- FDA is a science-based agency, but has been involved more and more with political and other pressures. In 2009 FDA issued a Preliminary Report on the review of a 510(k) clearance of ReGen’s Menaflex device for meniscal repair that discusses possible external pressures on FDA. See the FDA Report on the FDA website - https://www.fda.gov/downloads/newsevents/publichealthfocus/ucm183642.pdf (Links to an external site.) and a Wall St. Journal article that first broke the story - http://online.wsj.com/article/SB123629954783946701.html (Links to an external site.). If you don't have access to the WSJ, you can read about the story here http://www.ucsusa.org/our-work/center-science-and-democracy/promoting-scientific-integrity/fda-medical-device-approval.html#.WfdQa4ZrylM (Links to an external site.)
Two previous 510(k) submissions for the device were determined to be Not Substantially Equivalent. The third 510(k) was cleared after two Congressmen and two Senators asked then Commissioner von Eschenbach to intercede. The Report cites the Congressional influence and personal involvement of the Commissioner for creating irregularities in this review process. FDA has revised its procedures and the Center Director at the time resigned. What does this do to the ability of FDA to accomplish its mission? Is it good or bad to allow these political issues to influence the FDA? - Looking at FDA's 2018 Strategic Policy Roadmap, which do you think is most urgent for FDA to address for the future and why?
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https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm591993.htm - In September of 2016, the FDA granted accelerated approval to a drug called etiplirsen to treat Duchenne Muscular Dystrophy (DMD). Etiplirsen is the first drug approved to treat DMD, but this has been a highly controversial decision by the FDA, particularly since an advisory committee recommended against approval, and ultimately the decision to approve came from Janet Woodcock, the Directer of CDER, against the recommendation of her staff reviewers. In light of the other discussions on this week's discussion board, do you think that FDA should have approved etiplirsen? Should one individual at the FDA have the power to make this decision? http://www.raps.org/Regulatory-Focus/News/2016/09/19/25870/Sarepta-Wins-Controversial-FDA-Approval-for-First-DMD-Drug/ (Links to an external site.)
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