Is the FDA failing?

[BradleyRN]

With a booming pharmaceutical industry, the casualties from newly approved drugs have been in the news quite frequently. Drugs such as Rezulin, Celebrex, Vioxx, Fen Phen, Prempro, Bextra, and Avanida have all either been recalled, or required strict "black box warnings" regarding the potential serious risks of taking them. Sadly, after their release to the public, many people suffered liver and heart damage or strokes at the hands of some of these obviously under-scrutinized medications. At the same time, the pharmaceutical industry fought in court to defend them and keep them on the market, if only for a few extra months. How does the public not notice this profit-driven, underhanded lack of conscience on the part of pharmaceutical industry, who in the face of human beings suffering or even dying when taking their products, fight for years if necessary to keep them in use?

Now the pharmaceutical industry is fighting for legislation that prevents people from suing them, under the logic that the FDA had approved and deemed safe the drugs that may have caused the harm. If that legislation passes, then it will be long overdue for the FDA's unsound methods for drug approval to be revamped. At the same time, some drugs are able to go through a shortened approval process by the FDA. Rezulin was one of those, and it killed hundreds and caused permanent liver damage to thousands while it's manufacturer fought it's ban for 27 months before it was finally recalled. (drug recalls) The pharmaceutical lobby also recently halted legislation that would have put a stop to drug companies with name brand drugs paying generic manufacturers to delay the release of their generic equivalent. CBS reports that this practice will cost the public billions. How can that be legal in the first place?

It would seem that this pattern would eventually lead to a distrust in the safety of new drugs as well as the FDA's ability to provide an accurate assessment of their safety.

Do you believe the FDA is failing to effectively screen new drugs for their safety before release?

[BradleyRN]

The FDA merely says that if you claim your product cures, treats, or prevents diseases, you better damn well pony up the research on it.

"The disclaimer must also state that this product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim."

[hypocaffeinemia, BSN, RN]

Yes. If you such make a claim, you're legally defining yourself as a drug and therefore have to meet the stringent FDA drug standards.

The FDA is a regulatory agency, they didn't make the law.

[ozoneranger]

Pharma has more lobbyists in DC than we have representatives.

Patent holders from drug companies routinely sit on FDA panels & are allowed to vote to approve the very drug that stands to make them millionaires.

If you learn to navigate the FDA's web site, you'll discover that sometimes it's so dirty the "conflict of interest" statements are read behind closed doors & the information is never made public.

Sickening.....eh?