Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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FDA commissioner, Dr. Margaret Hamburg, to Resign in March

FDA commissioner, Dr. Margaret Hamburg, to Resign in March | Pharmaguy's Insights Into Drug Industry News |

Dr. Margaret Hamburg, commissioner of the U.S. Food and Drug Administration (FDA), who for almost six years has overseen public health initiatives ranging from tobacco control and food safety to personalized medicine, disease control and drug approvals, is stepping down, according to a person briefed on the matter.

The White House is expected to announce Hamburg's resignation on Friday, the person said. FDA spokeswoman Stephanie Yao declined to comment.

During her tenure the FDA has confronted major public health issues, including the rise of antibiotic-resistant bacteria, the abuse of opioid painkillers, the emergence of electronic cigarettes and the outbreak of Ebola and other infectious diseases.

Her ride has not always been smooth. She faced hostile questioning by Republicans in Congress following a fungal meningitis outbreak in 2012 that killed dozens and sickened hundreds more. And she has been caught up in some controversial political battles. 

In 2011, then Health and Human Services Secretary Kathleen Sebelius overruled the FDA's decision to allow an emergency contraceptive known as Plan B to be sold over the counter to young teenagers. Hamburg insisted Plan B was safe for use, and it was eventually approved two years later.

Hamburg was never a crusading commissioner in the way of one of her predecessors, Dr. David Kessler, who fought to bring tobacco under FDA regulation. But she has made her mark on multiple issues, including the use of targeted therapy to tailor medicines to an individual's genetic makeup. The FDA gained regulatory authority over tobacco products for the first time on her watch, in 2009.

Pharma Guy's insight:

December 7, 2011: A Date Which Will Live in Infamy for Women's Health!

"For the first time ever, the Health and Human Services secretary publicly overruled the Food and Drug Administration, refusing Wednesday to allow emergency contraceptives to be sold over the counter, including to young teenagers. The decision avoided what could have been a bruising political battle over parental control and contraception during a presidential election season."

The action was taken by U.S. Department of Health and Human Services Secretary Kathleen Sebelius in a letter addressed to FDA Commissioner Margaret Hamburg, M.D.

Read about it here.

Under Hamburg, FDA Cozied Up to Industries It Regulates, Protected Corporations More Than Patients

Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group

Feb. 5, 2015

The pending resignation of U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg will end a six-year period of weak and ineffective leadership at one of the most important public health agencies in the country.

Throughout Hamburg’s tenure, the FDA has grown even more cozy with the industries that it regulates. Too often, the FDA has succumbed to industry and political pressures, implementing policies and taking actions that tilt too far toward the bottom-line interests of pharmaceutical and medical device companies, and away from protecting public health. Transparency of agency decision-making also has suffered with Hamburg at the helm.

The agency needs a leader in the mold of Dr. David Kessler, someone who will be an aggressive, proactive crusader focused on protecting consumers and patients from medical products that are unsafe or ineffective.

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FDASIA Deadline UpDate: "Nearly All" Deliverables Completed, Says FDA

FDASIA Deadline UpDate: "Nearly All" Deliverables Completed, Says FDA | Pharmaguy's Insights Into Drug Industry News |

From Margaret A. Hamburg, M.D.

Anniversaries are a time for stock-taking and today, on the second anniversary of the Food and Drug Administration Safety and Innovation Act or FDASIA, I’m pleased to report on the progress we’ve made implementing this multi-faceted law.

To date, we have completed nearly all of the deliverables we had scheduled for the first two years after FDASIA became law. And many of the new authorities under FDASIA are already having a positive impact on health. It’s difficult to cover all of our FDASIA work, but here are some highlights:

Pharma Guy's insight:

One deliverable not "completed" and not mentioned by Dr. Hamburg is the one remaining piece of social media guidance FDA promised to deliver in 2014. Find more on that here.

Joel Finkle's curator insight, July 11, 2014 9:31 AM

FDA scores itself on their FDASIA achievements. I don't have any nitpicks, as the things I want (RPS, IDMP documentation) are all further out and dependent on external organizations.