Huffington Post: What Are They Waiting For? (Ed Markey)

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What Are They Waiting For?
By Ed Markey
5.31.2005

The FDA must not look the other way in the life or death matter of drug company follow-up studies.

In December 2004, the Food and Drug Administration (FDA) announced that AstraZeneca's cancer product, Iressa -- which had been approved through the FDA's accelerated approval process -- was not an effective treatment for most cancer patients. When I first heard about this, I was shocked that more than 15,000 Americans were spending about $1,800 a month for a drug that probably wouldn't work in treating their cancer. After asking a few questions about this, what I learned was even more shocking than I had initially imagined.

In 1992, the Food and Drug Administration (FDA) established a process that amounted to a trade-off between its mission to ensure the effectiveness of the treatment and the need to speed promising new drugs to market to increase treatment options for life-threatening illnesses. Called "accelerated approval," this process allows FDA to approve a drug on an expedited basis using promising but limited information about its safety and effectiveness, but only on the condition that the company agrees to conduct further studies to confirm the safety and effectiveness of the product. Under the law, drug companies are required to do additional studies to confirm that the drug is safe, effective and works for its approved indication.

In searching for answers about how Iressa remained on the market, I found that the case of the Iressa was only the tip of the iceberg of the problems existing with the "accelerated approval" process -- approximately half of pharmaceutical companies neglect to complete these critical follow up studies. I am releasing a report today which reveals that of the 91 postmarketing studies required by the FDA, 42 studies have not been completed and half of the unfinished studies have not even started.

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http://www.huffingtonpost.com/theblog/archive/ed-markey/what-are-they-waiting-for_1920.html