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FDA’s Indifferent Attitude Towards the First Amendment

Monday, April 1st, 2013

The FDA doesn’t care about the First Amendment rights of the companies it regulates. It cares even less about the “free speech” rights of those companies’ sales and marketing representatives.

And why should the agency care? One of FDA’s primary missions is to protect the public health and safety of the American people from illegal, adulterated and misbranded products. Doing so involves restraining food, drug, device and cosmetics companies from committing fraudulent and deceptive acts that are not protected by companies’ commercial free speech rights.  

Nonetheless, FDA Matters envisions opportunities for FDA and industry to broaden permissible product communications. The key is understanding history, not constitutional law.


I recently participated in a forum at American University Washington College of Law on “Evolving First Amendment Protection of Commercial Speech” and offered up my mantra that constitutional analysis is largely irrelevant from FDA’s perspective. I said “largely” because FDA is still part of the federal government and can’t act arbitrarily. On the other hand, the agency mostly operates within the zone in which government is given the most leeway: where public health and safety is at stake and the threat is from commercial (as opposed to individual) speech.

History, not constitutional law, provides the best explanation. The sale of bad food and drugs—often accompanied by slick, deceptive pitches—goes back millennia and was even addressed as a problem in most ancient legal codes.

FDA’s own birth comes from a time when state regulation and inspection of food and drugs was minimal, inconsistent and often corrupt. It is hard for any of us to imagine what an unregulated market in food and drugs is like.  Yet, it is not so long ago.

The 1938 Amendments to the Food, Drug and Cosmetics Act gained popular support in part because of a traveling exhibit that portrayed the death and disability that resulted from patent medicines, counterfeit products, false medical and scientific claims, and adulterated and misbranded products. Lax to non-existent cosmetics standards were particularly singled out for their role in causing burns and blindness, as well as some deaths.

It is nice to imagine that this world is behind us, just an interesting piece of history. But it isn’t.

No industry regulated by FDA is immune from shoddy products, false claims, unscrupulous behavior and greed-induced threats to public health and safety.  I am sure that none of my readers count themselves among these “bad guys,” but they exist in the U.S., as well as globally.

Further, even the great and innovative companies—household names that we view with great trust—have often proven to be quite fallible. A certain amount of informal off-label promotion of drugs and devices is rightfully ignored–when good studies have been published, when the off-label indication is very close to an approved use, when assertions are made with great care about the extent of proven scientific knowledge.

In contrast, most of the off-label promotions that have resulted in billion dollar settlements with big-name drug companies have not been based on such close questions. Nor have they been the result of an individual salesperson crossing the line in some excess of enthusiasm.

Rather, the off-label promotions have been the product of marketing departments and sales managers who encouraged, empowered, or authorized the off-label promotion. There never seems to be a good answer as to who was supervising marketing and sales, which is why so many drug companies are now operating under government-negotiated corporate integrity agreements.

From FDA’s perspective, there are legitimate, well-documented reasons to scrutinize all companies: none are immune from the impulse to over-hype products to expand markets and sales beyond what FDA has approved. This is not a matter of FDA being over-fussy. It is the inevitable conclusion from about 4000 years of human commerce in food and drugs.

In the face of this, the First Amendment really has very little place. Commercial free speech does not extend to misleading statements, blatant fraud, or deception. FDA sees too much of this to ignore. 

FDA Matters believes the agency still has an obligation—but not a constitutional one–to clarify its standards, provide published guidance, and demonstrate acceptance that the Internet has fundamentally changed the nature of product promotion. The lack of FDA guidance on social media (first raised at an agency hearing 15 years ago) is particularly outrageous and the agency’s tendency to create de facto policy with enforcement letters is an abdication of responsibility.

The drug and device industry can also improve the situation. They need to stop looking at the current controversies in product promotion as noble causes involving sacred constitutional rights. If these industries have a claim to better treatment and clearer policies, it needs to be grounded in the contributions they make to improve public health and evidence of serious efforts to rid their companies of unscrupulous promotional practices.


I have written previously on some of the issues in drug and device promotion, as well as about opportunities for FDA and industry to reach accommodation:


Off-Label Promotion: Best Resolved by Congress, Not Courts     December 2012

On December 3, a federal appeals court ruled against one of the FDA’s untouchable restrictions on industry—thou shalt not promote the off-label use of pharmaceutical products. An industry that is little interested in constitutional law suddenly finds itself talking about the First Amendment. At stake: permitting off-label promotion undercuts the incentive for companies to thoroughly investigate the safety and efficacy of a drug for a second or third use.


Off-Label Uses Need to Become On-Label Indications  December 19, 2009

A friend asked: what advice would you give a pharmaceutical company in the late stages of developing a new product that will be widely used off-label? The company’s concern was that FDA might hold the first use to a very high, perhaps unrealistic standard to protect patients that might receive the drug off-label after approval.


Internet Communications: FDA Needs to Divide the Issues to Conquer the Problem  Dec. 2nd, 2009.

Creating an Internet communications policy for regulated medical product companies is so daunting that FDA has largely ignored the responsibility. November’s FDA hearing on social media was an important step, but offered no sign that new policy will be announced anytime soon. FDA needs a different approach. This is not a matter of a large, complicated problem with many facets. Rather, it is a number of smaller problems that can be addressed separately. 


Off-Label Promotion and Whistleblowing    September 9th, 2009

Whistleblowing and off-label promotion of drugs and devices have become hot topics because of the September 2 Pfizer settlement with the federal government. While none of my views are specific to Pfizer, the company’s settlement provides an opportunity to comment on off-label promotion….and to encourage bio-pharma and medical device companies to engage in deeper soul-searching. 

A Salmon on Every Plate/The Hard Road of Innovation

Thursday, March 14th, 2013


Chicken was once an expensive delicacy. In 1928, America’s quest for a better diet and a better standard of living was summarized by the campaign promise of “a chicken in every pot.” Today, chicken is a ubiquitous, low-cost source of protein, which we largely take for granted. Despite depletion of ocean-based stocks, fish hold similar potential.

To begin this transformation, FDA must approve a scientifically-based innovative product—a faster growing genetically-engineered (GE) Atlantic salmon. When FDA Matters wrote about this subject 18 months ago, I believed the agency was near to approval of this first-ever food product from a GE animal. It is still not resolved and there are implications for all innovations that require FDA approval.

Final comments on the “environmental assessment” of GE salmon are due to FDA in April. Hopefully, this is the final procedural step before a decision. Approval could come mid-year or may take months or may not happen at all. The agency is still dealing with the political fall-out of questionable safety claims from environmental groups…and politicians and companies trying to protect the market for Pacific salmon.

The health benefits of fish are well-known. They are also a valuable source of dietary protein. However, our oceans are over-fished and aquaculture is now the source of almost 50% of the fish consumed worldwide. Expanding the availability of fish products meets a growing demand and is an important component of improved nutrition for Americans.

The proposal before FDA is for a genetically-engineered salmon that is biologically and chemically identical to the Atlantic salmon that is served in restaurants and at our own tables. The only difference is the inclusion of a Chinook salmon gene that provides the potential to grow Atlantic salmon to market size in about half the time.

Opponents have labeled the product as “Franken-fish.” It’s a catchy slogan that tries to devalue over a decade of scientific research and undercut many years of FDA review. Ultimately, the appeal is to emotion—that something dramatically new and different must automatically be dangerous. At some point, scientific review and product safeguards should be sufficient for FDA to make a decision that is based on facts and not fears.

Decisions about new and different products are hard for FDA, as I wrote in a column entitled: “FDA and Things that Might Go Bump in the Night.”  Among other things, I reminded readers that in the late 1970’s and early 1980’s, biotechnology was subject to the same types of concerns and evaluation as FDA is currently giving nanotechnology, GE food and synthetic biology. While there are risks to saying “yes” to innovation, there are also potentially large consequences to saying “no.” Imagine today’s world without biotechnology.

Approval of genetically-engineered animals will always require serious consideration of safety, environmental and ethical issues.  In this case, no one questions the legitimate demands for plentiful, high quality supplies of salmon. Further, the sponsor has agreed upon multiple redundant safeguards. For example, the GE salmon will be sterile females and grown in inland fisheries without access to either wild or farmed salmon stocks.

And yet, the years have piled up, waiting for FDA to be ready to say “yes” or “no” to GE salmon. This isn’t intended as a complaint about FDA…it’s really more of a reminder for the rest of us that a pro-innovation culture at FDA requires hard work from stakeholders.

Scientifically-based, well developed applications are a must. Those of us who support innovation must also make common cause. This is both policy-driven (e.g. by supporting development of regulatory science) and procedural (e.g. not complaining too loudly when FDA takes a somewhat longer deliberative path than we might like).

Further, brave thoughtful decisions by FDA are easier if they are met by public and stakeholder support. GE salmon may be a food, but FDA’s decision affects the environment in which drug, vaccine, and device innovation are also being judged.

Thus, the current fight is not just about “a salmon on every plate.” It is also about whether FDA has the resources and support to sort through the many “alternative futures” represented by the products submitted for its approval.


More information about salmon, aquaculture, regulation of genetically-engineered foods and the current controversy can be found at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/ucm222635.htm and http://www.aquabounty.com/PressRoom/#l7

A final note: I almost never write about or even mention individual products because FDA Matters’ aim is to analyze and comment on policy, regulation, and FDA trends.

This column is an exception because I believe that FDA’s consideration of GE salmon is an important part of understanding the agency’s role in innovation and how such decisions can become far more difficult that they should be. I have no clients or financial interests in development of GE food products.  On the other hand, a salmon dinner is a favorite.

The State of the FDA—February 2013

Thursday, February 7th, 2013


FDA is the only federal agency that touches the lives of every American several times every day. Despite this, FDA will probably not be mentioned when President Obama delivers his State of the Union (SOTU) address to Congress on February 12.


Instead, FDA Matters provides its third annual “State of the FDA.” As reflected in last week’s column, I think that FDA did well in 2012. And 2013 is very promising. Potential funding cutbacks are the primary impediment to future successes.


Strengths. Once again, FDA’s most important strength is the dedication of the agency’s staff.   Last year, I viewed staff’s efforts as invisible and largely unappreciated. I believe that more recognition is being given to the staff—driven by a banner year for drug approvals, progress on implementation of the Food Safety Modernization Act (FSMA), and the narrowing of the FDA-industry chasm on medical devices.


Another key strength is a growing self-confidence within the agency that it can solve problems and not just tread water to survive. Over the years, FDA has often spent extended periods in a bunker posture—harassed, defensive, waiting to be forced to act, speaking too softly for fear of unleashing criticism.


Over the last year or so, there appear to be many more instances where the agency has taken the initiative. To be sure, they have talked to stakeholders and checked in with experts first, but then they have acted by making an announcement, releasing guidelines, creating new policies or intervening to solve a problem. 


Both of these strengths have been heightened by continuity of leadership. In May, Commissioner Hamburg will have held the job for four years, the longest tenure of a commissioner since the mid-1990’s. It also feels like there have been fewer top-level personnel changes. In the past, constant changes have undercut achievement and sapped morale and self-confidence.


Weaknesses. Congress has given FDA an ever larger role without providing the funds to do the job. As a result, and despite the agency’s best efforts, important initiatives and activities are not getting the resources they need. Inadequate funding is the most pressing weakness of FDA.


There are really three parts to the problem:

  • three new laws over the last three years need to be implemented: food safety (FSMA), biosimilars (BPCIA) and user fee amendments (FDASIA).
  • Congressional pressure to do more in complex, expensive areas, such as medical innovation, safety, medical countermeasures, track and trace/counterfeit products, drug shortages and compounding.
  • FDA’s job is getting bigger, tougher and more resource-needy each year independent of whether Congress gives them new responsibilities. This emanates from greater scientific complexity, industry globalization, and increased workload (meetings, NDA’s, etc).  

 As will be discussed further under “threats,” there is a strong potential for cuts in funding that would take FDA far below even the current inadequate level.


Opportunities. Dr. Hamburg has made it a priority to improve the agency’s scientific bench strength—better credentials, better training and better tools. The next step—still very much a work in progress—is to integrate patients and human concerns into FDA decisionmaking.  


The agency understands the importance of this opportunity, but underestimates the tension between patient viewpoints and the scientific process. The task is more nuanced than current efforts suggest….and the risk is that patient-input becomes a box that gets checked, rather than a meaningful improvement to the agency’s science-based decisionmaking. 


In a different vein, FSMA is a well-conceived solution to achieving a safe food supply in the 21st century. The opportunity is enormous, the blueprint largely drawn, and only the inadequacy of funding a substantial barrier to success. I don’t know if the American people will ever properly appreciate the effort required by FSMA or the value its implementation adds to protecting the food supply. Without that public feedback and support, the challenge for FDA will be to continue to see FSMA as the transformative opportunity it is.


Threats. The largest threat to FDA is the potential for immediate and long-term cuts to the resources available to the agency. On March 1, FDA may lose more than 5% of its current-year funding. Even if that cut is averted, funding for domestic discretionary programs is going to be under pressure for the next decade.  


The increasing reliance of user fees for agency funding is also a threat. Including tobacco and the new generic drug user fees, the FDA is now 40% funded by industry. Those fees are put to good use and are not, by themselves, a problem. Rather, American taxpayers need to preserve–if not actually increase–their stake in funding FDA. There are philosophic reasons for this (the integrity of the agency) and practical ones (a large part of FDA’s mission cannot appropriately be funded by industry).


Conclusion. FDA’s strengths and opportunities are immediate and powerful…perhaps more so than in many years. The challenge is to preserve and expand the funding, particularly taxpayer funding, to support the agency. Trying to “do FDA on the cheap” is both a weakness and a threat to the agency and the American people.


FDA Post-Election: Continuity and Progress Likely to Mark 2013

Tuesday, January 29th, 2013

Looking back over the last 40 years at FDA (as I have), there are three characteristics that create a more progressive environment at the agency: continuity of leadership, presidential support, and increased funding. For FDA in 2013 (as the saying goes): 2 out of 3 ain’t bad.

In particular, medical innovation seems poised to flourish in an FDA environment where there is continuity of policy and leadership, instead of a new team learning the ropes. I explore this and other themes in the latest issue of Pharmaphorum.com. You can read my thoughts at: http://www.pharmaphorum.com/2013/01/29/fda-post-election-continuity-and-progress-likely-to-mark-2013/.


President Obama, Please Retain Commissioner Hamburg

Tuesday, December 4th, 2012


With President Obama’s re-election, many people are sitting back and assuming that the U.S. Food and Drug Administration (FDA) won’t change much. In FDA Matters’ view, it doesn’t need to: Commissioner Hamburg is doing a good job; the agency is moving forward to improve food, drug and device safety; more rational and predictable review processes are being implemented; and there are at least three relatively new laws that need ongoing attention.

However, year five of an incumbent presidency almost always involves changes in personnel and policies, not the continuity one might expect. FDA may not be touched, but it seems short-sighted to think there won’t be any changes. And that could start at the top with Commissioner Hamburg.

The unwritten rule of senior political appointees is that you leave by the end of year three or you wait until after the election. Thou shalt not create vacancies during the campaign!

So, the list of who might be leaving now or over the next few months includes everyone who would have left anytime in the last year. There have been rumors that Commissioner Hamburg fits into this category….and equally plausible rumors that this is nonsense. Don’t ask me the answer on this; I have no idea. She may want to stay or she may have had enough of the job.

Then there is the matter of President Obama’s preferences. While those departing will be going to specific jobs or to pursue new (unspecified) opportunities, some will be truly voluntary departures and some will have been pushed out the door. At the moment, the focus is on Secretary of State (Hilary Clinton having said long ago that she would leave after the election) and other very high visibility jobs.

The next rung (individuals such as Health and Human Services Secretary Kathleen Sebelius) and the rung beyond that (FDA Commissioner Margaret Hamburg) will be playing out over the next two to eight months. Each individual will be evaluated—at least informally—and decisions made as to whether they fit into the President’s second term plans.  I would presume that they do fit—and that Secretary Sebelius and Commissioner Hamburg are welcome to stay if they want.

However, unless you have been at the table when White House, HHS and FDA have interacted AND been party to conversations among White House staff as to who they count on and trust, then you really have no idea what President Obama’s intended or evolving  position will be on the continuation of Commissioner Hamburg.  There are always surprises about who will be part of the second term team. Presuming a continuing role for Hamburg is just that—a presumption.

As stated at the outset, I hope that Commissioner Hamburg wants to stay and that President Obama chooses to keep her.  There are positive, agency-affirming reasons supporting this.

In contrast, the Commissioner’s departure, for whatever reason, would be bound to have negative consequences for the agency. Her successor, regardless of the quality of his/her credentials, would face a U.S. Senate confirmation hearing that is likely to be painful. To appreciate why requires an understanding of the confirmation process and its true goal.

The vast majority of Presidential appointees requiring Senate confirmation are clearly qualified to carry out the duties of the position for which they have been nominated. If competence were the primary criteria, then most nominees could be approved with just a staff-level review of their record and positions and an FBI check for character and national security.

Why hold confirmation hearings? In most cases, the purpose is for members of the Senate (acting on their own behalf, as well as those of various stakeholders) to restrict the appointee’s discretionary decisionmaking once in office. In the case of a newly-appointed FDA commissioner, that would mean running a gauntlet of questions about product approvals, medical device policy, unrestricted access to plan B “day-after” contraceptives, how to name biosimilars, etc.

A talented nominee can fend off most of the hardest questions with non-committal answers. However, at the end of the process (when the nominee is confirmed) they are certain to have provided a number of answers that restrain their ability to make the best medical and public health decisions.  Equally important, a new Commissioner will mean a new leadership team and an extended learning curve.

For the FDA, this IS the time for continuity. Let’s hope that Commissioner Hamburg and President Obama will deliver it.


A version of this article appeared in the December 3, 2012 online edition of Scrip Regulatory Affairs.

“Governing,” Not “Campaigning,” Key to Post-Election FDA

Monday, November 5th, 2012

Since last week’s two columns on “FDA After the Election” (here and here or a combined version here), FDA Matters has been treated to some wild speculation about what will happen next. I have been told, in effect, that “if Obama is re-elected, there will be massive new industry regulation” and also that “if Romney is elected, FDA will be transformed into a non-entity that only says ‘yes’ to industry.”

What history tells us is different: whoever wins will have the burden of governing. As a result, massive new regulation is no more likely than FDA becoming a toothless regulatory agency. Winners, it turns out, spend a lot of time explaining why campaign promises haven’t been translated into action.

Of course, everyone is entitled to their own opinion—particularly to imagine their own worst fears.

My advice, however, is to pour a glass of your favorite beverage (alcoholic or not) and watch the election returns with the calm that is appropriate for democratic elections in the United States. Our Founding Fathers intentionally created a system of checks and balances that limits the ability of any one party or any one election to radically re-create government institutions.

FDA is one of those institutions that is changeable (which is actually a good thing), but not likely to be transformed into something dramatically different.

If Obama Wins.  Year 5 of an incumbent President almost always stresses changes in personnel and policies, rather than continuity.  The focus will shift toward new ways of dealing with budget and fiscal matters, jobs and unemployment, and stabilizing our nation’s global position while winding down our involvement in Afghanistan.  Implementing ObamaCare will likewise be a key priority, as major provisions of the law go into effect over the next few years.

While Obama’s focus will follow the campaign promises, the specific actions will probably not. Most likely, he will still be dealing with a hostile House of Representatives and a sharply divided Senate. Events will occur that will also reshape what happens—something unforeseeable like 9/11 or Hurricane Sandy or something foreseeable like a massive fight over the next extension of the federal debt ceiling.

Given this larger picture, what is the probability that FDA will suddenly turn regulation-happy and start a major push to burden industry? I say “none at all.” The entire tenor of Commissioner Hamburg’s tenure—public statements and actions—has been to try to create more science-based decisionmaking, publish more guidances for industry, and to listen to both Congress and industry about FDA’s role in supporting medical innovation.

If there is more regulation in 2013 and 2014, it will be largely to satisfy the legal requirements of new laws passed by Congress on a bi-partisan basis over the last three years. If that winds up feeling excessive to industry, it will certainly not be because of President Obama’s philosophy.

If Romney Wins. Year 1 of a new President is inherently one of change—but remembering back to four years ago, one could argue that the predominant motif is uncertainty, not change. If Governor Romney is elected, there will be a continuous stream of speculation. Nobody knows…and those fearing the worst will get the most attention.

A newly-elected President Romney will actually be dealing with the same issues as President Obama would be: budget and fiscal matters, jobs and unemployment, foreign policy and implementing (or failing to implement) ObamaCare.  FDA will be very low on the list of priorities—if it appears at all. (A conclusion also reached by Matthew Herper of Forbes).

What changes should we expect with a Romney victory and when will we know? The answer is nothing too dramatic and it will take months to play itself out.

I have argued that a Romney Administration would do best to find a well-known, well-respected, candidate who could win easy Senate confirmation. Taking me at my word, Ed Silverman in a Pharmalot column has suggested that Romney could nominate a well-respected commissioner to cut back on safety and speed up approvals (i.e. carry out Romney’s campaign promises and please industry). However, Senate confirmation will not be easy for such an individual—regardless of how well respected—unless they commit to fairly specific boundaries for such changes. (If Romney wins, you will be hearing much more about this in future columns).

If you are an American citizen, please take the time to vote.


FDA After the Election—Part 2: Leadership and Change

Tuesday, October 30th, 2012

Apart from an occasional reference, FDA is not part of the campaign dialogue leading up to the November 6 nationwide U.S. election. Yet, FDA Matters believes that FDA will be strongly impacted by the election’s outcomes.  Part 1 of “FDA After the Election” concentrated on the agency’s budget situation.

Part 2 of “FDA After the Election” focuses on leadership and change–directly and as they may be affected by potentially large budget cuts. There are some predictable elements, but other elements with great impact may depend upon the perspective of those in power for the next two years and beyond.

Drivers of Change, Post-Election.  Whether President Obama is re-elected or Governor Romney becomes President-elect, FDA’s primary responsibilities remain roughly the same: to be the guardian of food, drug and device safety and to provide a reasonable and responsible pathway for pre-market review of drugs and devices. Likewise, no President has the power to alter the main drivers of FDA’s increasing workload: globalization, scientific complexity, growing regulated industries and new legislative and regulatory mandates in food safety, drugs and devices.

Historically, change at FDA is affected by:  

  • the interest level of the President (most Presidents aren’t interested in FDA),
  • a growing or shrinking agency budget  (budget cutbacks distract, reduce options),
  • an acting vs. a confirmed Commissioner (“acting’s” tend to be placeholders),  and
  • the political will of Congress (legislation, oversight/investigations, or indifference).

If President Obama is Re-elected….then the two main drivers of change are likely to be whether Commissioner Hamburg decides to stay and the federal budget situation.  

This chart explores the variables and draws some conclusions about the opportunities for change. Not surprisingly, they are greatest if Dr. Hamburg stays and there is no sequester. The worst case would be a sequester and a long-term “acting” commissioner; it is only a slight exaggeration to suggest the agency would be set adrift and some panic might set in.



Most like what prior situation?

Budget Status

Opportunities for change






Obama Year 5


Kessler 1993-1994

No sequester

Change continues


Orderly retreat?


New nominee

Von Eschenbach    2006-08

No sequester

Orderly transition: some change


Disorderly retreat?


“Acting” for >  than 6 months

Crawford 2004-05

No sequester

Orderly transition: few changes


Agency set adrift?


If Governor Romney is Elected…..then the main drivers of change are likely to be his interest level (his plate is likely to be full elsewhere), how quickly he nominates a new commissioner, how controversial his nominee is, and the federal budget situation.

This chart (as the one above) explores the variables and draws some conclusions about the opportunities for change. The best situation would be a well-known, well-respected, candidate who could win easy confirmation. That person would have the opportunity to make a lot of changes—although there would be notable differences if a new commissioner faces budget cuts. The worst case for change would be a replay of 2001-2002, when President Bush allowed more than 18 months to go by without a commissioner in place.



Most like what prior situation?

Budget Status

Opportunities for change






Romney Year 1

New nominee easy to confirm

Hamburg  2009-2010

No sequester

Time to shake the place up


Accelerates shake-up?


New nominee  hard confirmation (not “acting”)


No sequester

Congressional constraints in exchange for confirmation?


How long is someone acting?


“Acting” for >  than 6 months


No sequester

Confusion: who to serve?


Panic in the streets?


Timeframes.  While the charts provide a more comprehensive overview of the prospects for leadership and change at FDA, the scenarios will actually unfold over a period of months. Presumably, we will know who will be President within a day or two of the election. However, sequester (or other budget cuts) are not likely to be determined until later this year or may be delayed into next year.

Whether Dr. Hamburg stays will be both her decision and that of President Obama. That might be announced quickly or not.  If there is to be a Romney Administration, it is likely to be at least March 2013 (more likely later) before a nominee is announced.


FDA and the Republican Platform: Harsh Words, Unclear Intent

Monday, September 3rd, 2012


Between “the FDA today” and the “FDA in 2013” stands a U.S. presidential election—one that appears to offer Americans a choice of philosophy about the size of government and the role of regulatory agencies.  FDA Mattersprevious blog laid out some very early comparisons between the candidates on regulatory policy and the role of Commissioner.

Along with nominating Mitt Romney as its Presidential candidate, this past week’s Republican Party convention produced the party’s 2012 Platform –a series of policy positions to guide the campaign. FDA reform commands about 180 words—laying out the case for aggressive (although unspecified) changes.

Campaigning vs. Governing. Before looking at the specific words and thoughts in the Republican Platform, it is worth providing some context. One of the enduring lessons of my 50 years watching American politics is that there is often a profound difference between campaigning and governing. The Platform is put together by party delegates from every state, working with subject-matter experts and overseen by the Presidential nominee’s team.

Mitt Romney would not allow a party platform with which he disagreed. However, should he be elected, he will not feel bound by the positions taken in it. That said, the Platform’s words on FDA reform appear to generally reflect other things that Mr. Romney (and his surrogates) have said on other occasions.  What he will want to do about FDA if elected (or even what he will be able to do) is unknown.

The 2012 Republican Platform on FDA Reform. The  platform report states:

America’s leadership in life sciences R&D and medical innovation is being threatened. As a country, we must work together now or lose our leadership position in medical innovation, U.S. job creation, and access to life-saving treatments for U.S. patients. The United States has led the global medical device and pharmaceutical industries for decades. This leadership has made the U.S. the medical innovation capital of the world, bringing millions of high-paying jobs to our country and life-saving devices and drugs to our nation’s patients. But that leadership position is at risk; patients, innovators, and job creators point to the lack of predictability, consistency, transparency and efficiency at the Food and Drug Administration that is driving innovation overseas, benefiting foreign, not U.S., patients.

We pledge to reform the FDA so we can ensure that the U.S. remains the world leader in medical innovation, that device and drug jobs stay in the U.S., that U.S. patients benefit first from new devices and drugs, and that the FDA no longer wastes U.S. taxpayer and innovators’ resources because of bureaucratic red tape and legal uncertainty.

While the rhetoric expressed in the platform is not new to FDA Matters—it has a certain menacing quality when it is “the voice” of an American political party as opposed to a “government is bad” Tea Party leader or a frustrated medical device executive.

It begs the question: didn’t America’s global leadership in the life sciences come in part from the FDA’s competence and high standards and not despite them? I would emphatically say “yes,” but there certainly seem to be others that would answer “no.”

Harsh Words for FDA: Consistent with the Overall Tone of the Platform. FDA definitely needs some improving—as past FDA Matters’ columns have made clear. I try to stay constructive and be mindful that complex problems rarely have simple solutions.

Perhaps more to the point, FDA—by itself and working with Congress—seems to have made enormous strides over the last few years. One could even argue that FDA is already working hard on implementing a “pro-innovation” and “create more predictability” agenda that Republicans should like.

This, perhaps, brings us full circle around to our prior warning not to read too much into campaign rhetoric.

FDA reform is two paragraphs in a 50 page document—one that stridently and broadly promotes smaller government and fiscal prudence, almost regardless of consequences. For example, on budget issues, the Platform calls for “Reining in Out-of-Control Spending, Balancing the Budget, and Ensuring Sound Monetary Policy.”

When government is cast as incompetent and out-of-control, it leaves little space to say good things about federal agencies, such as FDA, that work hard, are underfunded, and are committed to improving their performance. When it comes to FDA, we can be hopeful that Republican candidates are more judicious while campaigning…..and, if elected, more restrained in their actions than their rhetoric suggests.


FDA and the 2012 U.S. Presidential Election

Wednesday, August 1st, 2012


FDA Matters has been wondering: when is the right time to start talking about the 2012 U.S. Presidential election and how it might affect FDA’s future? The best answer is: when Congress has finished its FDA policy work for the year. With the enactment of FDA user fee reauthorization legislation and a pending agreement on government funding for the first half of FY 2013 (starts October 1, 2012), it is now time to start talking. 


Without picking sides: what issues face FDA after the election and in 2013? How might the agency be affected by whether President Barack Obama is given another four year term or challenger Mitt Romney is elected President?


For those of us deeply involved in the FDA world, the most important difference between the candidates might well be their approach to the agency and particularly toward FDA leadership.


President Obama has not yet issued any statements about FDA on his   campaign website  . However, based on the last 3 ½ years, he supports FDA and its mission and sees that the agency’s role is likely to continue to grow because of globalization, public health and safety, and the need to encourage innovation. 


His overall regulatory positioning might be considered less favorable to FDA. New agency regulations must pass through the Office of Management and Budget (OMB)’s Office of Information and Regulatory Affairs (OIRA). Cass Sunstein, a distinguished legal scholar appointed to head OIRA in 2009, is considered to be more open to de-regulatory approaches that may be inconsistent with FDA’s growing responsibilities. For example, it is his office that is currently holding up some of the regulations needed to implement the Food Safety Modernization Act.


The Republic nominee, Mitt Romney, has not yet issued any specific policy statements on FDA. However, he appeared at a medical device company event in late March and       su   ggested     that FDA is part of an “attack on free enterprise” by “the thousands upon thousands of bureaucrats that work in Washington.”


His campaign website does not reference FDA, but it does have a position paper on regulation. In it, he advocates:

·                  Imposing a regulatory cap of zero dollars on all federal agencies*

·                  Requiring congressional approval of all new “major” regulations


One should never take campaign speeches too seriously. Even allowing for that, it would appear there are significant differences in how the two candidates view FDA today.  These differences may narrow or expand in the three months until Election Day. 


Just as the two candidates appear to differ strongly on the role of FDA, they are also likely to differ on their choice of FDA commissioners. This is not just a matter of whether Romney wins, but also if Commissioner Hamburg is thinking about leaving (and we have no knowledge of this, only that it is not uncommon for Administration leaders to leave in the year after a President is re-elected).


The history of appointments of FDA commissioners is quite varied, starting with 1991 when Dr. David Kessler became the first Commissioner to face a Senate confirmation hearing. He resigned at the beginning of Clinton’s second term (analogous to an Obama victory and a decision by Dr. Hamburg to leave). It took nearly two years for President Clinton to appoint his successor and the Senate to confirm the appointment.


Hiring a new commissioner was not a priority for the new Bush Administration in 2001. Dr. Mark McClellan was confirmed in November 2002, more than 20 months after the new Administration took office. In contrast, Dr. Hamburg was appointed by the Obama Administration and was confirmed by May, a delay of less than 5 months.


So, if Romney wins or Obama wins/Hamburg resigns….we may have a new Commissioner quickly or the job may be vacant for a long time.


Overall, the differences between Barack Obama and Mitt Romney are likely to matter a great deal to FDA. In turn, this will affect FDA stakeholders….regardless of their politics or their views on whether FDA needs continuous improvement or an outright overhaul.




*   My understanding of this: the private sector cost impact of any new federal regulation must be offset by the private sector savings from repealing or significantly revising an existing federal regulation.


P.S. For those wanting more on FDA and the U.S. elections, FDA Matters intends to write often on this topic over the next few months.

FDA’s E-Mail Scandal: First Impressions

Monday, July 23rd, 2012

According to the New York Times, FDA collected more than 75,000 employee e-mails in an effort to identify leaks of confidential trade secret information. At some point, a narrow, possibly legitimate inquiry into a handful of scientists at the Center for Devices and Radiological Health (CDRH) turned into a massive e-mail surveillance of selected individuals and their contacts.

So far, FDA is not contrite. FDA’s position, while still not quite official, appears to be: we tried to accommodate these individuals’ complaints within the personnel and dispute resolution systems. We had legitimate concerns that trade secrets were leaving FDA in their correspondence with third parties.

FDA Matters believes we don’t know the whole story yet.

The immediate perception is that the agency–in the name of protecting trade secrets–targeted internal critics and found ways to monitor their strategy and actions.

Fueling concerns is that a number of the monitored e-mails were sent to media, the President, and Members of Congress. Among others, Republican Senator Charles Grassley and Democratic Congressman Chris Van Hollen, have expressed concerns that correspondence with their staffs had been part of the surveillance.

Further, the surveillance appears to have included correspondence with the Office of Special Counsel, an independent federal investigative and prosecutorial agency with jurisdiction to oversee whistleblower complaints. Understandably, they are unhappy when they perceive that other federal agencies are interfering in their investigations.

In short—even with Congressional recess coming up and a national election—this issue is not likely to go away.

Every day FDA receives confidential trade secret information that it is legally obligated to protect. Any individual failing to do so is open to penalties—I assume both criminal and civil. To me, the key paragraph of the NY Times story is this one:

F.D.A. officials went to the inspector general at the Department of Health and Human Services to seek a criminal investigation into the possible leak, but they were turned down. The inspector general found that there was no evidence of a crime, noting that “matters of public safety” can legally be released to the news media.


Undeterred, agency officials began the electronic monitoring operation on their own.

If true, this is quite damning of the agency and provokes the usual question of why senior FDA officials did not exercise more restraint and better judgment.  

However, the agency’s unofficial semi-response suggests that this is not the full picture. At some point, the Office of General Counsel (OGC) at FDA became involved and authorized surveillance. Assuming this is true, did OGC have the authority to do so…and did they know that they were authorizing a broad surveillance? (I refuse to think of 75,000 e-mails as a narrow search).

According to an on-line Wall Street Journal article, the key individual in this case is a “serial whistleblower” (my term, not theirs), having filed lawsuits at two previous jobs. Supposedly, in both cases, the allegations of institutional misconduct were not proven in court, but he received settlements for “wrongful terminations” that followed his whistleblowing. What happened previously and elsewhere is irrelevant, except perhaps to remind us how hard it is for government agencies and public entities to fire an employee who they believe to be a disruptive force.

There is no way that FDA can look good if it is seen as approving devices that should not be on the market, squelching internal scientific disagreements, pursuing vendettas against its employees, or interfering with the prerogatives of Congress and the Office of Special Counsel.

In the face of all of this—the allegations and FDA unwillingness or inability to respond fully–it is hard not to worry about the agency. It is an institution that badly needs public and congressional support to do its job, especially when its responsibilities are growing and its budget isn’t.

FDA Matters hopes that Commissioner Hamburg and her senior staff are able to respond more fully and “on the record” in a way that helps stakeholders, Congress, the media and OSC understand why the extensive surveillance became necessary and what public purposes it served.


Here is more background, provided as a courtesy by BioCentury:  http://www.biocenturytv.com/freecontent/tbr_072312.pdf.

Some of the other relevant documents available only through subscription trade media:


1/ FDA’s response to Senator Grassley is available from Inside Health Policy (www.insidehealthpolicy.com, by subscription) at: FDA letter to Grassley.


2/ According to Dickinson’s FDA Webview (www.fdaweb.com, by subscription) Commissioner Hamburg on 7/17/12 sent the following email to all employees:


Over the past few days, a handful of stories, first appearing in The New York Times, were written regarding the agency’s monitoring of the computers of five CDRH employees.


I want to reinforce that the FDA’s greatest strength is our people. I value the expertise, professionalism and dedication each of you brings to this agency every day. There is no greater mission than that with which we are charged – protecting the public health. I have great confidence in FDA’s leadership and employees, and we have worked hard to foster a culture where differing opinions on scientific data, regulatory issues and product approvals may be expressed freely. In addition, employees have avenues available to them to voice their concerns both inside and outside the organization without disclosing proprietary information that is protected by law from unauthorized disclosures. I want to reiterate the FDA's commitment to protecting the rights of whistleblowers who are doing a service by bringing public safety concerns to the forefront. It is only in working together with the highest levels of professionalism and ethics that we will continue to achieve our mission.


Regarding the recent news stories, I want to stress that the FDA’s ability to fulfill our mission of protecting and promoting public health necessarily relies upon our ability to protect confidential information. Protecting such information in our possession allows us to work with industry and other stakeholders to ensure the quality of FDA-regulated products and the integrity of FDA-decision-making.


In 2010, the agency initiated monitoring limited to the government-owned computers of five CDRH employees. The impetus for the monitoring was a March 2010 New York Times article and a letter from GE Healthcare that indicated a pattern of unauthorized disclosures of confidential information related to pending medical device applications and submissions over the course of more than a year. The intent of the monitoring was to determine whether confidential commercial information had been inappropriately released and to stop any further unauthorized disclosures, since any such disclosures are a violation of the law.


Although the FDA, as with other federal agencies, has the discretion to conduct appropriate monitoring of government computers, we do so only in very limited circumstances. We do not take lightly the decision to monitor government computers.


I hope this note offers a bit more context to the situation. We will continue to update you as best we can. Please be assured that your work and your opinions are appreciated.

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