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Rottenstein Law Group Hopeful that Updated Version of Medical Device User Fee Act Improves FDA's Approval Process

Wed, 22 Feb 2012 09:00:00 EST

(New York, NY, February 22, 2012) The Rottenstein Law Group, which represents clients with claims stemming from the adverse effects of the surgical implantation of vaginal mesh, hopes the final version of the U.S. Food and Drug Administration's (FDA) agreement with the medical device industry, known as the Medical Device User Fee Act (MDUFA), will make the FDA's medical device approval process safer for future recipients.
MDUFA represents an agreement first reached by the FDA and the medical device industry in 2002, according to a February 15 article that appeared on the Web site, MedPage Today. The agreement must be reauthorized every five years; the version Congress reauthorized in 2007 increased fees medical device makers must pay to have their products reviewed by the FDA for approval. This latest version, being considered for reauthorization in 2013, would again increase those fees.
Earlier this month, the House Energy and Commerce Health Subcommittee – the group responsible for eventually turning the proposed updates to MDUFA into an actual bill – met to discuss the bill's new terms. At the meeting, the head of the FDA's Centers for Devices and Radiological Health, Dr. Jeffery Shuren, said that the $595 million in user fees that the new MDUFA would allow the FDA to collect from medical device manufacturers from 2013 to 2017 is essential to solving the agency's many problems, including shortfalls in management that oversee new medical device approvals. The deadline for Congressional approval is the end of September, 2012.
Many vaginal mesh products, which according to several sources have seriously injured thousands of women, were approved by the FDA via an expedited process that, according to the MedPage Today article, the Institute of Medicine has identified as incapable of ensuring their safety and efficacy.
Anyone seeking more information about vaginal mesh can visit the Rottenstein Law Group's Vaginal Mesh Lawsuit Information Center. The site has vital information about the dangers of this medical device, along with easy-to-use social media features that allow for easy sharing on sites like Facebook and Twitter. Visitors are also encouraged to link to their own Web sites and blogs in order to spread the word about defective medical products and dangerous drugs.
About the Rottenstein Law Group
The Rottenstein Law Group is a New York-based law firm that represents clients in mass tort actions. The firm was founded by Rochelle Rottenstein, a lawyer with over two decades of experience in compassionate representation of clients in consumer product injury, mass tort, and class action law suits. For more information, please visit their Web site, or call (888) 9-ROT-LAW.