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Food & Drug Administration (FDA)
Related Resources (government documents and letters)
POGO Files
FDA Advisors who Endorsed Contraceptive had Industry Ties
January 12, 2012
POGO Letter: FDA Advisors on Yaz and Yasmin Have Industry Ties
January 11, 2012
POGO Letter Urges FDA Not to Weaken Conflict of Interest Standards at Center for Drug Evaluation and Research
August 3, 2011
Podcast: Conflict Zone: Increasing Transparency of NIH-Funded Researchers' Financial Conflicts of Interest In May 2010, leaders at the National Institutes of Health (NIH) proposed a rule that would require NIH-funded researchers to publicly disclose their financial arrangements with drug and medical device companies.
August 2, 2011
This proposal would bring a much needed dose of transparency to federally funded medical research. Now, one thing stands in its way: the Office of Management and Budget (OMB). POGO is concerned that OMB will weaken or block this proposal, and in July, we sent a letter urging OMB to leave the rule intact.
For this podcast, POGO Staff Scientist Ned Feder and POGO Executive Director Danielle Brian discuss why this proposal is so important. After we recorded this podcast, Nature News reported that the proposal has been dropped. Things aren't completely final just yet--but if the NIH's disclosure proposal does wind up on the cutting room floor, it would be a significant blow to transparency and taxpayer interests.
POGO Letter to FDA Commissioner Hamburg Concerning the Potentially Dangerous Interaction of the Drugs Seroquel and Methodone
July 19, 2011
POGO Statement Regarding Potential Dangerous Interaction Between Seroquel and Methadone
July 19, 2011
POGO asks DHHS Secretary Sebelius to reinvestigate FDA's negligent oversight of unsafe medical devices
January 13, 2011
Obama Administration Should Re-Open Investigation of FDA Wrongdoing After Inspector General Office Rejected Whistleblower Complaints
January 13, 2011
POGO Letter to FDA Commissioner Margaret Hamburg Regarding Potentially Dangerous Drug Interaction Invovling Seroquel and Methadone
October 25, 2010
POGO's letter to Deputy HHS IG on FDA's CDRH's low standard of medical devices approval
September 28, 2010
Investigation into Wrongdoing at FDA Re-Opened: But Will It Be Different This Time?
September 28, 2010
POGO's Statement on the FDA's Decision to Keep Avandia on the Market
September 23, 2010
The Finances Of FDA Advisory Committee Members: If Information Must Be Withheld, Let It Be Done Openly
August 16, 2010
POGO's letter to Commissioner Hamburg regarding medical devices
October 14, 2009
CDRH Director Offers Resignation
August 11, 2009
The FDA's Deadly Gamble with the Safety of Medical Devices The Food and Drug Administration's Center for Devices and Radiological Health (CDRH) oversees the safety of medical devices. Internal documents obtained by POGO reveal a decision made by senior CDRH officials that could put patients' lives at risk. Since 2006, the FDA is not ensuring that medical devices such as cardiac defibrillators, pacemakers, replacement heart valves, and coronary artery stents are being tested according to good laboratory practices.
February 18, 2009
FDA's Risky Gamble with the Safety of Medical Devices
February 18, 2009
Correspondence between POGO and the Center for Devices and Radiological Health (CDRH) of the FDA
October 9, 2008
Conflicting Interests at FDA
August 8, 2008
Related Resources
Letter to POGO from DHHS, Center for Drug Evalutation and Research Director, Janet Woodcock, MD Regarding Dangerous Drug Interaction
Janet Woodcock, MD, Director, Center for Drug Evaluation and Research; Department of Health and Human Services; Food and Drug Administration
April 15, 2011
Letter from FDA Commissioner Hamburg to POGO regarding medical devices
Margaret A. Hamburg, M.D., Commissioner for Food and Drug Administration, Department Of Health & Human Services
September 25, 2009
Response Letter from Casper Uldriks, DHHS
Casper E. Uldriks, Associate Director, FDA, Regulatory Guidance and Government Affairs, Center for Devices and Radiological Health, Department of Health & Human Services
May 27, 2008
POGO in the News
Group seeks re-vote on birth control clot risk, Anna Yukhananov, Reuters, January 12, 2012
The Yaz Men: Members of FDA panel reviewing the risks of popular Bayer contraceptive had industry ties, Jeanne Lenzer and Keith Epstein, Ten Miles Square; The Washington Monthly (blog), January 9, 2012
Senator pushes transparency in federal health research, Sarah Chacko, Federal Times, August 5, 2011
Watchdog group hits FDA on drug experts, Dave Levinthal, POLITICO, August 2, 2011
Heart Warning Added to Label on Popular Antipsychotic Drug, Duff Wilson, The New York Times, July 18, 2011
Did Navy's Brain Injury Subjects Receive Substandard Care?, By Sharon Weinberger, AOL News, April 4, 2011
FDA Whistleblower Allegations Shouldn't Be Swept Under the Carpet, By POGO's Joe Newman, The Huffington Post, January 20, 2011
Feds dismiss misconduct claims at FDA device unit, By Matthew Perrone, Associated Press, The Washington Post, November 9, 2010
US Reviews FDA Scientists' Complaints, By Alicia Mundy, Wall Street Journal, September 30, 2010
Feds reopen probe into medical scanner approvals, By Matthew Perrone, Associated Press, WTOP.com, September 28, 2010
2009: Turmoil Erupts at CDRH, By James G. Dickinson, Medical Device Link.Com, December 1, 2009
Daniel Schultz Resigns Amid CDRH Controversies, By James G. Dickinson, Medical Device Link.com, October 1, 2009
Firm Aggressively Campaigned for Device, By Dan Eggen and Lyndsey Layton, The Washington Post, September 26, 2009
Fast-Tracked Medical Device Review Will Take Two Years, By Jane Akre, InjuryBoard.com, September 25, 2009
U.S. FDA seeks outside review of device approvals, By Susan Heavey, Reuters, September 23, 2009
FDA changes afoot?, By Shawn Rhea, Modern Healthcare (by subscription only), August 17, 2009
U.S. FDA device chief leaves, changes seen, By Susan Heavey, Reuters, August 11, 2009
Safety concerns over life sustaining medical devices, , WQAD.com, July 8, 2009
FDA Head to Look at Medical Device Safety, , NEWSInferno.com, June 17, 2009
Watchdog Group Wants Probe in Syringe Case, By Christina Jewett, ProPublica & Chris Walker, Chicago Tribune, June 8, 2009
Report: FDA Dropped Early Medical Device Lab Inspections, , Medical Report Outsourcing (Blog), June 8, 2009
A Covertly Drops Inspection of Medical Device Labs, By David Gutierrez, Natural News, May 30, 2009
Health First-Dangerous Devices, By Leslie Toldo, Health and Medical News from ABC12.com, May 20, 2009
HealthFirst-Dangerous Devices, By Leslie Toldo, ABC12.com, May 20, 2009
Is more regulation the answer?, By Rob Waters, Raleigh News Observer, March 1, 2009
As the federal stimulus billions begin to flow, oversight essential, , Stockton Record, On-line, February 27, 2009
FDA ignored debris in syringes, By Sarah Avery & Sabina Vollmer, Raleigh News & Observer, February 25, 2009
Feds searching for CEO in case of tainted syringes, By Mike Baker, Associated Press, February 24, 2009
Lack of GLP Inspections Leads to Hasty Device Approvals, By Renee Frojo, Device & Diagnostic Letter, February 23, 2009
FDA All But Stopped Inspecting Labs That Test Medical Devices, , FDA Week, February 20, 2009
Watchdog Says FDA Abandoned Safety Measure, By Lisa LaMotta, Forbes Online, February 18, 2009
Internal FDA Documents Reveal Agency Stopped Enforcing Standards, By Daphne Eviatar, Washington Independent, February 18, 2009
Activists decry paucity of US FDA device checks, By Susan Heavey, Reuters, February 18, 2009
Watchdog: FDA decision under Bush put patients in danger, By Greg Gordon, McClatchy Newspapers, February 18, 2009
Watchdog Blasts FDA On Loose Test Compliance Policy, By Anna Edney, Congress Daily, February 18, 2009
Report: FDA scaled back enforcement at labs, By Ricardo Alonso-Zaldivar, Associated Press; ABC News , February 18, 2009
FDA Not Enforcing Medical Device Testing Standards, By Jared Favole, DowJones Newswires, February 18, 2009
