• Personal Injury

    Posted on January 4th, 2011

    Written by sslates


    The Food and Drug Administration has been the subject of great criticism from California pharmaceutical liability attorneys because of its lax approval procedures. The concern over super-quick approvals of drugs that are not 100% safe for American consumers is probably the reason for the reduced number of drug approvals issued in 2010 by the agency.

    In 2010, just 21 new drugs were approved by the FDA, the lowest number since 2007. According to estimates based on the FDA database, the 21 drug approval tally is down from 25 approvals in 2009 and 24 in 2008.

    To California personal injury attorneys this may be an indication that the agency is now being much more cautious with its approvals, and is less likely to speed up drug approvals. Much of the criticism leveled against the federal agency has to do its approval processes, especially the controversial 510(k) approval process. Under this process, drugs or medical devices that are sufficiently similar to drugs or medical devices in the market, can be approved quicker, bypassing many of the normal rules and procedures.

    The rule has been severely misused by pharmaceutical companies and medical device makers, and has been the subject of severe criticism. In fact, California injury attorneys have called for a complete revocation of the rule and new rules requiring all pharmaceutical companies and medical device makers to go through the regular process before getting their devices and drugs approved.

    The rush to approve a drug so it can be released into the market as quickly as possible has often meant severe patient injuries, side effects, complications and even death. The agency’s new cautious approach, if true, is a welcome change from its attitude in the past.

    This entry was posted on Tuesday, January 4th, 2011 at 9:21 am and is filed under Personal Injury. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

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