FDA Commissioner Dr Margaret Hamburg to Step Down

Lisa Nainggolan and Robert Lowes

February 05, 2015

UPDATED // Margaret Hamburg, MD, commissioner of the US Food and Drug Administration (FDA), announced today that she is resigning after almost 6 years in her post. Dr Hamburg will leave the agency at the end of March.

She is one of the longest-serving FDA commissioners in recent times.

Stephen Ostroff, MD, the FDA's chief scientist, will fill the commissioner's position until a new appointee is named.

In a resignation letter shared with FDA staff this morning, Dr Hamburg said that "our collective efforts have improved the health, safety, and quality of life of the American people." She cited such accomplishments as improving the oversight of drug compounders, speeding up the review of new drugs and devices, and protecting the drug supply chain from counterfeit, stolen, or contaminated products. She pointed to a record year in 2014 for novel drug approvals — the most in nearly 2 decades — as well as the agency's work to limit trans fats in processed foods and require chain restaurants to post calorie counts on menus.

Sylvia Burwell, secretary of the Department of Health and Human Services, said the American people have been "well served" by Dr Hamburg.

"Her dedicated service leaves a legacy of incredible, historic accomplishment at FDA," Burwell said in a news release. "From keeping our food supply safe to significant advancements in biomedical innovation to the quickly facilitating the availability of critical products to help fight Ebola, Peggy's tireless leadership has impacted millions of people across this country."

"An Important Voice for Safety"

Dr Hamburg has been credited with balancing the responsibility to approve only those drugs and medical devices that are safe and effective with the need to place as few obstacles in front of manufacturers as possible.

"I think she has made progress on all fronts," Jack Lewin, MD, president and chief executive officer of the Cardiovascular Research Foundation, said in an interview with Medscape Medical News. "She has understood that we need industry as a partner."

Diana Zuckerman, PhD, president of the consumer-oriented National Center for Health Research, said Dr Hamburg understands the agency's public health mission, unlike some of her predecessors, who were focused more on speedy approvals and less on protecting the public from harmful or ineffective products.

"I think she has been an important voice for safety and trying to maintain that balance," Dr Zuckerman told Medscape Medical News.

Even so, as a result of political pressure, the agency has continued to cater too much to drug and device makers, said Dr Zuckerman. One example of that tilt is the various fast-track programs for product review that debuted during Dr Hamburg's watch.

This pressure to grease the track for drug and device makers at the expense of safety, she said, could become more intense if Republican lawmakers, now in control of both the House and Senate, manage to enact their 21st Century Cures initiative. It is designed, in their words, "to accelerate the pace of cures and medical breakthroughs." Dr Zuckerman said Dr Hamburg may have resigned rather than preside over an FDA that could be degraded by the GOP initiative.

"No FDA commissioner who cares about public health will want to deal with the enormous changes brought about by 21st Century Cures, which would be harmful to the agency," said Dr Zuckerman. "I think Hamburg's resignation is a real loss, and it's not clear whether the next commissioner will be able to stand up to the congressional pressure."

In contrast to Dr Zuckerman's overall assessment of Dr Hamburg, the consumer watchdog group Public Citizen gave the outgoing FDA commissioner a poor review.

"Her pending resignation ends a 6-year period of weak and ineffective leadership," said Michael Carome, MD, director of the group's health research group, in an interview with Medscape Medical News. "Throughout her tenure, we've seen the FDA grow even more cozy with the industry it regulates. Too often we've seen the FDA succumb to industry and political pressure."

Dr Carome cited the approval of two weight-loss medications, phentermine/topiramate (Qysmia, Vivus) and lorcaserin (Belviq, Eisai/Arena Pharmaceuticals), as an example of the FDA abdicating its proper role during Dr Hamburg's tenure.

"Those drugs offer limited benefits and have serious side effects," said Dr Carome. "We didn't think they should have been approved."

Resignation May Have Been Timed With Hiring of Robert Califf, MD

One possible contender for the FDA's top job is Robert Califf, MD, from Duke University Medical Center, Durham, North Carolina, who was named FDA deputy commissioner for medical products and tobacco.

 

Long synonymous with cardiovascular medicine, Dr Califf is scheduled to join the FDA later this month. He could not be reached for comment.

Dr Hamburg may have timed her departure with the arrival of Dr Califf, who is highly respected in healthcare circles, said Dr Lewin.

"I think having him there at the time of this decision is a very positive thing," Dr Lewin, a long-time executive in organized medicine, told Medscape Medical News. "He's been focused on science and innovation, and building relationships both with consumer groups and industry."

Dr Zuckerman, however, questions the wisdom of a newcomer taking over the agency, given the priorities of a Republican-controlled Congress. "This is a dangerous time to have an outsider," she said.

President Barack Obama can either replace Dr Ostroff with another acting commissioner, who would not need Senate confirmation, or nominate a full-fledged leader, who would. In the latter scenario, Dr Califf stands a chance of winning enough Republican votes to get the job, said Dr Lewin. "He's not a partisan person."

FDA Has Been "Enormously Rewarding"

Immediately before her FDA appointment in 2009, Dr Hamburg worked 8 years at the Nuclear Threat Initiative, a foundation aiming to protect the public from weapons of mass destruction. She initially was the group's vice president for biological programs, and later its senior scientist. She served in the Clinton administration as an assistant secretary for policy and education in the Department of Health and Human Services. From 1991 to 1997, she was commissioner of the New York City Department of Health and Mental Hygiene.

In an interview with Medscape Medical News in November 2014, Dr Hamburg said the FDA "has been a terrific opportunity and it is an inspiring place to work."

She discussed some of the challenges of her career there, which have included trying to regulate rogue compound pharmacies, finally getting the Plan B emergency contraceptive approved for over-the-counter use, and navigating the fine line between making opiates available for pain relief while attempting to prevent their abuse.

The agency has also faced major public health issues during Dr Hamburg's tenure, including, most recently, the outbreak of Ebola and other infectious diseases.

"Most of the real problems that underlie medical care and our desire to promote health are not going to be resolved simply in a doctor's office or in a hospital setting. We have to step back and look at all of the determinants of health," she said.

Nevertheless, "public service is enormously rewarding, and you feel that every day you are making a difference," she added.

"Being engaged in health policy has made me look at things in a much more textured way. All of the problems before us are complex and multidetermined, and the solutions have to be multifaceted."

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