What it Takes to Actually Change Washington and Change Policy

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When I started working in the US Senate in the mid-1990s, my then boss Senator Jeff Bingaman handed me, like he did to every incoming member of his staff, a copy of Eric Redman’s book, The Dance of Legislation: An Insider’s Account of the Workings of the United States Senate.

The book tells Redman’s own story of then working on Senator Warren Magnuson‘s team and getting to know through error and success the machinery of the Senate legislative process.
Redman learns that gravitational forces work differently for a Senator and his or her staff than they do for others in the administration, or the courts, or in the lobbying and advocacy arena.
Senators, if they desire to, don’t have to be spineless and passive — but can make their own weather. They can write and pass laws – though successful legislating can be an excruciatingly frustrating, irrational process. In the end, Redman plays a tipping point role in getting a National Health Service bill passed.

One can overdo typologies and models in trying to describe social phenomena – but sometimes they work. When I was absorbing what I could about how
the mechanics of politics and policymaking worked, I was influenced by
the writing of Ripley and Franklin, who wrote Congress, the Bureaucracy and Public Policy.  They suggest that there are many factors — among them
“time”, the nature and number of policy actors in a decision, and the
regularity or irregularity of the policy under consideration — that effect
legislative and political outcomes.

bill.jpgIn other words, Ripley and Franklin argued
that structure and the context in which policy is debated and formed matters –
and Eric Redman shows that empowered political actors who understand the tools
and mechanisms of politics and legislative process can have significant impact.

This is a round about way of saying that I am
intrigued by stories of those who try to pass or change
legislation.  No matter whether the
impulse for change is outside the system – like HIV/AIDS activists were during the Reagan administration battling for attention and resources – or inside, like Senator Warren Magnusson’s
legislative assistant — it’s nearly always a byzantine process that changes the roster of winners and losers.  It’s how American style democracy works, and I find it fascinating.

In part because of America’s and the world’s growing dependence on China’s production muscle, I have been interested in what the US needs to do to prevent its standards from being undermined by lesser standards, poor regulation, illiterate workers, and corruption abroad.  What are the legal and regulatory adjustments that need to be made to shore up American standards — rather than have them slip to levels seen elsewhere around the world?

g242332_u94601_FDR_fireside_chat_March_1933.jpgThe US Federal Food, Drug, and Cosmetic Act, passed in
1938, and only modified in minor ways since was originally introduced because more than 100 patients died because of a highly toxic hospital-administered drug.  Today, there
are scores of stories emerging around the world in which counterfeit drugs are proliferating in a
lightly, often corruptly, regulated global drug industry. The media in China, India, countries in Africa and Southeast Asia often run stories about deaths and illness stemming from drugs being taken that are unsafe.

In the past, when the American drug and
pharmaceuticals industry was mostly based inside the borders of the
country, the regulatory and inspection scheme provide by the 1938 Food and Drug
Act was adequate.  But those days are gone.

Today, roughly 80% of the
active ingredients for drugs sold inside the United States are manufactured
abroad – often in lightly regulated environments, or ones where corruption
undermines what is often just a fa

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