FDA, Me and Maybe the Mafia—A True Story

In honor of FDA Matters’ third anniversary, I am sharing a personal story. It reflects FDA’s history as a struggle of competing interests—where sometimes reasonable people disagree, often vehemently, while at other times it is obvious that indifference or greed are the driving forces.

Both are a fact of everyday life at FDA and in the FDA-regulated world. Here is my own little story and I still can’t say for sure whether it involved reasonable people or dark forces.

My first recollection of the artificial sweetener, saccharin (distributed under the brand name “Sweet‘N Low”) was a 1977 visit to the House health subcommittee’s staff office. It was overflowing with boxes that contained letters begging Congress to prevent FDA from removing saccharine from the marketplace.

Later that year, Congress passed the Saccharin Study and Labeling Act. This prevented FDA from acting for 2 years and required a warning label on the packaging that said “This product contains saccharin, which has been determined to cause cancer in laboratory animals.”  The law was extended seven times until the issue disappeared in the 1990’s. The labeling requirement was repealed in 2000.*

After I became a Senate staffer in 1979, I was responsible for shepherding through the 1981 and 1983 extension and probably the 1985 extension, which occurred just before I left the Hill.

These were simple bills—short, totally clear in their meaning, and noncontroversial. The only issue (and not a very large one) was that one committee member refused to consent to its unanimous adoption---which slowed the bill at committee and when it got to the Senate floor. I can’t remember any Senator expressing actual concerns about these bills. 

Sometime around 1983, I started receiving regular visits and calls from Joseph Asaro, Vice President of Governmental Affairs for Cumberland Packing, makers of Sweet ‘N Low and a business located near the Brooklyn docks. I remember him as pleasant, but terribly anxious that nothing stand in the way of extending the moratorium every two years.

It never seemed to sink in to him that passage of the extension was routine business of the most ordinary sort. The more I reassured him (so he wouldn’t call as often), the more solicitous he became. Then one afternoon, I received a call from my family—who lived on Long Island, maybe 20 miles from Cumberland Packing’s headquarters. That morning, a delivery truck had arrived with multiple cartons of Cumberland products, including several 1000-packet boxes of Sweet’N Low, and the message: let us know when you run out.**

Although it was probably meant as a generous gift (and didn’t violate any Senate rules), I was quite upset. I had mentioned to Mr. Asaro that I had grown up on Long Island, but never my family’s names or where they lived (and 30 years ago, pre-Internet, identifying people’s connections was a difficult task without such information.)

In my imagination (or maybe in actuality), I felt that I was being reminded that he knew where my family lived….and I needed to pay more attention to the legislation. Despite all efforts on my part to banish such thoughts, I admit I considered the possibility that Cumberland was involved in some way in organized crime and I had been threatened.

In 2006, an unauthorized history of Cumberland Packing was published and I found that my concern was well-founded, although perhaps not true. According to the book, a 1994 Washington Post article stated that Joseph Asaro had been “identified as an associate of the Bonanno crime family in a prosecution memo….” Subsequently, a New York Times article reported that federal prosecutors and Mr. Asaro’s attorneys denied there was any connection.***  

Threats, even implicit ones, are inherently scary—even if the goal was to make me do something that I was planning to do anyway and for which there was strong Congressional and public policy support. Even at the time, I didn’t really think my family was in “harm’s way.” Still, it made me anxious and self-conscious about what was otherwise a routine task.

Other than being an interesting tale, I hope it is a small reminder to every reader that there are employees of the FDA—sometimes inspectors, but more often in the Office of Criminal Investigations and their colleagues at the FBI and Customs---who do put themselves in “harm’s way” in order to protect us. These threats are invisible to most of us, but are no less real because we don’t see them.

We should salute and remember those who take these risks on our behalf, so that we can enjoy the benefits of a safe food and drug supply.

Steven

* Subsequent studies never strengthened the connection to cancer in humans. In 1985, FDA supported extension of the moratorium and in 1991 withdrew the proposal to ban saccharine from food. It was delisted as a possible carcinogen in 1997 and the warning label requirement was repealed in 2000. http://www.icarus-japan.com/pdf/Saccharin_English.pdf

** Thanks to my mother and sister for their memories of that day, still quite vivid nearly 30 years later.

*** Sweet and Low: A Family Story by Rich Cohen. Published by Farrar, Straus and Giroux, 2006. The material on the possible linkage with organized crime is a footnote on page 144.

About FDA Matters

FDA Matters has grown steadily since I started it less than a year ago. My inaugural column was about the goals of the blog, but I have not written on the topic since or about my background and viewpoint.

I started the blog because of my frustration about how FDA was being described and analyzed during the period from Election Day to Dr. Hamburg's confirmation. In particular, I spent a month telling colleagues: it is not true that there is going to be a power-sharing arrangement where Dr. Hamburg will concentrate on foods, while Dr. Sharfstein will concentrate on drugs and devices.

Even though I had no inside information, it was so clear to me…and yet many people thought otherwise and were impossible to persuade. I wished I had a platform to speak out, so I created one and launched it about 6 weeks later!

My goal is to write a blog that provides fresh insights and new perspectives for the broader community of people "involved in FDA matters and for whom FDA matters." Hopefully, it is achieving that purpose by focusing on what the agency is thinking and how its actions are shaped by Congress, the media, stakeholders and external events. FDA Matters aspires to be a source of understanding about FDA, both directly and by stimulating dialogue.

Since FDA Matters began, one continuing theme has been the need to plan for FDA's future. Another has been how the public health backgrounds of FDA's leadership team make their thought process and actions quite different from any of their predecessors. Some themes I want to explore this year: re-inventing the clinical trial, the roll-out of the new regulatory pathway for follow-on biologics and improving regulatory science.

FDA Matters is not a voice for any interest group. The blog reflects my own analysis and commentary based on 35 years working in DC on health policy and legislative and regulatory issues. Earlier in my career, I was Health Staff Director and Counsel to the Senate Committee on Labor and Human Resources (now the HELP Committee). I had the great fortune to be one of the negotiators on the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman) and on the Orphan Drug Act.

Subsequently, I was a Deputy Assistant Secretary for Health at HHS, responsible for policy development, planning and evaluation for the Public Health Service agencies. Since then, I have been a public affairs and regulatory consultant for a big firm, then started HPS Group, LLC in 2001 (www.hpsgroup.com).

One of my more recent accomplishments was helping to found the Alliance for a Stronger FDA (www.strengthenFDA.org). I serve (part-time) as the Deputy Executive Director of the organization. I believe strongly that FDA is dramatically underfunded and I write about this a lot. However, anything I write in FDA Matters is my own view and not that of the Alliance.

Over the years, my clients have included patient groups, health professions societies, research advocacy groups and individual companies. Many clients use me for legislative and regulatory analysis and to facilitate the development of policy and regulatory positions. Other clients use me for strategic regulatory counsel to help with development of medical products that are in phase II or phase III.

I welcome reader's comments, either posted on the blog or by e-mail. I would be pleased if readers helped me initiate two features of the blog: point/counterpoint exchanges and "Ask Steven About FDA."

Most of all: I believe that a better FDA is worth the effort to stay involved. I hope you see it that way, too.

Steven

Upcoming at FDA Matters

Columns to expect this week and next:

• Update on Follow-on Biologics and the Dance of Legislation
  
• Status of FDA Appropriations
  
• How FDA Could Be Affected by Health Reform Legislation
  
• Exploring the Office of Regulatory Affairs
  

FDA Matters: A Prologue

FDA Matters will provide fresh insights and new perspectives for the community of people "involved in FDA matters and for whom FDA matters." Our goal is to create an information community around the mission and activities of the Food and Drug Administration.

It is fashionable to use blogs to advance strongly-held, singular viewpoints. FDA Matters will be different. It will focus on what the agency is thinking and how its actions are shaped by Congress, the media, stakeholders and external events. It will be a source of understanding about FDA, both directly and by stimulating dialogue.

One continuing theme will be the need to plan for FDA’s future. As long as FDA moves from crisis to crisis, it can never create the orderly systems that increase effectiveness and provide predictability of action.

FDA Matters is not a voice for any interest group. The blogs will reflect my views, formed from more than 30 years working on policy and politics in DC. Every reader is encouraged to share their views through posting comments and other features.

Between my blog and posted comments, FDA Matters is likely to air many criticisms of FDA. Whenever possible, I will offer constructive suggestions for improvement and kudos for jobs that are well done. The FDA employees I know have demonstrated intelligence, commitment and fairness. They deserve our support, even if we disagree about agency policies and actions. Readers are encouraged to post comments in the same spirit.

Are there problems at the agency? Are bad decisions being made alongside good ones? Of course, on both counts. As FDA Matters will amply demonstrate, people of good will can hold opposite views about FDA and its policies and actions.

FDA Matters will reach out through several short blog columns each week, point/counterpoint exchanges, and an “Ask Steven About FDA℠” feature. The very best opportunities to learn and share are to get involved yourself—by posting your comments and adding the benefit of your experience and insights.

Sign up, stick around for a few columns, and give FDA Matters a chance to gain momentum and grow. A better FDA is worth the effort to stay involved.

Steven

Click FDA Matters logo at top of this page to return to the home page.