Engineering Trends Medical Device Manufacturing Kendall Christian, Aramark CTS/Floyd Medical Center Noah McNeely, Slingshot Product Development Angela Sinton, Medical Device Marketing Stacy Williams Shuker, Georgia Center of Innovation for Life Sciences Diane Lewis, Lewis Chemical Company
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. . . and to President Obama “ The purpose of this letter is to draw your attention to the frustration and outrage that FDA physicians and scientists, public advocacy groups, the press and the American people , have repeatedly expressed over the misdeed of FDA officials.” … “… sweeping measures are needed to end the systemic corruption and wrongdoing that permeates all levels of FDA and has plagued the Agency far too long.”
The Minnesota Medical Device Alliance (MMDA) presents its White Paper to Dr. Shuren at the FDA Town Hall in Minneapolis on May 18, 2010 Can be obtained at www.duvalfdalaw.com See “Resources: Client Alert—FDA Town Hall Meeting”
. “ . . . advancing the public health by helping speed innovations . . .” “ . . . Responsible for protecting the public health. . .” Let’s start with the past
What really prevents FDA from making clearances?—an over-emphasis on safety, depriving patients of benefits .
UPDATE: CDRH chief Shuren blasts Stanford study on medical device regulations December 1, 2010 by MassDevice staff Center for Devices and Radiological Health director Dr. Jeffrey Shuren fires back at recent study from Stanford University on the costs associated with satisfying Food & Drug Administration rules during the 510(k) process. Center for Devices and Radiological Health director Dr. Jeffrey Shuren strongly refuted findings from a recently study that said more than three-quarters of the cost to bring a medical device from concept to the U.S. market is spent clearing regulatory hurdles. Shuren told MassDevice that a study by researchers at Stanford University titled "FDA Impact on U.S. Medical Technology Innovation," which said that millions of U.S. patients were being denied or delayed access to leading medical devices that are first (or exclusively) brought to market in other countries, was " highly flawed ." The Nov. 18th report was based on a survey of 204 public and venture-backed medical device companies out of a possible 1,023 companies in the domestic medical device industry, according to its authors. " That's well below the quality level of a good study ," Shuren said, pointing out that lower response rates would magnify the opinions of people unhappy with the process. He added that a sufficient response rate would have been 35 to 40 percent. "We want to have good data."
Bipartisan U.S. Senate Pressure Continues Signatories: Amy Klobuchar (D-MN), Al Franken (D-MN), Scott Brown (R-MA), John Kerry (D-MA), Pat Roberts (R-KS), Ben Nelson (D-NE), Mike Johanns (R-NE), Kay Hagen (D-NC), John Cornyn (R-TX), Kay Bailey Hutchinson (R-TX), Olympia Snowe (R-ME), Evan Bayh (D-IN), Debbie Stabenow (D-MI), Bob Casey Jr. (D-PA), and John Barrasso (R-WY). Senators Feinstein and Boxer from California notably missing
“ Under Hamburg and Sharfstein, the agency has ‘become more aggressive in regulatory matters,’ the paper says , ‘issuing more warning letters to companies for manufacturing and marketing violations with less negotiation time . . .’”
14 Fairly Recent Drug Warning Letters FDA cites specific sponsored links “ The sponsored links cited in this letter are misleading because they make representations and/or suggestions about the efficacy of Cymbalta, Evista, and Gemzar, but fail to communicate any risk information associated with the use of these drugs. In addition, the sponsored links for Evista and Gemzar inadequately communicate the drugs’ indications.”
Beware of the Unholy Alliance Anti- kickback Off-label information False Claims Act
True, but no one would ever do a study to see if you caused BC in a woman, that would be unethical. 4. The company sponsored a magazine called “Seasons” which was sent to women on HRT who subscribed. Plaintiff’s counsel argued that the company could have used the very large database of women who subscribed to this magazine to gather adverse event information. Again, this has jury appeal in spite of the obstacles apparent to industry.
See, pages 15-17. This is dated materials and likely lower in light of FDAAA funding mechanisms.