I recommend that anyone interested in this topic get ahold of a copy of each of the following:
White Coat, Black Hat: Adventures on the Dark Side of Medicine by Carl Elliot.
Watch Your Back!: How the Back Pain Industry Is Costing Us More and Giving Us Less by Richard A. Deyo
Huge federal regulatory agencies are not particularly good sources for consumer information, as they are subject to the governance from executive and legislative interests which answer to the influence of the pharmaceutical and medical devices lobbys. The direction of regulatory agencies is done by those either waiting to enter the well-paid ranks of executives in the for-profit 'health care' industry, or have recently left the regulated industry to join the ranks of the regulators. It is a revolving door in the worst possible way.
For those seeking a bit more reliable information on new pharmaceuticals or therapies, I recommend checking with the following two sources:
Cochrane Collaboration reviews...accessible online through the
Cochrane Library.
US Preventive Task Force Reports....also
available online.
These organizations are at the forefront of the emerging 'Evidence-Based Medicine' paradigm.