News: March 6, 2008
FDA Science Board Calls for Budget Increase. According to a recent report by the FDA Science Board (the “Board”), the agency’s budget needs to double over the next five years. The report calls for a $375 million increase over fiscal year 2008 in direct appropriations to FDA for fiscal 2009 and for additional increases in the following five years. The report explains that five-year cost estimates were provided because the Board recognizes the need for a phased-in approach, even though substantial new resources are needed immediately. The original report was entitled, “FDA Science and Mission at Risk” and identified FDA’s major weaknesses, highlighting gaps in scientific expertise and insufficient information technology. Although the Board was originally asked not to assess available resources, it quickly became apparent that the agency’s weaknesses are directly related to two decades of inadequate funding, making it impossible to assess one without also looking at the other. Additional information is available at www.fdalegislativewatch.com.
FDA Looking to Open International Offices. According to FDA Commissioner Andrew von Eschenbach, the agency needs to increase foreign inspections to adequately regulate products in the 21st century. Accordingly, he believes that the agency must increase risk-based inspections, increase collaborations with foreign partners, and establish offices in other countries. “FDA Without Borders” is a new agency initiative that aims to establish offices in at least five regions, beginning with China. FDA is also working with the State Department to establish offices in other regions, including India, the Middle East, Central America, and South America. At present, FDA is also developing a new system called Predict that will enhance the agency’s information gathering capabilities, allowing it to better identify where to allocate inspection resources. The agency plans to increase the overall number of inspections this year; to do so, FDA intends to hire 700 additional employees. Additional information is available at www.fdanews.com.
Standard Template for Recall Press Releases Proposed. FDA is proposing a new template for press releases on recalls of all products regulated by the agency, including medical devices. The forms are designed to ensure that manufacturers put recalls in the proper context, but offers some flexibility in the wording of such announcements. The new template would structure the information in a more useful way and would allow FDA to get safety recall information out faster. It includes sections for describing the problem, persons at risk, how to identify the product, where the product is distributed, what symptoms to look for, and who should be contacted. Insiders recommend that FDA remove the word “recall” from all public communications regarding implantable products out of concern that it confuses patients as to whether they need to have their devices explanted. Still, others are concerned that the word “recall” is necessary to adequately inform consumers of the nature of the situation. Additional information is available at www.medicaldevicestoday.com.
FDA Approves Amniotic Fluid Detection Device. Barr Pharmaceuticals recently announced FDA approval of its AmniScreen at-home test for amniotic fluid leakage during pregnancy. The device consists of a panty-liner embedded with a proprietary polymer-coated polyester strip that detects amniotic fluid leakage, which may indicate a problem during pregnancy. The device is the first of its kind to obtain FDA approval. Additional information is available at www.fdanews.com.
FDA Genetic Test Oversight to Increase. Industry insiders and government agency representatives are calling for FDA to review all diagnostic tests, including those developed by laboratories. Under current FDA policy, most lab-developed tests (“LTD”) sold as diagnostic services are not regulated by the agency. However, FDA consistently regulates in vitro diagnostic test kits, which are sold as packaged products. At its recent meeting, the Health and Human Services (“HHS”) Secretary’s Advisory Committee on Genetics, Health, and Society (“SACGHS”) announced that it will recommend that all such tests be addressed, if not regulated, by the agency. While agency officials agree that FDA has the authority to regulate these tests, many are skeptical about whether the agency has the resources to handle the task. Additional information available at www.thegraysheet.com (paid subscription service).
Lawmakers Threaten to Overturn Supreme Court Preemption Decision. The U.S. Supreme Court (“the Court”) recently decided Riegel v. Medtronic, ruling 8–1 that the express preemption provision of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) preempts state-law claims seeking damages for injuries caused by devices with FDA approval. Following the Court’s decision some Congressional leaders have called for legislative action to “correct” the courts decision. In particular, Sen. Edward Kennedy (D-Mass.) has called for lawmakers to overturn the Court’s decision through legislative action, warning that otherwise, “FDA approval will become a green light for shoddy practices by manufacturers.” Additional information available at www.fdanews.com.
Device Industry Looks to Civil Settlements for Compliance Standards. In the wake of the recent anti-kickback violation settlement of five orthopedic device manufacturers, companies are looking for judicial or statutory guidance to help them avoid legal trouble related to corporate sales practices. However, legal experts predict that medical device manufacturers may have to rely on previously negotiated settlements for guidance. To the extent that new “law” in this area is created, it is expected to come in the form of civil settlements, corporate integrity agreements, and other negotiated remedies. Deferred prosecution agreements, under which companies can avoid criminal prosecution by making reforms and submitting to monitoring, are also likely to become more common. Additional information is available at www.thegraysheet.com (paid subscription service).