GOVERNMENT

Pharma, Biotech, Devices, Vaccines…Why the New FDA Commissioner Will Need to Engage Them All

MAR 17

This month, Dr. Margaret Hamburg, commissioner of the Food and Drug Administration (FDA) is stepping down after six years at the helm. Hamburg’s resignation comes at a crucial time for the FDA as Congress pushes initiatives to speed new drug development, President Obama supports the creation of a separate food safety agency, and the regulation of healthcare technology and applications is in limbo.

What type of leadership does the FDA need now?

Archelle Georgiou, M.D. is the Chair of our Health Executive Roundtable. She posed this question to Dr. Susan Alpert, also a Roundtable member, who has held a variety of positions at the FDA including a six year stint as director of the Office of Device Evaluation and eight years as SVP of Global Regulatory Affairs at Medtronic.

AG:  Let’s start with some historical context. Did you ever work under the current FDA commissioner?

SA: No, I didn’t work for Dr. Hamburg, but I did work at the FDA under three different Presidential administrations, Democratic and Republican.  So I can tell you what changes and what doesn’t. The majority of the people working at the FDA are government employees; they’re not political appointees except at the top of the agency – such as the Commissioner. Incidentally, the commissioner of the FDA was not a political appointee confirmed by the Senate until David Kessler was confirmed in 1990.

AG:  Do you believe that making the Commissioner a political appointee results in politicizing the FDA itself?

SA:  It politicizes high-level policy direction, but it has very little impact on the review staff since the work of reviewing and approving products is governed by statute, regulations, and policies.

AG:  Can you give me an example?

SA: The FDA’s position on the ‘morning after pill’ was a policy issue and highly politically influenced. But, that actual review process —assessing the clinical research and determining if the drugs were safe — wasn’t political.

AG:  When you look back at Hamburg’s tenure, what policy decisions do you believe were good for healthcare in the U.S.?

SA:  I think what Hamburg brought to the agency was reinforcement of the FDA’s public health responsibility and ensuring an understanding that the FDA isn’t about selling drugs or devices.  Another area that she focused on is the international environment.  Under her leadership, the FDA expanded its global presence and now has offices around the world. It’s notable that many of these FDA employees live and many times are natives of the countries where they’re working.  The FDA doesn’t regulate what happens in other countries, but they are on the ground and close to the companies developing new products. Having FDA people right there means that there is more consistent oversight, as well as unannounced audits, which, in turn, improves public safety. In addition, these close interactions improve the probability that submissions for novel drugs and technologies meet all the FDA’s standards, which then accelerates approval and product availability in the U.S.

AG: Dr. Stephen Ostroff has been named acting commissioner. What do you think about that?

SA: Ostroff was the chief scientist so they’ll move him in when she leaves, but many people think it’s temporary and that he won’t be there for the two years. Remember that policy is always being developed and there are always new regulations being proposed. So, an acting commissioner can influence a lot by deciding what gets through and what doesn’t.  It will be interesting to see whom they’ll appoint as the acting commissioner.

AG:  Any speculation?

SA: In January, the FDA named Dr. Rob Califf from Duke Clinical Research Institute as the new principal deputy who will oversee drug, medical device and tobacco policy.  Rob is very well-known and experienced as both a cardiologist and a clinical trialist.  He is the head of the Duke Clinical Research Institute, and Duke has done a number of public-private partnerships with the FDA so he has a lot of exposure to the Agency and the industry.

AG:  So it was interesting to see your body language change when you talked about Rob. You got excited about it.

SA:  I’ve worked directly with Rob for many years and I’ve had exposure to both his leadership style as well as his knowledge set.

AG:  So whether it’s Rob or someone else, what do you hope the new commissioner brings to the FDA?

SA: There are a couple of things.  First is they need to engage the varied industries in the goals of the agency. When I joined the FDA in 1987, it was a black box. During Commissioner Hamburg’s tenure, she has been a strong supporter of a transparency initiative at the FDA. But, most of the progress has been focused on making the industry’s data, internal workings, and inspections more visible.  It is now equally important to have visibility to the inner workings of the FDA itself.  Another thing that’s on the table right now is the device user fee issue.  Even though this is three years away, discussions start now, and the new commissioner can influence what the Agency is willing to do and how they interact with all of the industries developing proposals for user fees.  And, of course, a big issue is the device tax, which is a political topic, but one where the FDA is in a better position than any to educate the legislators and Administration.

AG:  Okay, what else?

SA:  In my opinion, I don’t think Dr. Hamburg spent sufficient time getting to know the industry. The new commissioner really needs to understand the unique aspects of the pharmaceutical industry, the biotech industry, the medical device industry, and the vaccine industry. They are all very different.

AG:  One of the areas that TripleTree thinks about is regulation of electronic health records, software analytics, and decision-making tools. How do you think this will play out?

SA: These are big issues coming up that need to be addressed. Today, the FDA doesn’t regulate electronic health records, as they are regulated by the Office of the National Coordinator­ (ONC). But you can envision a time not far into the future when EHR data will be used to figure out how this patient responds best to that drug, or who should get which interventions, and what individual decisions need to be made about a treatment. Who will oversee these tools — the Office of the National Coordinator?  They’re only tech people.  They’re not healthcare people.

AG:  Do you think this will be a major agenda item for the incoming acting commissioner, or do you think it’s too ‘futuristic’ and will be left to the Commissioner appointed in the next Administration?

SA:  Some decisions are being made now. There is legislation being considered in the new Congress that would give oversight of medical apps to ONC. However, ONC’s skill sets are very different and I don’t think a bunch of tech guys sitting in the ONC should be making decisions about the safety and effectiveness of analytics and tools that determine how chronic illnesses are managed and who should have access to certain interventions.  I would like healthcare eyes on that data— not just financial eyes or technology eyes— it’s important to public health.

Let us know what you think.

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Archelle Georgiou, MD
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Susan Alpert