05.14.09
New Era at FDA
FDA again makes news in the Wall Street Journal (WSJ). This is never good news for companies and in this case specifically medical device manufacturers. On May 12, 2009, the WSJ reported the FDA will re-review the decision on approval of a knee device, Menaflex. The device was approved “last December over the objection of several scientists and managers” at FDA. In addition Public Citizen appeared before the FDA advisory committee meeting and recommended the device not be approved. www.citizen.org/pulications/release.cfm?ID=7640
Will FDA reverse itself? The agency is unlikely to reverse a decision once made. However, this will certainly affect how FDA makes decisions in the future especially for medical device approvals. There has always been controversy over whether a product should be subject to the PMA or whether the 510 (k) process is acceptable to the agency. Most companies opt for the 510(k) process because it is considered less burdensome. Others prefer the PMA process which can afford companies more protection from competition.
How will this re-evaluation affect medical device manufacturers? Medical device companies can expect more stringent approval criteria in the future. The rules and regulations at FDA traditionally tighten after a controversial decision and particularly when Congress becomes involved.
What next? In February President Obama signed into law an initiative to support research on comparative effectiveness of drugs, medical devices and surgical procedures. Has this comparative-effectiveness research also known as CER, created an opportunity or an additional burden for pharmaceutical and medical device industries? Companies can no longer rely on what worked in the past. It’s a new era at FDA.
May 14, 2009
05.07.09
Former FDA Medical Officer; “an insider perspective”
Today, I begin a new blog with my perspective as that of a former “insider”. FDA has a number of moving targets. Generally, I follow pharmaceutical and medical device issues that are current and will affect sponsors, CROs, and clinical sites. My focus has and will continue to be in the clinical arenas that affect PIs, CRCs, CRAs, Project Managers, Directors and those in Regulatory Affairs.
One question consistently asked is “will we be audited”. If you are involved in clinical research, expect to be audited someday. What is new is the recent
IRB sting operation, which revealed that one of the 3, IRBs selected failed in responsibility. IT was not the FDA but the GAO who conducted this operation.
“The GAO selected three independent IRBs from on an online search and submitted a fictitious protocol to each IRB for their review. The GAO testified that Coast IRB, LLC, was the only IRB selected that reviewed and approved the research protocol and did so with only minor edits to the submitted materials. Mr. Kutz testified that Coast IRB failed to verify the false assertion contained in the protocol submission that the Food and Drug Administration (FDA) had already cleared the device for marketing, which could have been accomplished through a search of FDA’s online database. In addition, the GAO testified that Coast IRB meeting minutes showed that the board members thought the protocol was “probably very safe” and voted unanimously to approve it even though the materials submitted to the IRB for review contained insufficient safety information to make such a determination. “ FDA imposed restrictions on Coast IRB due to violations. FDA News For more information on this Sting Operation go to FDA web site of April 14.
FDA oversight of IRBs has intensified in recent years. Guidance for Instutional Review Boards and Clinical Investigators The question is will FDA intensify IRB scrutiny? FDA history has shown that regulations tighten after a public incident. Expect FDA to look even more closely at your IRB in the future. If you don’t know your IRB, now is the time to ask the right questions about your IRB.
What happens to your IRB not only affects them it affects the clinical trials they reviewed, the sponsors, the sites and most importantly the study participants.
On June 17, 2009, I will travel to MA as a guest speaker for the Boston SoCRA Chapter. The objectives of my presentation will be (1) to ensure that investigational sites are prepared for an FDA inspection, (2) understand FDA audit expectations and (3) to know what future steps to take to avoid a negative audit. And yes, IRB issues will be included.
May 6, 2009
http://www.xfda.net
