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Corinne Ramey

The FDA Amendments Act of 2007, or the Law Inspired by 27,000 Lawsuits

Merck Pharmaceuticals has had a rough couple of years. Not only have they been sued by New York City, New York State, and 27,000 various individuals who suffered everything from strokes and heart attacks to death, but they've gotten loads of bad press, bad publicity, and a general bad reputation.

Merck, one of the largest pharmaceutical companies in the world, has been dragged to court repeatedly because of some tiny little pills that have some very big side effects: Vioxx.

Vioxx is a prescription painkiller that was one of the most widely prescribed drugs used for treating arthritis and other causes of acute pain. Since Vioxx was approved by the FDA as "safe and effective" in 1999, over 84 million people have taken the drug worldwide. However, Vioxx wasn't as safe as the FDA and Merck would have liked consumers to believe, as the medication was actually shown to lead to increased risk of strokes, heart attack and even sudden death.

Merck eventually withdrew the drug from the market in 2004, amid scandal that the company had kept results from clinical studies from the public and known of the risks but didn't want to curb the sales of its best-seller drug. More than 27,000 individuals sued the company, and Merck eventually settled for $4.85 billion, which may have actually been a "good deal," considering that "original estimates of Merck's liability reached as high as $50 billion." Several states also sued the company for the taxpayer money spent on Vioxx for use in Medicare and other public health programs. ''Merck's irresponsible and duplicitous conduct endangered the health of New Yorkers and wasted our tax dollars,'' said then Attorney General Andrew M. Cuomo. ''Even as evidence was piling up showing just how dangerous this drug was, Merck put profits above all else.''

Although Vioxx is no longer on the market or the leading story on the nightly news, concerns about regulation of drugs like Vioxx is part of what led to the FDA Amendments Act of 2007 (FDAAA). The bill passed with overwhelmingly bipartisan support -- 405-7 in the House and unanimously in the Senate -- and has been signed into law by the President. The FDAAA extends the scope of the FDA in several ways. It increases the fees that the FDA collects from drug companies to review new drug applications and requires some drug sponsors to conduct clinical trials on high-risk drugs after the drugs have already gone to market. The FDAAA also requires the FDA to establish pet food standards, encourages development of research and labeling for pediatric drugs, and establishes fines for ads that the FDA determines are false or misleading. The law also creates a database of clinical trial information that is searchable by the public and an adulterated food registry.

This bill is definitely a step in the right direction for the safety of the American middle class. As says,

"Middle-class Americans depend on over-the-counter and prescription drugs for everything from relieving aches and pains to sustaining life. Because these medications are so important, and because every drug has risks associated with it, the power this legislation provides the FDA to more closely regulate the pharmaceutical industry is vital. Middle class Americans, inundated with advertisements extolling the benefits of innumerable and at times indistinguishable medications, need the FDA to ensure that the drugs they rely upon are safe and appropriate for the individuals to whom they are marketed...A public database of clinical trial data with mandatory disclosure requirements will allow consumer advocacy groups, concerned academics, and products liability litigators, along with jealous industry competitors, to expose misinformation, ultimately protecting middle class consumers."

However, the new bill doesn't go far enough to reform an agency that Americans depend on for their health and safety. The FDA will still be reliant on industry fees, which some consumer watchdog groups charge can influence the agency's decision making. The creation of the food registry also doesn't go far enough, as the FDA still doesn't receive enough funding to inspect food imports and cannot order mandatory food recalls. Finally, the FDA should have more authority to regulate advertising, especially for newly released medicines, and be able to set conditions for drug distribution.

"If you could have identified Vioxx problems in three or four months instead of five years, it would have had a huge impact," said former FDA commissioner Dr. Mark McClellan at a health care conference. Undoubtedly it would have, and the FDAAA will hopefully prevent future Vioxx-type debacles from occurring in the future. However, what the middle class needs is an FDA with the power and lack of reliance on industry funding to create a system where Americans never have to worry about unsafe drugs or food.

Corinne Ramey: Author Bio | Other Posts
Posted at 7:00 AM, Dec 13, 2007 in
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