Head of Scandal Ridden FDA Device Division Resigns

Finally, following months of criticism, the U.S. Food and Drug Administration’s (FDA) head of <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">medical devices just announced his resignation. In a letter, which was obtained by the Associated Press (AP) and sent to agency staffers, Daniel Schultz said he and FDA Commissioner Margaret Hamburg agreed his resignation “would be in the best interest of the center and the agency.” Schultz managed the division for five years, said the AP.

Earlier this year we wrote that many agency critics have long complained of the corruption, conflicts of interest, and budgeting and system problems that appeared to be routine at the FDA under the former administration. In January, following President Barack Obama’s entry into the White House, one of the FDA’s most outspoken critics contributed to a public opinion piece geared to the new president on what he “needs to do to move beyond the Bush legacy,” said WebMD’s The Heart, quoting Nature.

Nature published comments from its so-called “six leading voices” offering opinions on how to correct some significant America-specific and global scientific concerns, said TheHeart, previously. Dr. Steven Nissen, a prominent cardiologist with the renowned Cleveland Clinic in Ohio, was one of those who offered opinions. In his piece, said TheHeart, Dr. Nissen called for “’an end to secrecy,’ to ‘revive’” the agency.

Also earlier this year, some scientists at the FDA wrote to President Obama’s transition team basically begging for help and outlining a number of problems with an agency they described as “fundamentally broken,” reported The Wall Street Journal previously. Dr. Nissen was also reported to have scolded the FDA in December 2008, said BioPharmaToday, for failing to maintain its commitment regarding fees under the Pharmaceutical Drug User Fee Act (PDUFA).

As we have previously written and the AP also just noted, scientists under Schultz’s leadership claimed, “they were pressured to approve certain products” against their best judgment. It was the nine-scientist letter that added to the call for reform at the agency. Following the letter, a number of lawmakers—such as Representative Henry Waxman (Democrat-California) and Senator Chuck Grassley (Republican-Iowa)—called on the FDA to investigate the alleged corruption, reported the AP.

In one stunning example cited by the AP, between 2006 and 2008, even though agency scientists rejected a Regen Biologics knee repair device on a number of occasions Schultz approved it in 2008. The AP said that, citing a 2007 FDA rejection letter to Regen, an FDA reviewer said the device had “an increased risk” compared with other available products; the scientists rejected another application in 2008 saying the company had not indicated, “that patients who received the device experienced any benefit.”

TheHeart previously reported that the inspector general at the Department of Health and Human Services released a report in January scolding the FDA for insufficient attention to how it reviewed financial conflicts of interests among researchers, most notably those conducting industry-sponsored clinical trials of drugs and devices. Also, the US Government Accountability Office went public with a report scolding the FDA for not correcting its lax Class III medical device approval processes, which rushes sensitive devices to market, posing significant risks to patients.

Consumer health advocates are thrilled with this change as well as President Obama’s choice of Hamburg to head the long-failing agency.

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