President Bush Signs US FDA Bill Into Law
As anticipated in a recent Pharmaceutical International News Item, the US President, George W. Bush, has now signed into law a new ruling strengthening the regulatory powers of the US Food and Drug Administration. The ruling previously received Congress approval.
Under its terms, the US FDA will gain much more control over drugs once, post-approval, they are available on the market. Additionally, it will be able to collect user fees from firms within the pharmaceutical industry, which will be injected into the administration until 2012. According to officials within the regulatory body, the fees - which have been quoted as millions of dollars - represent approximately 25 per cent of its total yearly budget. Instances where these fees will be charged include when applications for the body's approval of a new product are sought.
A further factor is the authority given to the body, whereby it can enforce rewrites of drug labels if a safety issue comes up. Furthermore, the FDA can carry out new assessments of products presently on the market, and place restrictions on the extent to which drugs are distributed. Also, it gains the authority to impose fines on firms that fail to carry out their own assessments of drugs.
Commenting on the revised US FDA, its Deputy Commissioner/Chief Medical Officer, Janet Woodcock, said: "On the whole, this provides new authority to promote and protect the public health."
Another component of the bill is the power by which the administration can demand that new entrants to the market join a risk-mitigation plan, through which the drugs in question can be monitored in terms of potential safety issues.
A considerable amount of flak has been projected at the US FDA in recent times, in regards to a number of high profile cases where approved drugs have caused side effects in patients. These include Merck's painkiller Vioxx, which was withdrawn three years ago. Another example is GlaxoSmithKline, whose Avandia diabetes drug was linked to an increased risk of heart attacks among its patients.
Under the terms of this new legislation, pharmaceutical firms are required to register each clinical trial they instigate with a central database - which is maintained by the National Institute of Health.
Source - Pharmaceutical International's US Correspondent
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