To answer your question about off-label uses:
http://www.fda.gov/cder/guidance/105-115.htm#SEC. 401
Section 401 of the FDA Modernization Act.
b) Specific Requirements.--A manufacturer may disseminate
information under subsection (a) on a new use only if--
``(1)(A) in the case of a drug, there is in effect for the
drug an application filed under subsection (b) or (j) of section
505 or a biologics license issued under section 351 of the
Public Health Service Act; or
``(B) in the case of a device, the device is being
commercially distributed in accordance with a regulation under
subsection (d) or (e) of section 513, an order under subsection
(f) of such section, or the approval of an application under
section 515;
``(2) the information meets the requirements of section 552;
``(3) the information to be disseminated is not derived from
clinical research conducted by another manufacturer or if it was
derived from research conducted by another manufacturer, the
manufacturer disseminating the information has the permission of
such other manufacturer to make the dissemination;
``(4) the manufacturer has, 60 days before such
dissemination, submitted to the Secretary--
``(A) a copy of the information to be disseminated;
and
``(B) any clinical trial information the
manufacturer has relating to the safety or effectiveness
of the new use, any reports of clinical experience
pertinent to the safety of the new use, and a summary of
such information;
``(5) the manufacturer has complied with the requirements of
section 554 (relating to a supplemental application for such
use);
``(6) the manufacturer includes along with the information
to be disseminated under this subsection--
``(A) a prominently displayed statement that
discloses--
``(i) that the information concerns a use of a
drug or device that has not been approved or
cleared by the Food and Drug Administration;
``(ii) if applicable, that the information is
being disseminated at the expense of the
manufacturer;
``(iii) if applicable, the name of any authors
of the information who are employees of,
consultants to, or have received compensation
from, the manufacturer, or who have a significant
financial interest in the manufacturer;
``(iv) the official labeling for the drug or
device and all updates with respect to the
labeling;
``(v) if applicable, a statement that there
are products or treatments that have been approved
or cleared for the use that is the subject of the
information being disseminated pursuant to
subsection (a)(1); and
``(vi) the identification of any person that
has provided funding for the conduct of a study
relating to the new use of a drug or device for
which such information is being disseminated; and
``(B) a bibliography of other articles from a
scientific reference publication or scientific or
medical journal that
[[Page 111 STAT. 2358]]
have been previously published about the use of the drug
or device covered by the information disseminated
(unless the information already includes such
bibliography).
``(c) Additional Information.--If the Secretary determines, after
providing notice of such determination and an opportunity for a meeting
with respect to such determination, that the information submitted by a
manufacturer under subsection (b)(3)(B), with respect to the use of a
drug or device for which the manufacturer intends to disseminate
information, fails to provide data, analyses, or other written matter
that is objective and balanced, the Secretary may require the
manufacturer to disseminate--
``(1) additional objective and scientifically sound
information that pertains to the safety or effectiveness of the
use and is necessary to provide objectivity and balance,
including any information that the manufacturer has submitted to
the Secretary or, where appropriate, a summary of such
information or any other information that the Secretary has
authority to make available to the public; and
``(2) an objective statement of the Secretary, based on data
or other scientifically sound information available to the
Secretary, that bears on the safety or effectiveness of the new
use of the drug or device.
As to using drugs in children, it is true that many drugs have not specifically been tested for children. They have been tested for adults and the results are extrapolated. Howeve,r the FDA is currently pushing for more testing in children, so that specific effects and reactions can be identified. See here:
http://www.fda.gov/fdac/special/newdrug/kidmed.html
As to vaccines, try here:
http://www.fda.gov/fdac/features/095_vacc.html
All this is about 30 minutes of looking on the FDA's website. The results are compared to other vaccines; the vaccines currently in use have been tested and found safe and effective, thus new vaccines must be measured against existing ones to see if they are as safe as exiting vaccines, and if they provide a higher level of protection. Now, tthey do not mention (nor do I know yet) if they include placebo or not, but they do measure against the baseline (the general population that does not recieve the new vaccine).
More information is available here:
http://www.cdc.gov/nip/vacsafe/#Prelicensure.
From that page:
"Typically these trials last several years. Because the vaccinated group can be compared to those who have not received the vaccine, researchers are able to identify true side effects."
In other words, they compare vaccine to unvaccinated. If anything, this would increase the side-effect picture of the vaccines (many people experience side-effects because of placebo effect, especially when warned beforehand that they may experience a side effect).
And sorry to be so harsh in my first post, but these are really issues that set me off. Especially when answers are so readily available. The FDA does not approve off-label use, but does regulate it, as section 401 of the Modernization act states.
IN any case, even if your assertions are true, this does not really say anything bad about conventional medicine compared to homeopathy. Homeopathic rememdies do no testing for efficiency, and little testing for safety. Where as a vaccine might easily be in trials for ten years or more, and a new drug five to ten years in some case, homeopathic remedies are covered under the "dietary supplement" regulations. From the fda (
http://www.cfsan.fda.gov/~dms/supplmnt.html):
"FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading.
FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.
Almost all the regulation here is after-the-fact and based on voluntary reporting from the manufacturers and users.
