Talk:Food and Drug Administration/Archive 1

message: 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)
thread_title: Criticism of page

message: 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)
replies: text: 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)

text: 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)
thread_title:  Criticism 

message: 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)
thread_title:  Regarding "FDA heads and G.D. Searle & Company" 

message: 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)
replies: text: 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)
replies: text: 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)
thread_title:  Criticism overload 

message: I cut the following from the article: "It costs approximiately $800 million dollars to bring a drug to market in the U.S. "  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)
replies: text: 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)
replies: text: 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)
replies: text: 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)
thread_title:  Weak Citation 

message: 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)
thread_title: IS IT REALLY TRUE?

message: 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)
thread_title:  FDA conspiracy theories 

message: 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)
replies: text: 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: .  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)
thread_title:  Wilhelm Reich 

message: 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)
thread_title:  Drug prices debate sections 

message: 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)
thread_title:  Conflicts of interest 

message: 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)
replies: text: 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)
thread_title: "Final Rule"

message: 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)
thread_title:  different paragraphs saying pretty much the same thing 

message: IT seems to support the FDA too much
  
 It really does in my opinion too. Bobafett12 08:22, 7 August 2006 (UTC)
thread_title:  Too pushed to FDA 

message: 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)
replies: text: 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)
thread_title:  FDA not only in US 

message: 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)
thread_title: rewrite

message: --Dream Focus 04:20, 13 September 2006 (UTC)
thread_title:  Confirmable evidence of FDA corruption, with proper referances