FDA Commissioner Margaret A. Hamburg’s Statement on the Passing of Dr. Charles Edwards 

September 1, 2011


FDA Commissioner Margaret A. Hamburg’s Statement on the Passing of Dr. Charles Edwards

FDA repeat violations warning letter

Former FDA Commissioner
Dr. Charles Edwards

The death of Dr. Charles Edwards is a great loss to the Food and Drug Administration and to Americans who enjoy the safest supplies of food and medicine in the world, thanks to his leadership. During his tenure as FDA commissioner, Dr. Edwards was one of the country’s most ardent drug safety advocates, ordering the extensive review of over-the-counter drugs for safety, effectiveness, and accuracy in labeling. In addition, he ordered that one of the first mandatory package inserts be included with oral contraceptives to warn patients about the possible risks.

Dr. Edwards led FDA from December 1969 to March 1973, taking the reins in a time of great change at the agency. Under his leadership, FDA’s budget doubled from 1970 to 1972 as the commissioner steered the agency towards a greater regulatory role. During these years FDA began regulating biologics and radiological health.

From FDA, Dr. Edwards continued serving his country as assistant secretary for health in the Department of Health, Education and Welfare. There he proposed major reforms in health care and gave greater standing to the Centers for Disease Control and Prevention.

In 1990, long after Dr. Edwards had left government service, Health and Human Services Secretary Louis Sullivan named him head of the Advisory Committee on the FDA to review the agency’s mission, structure, priorities, staffing, and budget.

In a warning that seems a foreshadowing of current concerns about FDA resources, the Edwards committee warned: “An agency charged with such a broad array of vital health protection responsibilities, yet one that lacks the tools to carry out those responsibilities, is in serious danger. And hence, so is the American public.”

While he was still commissioner, Dr. Edwards wrote in a journal article, “I firmly believe that the FDA today represents the soundest and most effective approach to carrying out the vital public functions with which it is charged. I also believe that we are constantly challenged to do a better job, and I can assure you that we intend to meet that challenge.”

His words echo today.

Serving during the turbulent Watergate years, Dr. Edwards was confronted with myriad crises and a skeptical public, but he met each with an integrity and dedication that did honor to his office, the agency, and his country. It is this dedication that I strive to emulate each day as I follow in his footsteps as commissioner. He will be greatly missed.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

I was just a wet behind the ears scientist when Dr. Edwards made the transition from FDA to being the ASH. I remember years later, he was the first ASH to whom I made a presentation (and wouldn’t you know it, I can’t remember the topic – probably laser safety). FDAAA alumni member Phil White worked for him as his special assistant in the OC in the early 70’s. Phil’s take is straightforward: “My favorite Commissioner.”

Read the New York Times Obituary


Major Reorganization at FDA

July 14, 2011

Dr. Margaret Hamburg

Dr. Margaret Hamburg, FDA Commissioner

Every organization needs to take stock of personnel and responsibilities, including FDA. The world of FDA regulaton is changing rapidly and in an effort to keep current Commissioner Margaret Hamburg has announced a major reorganization in an FDA-wide announcement reprinted below. She announced a new position, stating “I am establishing a new Deputy Commissioner for Medical Products and Tobacco.” The position will be filled by Dr. Steven Spielburg (no not That one) the former Dean of Dartmouth Medical School to fill the position. There are a number of other changes at the top. Here’s what the announcement said:

From: A Message from the Commissioner
Sent: Wednesday, July 13, 2011 3:41 PM
To: FDA-Wide
Subject: A Message from the Commissioner

Dear Colleagues,

I am writing today to let you know about some changes that I will be making to the agency’s management structure. As you probably recall, back in January, I told you that I was initiating a review of the Office of the Commissioner. As I explained at that time, this review was driven by the expanding and rapidly changing nature of the Agency’s responsibilities, and the need for a management structure that reflects these changes and best supports your efforts.

I consulted with former Commissioners, as well as with HHS Secretary Sebelius, and considered many options before arriving at the structure that I am announcing today.

The most important thing driving my consideration of this is the changing nature of both the Agency and the job of Commissioner. Today, the Agency faces several key challenges:

First, we are a very large agency, with an incredibly broad span of responsibility. We regulate products that account for between 20 and 25 percent of every consumer dollar spent in the U.S. and that total more than a trillion dollars annually. For the most part, these are products that people rely on in fundamental ways every day.

Second, as technology and science continue to evolve, we are faced with the challenge of making sure that new ideas translate into the products and opportunities that people need and count on to protect their health. Innovative products that are truly transformative create unique scientific and regulatory challenges, and FDA must be a consistently powerful catalyst for innovation.

FDA Change

The Challenges of Globalization

Third, we have seen the dramatic transformation of globalization – more products, more countries, more access by consumers and companies to global supplies – and this presents an enormous challenge to FDA in ensuring the safety and quality of the products we regulate.
Finally, we continue to be faced with administrative challenges. In these difficult economic times, our agency’s budget requires constant attention. And, simply providing the support and services for our 12,000 plus employees – everything from phones to IT to office space on our beautiful, growing White Oak campus – is a daunting job.

I take very seriously my responsibility to lead FDA along a path that will meet these challenges. One crucial part of this responsibility is to create a structure in the Commissioner’s Office that best supports your efforts and reflects the changing nature of the Agency.

FDA reorganization

'The structure of the Office of the Commissioner that I inherited was created in 1970'

The structure of the Office of the Commissioner that I inherited was created in 1970, when the FDA consisted of three Centers and a field office. By 2011, we had grown to seven Centers, and a Commissioner’s Office with more than 1,600 staff. Over the years, as Congress created new programs that cut across Center responsibilities, those programs were placed by default in the Office of the Commissioner.

The new organizational alignments more accurately reflect the agency’s responsibilities, subject matter expertise and mandates in an ever more complex world, where products and services do not fit into a single category. Let me begin by saying that, for most of the FDA, this organizational alignment will likely not have a significant impact on you or your day-to-day work.

The most obvious change you will see is that the Agency’s programs, in terms of a reporting chain to me, will be divided into “directorates” that reflect the core functions and responsibilities of the Agency. This new management structure will enable the Office of the Commissioner to better support the agency’s core scientific and regulatory functions, and help tie together programs that share regulatory and scientific foundations. I will rely on the leadership of these directorates to help provide the necessary direction and coordination needed by an Agency of this scope.

FDA changes

Dr. Steven Spielberg

I am establishing a new Deputy Commissioner for Medical Products and Tobacco, who will provide high-level coordination and leadership across the Centers for drug, biologics, medical devices, and tobacco products. The Centers will, of course, remain as discrete management entities under their current expert leadership. In addition to this strategic role with the Centers, this position will oversee our Special Medical programs.

I am pleased to announce that Dr. Steven Spielberg, former Dean of Dartmouth Medical School and currently Director of the Center for Personalized Medicine and Therapeutic Innovation at Children’s Mercy Hospital in Kansas City, has accepted this position. In this role, Dr. Spielberg will serve as both advocate and a support for Center Directors in their important work for FDA.

I will also be creating a directorate focused on grappling with the truly global nature of today’s world — food and drug production and supply, as well as the science that undergirds the products we regulate — so that the FDA can move from being a regulator of domestic products to one overseeing a worldwide enterprise.

fda reorganization

Global Regulatory Operations & Policy

To oversee this transformation, I have asked Deborah Autor, now Director of CDER’s Office of Compliance, to take on the role of Deputy Commissioner for Global Regulatory Operations and Policy. In this position, Deb will provide broad direction and support to the Office of Regulatory Affairs and to the Office of International Programs, with a mandate from me to make response to the challenges of globalization and import safety a top priority in the years to come. Dr. Murray Lumpkin, who has served with dedication and accomplishment as Deputy Commissioner for International Programs and Director of the Office of International Programs, will take on a new role as Senior Advisor and Representative for Global Issues. In this role, he will be charged primarily with special projects that draw on his expertise working with counterpart regulatory agencies on issues of global regulatory harmonization, governance and capacity-building.

The third directorate is the previously established Office of Foods, which we created to make our oversight of FDA’s food and feed program a more seamless enterprise. That task is even more important today as Mike Taylor leads the implementation of the Food Safety Modernization Act.

fda reorganization

Office of Operations

The fourth directorate will be a new Office of Operations, headed by a Chief Operating Officer. The COO will oversee the agency’s administrative functions, such as human resources, facilities, information technology, finance, and other activities that provide support to your organizations. Within this Office, I am bringing the budget formulation and budget execution functions together under a CFO position. We have initiated a search to fill the Chief Operating Officer position.

The Office of the Chief Scientist, charged with our important efforts to improve FDA’s science and address issues of cross-cutting scientific concern, will continue to do so. The National Center for Toxicological Research will report to the Chief Scientist, Dr. Jesse Goodman, and, like the other Centers, will remain a discrete management entity within this new directorate model.

fda reorganization

John Taylor

Within the new, smaller, immediate office of the Commissioner, John Taylor will remain as Counselor and will have the additional responsibility to oversee the policy and planning functions, the Office of Legislation, and the Office of External Affairs. I want to thank John for serving as acting Principal Deputy these past months, in addition to his duties as Counselor. He has tirelessly supported me and the Agency with enthusiasm, energy, expertise, and good humor.

You can find revised organizational charts, reflecting this realignment at http://inside.fda.gov:9003/AboutFDA/FDAStaffInformation/OrgCharts/default.htm. (This org chart could not be accessed at time of publication. You can also try here for Office of the Commissioner) In addition, I will share a video message of this announcement shortly. Your managers will be available to answer any questions you might have in the coming days.

In closing, I want to take a moment to thank you so much for all that you do. FDA is an extraordinary place, with so many highly-dedicated professionals and support staff who are committed to promoting and protecting public health. You accomplish a tremendous amount every day and I am grateful for all of your work. These organizational changes are intended to help further your important work and the mission of this remarkable Agency.

Sincerely,
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs

(Information from FDA Alumni Association)

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On The Blogroll: I have updated the URL for RAPS, the Regulatory Affairs Professionals Society. It was at the 2009 RAPS Annual Meeting that I first heard Dr. Hamburg speak. RAPS has several conferences in the upcoming months.

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FDA Commissioner Stresses Regulatory Science at DIA

June 14, 2010

FDA commissioner DIA

Dr. Margaret Hamburg, Commissioner, U.S. Food & Drug Administration

Dr. Margaret Hamburg, Commissioner of the U.S. Food and Drug Administration, addressed the 46th Annual Meeting of the Drug Information Association (DIA) stressing the importance of regulatory science for the future of FDA and the biopharmaceutical industry. The DIA meeting, held in Washington, DC, is on the theme of “Facilitating Innovation for Better Outcomes.” Eight thousand participants are attending the meeting from 80 countries with representatives from 20 different regulatory agencies. Dr. Hamburg’s remarks stressed two specific points: regulatory science and the globalization of the commodities that are used in our food, drugs, medical devices and other FDA regulated products.

Dr. Hamburg spoke to a packed auditorium that had first been serenaded by the Adagio from Dvorak’s New World Symphony played by the Bel Canto Strings. She recounted that FDA had been formed as a result of the efforts of President Teddy Roosevelt who was president when the Pure Food and Drug Act was passed in 1906 and FDR who signed the Food, Drug, and Cosmetic Act into law in 1938. She gave ultimate credit to Abraham Lincoln who authorized the Bureau of Chemistry in the Department of Agriculture that eventually became FDA, noting that Lincoln was on the cover of the DIA program.

DIA Regulatory Science

Dr. Hamburg's First Year at FDA


She noted that she had now been FDA Commissioner for one year and that “the learning curve has been steep.” She said that it was a particularly challenging time with the different and complex requirements that come with the recognition that we live in a globalized world. Dr. Hamburg joked about her Aunt Minnie who asked why she didn’t become a “real doctor” when she took over the New York City Public Health Department. She said that her public health training has helped prepare her for the job of FDA Commissioner and to be a “real doctor to 300 million people.”

Dr. Hamburg stressed that a gap had been formed between bioscience and regulatory science, that the tremendous advances in research could not translate into products for the public health without the resources and skills for the regulatory scientists at FDA. She gave four specific examples where promising research required advances in regulatory science to bring products to market. She spoke about stem cell research for Parkinson’s disease that needed valid processes for development of the stem cells. She listed an Artificial Pancreas for diabetes that would allow a testing path that wouldn’t lead to severe hypoglycemic events. She also cited research from the National Institutes for Health that had lead to progress in tumor markers and in advances in drug-resistant tuberculosis.

FDA DIA Hamburg

The Percentage of Imported Food and Drugs Continues to Rise

Dr. Hamburg emphasized that regulatory science was “much bigger than FDA” and encouraged participation by industry and academia. She then turned to the challenges from a globalized market place noting that there are 20 million shipments of FDA regulated products imported into the United States each year. This includes 40% of produce, 70% of seafood, and 80% of active pharmaceuticals ingredients (APIs) and drug products. She said that FDA would increase the number of international inspections and personnel stationed overseas. However, she said that FDA alone couldn’t guarantee safe food and drugs and that there was a need to harmonize standards and approaches saying that the “new paradigm goes far beyond our borders.”

FDA DIA Regulatory Science

A Missed Opportunity?

Hamburg’s speech did not have any specifics regarding current issues in drug regulation including the recall situation at McNeil for children’s tylenol. It is unfortunate that she did not take the opportunity to directly address the biopharmaceutical industry with FDA’s current viewpoints or concerns regarding drug safety. It was a speech that did not mention the terms “good manufacturing practice” or “clinical trials.” In fact, it was remarkably similar to her speech to RAPS last summer in Philadelphia. That’s too bad. A very good speech but an opportunity missed.

However, DIA had a number of good sessions the first day. They included an excellent session on “Virtual Realities: Quality Considerations When Using Outsourcing Providers” chaired by Bruce Wagman and the equally excellent session on training chaired by Steven Steinbrueck. I’ll discuss these and the other sessions I found the most interesting in a few days.

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FDA’s Dr. Hamburg Speaks to RAPS in Philadelphia

September 16, 2009

Dr. Margaret Hamburg, the new FDA Commissioner spoke to about 1,000 people attending the annual

FDA Dr. Hamburg RAPS

Dr. Margaret Hamburg

meeting of the Regulatory Affairs Professional Society (RAPS) in Philadelphia. Her prepared remarks noted that when she took the job four months ago FDA was an organization in crisis. She noted that in a recently published poll FDA received the second worst approval ratings of any federal agency, worse than the IRS. She also congratulated RAPS for its continued excellence and the importance of industry professionals in maintaining public health through “Quality by Design.” She used the Orphan Drug Act as an example of how FDA could adapt to public health needs in the drug approval process. She repeatedly praised FDA staff as committed public health professionals.

Dr. Hamburg continued to discuss her theme of “effective enforcement” that she outlined in a previous speech to the Food and Drug Law Institute. She repeated themes including clear enforcement standards, publicizing enforcement actions, and explaining the reasons for those actions. She also took questions in a lively Q & A session that lasted nearly a half an hour.

Responding to one question she stressed the importance of food safety and addressed legislation moving forward in Congress that would give FDA new powers including mandatory recalls and tracebacks during a food safety crisis. FDA currently cannot require a company to recall an adulterated product. She also said that there would be a Deputy Commissioner for Food that would be part of the Office of the Commissioner in addition to the Director of the Center for Food Safety and Applied Nutrition noting that food crossed multiple jurisdictions in FDA (veterinary food) as well as government agencies (15-16).

She was asked about the foreign inspection program which the questioner said had “less rigor” than domestic inspections. Hamburg candidly replied that “we have a system that is inadequate,” and that FDA doesn’t have the strategic framework for their international program. Hamburg stated that there was an ongoing “intensive internal discussion” on international issues. She spoke of the need to collaborate with other regulatory agencies around the world, to “share on the ground information,” and work with other developed countries to develop the regulatory capacity of developing nations. “We cannot and should not go it alone,” Hamburg emphasized.

She also said that FDA had a “very large agenda with respect to clinical trials.” Unfortunately she didn’t elaborate very much on this point as it was the last question she took before leaving the conference. She received very strong applause as she concluded, indicating that many in regulated industry think that she is a breath of fresh air, as well as very smart. I’m in agreement.


FDA Sends J&J a Warning Letter for Clinical Trial Failures

August 19, 2009

Johnson and Johnson received a Warning Letter from FDA for their failure to properly supervise clinical trials. The letter, issued by the Center for Drug Evaluation and Research’s Division of Scientific Investigations (DSI) on 10 August 2009, was addressed to the J&J Pharmaceutical Research & Development group in Raritan, NJ and cited failures for sponsor responsibilities.FDA Warning Letter

It is pretty rare for a pharmaceutical company to get a Warning Letter for clinical trial sponsor activities (called “Sponsor-Monitor” inspections). Approximately 10 were issued in fiscal year 2008 and most of those were to small medical device firms or to sponsor-investigators, physicians who both sponsor and conduct a clinical trial. The last major Warning Letter to a large pharmaceutical company was to Sanofi Aventis in October 2007 for research misconduct in the Aventis clinical trials for the drug Ketek. So DSI sending a Warning Letter to an industry giant like J&J is a pretty big deal. It certainly is in keeping with Commissioner Margaret Hamburg’s new emphasis on enforcement (see previous posts).

The Warning Letter cites J&J for “Failure to ensure proper monitoring of the clinical investigations.” This is the most common citation for a Sponsor-Monitor Warning Letter and has been for many years. DSI charges that J&J’s monitors failed to identify that drug infusions were given at the same identical time to multiple subjects. The drug is administered by an IV infusion and the source documents were contradictory and should have alerted the monitors of possible fraud. The Warning Letter cites detailed violations for study drug administration, shipments, and the necessary refrigerated storage.

The lengthy Warning Letter also cites J&J for “Failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols” and “Failure to secure investigator compliance.” These are also common violations for a Sponsor-Monitor Warning Letter. You can read the letter for yourself on the Blogroll: 1 FDA Warning Letter to J&J.

It will be interesting to see if the new enforcement climate will deal new Warning Letters to pharmaceutical and medical device sponsors or if this was an aberration. The one thing that it has in common with the Sanofi Aventis Warning Letter is that there is a suggestion of fraud. There are many things other than fraud that can go wrong in a clinical trial. Is this FDA’s standard?

I am attaching an article that I wrote for RAPS Regulatory Focus magazine in July 2008. It deals with the topic of quality systems in monitoring clinical trials.

July 08_Anderson_RAPS Focus_Monitoring

Update: FDA also sends a Warning Letter to the CRO involved, ICON Clinical Research. Read the Post:

https://carl1anderson.wordpress.com/2009/12/08/fda-hits-icon-with-warning-letter-for-j-j-studies/

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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.


A Question of Significance: Dr Hamburg & FDA Enforcement

August 9, 2009

Since January of 2001 FDA has been lax in protecting the public and enforcing their regulations. I will let you put 2 and 2 together to figure out why. However, FDA enforcement needs to be relevant and meaningful. It needs to be for the right reasons, not just because someone wants to come across as tough.

Saturday I had a disturbing phone call from a client and friend who had just received a Form FDA 483, Inspectional Observations, at the conclusion of an FDA inspection. In reviewing the 483 with my client it was obvious that the FDA inspector had overstepped his bounds and that the 483 should not have been issued. However it is now part of the public record and available through the Freedom of Information Act. Without knowing the background, one of the observations could seem very serious and could result in FDA issuing a Warning Letter. The Warning Letter would then be posted on the internet for the entire world to see.

I am one of those that feel that FDA enforcement was lax during the past eight years. Part of the reason I left FDA after 17 years was a concern that the Agency just wasn’t doing its job. However, I also spent the summer of 2004 working at FDA headquarters reviewing inspection reports (EIRs) and found many of them to be lacking. Many field investigators were not technical experts in the area they were inspecting and cited violations that were not “clear and significant” violations of the regulations. Since leaving FDA I have seen a number of FDA 483s written that just didn’t rise to the level of significance necessary for a 483 to be issued or enforcement action taken. Many times this is because the front line supervisors do not have the technical and legal skills to properly review the 483s.

In the previous post (see below) I discuss the new enforcement climate at FDA. Although I am happy that Dr. Hamburg is taking her job seriously I have some concerns. We all want safe drugs, medical devices and food. We all want clinical trials to adequate and well-controlled. But we need clear enforcement standards and a well trained inspectional force for that to happen. And I fear that small companies and clinical trial sites will bear the brunt of a tough new enforcement climate. The larger firms have the legal resources to prevent Warning Letters and other enforcement actions. A small firm bringing their first product to market or a clinical investigator who has never been inspected by FDA may find themselves in a lot of trouble. This could be an unintended consequence of the new “effective enforcement” that Dr. Hamburg mentions in her recent speech to FDLI (see below).

The country needs a well-financed FDA to protect consumers from fraudulent and unsafe products. But we also need modernized regulations and a well-trained workforce to accomplish this. Dr. Hamburg needs to first look inside FDA before a wholesale enforcement campaign. She needs to take on the really significant problems, including internal problems, first. I would suggest quality control of FDA 483s as a good place to start. And that means properly training supervisors and middle management in the Office of Regulatory Affairs (the FDA field organization that conducts inspections).

UPDATE: An interesting comment is listed under: Enforcement


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