers should familiarize themselves with FDA’s guidance and inspectional and regulatory procedures manuals. Drug companies should learn and develop policies and procedures to host an FDA inspection and train their personnel.”

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

Read more

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