Senate to vote on ‘the oofahs’, critical to future of FDA

The beginning of today’s Senate Health, Education, Labor and Pensions (HELP) Committee sounded like a comedy skit with Senator Mike Enzi outlining the difference between ‘the oofahs’ (PDUFA, BSUFA, MDUFMA, etc.) as relates to user fee agreements covering drugs, medical devices, generic drugs, and biosimilar products. Once the chuckles ended, the Committee called for swift passage of the legislation before the current agreement expire in September.

The user fee agreement combines accountability, transparency and added resources for FDA. “Put simply, the agreement is good for FDA; it is good for industry; and most of all, it is good for American patients.” In a press release, AdvaMed said that the device industry appreciates efforts by several Congress members who have introduced legislative proposals to give FDA the Among those testifying included officials from PhRMA, the Generic Pharmaceutical Association, AdvaMed and BIO, as well as Dr. Janet Woodcock (CDER) and Dr. Jeffrey Shuren (CDRH) from FDA.

http://www.beaker.com/blog/index.php/2012/04/03/senate-to-vote-on-the-oofahs-critical-to-future-of-fda/

BIO Testifies on Importance of Timely Passage of BsUFA and PDUFA

BIO Testifies on Importance of Timely Passage of BsUFA and PDUFA

Washington, D.C. (March 29, 2012) – Sara Radcliffe, Executive Vice President of Health at the Biotechnology Industry Organization (BIO), testified today on biosimilar user fees (BsUFA) and the Prescription Drug User Fee Act (PDUFA) before the Senate Health, Education, Labor and Pensions Committee in a hearing entitled, “FDA User Fee Agreements: Strengthening FDA and the Medical Products Industry for the Benefit of Patients.”

In her testimony, Radcliffe expressed support for the establishment of a biosimilars user fee program as part of the Food and Drug Administration’s (FDA) implementation of a well-constructed, science-based pathway for the approval of biosimilar products that protects patient safety and preserves incentives for innovative new therapies.

“A transparent, predictable, and balanced regulatory framework for the review and approval of biosimilars, accompanied by reasonable performance goals and a dedicated, independent funding stream, will ensure that FDA can facilitate the development and evaluation of biosimilars products,” Radcliffe testified.

click link for full article: BIO Testifies on Importance of Timely Passage of BsUFA and PDUFA