FDA board memberships are a matter of public record, and are readily available at the FDA website. On the current FDA Science Board, I only see one person listed as a pharmacologist, and he is actually a university professor. I do not see a single person whose professional qualifications suggest past employment at a pharmaceutical company. The FDA makes public the laws and regulations regarding who may sit on a committee, and there is a specific guidance that addresses conflicts of interest. If people with a financial interest in the outcome of any drug review panel's decision choose to misrepresent themselves so as to gain membership on the panel, they are breaking the law--you can't claim that the FDA condones or supports their actions.
Look how the drug companies are allowed to leave out studies which show side effects and non-efficacy. FDA approval has become a complete joke.
They're not "allowed" to leave out studies. Companies that choose to omit relevant data are, in fact, breaking the law. You can't blame the FDA for criminal acts committed by persons not affiliated with the FDA.
Look at how many drugs were introduced after approval and later turned out to be deadly under normal use. Then it turns out that the negative information was known before approval.
Please provide a list of these drugs, along with the evidence that the FDA was complicit in allowing companies to flout the law so as to gain regulatory approval.
Since stage 3 clinical trials typically enroll from 1,000 - 3,000 patients, it is very likely that a drug that causes lethal complications in 1 out of 10,000 patients won't be caught during clinical trials. That is why there is a post-approval stage 4 trial, and the FDA maintains an adverse event reporting system. The fact that FDA withdraws approval from drugs that later turn out to be too risky in relation to the benefit they provide is an indication that the FDA is doing its job.
Anyone developing a drug with intent to gain regulatory approval is required to register the clinical trials with the FDA. These trials are all publically available at www.clinicaltrials.gov. Likewise, you can examine all the relevant regulations, procedures, etc., etc., at the FDA website. It is, IMHO, a very user friendly site.
The FDA needs serious reform. At least Rand Paul understands that.
The only "reform" I would agree that the FDA needs is actually a reform of the politicians trying to use the FDA to force people to conform to a diet the politicians approve of. Trying to control the amount of salt or saturated fat one consumes is way outside of the FDA's regulatory purview and constitutional mandate, and should remain so.
I've also looked at Rand Paul's proposal, and see a combination of grandstanding and relaxing of current regulations. If you're upset that it is possible for companies to break the law and misrepresent their drug to the FDA to gain approval, it makes no sense that you would want the regulations weakened--logically, you'd want mechanisms for stronger enforcement of the regulations. Rand Paul's "Part I: Health Freedom Act" weakens the regulations with this provision: Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to deem a food to be misbranded only when its label includes a claim adjudicated to be false and/or misleading. That would mean that the FDA would actually be required to go to court to force manufacturers to remove false claims from their product. Under current regulations, the FDA sends a warning letter, giving the manufacturer the option of voluntarily changing their product labeling; only if the manufacturer persists in making false claims will the court route be taken. By requiring that the court route be the first recourse, many manufacturers will be able to get away with false claims, since the court option is time-consuming and costly, limiting the number of false claims the FDA can actually deal with.
A couple of examples of Rand Paul's grandstanding are these, also found in "Part I":
■ Stops the FDA from censoring truthful claims about the curative, mitigative, or preventative effects of dietary supplements.
■ Stops the FDA from prohibiting the distribution of scientific articles and publications regarding the role of nutrients in protecting against disease.
The FDA does not censor truthful claims. A claim that is supported by solid peer-reviewed studies (which are publically databased over at www.PubMed.org) won't be censored. For example, the Quaker Oats company is well within its legal right to claim that consumption of soluble fiber (such as that found in oats) may help heart health, because numerous peer-reviewed studies support that claim. Nor does the FDA prohibit the distribution of scientific articles and publications. These are all publically available through PubMed. There may be copyright issues with distributing scientific literature without the consent of the copyright owner--but that concerns a different governmental agency, not the FDA.