FDA Matters Blog
A New Food Agency Has Become Unnecessary (For Now)
FDA Matters applauds the appointment of Mr. Michael Taylor to be Deputy Commissioner for Foods at FDA. With more authority, experience and stature than any previous food leader, he has the opportunity to shape and re-shape food regulation and the safety of the food supply. Because Mr. Taylor will be outstanding in this new post, the campaign for a separate food agency will go away, at least for a couple of years.
FDA Matters applauds the appointment of Mr. Michael Taylor to be the first Deputy Commissioner for Foods at FDA. With more authority, experience and stature than any previous food leader, he has the opportunity to shape and re-shape food regulation and the safety of the food supply.
Because Mr. Taylor will be outstanding in this new post, the campaign for a separate food agency will go away, at least for a couple of years.
People solve problems, reorganizations don't. Whatever problems exist within FDA would still exist within a separate food agency. Sometimes matters get even worse, as they did with the creation of the Department of Homeland Security.
Enter Mike Taylor, the person who can solve the problems. He has been an advisor on foods to the Commissioner for months and has been promoted to line manager and decisionmaker for every food activity within FDA. Most of us think only of the Center for Food Safety and Applied Nutrition (CFSAN), but there are food programs in the Center for Veterinary Medicine, Office of Regulatory Affairs and elsewhere at FDA. He will be responsible for all of them.
Mr. Taylor has all the elements for providing transformational leadership: experience, knowledge, respect, determination and foresight. By bringing leadership to foods, he will eliminate the urgency-- and probably the need-- for a separate food agency.
Intriguingly, Mike Taylor has been an advocate for a single food agency and there is some question about how that might affect his leadership. It won't. Some might think his appointment accelerates the move to a separate food agency. It doesn't.
Circumstances have changed. To continue to advocate for a separate food agency, Mr. Taylor would need to point to activities and policies that would be different and better if done outside FDA. It is hard to imagine what those would be--with him in charge and a supportive Commissioner. Or said another way: neglect, not the organizational structure, has always been the problem.
Things may look different in a couple of years. A new food safety law seems certain to be adopted in 2010. Implementing that law might create new reasons to support a separate food agency.
If so, an additional benefit of Mike Taylor's appointment would be continuity. His leadership and his structure would be carried over into a new organization. And he would have no trouble being confirmed by the Senate if that were required.
Which leaves one remaining question: will increased attention to food come at the expense of attention needed by the medical products function at FDA? I see no reason to think so. The broad, grassroots push of patient groups for safe and effective treatments has no counterpart on the food side.
Steven
Has FDA Slipped Back into Anti-industry Mode?
An industry CEO wrote me to observe: FDA is returning to the anti-business paradigm of the past. His concern is understandable. Yet, I respectfully disagreed with him. It is natural to fear change. It is easy to confuse activism with ideology.FDA Matters believes there are two perspectives from which to judge the situation of FDA versus industry.
An industry CEO wrote me to observe: FDA is returning to the anti-industry paradigm of the past. His concern is understandable. Yet, I respectfully disagreed with him. It is natural to fear change. It is easy to confuse activism with ideology.
FDA Matters believes there are two perspectives from which to judge the situation of FDA versus industry.
The first perspective is relative. The nation elected a liberal Democratic president committed to change. He had the opportunity to appoint an ideological FDA commissioner…someone who would have seen FDA's mission as re-regulating the entire FDA world after 8 years of perceived neglect.
Instead, the President appointed Dr. Margaret Hamburg, an experienced administrator whose strength is pragmatic approaches to public health problems. As I have written before, being a big city health commissioner predisposes and reinforces pragmatic rather than ideological thinking.
Compared to what might have been in a Democratic administration with Democratic congressional majorities…FDA and Dr. Hamburg are a lot more open to industry concerns than could be expected.
The second perspective is thematic. Commissioner Hamburg has been explicit about embracing innovation and recognizing that a safety-only perspective is counter to the public health. New medical products are more than just hope; they relieve suffering, restore functioning, strengthen families and sometimes they provide cures. These are all public health values, too.
The ongoing revolution in biological sciences is very much on Dr. Hamburg's mind. The commissioner speaks often about how FDA needs to strengthen and expand regulatory science at FDA to develop the tools necessary to evaluate increasingly complex medical products.
This is definitely pro-industry. An FDA that is ill-equipped and uncertain is one that won't be able to evaluate new science or recognize subtleties. FDA's default response then becomes "no." Dr. Hamburg does not want this to happen any more than industry does.
Some of the alleged anti-industry initiatives need to be seen in context.
Almost all FDA-regulated companies intend to abide by the law. Yet, there are lots of missteps that go unrecognized and lots of evidence of people cutting corners or being outright frauds. In the face of this, FDA enforcement had become lax. For the most part, companies are being pushed into greater vigilance of their own actions…..where good and bad practices may mean life or death for some patients and consumers. While painful to some, I don't see this as anti-industry.
Context is also important in assessing whether the current review of the medical device approval process is anti-industry, which some believe. I see the review as long overdue, given the importance of medical devices and the arcane way in which they are approved. A comprehensive re-examination has not occurred in more than 15 years. In the end, I think FDA and the Institute of Medicine (IOM) are going to reach conclusions that are "uncomfortable but acceptable" to industry. The industry will be able to flourish once the controversy is behind them.
It hurts FDA, as well as industry, if there are fewer new drug and device approvals or if systems cannot be put in place to make our food safer. The success of FDA-regulated industries is important to FDA.
Dr. Hamburg understands this and is acting accordingly.
Steven
Some related columns from FDA Matters:
Public Health Leadership Comes to FDA. FDA leadership–Dr. Hamburg and Dr. Sharfstein– come from an entirely different mold than their predecessors. They have begun an era of public health leadership at the agency. FDA staff and agency stakeholders will eventually come to appreciate that this difference is good for FDA. Read the rest of this entry »
CARS: The Vehicle for FDA's Future. Commissioner Hamburg has spoken a number of times about the importance of regulatory science. She is right. FDA must have the scientific tools and methodologies to be a 21st century regulatory agency. FDA needs to define regulatory science, develop programs to support it, and package them in a way that will quickly bring recognition and funding. Read the rest of this entry »
Executions in China: A Thanksgiving Message. Sometimes it takes other people to give us a perspective on our own values. Today, Associated Press reports that two men were executed in China for tainting milk powder with melamine, an industrial chemical. The adulterated milk killed at least six children and reportedly sickened more than 300,000. Read the rest of this entry »
"No Surprise" That Medical Devices Are Under Scrutiny. My column entitled, "Re-Evaluating the Medical Device Approval Process" was not widely-read. I assumed it was because everyone already knew that a review was underway at FDA, with more activity coming. Apparently, I was wrong. Read the rest of this entry »
Stigmatizing the Obese and Criminalizing Food
Well-meaning policymakers are constantly advocating for specific solutions to societal problems. They intend to create a better world and often they do. In the process, their good purpose is sometimes hijacked by unintended consequences. FDA Matters believes this is the inevitable fate of policies that tell Americans what foods they are allowed to eat
Well-meaning policymakers are constantly advocating for specific solutions to societal problems. They intend to create a better world and often they do.
In the process, their good purpose is sometimes hijacked by unintended consequences. FDA Matters believes this is the inevitable fate of policies that tell Americans what foods they are allowed to eat.
I applaud the enthusiasm of public health advocates for their anti-obesity initiatives and hope a large number of Americans will cut their food intake and make wise food choices. Unfortunately, unintended consequences are likely to neutralize these public health efforts, resulting in little or no net progress against obesity. It is a wasted opportunity.
Stigmatizing the obese. I suspect that most obese people (1/4 of the American population) already experience substantial negative feedback about their weight. It comes from family and friends, strangers in the mall, and the persistent cultural message that "thin is in." Obese people surely feel they are under assault from the world around them.
In the current environment, the self-worth of obese people is under attack by society…and ill-will toward the obese is increasingly acceptable. These are not effective ways to encourage behavioral changes.
Public health may not have caused the cultural shift toward stigmatizing obesity…but the public health community has a responsibility—by its utterances and its campaigns—not to make the situation worse.
These are foreseeable, albeit unintended, consequences of campaigns to reduce obesity. Public health should not be complicit. There is still time to send a more nuanced message that discourages ridicule of individuals who are obese and provides more encouragement and assistance to those who struggle to lose weight.
Criminalizing Food. Efforts to restrict access to foods that are sugary, fatty, salty, high-calorie, etc. are also doomed to failure. People want these foods. And by now Americans should understand that prohibition is not an effective public health strategy.
Where access to foods is restricted, black markets will form. A recent BBC news story describes an enterprising English lad who was caught selling "crisps" (British equivalent of our potato chips) at his school. He was suspended for violating the school's "healthy snacks policy." With true entrepreneurial spirit, he had also marked up the price.
Things are just starting to heat up on this side of the Atlantic. Last year, New York City decided to severely limit school bake sales and regulate what foods are allowed in school vending machines. Ironically, sports programs are likely to be the hardest hit by loss of income from these sources.
We are not to the point of criminalizing foods. But I worry that moralism about food is on the ascendancy. It is absurd to be worrying about "food pushers" lurking on the edge of the school grounds trying to corrupt our youth. It is sad to see time, energy and money diverted from what really counts: improving nutritional education and increasing support for obese people who want help losing weight.
Our relationship to food is both complex and highly emotional. By all means, let's spread the public health message that obesity has serious personal health consequences. But we need to do it in a way that helps people, not hurts them. To do this, we must be careful that the unintended consequences don't ruin the good that could be achieved.
Steven
The BBC story on the student suspended for selling unhealthy snacks on school grounds:
http://news.bbc.co.uk/2/hi/uk_news/england/merseyside/8412310.stm
A description of the situation in New York City: