Fourth Question of the Day: November 6, 2013 Do we need to remind Senator Vitter of David Kessler and Sarah Sellers prior warnings that Congress ignored in the past? Do we need to remind him of the dangers of the shadow industry and the human-made tradegy? What about the youngest victim of the NECC ourbreak, Senator Vitter, what do you say to him and his family about why you are holding up a vote on a bill that clearly would pass if you would just allow the vote?

“Because they don’t register with us, we don’t know who they are, we don’t have a list of what products they produce,” Howard Sklamberg, director of the office of compliance for the FDA’s drug division, told the New York Times last week.

The problem is hardly new. In 1996, FDA Commissioner David Kessler warned Congress about what he called this “shadow industry.” Their activities — mixing drugs to create new ones — is comparable to what pharmaceutical manufacturers do. The FDA sets tough sterility standards. Drug firms can’t market their products without FDA approval. Without adequate federal standards and regulations, he said, the drugs produced by these firms “could result in serious adverse effects, including death.”

In 2007, Senators Edward Kennedy (D, Mass.), Pat Roberts (R, Kan.), and Richard Burr (R, N.C.) proposed the Safe Compounding Drug Act to bring these drug makers within the FDA’s authority and set standards, inspect facilities, and regulate interstate sales.

A coalition of nine pharmacy organizations — in reality, drug companies — claimed that the legislation would “negatively impact patient access to necessary compounded prescription medications.”

In the face of that industry mobilization, Kennedy’s legislation never made it out of committee and no other legislation has generated much momentum.

Since 2007, The National Community Pharmacists Association (NCPA) has spent about $2 million on campaign contributions and over $4.3 million in lobbying, according to the Center for Responsive Politics, a nonprofit watchdog group. During that period, its sister organization, the International Academy of Compounding Pharmacists, has spent over $1 million on these political influence-peddling activities

Industry groups inundated Capitol Hill with campaign contributions and lobbyists, voicing the familiar predictions of disaster. They denied there was a problem that required federal regulation since “state boards of pharmacy have done a great job,” according to L.D. King, executive director of the International Academy of Compounding Pharmacists (IACP), the lobby group for this wing of the drug industry. Another IACP official, David Miller, warned that FDA regulations would “strangle the industry.”

quoted from here