Talk:Food and Drug Administration/Archive 1

Archive 1

Archive 2

Criticism of page

I moved the following quote to this section for a better format on the discussion page: "The explanation given is comprehensive. While the FDA may have some value, I find that hypotheses questionable, this is a mega growth in the US Government gone wild (cancerous). You may spend vast amounts of ink, describing departments, objectives, mandates, job descriptions, create any number of organizational charts etc. In the end the FDA is government sponsored rubber stamp of approval for the pharmaceutical companies. The Data used to qualify a drug is researched and you guessed it, provided to the FDA for approval. The FDA personnel considering a drug approval procedure are subsidized and routinely supervised by the submittttttttttttting pharmaceutical company. There is legislation being considered that exempts drug companies from lawsuits if in fact the drug in question has been approved by the FDA. Hhmmmm Vinmax - I know this is no soap box, but people don't waste your time describing chaos."

I disagree with the above comments. FDA does not merely "rubber stamp" pharmaceutical company's studies. They actually do a good job of requiring companies to submit adequate data to support a claim that the drugs are safe and effective. This is much more than is done for many other products. Most other products and even dangerous products (e.g. cars, heavey machinery) do not have to go through government pre-approval before they can enter the marketplace.

As for the claim that "FDA personnel considering drug approval procedure are subsidized", well that may be true to the extent that user fees under MDUFA and PDUFA help pay for drug approval, but that was intended to temper critics that claimed that USA had a drug lag behind other countries because we did not adequate fund the FDA. While some have claimed that these user fees have made FDA beholden to the industry, there is not much hard evidence to back up these claims.

As for legislation that bars drug companies from lawusits after FDA has approved the drug, the idea behind this is that FDA sets the standards for a drug to be safe and effective. Once a pharmaceutical company can past that test, all they get to do is put their drug on the market. They can't force anyone to take it. In fact, consumers have to go through a doctor (or what is referred to in law as the "learned intermediary") to even get the pharmaceutical companies product. And even then pharmaceutical companies are required to give you, along with the drug, prescribing info where they have to disclose all serious side effects that came up in the studies. Thus, there seems to be a legitimate argument that preemption may be warrented for pharmaceutical companies as long as they allow FDA full access to all of its clinical data. Remember 03:37, 1 June 2006 (UTC)

Footnote format

I've applied a new footnote template to this article, which is described @ Wikipedia:Footnote3. Courtland 17:55, 2005 Mar 7 (UTC)

I feel attention is needed to this article

My feeling is that information that presents the FDA in a negative light in this article significantly outweighs information that reflects positively on the institution. I don't think this is a POV issue but rather a consequence (in part) of the current media coverage of FDA gaffs and the controversy that the agency has gotten itself into "recently". If more of a historical perspective could be provided, beyond a list of events / timeline, that would help significantly, I think.

Regards, Courtland 18:06, 2005 Mar 7 (UTC)

It could just be that there's a lot more bad about the FDA than there is good. RJII 05:25, 8 Mar 2005 (UTC)

I suspect that this is indeed the problem, not NPOV. I would suggest moving the criticisms to after the history and legislations section; otherwise, it isn't clear that there's a negative bias. It may simply be (see http://www.fdareview.org/harm.shtml ) that the FDA is a clearly and systemically harmful entity. —The preceding unsigned comment was added by 69.106.243.61 (talk • contribs) .

The fdareview.org site, while potentially useful, clearly has an overt agenda. For example, "We believe, however, that the health and well-being of Americans and others worldwide would be best served by more significant reductions in FDA powers." (on the "Reform Options" page).

I don't think citing a site with an explict POV to support a claim of NPOV is valid. A little work with Google found some controversy about The Independence Institute (who runs FDAreview.org). For example, this page at sourcewatch.org, which asserts TII has an explict agenda. Of course, I have no idea if sourcewatch.org is itself biased; I rather suspect they are. Point being: Linking to a website does not prove NPOV. Also, please sign your comments so we know who you are. Thanks! --DragonHawk 04:10, 18 January 2006 (UTC)

How does that illustrate a clearly overt agenda, rather than a conclusion? That said, I agree they have an agenda (or at least strongly held opinions), but my point in linking to the site here was just illustrative. More relevant in terms of removing the NPOV label would be to find out more broadly what the views are of economists who have studied the FDA. Is there a consensus about the effects of FDA powers, or are there widely held views, some concluding, for example, that the FDA powers are best as they are, and some concluding that they should be increased further? If so, this article should reflect that balance. What I think you will find, though, is a consensus critical of the FDA along the lines of the current Wikipedia article. (But please correct me if I am wrong.) 69.106.243.61 03:31, 19 January 2006 (UTC)

At very least shouldn't we include a reference to something like Marion Nestle's Food Politics (Berkeley: University of California Press, 2002), instead of just having the critiques of the FDA itself? from bill, 18:00, 9 Apr 2005 (EST)

I agree that this article needs cleanup. There should be more information on the organizational structure, the various centers/offices/etc, and their missions and activities. I suspect the various centers don't need their own articles, but can be adequately described in the context of this one. There should be more on the history of the FDA -- not just a list of events, but commentary on how those events influenced the creation/direction of the FDA. I also think the controversy section is currently very biased against the FDA. I have changed the section name to "criticism" to try and reflect this. The section makes many citations, but most of them are to works which are overtly against some or all of the FDA. While I think it is very important that we do report on such criticisms, we also need to maintain a NPOV. However much any of us may dislike the FDA, we need to stick to reporting facts in an unbiased manner, not regurgitating the opinions of others. I can probabbly do some work on the description section -- the FDA website has various info -- but I'm not sure how to tackle the critisim section. Anyone have ideas? --DragonHawk 01:33, 9 January 2006 (UTC)

While I agree that this article needs cleanup, I don't believe that using a POV website reference is invalid in an NPOV article. It has to be made clear that sources may be POV and that their opinions constitute a part of the whole context of the FDA Vanessa kelly 20:30, 24 January 2006 (UTC)

On the other hand, there seem to be an awful lot of criticism links--they outnumber informational links by 2:1. JDowning 18:20, 24 April 2006 (UTC)

I agree that the article is extremely biased and lacks substantial information about FDA. At the very least, a short blurb on each of the centers within FDA would be a good start. I also think that there is enough information about each of the centers that would be useful to a general reader that the centers probably deserve their own pages. A more complete history of FDA is also needed. I will start working on updating the History section - it's a favorite topic of mine. If anyone is working on the organizational structure and needs help, let me know. FDA's GMP's for the 21st Century initiative is probably also worth a mention and short explanation. --MEGaMark 14:34, 15 July 2006 (UTC)

Bravo! Excellent suggestions. The criticism in the current article is so overwealming in part because all FDA functions are addressed together. Separate articles on each Center will put related criticisms in those separate articles. With related criticisms drawn together, it should be less difficult to return to NPOV than with everything jumbled together - and some Centers simply receive less criticism than others.

Go to it. I've always thought that addrssing the history is an effective way to find a good structure and also to give perspective (context) to both criticisms and achievements. Even if you don't establish separate articles for each center, criticism ought to be a subsection of each Center's section in the article. Pzavon 23:37, 15 July 2006 (UTC)

I think this article does suffer from POV issues, mainly in the last half. If you look at the news, there's more bad than good--that's true. But that's true for ANYTHING that's covered in the news--not just the FDA. While the FDA can be @$&% frustrating at times (VERY, VERY bureaucratic: 500 pieces of paperwork, submitted in the proper order--no, that's NOT enough, you need more tests, submit test results and 100 more pieces of paperwork...), they keep a lot of questionable stuff off of the market that few outside of the medical industry (where I work) ever hear about.
While medical companies keep track of their competitor's failed projects and FDA warnings, the news industry never reports this stuff--because this ususally happens as a way of preventing death or injury (much more often than as a reaction to it). Hearing, say, that the FDA stopped a questionable product at the border (for lists of this stuff, see [1]) just never makes the news. Their watching over of public health just shows up as "don't use this product warnings" (see [2] and [3]). Even when the FDA shuts down production plants of major companies because of safety issues, ([4]), this doesn't seem to make anything but the local area's news and medical industry publications.
One thing I do agree with: they do keep some useful stuff off of the market, mainly by requring extensive (=$$$) safety testing on products (often, frankly, on products that aren't likely to cause any harm) with such a small market that the cost could never be recouped.
Also--they are VERY bureaucratic. (I know I said that before, but it bears repeating....)
Still ... this doesn't justify the long list of unbalanced negative stuff in this article.
JDowning 21:18, 18 April 2006 (UTC)

Criticism

Nothing is said in the article about the FDA causing inflated drug prices. Anyone care to work on that? RJII 06:18, 9 August 2005 (UTC)

Do you have any particular sources in mind? I can check the library for book references, does anyone have a good internet source? Vanessa kelly 20:31, 24 January 2006 (UTC)

I don't think the FDA is particulary at fault here; the greater issue with drug prices seems to be that the US funds more than its share of research and development through higher US drug prices than could be sustained in most other countries. JM Dahl 17:10, 25 May 2006 (UTC)

Regarding "FDA heads and G.D. Searle & Company"

G.D. Searle has not been a company for some years. G.D. Searle was acquired by Monsanto in 1985 and became Monsanto's pharmaceutical unit. In 2000 Monsanto merged with Pharmacia and Upjohn to form Pharmacia. Pharmacia chose to eliminate the G.D. Searle name. In 2003 Pfizer acquired Pharmacia, eliminating any vestiges of the former G.D. Searle. Pfizer closed the Skokie location, which was the original headquarters for G.D. Searle. I am not sure how all of this fits in with the claims about FDA heads and G.D. Searle & Company. Anyone have a suggestion? —The preceding unsigned comment was added by Steve Vinson (talk • contribs) .

The FDA is the most corrupt organization in the world. As long as the FDA regulates things in America, people will die and suffer because of the FDA not wanting to cure anything. —The preceding unsigned comment was added by 216.229.223.252 (talk • contribs) .

I really think that this section should be moved to perhaps a page that discusses FDA and accusations against it in regards to its role with aspertame. To put these accusations on the general FDA article page, I think is a poor representation for wikipedia. - User Remember

I support taking this section out of this article. I will leave it up to someone else to decide whether another article is needed. --Steve Vinson 03:39, 8 October 2005 (UTC)

This article was referred to in...

Morgan Spurlock's "Don't eat this book." :) That's nice to know. —The preceding unsigned comment was added by Occono (talk • contribs) .

Dietary supplement section

This needs a lot of work. I know that a lot of supporters of dietary supplements are frustrated by FDA prohibiting drug claims, but FDA has a valid argument that under the law only drugs can make drug claims. In order for dietary supplements to make drug claims they would have to be supported by the same level of evidence and go through the same approval process as all other drugs. They have tried to create a middle ground for dietary supplements, but this argument is currently ignored by the article. Remember 12:25, 15 December 2006

Criticism overload

There is an imbalance between the actual description of the FDAs function (including its legal remit) and the MASSIVE criticism section. I'm wondering whether someone could expand the "non-critical" part of the article. Shall we dare an email to the FDA press office? At some point, the FDA may send Jimbo an email. JFW | T@lk 22:15, 30 January 2006 (UTC)

I agree that the article is less of a description of the agency. I'd suggest splitting the criticism to its own article, e.g. "Controversies involving the FDA" or some such. -- Gyrofrog (talk) 02:25, 2 March 2006 (UTC)

You see some of the same criticism overloads with company pages like The Coca-Cola Company and IBM. You might work to expand the other parts of the article and tighten up the criticisms sections to state them more concisely or in less detail, but splitting all the criticism off to another page is going to be seen by some as white-washing POV. AUTiger ʃ ^talk/_work 06:18, 2 March 2006 (UTC)

I have promoted both the NPOV and claims tag to cover the whole Criticism section, and not just a subsection within it. This whole section is in great need of rework. I would agree that perhaps it would be wise to split that section off into its own article, so that the main FDA article can place a more dispassionate focus on the verifiable facts of what the FDA is and what it does. Thanks, Argon233 ^T C _@ ¶  18:21, 24 April 2006 (UTC)

I don't know if it needs an entirely new entry for "Criticisms", but certainly more of the article focuses on the criticisms of the FDA and is very subjective in its broad POV with criticism being a large consideration. At this point, a serious way to improve this article, as is suggested above, would be to add factual information to the article regarding the function, participants and expertise of the agency. Certainly, the criticisms need to be segregated or sectioned from the rest of the article. Stevenmitchell 01:58, 9 June 2006 (UTC)

Weak Citation

I cut the following from the article: "It costs approximiately $800 million dollars to bring a drug to market in the U.S. [5]" The citation for this was to an article from a partisan magazine that itself did not provide a citation as to what agency or study produced this estimate. Until the source of this number can be properly cited, this figure should not appear in this article.

Ok, I put it back in with a different sources that cites the study. RJII 04:14, 10 February 2006 (UTC)

I tracked that cite down to a more original source, and cited that. I also included some of "the other side," and a link since that $800 million figure is very controversial. I made some other minor edits to that paragraph and the one following it, too. I hope this seems a helpful improvement. 12.210.83.193 05:25, 10 February 2006 (UTC) Whoops. Forgot (again) to sign. ThaddeusFrye 05:26, 10 February 2006 (UTC)

Unfortunately the site that disputes it doesn't say whose disputing it --doesn't cite any studies. How is what is said credible? So I could delete that by the same justification you deleted the claim couldn't I? RJII 05:32, 10 February 2006 (UTC)

The document I link to is a criticism of Dimasi's methodology, and not itself a study. It relies on claims and methods however from a report from an OTA report: Pharmaceutical R&D: Cost, Risks, and Reward (available here: http://www.wws.princeton.edu/ota/disk1/1993/9336_n.html), which could be cited as a study in article, but which seems to introduce more detail and complexity than is warranted here, especially since the OTA report is pretty easy to find via the Public Citizen critique that I linked to. ThaddeusFrye 05:50, 10 February 2006 (UTC)

IS IT REALLY TRUE?

some people think that the FDA bans certain drugs and plants. maybe that ought to be put in the controversy article. just a suggestion.

Of course the FDA bans certain drugs and plants when they are perceived as harmful by review panelists. What are you suggesting? JFW | T@lk 22:31, 13 February 2006 (UTC)

FDA conspiracy theories

I'm uneasy about having an entire See Also section with a solitary link to FDA conspiracy theories. I would feel better about it if the article in question were solidly formatted, spell-checked, wikified, and otherwise fleshed out. As is, it doesn't seem to provide much extra information. Mistercow 03:15, 16 March 2006 (UTC)

Wilhelm Reich

I think this section needs to be re-worked. First, I'm not sure that the whole incident really impacted FDA early reputation that much. I would like some sort of citation that shows how FDA's reputation was hurt by this action. While in retrospect people may find this action to be wrong, that doesn't mean at the time FDA actually lost clout because of it. Second, it is incorrect to state that FDA "jailing Reich and ordering the burning of his published works." FDA does not have the power to do this. Only a court can. While FDA could make this request, the entry should be reworded to reflect the fact that FDA does not have this power. Third, I'm not sure this entry is a big enough part of FDA's history to warrant being on their primary FDA article and all of this could be described on the Wilhelm Reich article with a simple link to this page on the FDA main page. Let me know what others think. Remember 13:07, 5 April 2006 (UTC)

If anyone can fish up some citations and correct the facts (like who actually ordered Wilhelm jailed), I think this bit should stay. While not typical of what the FDA does do, it's typical of what the FDA would like to do (with justification, in my personal opinion--though jail for Mr. Reich was a bit extreme. He was nuts *again, my opinion,* not criminal.). See this FDA explanation of goals: [6]. Perhaps this could be worked in--the power the FDA would like to have, vs. what it currently does have and what it, theoretically, ought to have. Mr. Reich is a good example, I think, of what the FDA would really, really like to do. Especially, say, with the promoters of laetrile. JDowning 21:40, 18 April 2006 (UTC)

Drug prices debate sections

The sections on criticism of the FDA and it's role in the drug prices debate seems to be both original research and not NPOV. Their are various unsourced counter-arguments in the sections and the critics arguments are not well fleshed out either. Their seems to be a "critics claim...but the reality is..." format to the counter arguments. Almost seems as if it was written by PhRMA (the US pharmaceutical lobbying group). --Cab88 08:21, 22 April 2006 (UTC)

Censorship section

This seems to have POV problems--it's fairly one-sided. Limiting health claims can be viewed as censorship, but it can also be viewed as a way of preventing manufacturers from claiming unproven (and, concievably, nonexistent) health beneifts for their products. To see how bad things used to be before the FDA started regulating labels, you can look at their gallery--it even has a photograph of genuine Snake Oil. FDA gallery (Just to make things worse, even generally reputable pharmaceutical companies produced nostrums with such silly claims--something likely to confuse ill people looking for a genuine cure.) JDowning 16:25, 24 April 2006 (UTC)

Remember it is a criticism section, so it is going to be "fairly one-sided." Maybe create a "support" section? I think it's pretty clear that the censorship (and that's exactly what it is) has good and bad effects. It prevents both incorrect and correct information from being revealed. The question is whether a central authority should force their judgement on what is incorrect and correct on everyone else. If a claim hasn't been shown to be fraudulent in a court of law, what justifies censorship? RJII 18:43, 24 April 2006 (UTC)

The censorship is justified because that is the way the law was written. FDA doesn't write the statutes; Congress does. Congress told FDA that a drug is something that is intended to be a drug. Therefore, it puts FDA in the odd position of regulating any disease claim on a product. Once a product claims to cure or mitigate a disease, the manufacturer must show that the product is safe and effective through clinical trials because that is what the law requires.

You may not like the fact that FDA restricts certain claims from appearing on certain products, but one would have to admit that they have a good legal basis for going after these claims. Remember 21:48, 24 April 2006 (UTC)

"Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances." U.S. Constitution. RJII 05:05, 25 April 2006 (UTC)

I'm not trying to get into a First Amendment debate, but just because the Constitution has this language in it does not mean that Congress can't give FDA the power to restrict drug claims on products. At least that is what the Supreme Court says, and usually they are the one that get to decide such things. Remember 12:12, 25 April 2006 (UTC)

Conflicts of interest

An interesting paper in this week's JAMA, and potentially worthy of inclusion in this article: "Financial Conflict of Interest Disclosure and Voting Patterns at Food and Drug Administration Drug Advisory Committee Meetings". Basically, many members of advisory panels disclose potential conflicts of interest, and this may influence their voting, but if their votes are disregarded there is not much difference in the outcome of the meetings.

I'm interested to hear responses on this one! JFW | T@lk 22:10, 25 April 2006 (UTC)

"Final Rule"

Is this true? If so, it should be added to the article as it seems to be big news:

In an unprecedented power grab, the FDA has declared that all drug companies are now immune to lawsuits on any drug that has been granted FDA approval. It's the biggest handout to drug companies ever, and the action further establishes the FDA as a rogue agency acting to protect Big Pharma, with no respect for the laws of the land or the safety of health consumers. http://www.newstarget.com/019497.html Badagnani 12:44, 2 July 2006 (UTC)

It is true to the extent that FDA has stated that it believes that FDA's approval of prescription drug labeling preempts state courts from second-guessing this labeling in a tort action. While this will insulate pharmaceutical companies from tort damages in some cases, FDA argues that this action is fair considering the fact that FDA's approval of the labeling represents both the minimum and maximum that an drug company is allowed to do. Therefore, it would be unjust to hold a drug company liable in state court for failing to place a warning on a label when the federal government (i.e., FDA) prohibited them from placing such warning on the label. This is not really that big of news, FDA has been arguing for preemption for awhile. In addition, one should note that what FDA says in the preamble to final rules is not binding law, but just the agency's opinion on a matter. Remember 18:00, 3 July 2006 (UTC)

Card blanche / Final rule

I've introduced some text regarding this in the article.

Such is a definite trend in law-making: compare the European Union's GMO-directive, which says that companies shall never be accountable when a GMO was approved at a time when no scientific evidence was around to prove it unsafe. The definition of scientific is, of course, peer-reviewed. And safety-research is seldom peer-reviewed. Would such a company know themselves, or find out later, that there are problems, they need not do anything, since at the time of approval it was not "state of the art" knowledge that there was a problem. — Xiutwel (talk) 15:10, 4 July 2006 (UTC)

That looks to me like two separate examples intended to support that particular criticism, not like duplication.

Pzavon 23:27, 8 July 2006 (UTC)

different paragraphs saying pretty much the same thing

There are 2 different paragraphs in the criticism section that say the exact same thing. This involves the FDA protecting US drug companies from foreign competition. This may have been just an oversight.--Asulca593 03:08, 8 July 2006 (UTC)

actually.. i think IT IS NOT AN OVERSIGHT! i feel it is PROTECTING THIER PROFITS AND NOT US!! theres proof right there!Jackass358 02:35, 2 August 2006 (UTC)jackass358

Too pushed to FDA

IT seems to support the FDA too much

It really does in my opinion too. Bobafett12 08:22, 7 August 2006 (UTC)

FDA not only in US

There are actually several Food and Drug Administration Offices around the world. Direct linking of FDA and FDA in US omits other countries´ FDAs. For example, Thailand and Singapore have FDA and probably other countries, too, where English is a well-represented or official language. I would like to change the FDA page to be a general item describing FDA´s in general and then having links to national sites. Unfortunately I do not know how this could be done in an easy way. roki 01:39, 15 August 2006

While other countries do have their own administrations that regulation food and drugs, they are not all called FDA. If other countries have administrations that are called the "Food and Drug Administration" than we should retitle this page (something like FDA (United States) and create a disambiguation page so that people can get to the right FDA. But I don't think we should create one page that includes all the Food and Drug Administrations of every country. Remember 13:05, 15 August 2006 (UTC)

Just checked. The only countries with a "Food and Drug Administration" (with those words precisely) are Korea and Thailand. China has a "State Food and Drug Administration." Singapore has a "Health Sciences Authority." I concur with user Remember's position. Also, it seems to me, if disambiguation becomes necessary, we should keep the U.S. article at the current location and put the lesser-known Korean and Thailand organizations in separate articles. --Coolcaesar 21:18, 15 August 2006 (UTC)

rewrite

This entire article is a mess. It bugged me so bad that I started the process. I stopped at the criticisms section because that still contains a huge amount of biased material and I don't have time to evaluate all the facts presented.

NOTE: I did not omit any claims or change any facts present in the article before I started, I just organized it for readability and structure, which it badly needed (and the remainder still needs.)

Dennis 18:00, 24 August 2006 (UTC)

Confirmable evidence of FDA corruption, with proper referances

--Dream Focus 04:20, 13 September 2006 (UTC) There are a vast number of websites out there accussing the FDA of all sorts of things, but most of them, unfortunately, don't back it up.

It is well known that the FDA has a revolving door policy, where people that work there often get high paying jobs in the industry they are suppose to regulate.

http://www.google.com/search?hl=en&q=revolving+door+FDA&btnG=Google+Search

I added a link on the page for the Union for Concerned Scientist's website, using the name of their artical for the link. http://www.ucsusa.org/news/press_release/fda-scientists-pressured.html

FDA Scientists Pressured to Exclude, Alter Findings; Scientists Fear Retaliation for Voicing Safety Concerns from the Union for Concerned Scientist.

I only read the bottom few paragraphs of this next bit, it naming the FDA officials that approved something for a company they made money from, and how they fired the guy who made the original test and complained when they kept trying to alter the results. http://www.monitor.net/monitor/9904b/monsantofda.html

There is a lot more evidence like that around. Perhaps a page listing FDA corruption could be created seperately. What does everyone think about that? [user:Dream_Focus]

  I agree FDA corruption/criticism should be a separate wiki entry.[user:mcpucho]