Dr. Sharfstein to Leave FDA on Friday

January 5, 2011

FDA Joshua Sharfstein

Dr. Joshua Sharfstein to Leave FDA on Friday, January 7th

Dr. Joshua M. Sharfstein, Principal Deputy Commissioner of the U.S. Food and Drug Administration, will be leaving FDA this Friday, January 7. Since joining FDA two years ago, Dr. Sharfstein has brought much needed energy and a passion for public health to FDA. Together with Dr. Margaret Hamburg, he has revitalized the agency, in my viewpoint, for the better. There are a lot of opinions about his leaving to become the Director of Maryland’s Department of Health and Mental Hygiene. I’ll let you scour the web for interpretations. I don’t have a clue. However, I would like to share his message to FDA employees about his departure:


From: A Message from the Principal Deputy Commissioner
Sent: Wednesday, January 05, 2011 1:30 PM
To: FDA-Wide
Subject: Thank You

Dear Friends and Colleagues,

Just over two years ago, I was led through the Parklawn Building to a small, windowless room known as 15B08. Over the next few weeks, our small group on the Obama transition team met there for many hours with dozens of FDA staff, and then elsewhere with industry representatives and patient and consumer advocates.

Amidst hundreds of individual notes, we heard one melody: broad support for a strong FDA that protects and promotes public health.

Two years later, this melody can be heard at White Oak and in the agency’s offices around the country and across the globe. FDA now has the public health responsibility of tobacco regulation, a new law that will transform the food safety system, a renewed commitment to innovation in regulatory science and the regulatory process, and a growing reputation for transparency, accountability, and action.

In these two years, I have come to understand that FDA can succeed beyond everyone’s expectations by developing and explaining the public health logic underlying key regulatory steps.

I have found that by communicating like a public health agency – directly, clearly, and with credible partners – FDA can generate support and make further progress.

And I have seen that good judgment is as important as good data. It is good judgment that can answer the essential question of when the agency has enough data for action.

Through FDA-TRACK, the transparency initiative, numerous crises du jour, trips to regional and district offices, and other settings, I have had the pleasure of working with many remarkable FDA staff. I appreciate all of your patience and understanding during my first few months, and all of your dedication and accomplishments over the last two years. I know that even more progress and innovation is in store to benefit patients and consumers across the country.

It has been an honor to serve in the Administration of President Obama and Secretary of Health and Human Services Kathleen Sebelius.

And it has been a special pleasure to work for and learn from Dr. Margaret A. Hamburg, a leader with extraordinary judgment, kindness, and vision.

My tour at FDA is, however, coming to an end this Friday. Recently, Governor Martin O’Malley offered me the opportunity to serve as Secretary of Maryland’s Department of Health and Mental Hygiene, and I accepted. I will start next week in time for the state’s legislative session. My new role will span a wide range of exciting and important areas, including public health, mental health, substance abuse, developmental disabilities, Medicaid, and healthcare reform.

I would say good-bye — except that I will not be far away.

Dr. Hamburg has even invited me to run in the upcoming White Oak Classic, the annual 5K run around the campus. This has been an annual event that celebrates health and fun, and involves, for me, no small amount of personal humiliation.

I am in training for the race . . . and I hope to see you there.

Thank you, and take care,


Joshua M. Sharfstein, M.D.
Principal Deputy Commissioner
U.S. Food and Drug Administration


GxP Perspectives wishes Dr. Sharfstein all the best at his new job.

FDA Report on Faulty Device Approval

September 25, 2009

Medical device safety and the FDA are in the news again. One of the first posts I wrote for the Blog was “FDA Hit With Yet Another Negative Report.” And there it was, top of the fold on the front page of the New York Times, and many other papers across the country, “F.D.A. Admits Role of Politics In Safety Case.” The article was on FDA leadership ordering the approval of Menaflex, a medical device, over the objections of FDA scientists. But this time is different. This time the report didn’t come from an outside investigation. This time it came from FDA.

faulty medicl device FDA

FDA Discusses Device Approval Process

The Times wrote, “The agency has never before publicly questioned the process behind one of its approvals, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.”

That certainly is my experience. I first joined FDA in November 1987 as a temporary under assistant support staff making Xerox copies of inspection reports to be redacted for release under the Freedom of Information Act. I was hired in January 1988 and worked for the next 17 years (and three days) and not once saw FDA publicly admit they made a mistake (I left in January 2005). Not once. Trust me. during that period FDA made many mistakes (some of them by me).

Now it seems that new commissioner, Dr. Margaret Hamburg and the new principal deputy commissioner Dr. Joshua Sharfstein, have a different approach. I personally saw Dr. Hamburg speak at the annual meeting of RAPS (Regulatory Affairs Professionals Society) and discuss FDA’s shortcomings (see previous posts). And as a result of the FDA report on the approval of Menaflex, Dr. Sharstein said the following:

“The message here is that there were problems with the integrity of F.D.A.’s decision-making process that have solutions.”

I have never heard an FDA leader say anything remotely like that before. And Dr. Sharfstein is not just concerned with FDA’s problems; he actually wants to fix things. My personal opinion is that things are changing at FDA. Dr. Hamburg and Dr. Sharfstein certainly have my attention. And they have my support. FDA needs significant, meaningful change to fulfill its public health mission. It looks like the agency has two determined leaders to begin that process.

When I first joined FDA the agency would always state that we were a science-based agency. It will be better for patients, industry, and the public at large if once again we can make that an accurate statement.

UPDATE: Here is a comment from the Blog’s very own book reviewer, Sid Olufs:

Yes, fascinating report, deserves to be read closely. OK Times stories yesterday and today, but here is the line I found worth copying from the report: “Our ability to assess the effect of these departures on the decision-making process was in many cases undermined by the failure of important decision-makers to sufficiently explain and document the bases for their decisions in an administrative record. This failure constitutes a clear deviation from the principles of integrity used in this review and undermines the ability of the agency to counter the suggestion that lobbying on behalf of ReGen affected the decision.” I think you are right, Carl. Yet I find it troubling that integrity depends entirely on who does the appointing of top officials. No set of rules guarantees integrity, but the political lines of authority here make it too uncertain. More independence, tighter mission, seem in order.


Dr. Hamburg and Dr. Sharfstein confront FDA’s “Invisible Line”

August 17, 2009

New FDA Commissioner Dr. Margaret Hamburg and her top deputy Dr. Joshua Sharfstein have made an impressive start and have announced a new era of “effective enforcement” for the Agency. They have done some house cleaning at the top and headquarters bureaucrats are beginning to get the message. Many FDA enforcement actions originate from headquarters and effective actions can be taken. But the bulk of FDA enforcement actions come from the hard working FDA field investigators (CSOs- consumer safety officers), compliance staff, and laboratory scientists distributed throughout the country in FDA’s field organization, ORA- the Organization for Regulatory Affairs. The CSOs are the inspectional force who carry out the Agency’s mission to ensure safe food, drugs, medical devices, and blood products for the American people. They’re the ones conducting the inspections on a day-to-day basis. (full disclosure: I worked for ORA for 17 years) They are hampered by an obsolete inspectional system and poorly trained supervisors and middle managers. And there is an invisible line that separates them from Drs. Hamburg and Sharfstein.

ORA, The FDA field organization, is divided geographically into twenty District Offices each headed by a District Director. In addition there are 13 laboratories and over 150 “Resident Posts.” My last job at FDA was as a CSO at the Tacoma, WA Resident Post, a part of the Seattle District. In reality, few CSOs or other field personnel communicate with anyone higher that a District Director. They have few interactions with FDA headquarters personnel unless it is very directly related to their specific job function. The District Directors form the Invisible Line between the field force and the rest of FDA. They filter all communication between the two sections. And their word is law.

To make matters worse, CSOs have little communication with their counterparts in other districts. This means that if there is a New Drug Application (NDA) filed and headquarters issues Bioresearch Monitoring (BIMO) assignments for clinical trial inspections to the Denver, Dallas, Chicago, Atlanta, and Florida Districts there is almost no communication between the CSOs conducting the inspections. If a CSO issues a Form FDA 483, Inspectional Observations, in Chicago, it is highly unlikely that the information will be shared with colleagues in the other districts. There is no project management, no conference calls, no training on the therapeutic area, the protocol, issues of concern to the review division, There is nothing of the sort for BIMO.

A large part of the problem is a question of turf. ORA is supposed to conduct inspections, all inspections, whether they know how to do them or not. There are no requirements that a BIMO CSO knows how to read medical records. Many do and are excellent inspectors. Many don’t and the quality suffers. Time after time I am questioned about an FDA 483 and why it was issued. Many times I just don’t have an explanation. Of course, I don’t have the report and exhibits in front of me. But there is a lot of poor judgement being shown. Many FDA inspectors do not have the appropriate qualifications, receive adequate training, and understand the significance of their observations.

It starts with the management of the BIMO program at the district office. There is no requirement that a BIMO supervisor have any BIMO experience. It does not matter if they have ever conducted a BIMO inspection. One supervisor once told me that it wasn’t necessary that a CSO know how to read medical records. They were conducting the inspection for compliance with FDA regulations and the regulations were all that mattered. I asked how the CSO was supposed to locate adverse events that weren’t reported if they couldn’t read the medical records. All I received was a shrug of the shoulders.

Another supervisor, who was responsible for IRB inspections in five states, once asked me, “What’s the Belmont Report.” This is the basic bioethics document produced by the United States Government. You might know what it is (you can google it) but the person responsible for making IRB inspection assignments, reviewing reports, recommending promotions, assigning training, THAT person should know. If there is a poorly written FDA 483, it is the fault of the supervisor and other FDA managers for allowing it to continue. However FDA supervisors don’t do inspections. They sit behind a desk and figure out work plans. They are not in touch with what is happening in the field. They receive no technical training on the increasingly complex world of drug and device development. NONE. And that is one of the primary reasons that industry complains about inconsistent FDA inspections and inconsistent Form FDA 483 observations. It is a very big problem.

The majority of FDA field employees are very dedicated and outstanding. The country is very lucky to have them on the job. The majority of FDA field managers are not. Standing at the head of the field managers are the District Directors, the Invisible Line separating the FDA field from the excellent new leadership of FDA at headquarters. If Dr Hamburg and Dr. Sharfstein want effective enforcement of FDA regulations, then they are going to have to take a Hard Look at the Office of Regulatory Affairs.

Hamburg and Sharfstein make their opening statement on the role of FDA

June 2, 2009

Dr. Margaret Hamburg and Dr. Joshua Sharstein, the new leadership of FDA, have made their opening statement in an article published 26 May 09 in the New England Journal of Medicine entitled, ” The FDA as a Public Health Service.” There they discuss their vision for the future of FDA. The first thing I noticed is that they published their article in a medical journal that will not reach most American consumers. That is really too bad. They should have used a different venue such as the NY Times. Oh well. If I wasn’t in the FDA Alumni Association I would have never known. You can read it under Interesting Articles on the right under Hamburg & Sharfstein in the NEJM. Scroll down to find it. At least they are talking, which is a start.

UPDATE: If you wish to hear Dr. Hamburg for yourself, she will be speaking at the closing plenary session of the Regulatory Affairs Professionals Society (RAPS) annual meeting in Philadelphia on the 16th of September. You can read about it on the Blogroll on the right under “RAPS.”

UPDATE 2: I have added two new sites to the Blogroll. One is a health oriented site that discusses today’s 3 June 09 NY Times editorial on FDA secrecy (365 Days Health Blog) and A world news service from France in English (France 24).

Live from SQA Annual Meeting

April 21, 2009

Day one of the annual meeting of the Society for Quality Assurance (SQA) proved interesting. Attendees knowledgeable about the current situation at FDA say that Acting Commissioner Joshua Sharfstein requested a short email from all FDA employees on current problems inside the Agency. I’m sure he received an earful as many current and former FDAers are dissatisfied with the Agency’s level of protection for safe food, drugs, and medical devices.

An interesting session on international issues highlighted the FDA Final Rule, 21 CFR.120, on foreign trials not conducted under FDA’s regulations. This is an issue well discussed elsewhere on this blog. There was also discussion on the requirements of the British regulatory agency, MHRA. They are sometimes much stricter than FDA and MHRA conducts inspections in the United States of U.S. companies conducting clinical trials in the U.K. There have been clinical trials suspended by MHRA if they do not meet their strict standards.

Finally, this is the 25th anniversary of the founding of SQA. The organization was founded in response to the Good Laboratory Practice regulations, 21 CFR Part 58. It started out as the “Quality Assurance Roundtable” in 1980 and for the first few years it was hotly debated whether to start a professional organization at first. SQA was then founded in 1984. Now it is a worldwide organization with chapters in the U.K., Canada, Korea, and even Nigeria! A lot of work in 25 years. I’ll provide another update before the conference ends on Thursday.

See the SQA link to the right under Blogroll. Also the Declaration of Helsinki under Important References and a Post. And finally, Enforcement of the GLPs.