• Defective Drug Side Effects

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The U.S. Senate voted 93-to-1 on Wednesday to pass a new bill authorizing important new powers for the Food and Drug Administration (FDA). Drafted by senators Edward Kennedy (D-Mass.) and Michael B. Enzi (R-Wyo.), the bill provides for increased funding and powers to enable the FDA to better police the safety of drugs used by American consumers.

It is estimated that half of the adult U.S. population takes at least one prescription drug, and the safety of several of the drugs already on the U.S. market has been questioned in recent years. The FDA’s critics have noted the safety lapses regarding medications such as Rezulin, a diabetes drug linked to more than 500 deaths, and Vioxx, the painkiller that is now the subject of thousands of lawsuits because of an increased risk of heart attack.

The Bill’s Provisions

The Senate bill would double the number of FDA scientists assigned to monitor and flag high-risk side effects of medications on the market, and additionally would provide for:

• A reduction in the secrecy surrounding the drug development process. The new bill mandates public disclosure of most clinical trials and of internal FDA memos revealing the frequent dissent within the FDA about medications awaiting FDA approval

• Significant new fines for pharmaceutical companies that fail to comply with FDA regulations

• A computer database designed to monitor the safety of new medications released on the market, to provide more post-approval safety information that is currently lacking

• A voluntary program in which the FDA will review drug companies’ television commercials before they are aired, in an effort to address the many consumer complaints about misleading drug advertising on television

• New legal powers for the FDA to impose drug label warnings and changes in prescribing instructions for physicians, and the leverage to make pharmaceutical companies conduct additional safety studies

Bringing the FDA into the 21st Century

The former FDA Commissioner Mark B. McClellan said of the bill, "This is unquestionably the biggest change in the FDA's regulatory authority in a very long time…It is really a new era for the FDA that will start after this law is implemented." The House of Representatives is expected to offer its own version of FDA improvements that will be tougher on the pharmaceutical industry, perhaps getting the bill to President Bush for approval by summer 2007.

(Source: The Los Angeles Times)

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