FDA Amendment Act

The early phases of these efforts laid both the intellectual basis for the signing of the Drug Safety Law, namely the FDA Amendments Act (FDAAA), by President Bush on September 27, 2007, and the timing requirements for implementation under that Act. On March 4,2008, Senate Finance Committee member, Chuck Grassley (R-Iowa), called for a General Accountability Office investigation into how the FDA monitors safety and efficacy of approved drugs. 

Various stakeholders have recognized the need to improve current pharmacovigilance practice and the opportunities that exist to expand the use of observational data in that pursuit (Berlin 2008). In 2007, the U.S. Congress passed the FDA Amendment Act, which in part mandated the "establishment of a postmarket risk identification and analysis system" that leverages observational health-care data, including administrative claims and electronic health records (EHRs), to monitor approved medicines on a periodic basis. In response, FDA established the Sentinel Initiative, an effort to create and implement a national, integrated, electronic system for monitoring medical product safety (Platt et al. 2009). 

Under the FD C Act as enacted in 1938, adulterated and misbranded drugs may lawfully be exported but an unapproved new drug could not. This was a drafting error, but it was nonetheless enforced by FDA. Congress therefore enacted the Drug Export Amendments Act of 1986, which authorised the limited export of unapproved new human drugs and biological products after FDA had approved an export application. An export application could be approved only if... 

Another important component of most vaccine formulations is a suitable preservative. The three most commonly used preservatives in available vaccines are phenol, 2-phenoxyethanol, and ethyl mercurithiosalicylate (thimerosal). Thimerosal, in particular, is used in multidose vials as an antimicrobial preservative. Concerns about the presence of mercury in thimerosal (25 pg/dose) has led to FDA stopping the use of this preservative in all vaccines by an amendment to the FDA Modernization Act of 1997. By 2001, thimerosal was removed from most childhood vaccines as a precautionary measure. The sources of all of the preservatives for vaccines are the same suppliers that supply preservatives for the parenteral dosage forms (J. T. Baker, Aldrich, Spectrum, etc. from U.S.A.). Table 2 lists some of the preservative concentrations in common vaccines. 

New devices. As part of the General Controls requirements, the FDA must be notified prior to marketing any new (or modifying an existing) device for patient use. This premarket notification, called the 510(k) process after the relevant section in the Medical Device Amendments Act, allows the FDA to review the device for safety and efltcacy. 

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