Talk:Food and Drug Administration/Archive 2

Add criticism?
Should we add "Red Yeast Rice" to the list of criticisms? Seems pretty important to me, since they banned a natural food just to protect the profits of a corporation.

75.73.201.199 04:08, 5 February 2007 (UTC)


 * Which corporation would that be? Lovastatin is generic - any company that submits proper evidence that their lovastatin preparation meets standards for purity, dose, and bioavailability can sell it. You shouldn't be able to evade the rules on drug marketing just because your lovastatin comes with mouldy rice.


 * To put it another way, should I be able to sell a mixture of pacific yew bark and rosy periwinkle leaves to cancer patients as an "Herbal Cancer Cure"? Both contain powerful chemicals used for chemotherapy, but they are appropriately regulated by the FDA.


 * This article is weak already because too many people have put in real or imagined pet peeves against the FDA.
 * Rustavo 00:23, 24 February 2007 (UTC)


 * Hear, hear, Rustavo...--Dr.michael.benjamin 04:24, 8 March 2007 (UTC)

Critique
I'm sad to say that most of the negative stuff in the article isn't really true. For example, FDA-regulated food coloring is safe, not dangerous. FDA is trying to take farm animal antibiotics off the market, but drug companies are fighting. There isn't any clear link between recombinant growth hormones in farm animals and human disease. If you add up a bunch of urban legends, it doesn't get you closer to the truth, people. Garbage is still garbage, even if there's a lot of it.--Dr.michael.benjamin 05:39, 6 March 2007 (UTC)

Drug packaging and distribution
I removed this criticism. There were no citations provided after a month, so it's unsubstantiated opinion. If anyone can find the basis for these statements, put it back up.--Dr.michael.benjamin 06:01, 9 March 2007 (UTC)
 * Good delete. I've been trying to find references for other people's work, but honestly, we shouldn't have to. Rustavo 21:51, 9 March 2007 (UTC)

Criticism

 * This section of the article is mostly point-of-view driven, and doesn't say much that is relevant to a scholarly discussion of the FDA. Also, the citations are of a poor quality.  I think it should be taken down (or moved to the discussion page).  I'll wait for comments here for a few days before acting...--Dr.michael.benjamin 04:55, 6 March 2007 (UTC)
 * I disagree with deleting the section entirely, see below. Rustavo 21:54, 9 March 2007 (UTC)

Controversy Section
I added a section on the FDA's role in the controversy over restrictions on who may donate blood. I attempted to explain the FDA's justification for the policy, but it's hard to do in the context of "controversy." I feel that the individual items under controversy need additional material to present a NPOV. I don't see an intentional bias, more a logical extension of the heading "controversy." It's not like that title naturally lends itself to a discussion of anything other than criticisms of the FDA. Ssbohio 08:03, 8 October 2005 (UTC)


 * I think it's probably ok, though need to double check FDA regulations of blood products--the section may not actually be true...--Dr.michael.benjamin 04:56, 6 March 2007 (UTC)


 * It appears to be legit. I cleaned it up a bit and added FDA refs. Rustavo 22:42, 9 March 2007 (UTC)

Imbalanced criticism section would require a separate article
I believe that a link to an article about the criticism of the FDA should be needed and preferred to the actual 80 percent criticism content of this article. It makes this article a little biased to see that most the space is spent on criticizing the FDA. I suggest a short paragraph commenting the criticism on the FDA and a link to an article containing the actual criticism section should be an approach far more appropriate for the neutrality and quality standards set by Wikipedia than what we can witness about this article at the present. Z E U S 06:54, 31 January 2007 (UTC)


 * The main problem is that the criticism section is disorganized and poorly referenced. There's plenty of criticism of the FDA, much of it justified, but currently the section is mostly unverified original research or weasel-worded "some have claimed..." statements. If the section is cleaned up and limited to verifiable criticism from reliable sources, presented neutrally, it should fit in here. MastCell 05:17, 5 February 2007 (UTC)


 * Unfortunately, many of the references in the criticism are from questionable secondary sources. For example, if one wishes to quote an enconomist regarding an estimate of the costs/benefits of FDA policies, the ref should be to a published, peer-reviewed journal article, not to a libertarian think-tank's paraphrase of a 25-year old PhD thesis (especially since FDA policies have been extensively revised since then). Rustavo 01:35, 7 March 2007 (UTC)


 * Absolutely. The Criticism section is such a morass that I've not waded all the way through yet, but I agree with your points. MastCell 17:25, 7 March 2007 (UTC)


 * Here's an idea. There are actually some interesting tidbits hidden among the criticism.  Like this: yes, the FDA probably contributes to the high cost of drug development, and some yahoo somewhere said that's not right and we should get rid of the FDA.  But replace the discussion of the yahoo's opinion with a discussion of the Prescription Drug User Fee Amendments program, and you now have a paragraph that is informative about the workings of the FDA, not currently a part of the article, and a discussion of the potential reasons how the FDA contributes to the high cost of drug development.  The criticism section is a hard slog, yes, but there is some opportunity there to add some more meat to the article. --Dr.michael.benjamin 07:35, 8 March 2007 (UTC)


 * I completely agree. I've been trying to gradually replace the "yahoo" and unreferenced criticisms with less subjective references that say similar things. Better to try to improve them before just deleting them. By the way, I'm not sure this was intentional, but you kinda messed up the organization of that section with your last edits - I'm going to re-group the criticisms the way they were. I think without grouping into "pro-reg" and "anti-reg" criticisms, it turns into a self-contradictory laundry list. Rustavo 02:21, 9 March 2007 (UTC)


 * Thanks for the nice story about ACT-UP--that adds a nice dimension to the article. I think the way to go is to take items out of the "criticism" section one by one, and make "real" sections out of them.  For example, "Criticism-high cost of drug development" becomes "PDUFA program".  The article will then become more information-rich, and less opinionated.  By the way, I read (a lot) of the EE report on IGF-1, and did a PubMed search, and there really isn't much known scientifically about the epidemiological effects of IGF-1 in human disease.  All the data are pre-clinical ("IGF does X or Y in cell culture").  I think the section on IGF regulation should reflect the scientific ambiguity.  In addition, whether IGF-1 causes human disease may not really be relevant to a page on the FDA--that's probably a debate for the IGF-1 page.--Dr.michael.benjamin 05:18, 9 March 2007 (UTC)


 * I agree with you in principle, but in reality, this is a controversial topic, and there will always be people introducing somewhat non-mainstream criticisms into the article. Some of these criticisms are major issues for the FDA, and they are worth mentioning, but in the past they have really interrupted the flow of the main article. I think "quarantining" them to a criticisms section is a necessary, if not ideal, solution. This doesn't mean we can't also strive to make the criticisms section as readable and accurate as possible. Rustavo 19:15, 9 March 2007 (UTC)

Reorganized criticism section
I tried to reorganise the criticism section to make it more coherent. I'd be interested in what people think. Rustavo 06:41, 23 February 2007 (UTC)


 * Looks like a good start. It was confusing with overregulation and underregulation complaints mixed together. Regulations 06:50, 23 February 2007 (UTC)


 * Although it kind of points up the bind the FDA is in... on the one hand, they get yelled at for supposedly over-regulating (supplements, ephedra), and on the other, for under-regulating (Vioxx, ephedra) - often by the same complainant. MastCell 19:57, 23 February 2007 (UTC)

Moved section from article
I've moved the following here from the article: ====Prescription drug labeling==== In the preamble to the new prescription drug regulations, which go into effect on June 30, the FDA has stated that it believes that the warnings it approves for prescription drugs represents both the minimum and maximum that a pharmaceutical company is allowed to state on its labeling. If courts adopted this theory of preemption, lawsuits against a pharmaceutical companies for failure to warn consumers on the possible dangers of a drug could not prevail if the FDA was fully aware of the information and did not require the warning. Essentially, the FDA is arguing that as a part of the federal government its decisions on what warnings should appear on labeling of a prescription drug product cannot be second-guessed by states or state courts because its federal action "preempts" states from regulating this arena. It should be noted that the FDA's pronouncements in the preambles to final rules are merely the FDA's interpretation of the law and have no binding effect on state or federal courts.

It's not clear what this section is trying to say, or how it's a criticism of the FDA. Also, the sources include an FDA page which is basically impenetrable and does not support the assertions made in the paragraph, and the second source is a clearly unreliable, highly partisan account of "the FDA's campaign against health consumers", from a site that also promotes, among other things, the Hoxsey method. Perhaps if it's clearer what the exact criticism is, and more reliable sources can be produced, we can reinsert the section. MastCell 00:53, 24 February 2007 (UTC)


 * I can explain more about this if you want but there is no need because it doesn't really belong in a criticism section. Remember 01:34, 24 February 2007 (UTC)


 * Do you have legal background? I think the main part of the article could definately use some filling out in terms of the major legal issues surrounding the FDA. A few months ago this article was basically one big criticism section, so I and others reshuffled a lot of things - I'm sorry if your section was inappropriately moved. Rustavo 19:07, 9 March 2007 (UTC)

New material
I reorganised the first part of the article and added details so that now there are separate sections for each of the major catagories of products the FDA regulates. The regulatory categories generally correspond to the major branches (centers) of the FDA, so I stuck those at the top. I filled out the drug regulation section with some details, but the other sections (especially food) could use some more work. Also it would be great if someone wrote a better history than the bullet points we have now. Let's try to quarantine controversy in the criticism section if possible.

Rustavo 08:20, 24 February 2007 (UTC)

rBGH in dairy cattle criticism
I have partially restored the entry in the criticism section on BGH. The last editor deleted all specific references to the concerns raised by the EU comission & others, including the potential for a role of IGF-1 in cancer and potential effects on the GI tract of infants. I'm passingly familiar with the medical literature on this subject (I am a medical professional), and from what I know the risks seem slight. However, these are the theoretical concerns raised by major industrialised nations in continuing a moratorium on this product, they are based on reasonable scientific premises, and they are widely discussed. I think it is appropriate to mention them specifically. Rustavo 03:22, 9 March 2007 (UTC)
 * Ok but let's make sure we state that there really is no literature on the risks of IGF-1 from BGH-treated cows, so criticism of the FDA on this point may not be founded on scientific information (I'm a medical professional too)...--Dr.michael.benjamin 06:25, 9 March 2007 (UTC)
 * Agreed, I think your last edit strikes a good balance.Rustavo 16:25, 9 March 2007 (UTC)

Criticism: Delays in drug approval section
The article says "For example, the recently approved HIV drug Fuzeon had a relatively brief approval process: the Investigative New Drug ("IND") application was submitted by the manufacturer on November 14, 1996, the New Drug Application ("NDA") was filed on September 16, 2002, the drug was made available for compassionate use in October of 2002, and final approval was granted on March 13, 2003." How can anyone contstrue that as a "brief approval process"? That's seven years! The claim that that is brief has to be changed. It's severely skewed POV. Before the Kefauver-Harris Billy, the average time from filing the IND to approval was seven MONTHS. Regulations 17:07, 9 March 2007 (UTC)


 * I agree with you that the Fuzeon example is not the strongest. The early HIV drugs were actually approved much more quickly (3 years for AZT I believe). Your claim that 7 months is a reasonable approval time for many drugs seems a bit silly though, given that a large proportion of new drugs treat chronic conditions and long-term effects are the primary indication. Even HIV is now essentially a chronic condition with existing medications. If you want to know how a drug affects patients over a five-year period, how could you do that study in seven months? It's unrealistic.Rustavo 18:55, 9 March 2007 (UTC)


 * It's about freedom, man. Don't you get it? Freedom of choice. Leave it to the individual to decide how much testing a drug should undergo before he takes it, whether it's 7 months, 2 years, 7 years, or 20 years. As long as the consumer has that information, he can make an informed decision and make his own life choices based on his own risk/reward scenarios. Not allowing individuals to make those decisions is tyranny over the individual. Only the individual himself is able to make those judgements. Only he himself knows what risks he is willing to take in light of the possible benefits. Regulations 19:37, 9 March 2007 (UTC)


 * No, I get that this is your point of view. Most patients are busy people - they prefer not to have to do months of reseach before deciding whether enough a drug is safe for them to take. Doctors are busy too - most of them rely to some extent on safety and efficacy information provided by the FDA, and based on mandated and regulated clinical trials. Your criticisms are represented on this page, but they should not be so extensive as to overwhelm factual information and other points of view. Rustavo 19:51, 9 March 2007 (UTC)


 * Patients prefer not having to do months of research? What? They would not be doing the research. They would just be looking at the label on the medicine to see who it is certified by, or check off a form at the pharmacists for the same, whether it's certified by the FDA or some other agency, like the American Hospital Formulary Service. The FDA can have as long as a certification process that it wants, but the consumer should be free to choose to purchase drugs that are not certified by the FDA as long as he knows that it was not certified by the FDA. The same argument applies to importation. People should be free to choose to buy drugs certified by other agencies outside the U.S. Leave the decision to the individual on how much risk he wants to take. A person is the owner of his own body. Regulations 20:07, 9 March 2007 (UTC)

Let's constrain the philosophical debate and focus on issues directly dealing with improving the article (see talk page guidelines). It might be worth including information on popular opinion (do people want the FDA to pre-approve their drugs?); for instance, I'm aware of a couple of community surveys (by Harris and the AARP) in which respondents expressed a preference for much greater regulation of the dietary supplement industry by the FDA than currently exists. MastCell 20:56, 9 March 2007 (UTC)


 * The same argument applies against the surveys you're talking about. It doesn't matter what a mob of people want. No majority of individuals should be allowed to prevent the individual from making his own decisions of what amount of testing he requires before he takes a medicine. So when you ask "do people want the FDA to pre-approve their drugs?," a survey doesn't answer that unless the survey results are unanimous. All it answers is what the majority wants. If the majority wants people the FDA to pre-approve THEIR drugs and PROHIBIT THEM from purchasing those drugs or dietary supplements when the FDA does not approve them, then let them have it their way. But don't decide for other individuals. Allow each individual the freedom to choose. If I want to purchase resveratrol, I should be allowed to purchase it whether the FDA approves it or not. No majority or government should forcibly prevent that. I alone know what risks I'm willing to take. Regulations 21:12, 9 March 2007 (UTC)


 * "It doesn't matter what a mob of people want"? I would argue it does matter, for better or for worse, if you live in a democracy. I understand your perspective, but the talk page is not the place for discussing your personal viewpoint; I proposed the surveys because they are sourced content that could conceivably be added to the encyclopedia. MastCell 22:29, 9 March 2007 (UTC)
 * Au contraire. "The United States relies on representative democracy, but [its] system of government is much more complex than that. [It is] not a simple representative democracy, but a constitutional republic in which majority rule is tempered by minority rights protected by law." (Scheb, John M. An Introduction to the American Legal System. Thomson Delmar Learning 2001. p. 6) "Unlike a pure democracy, in a constitutional republic, citizens are not governed by the majority of the people but by the rule of law.[1] Constitutional Republics are a deliberate attempt to diminish the threat of mobocracy thereby protecting minority groups from the tyranny of the majority by placing checks on the power of the majority of the population." (constitutional republic). You don't understand the principles behind the establishment of the United States if you think it is meant to be a place where majority rules. Do you know what kind of tyranny we would have if the majority were allowed to rule? Individual liberty must be protected and the majority must not be allowed to infringe on individual liberty. And essential to individual liberty is having the right to decide for oneself what medicine one injests without having someone forcibily interfere with your personal choice. Regulations 01:43, 10 March 2007 (UTC)

I removed reg's statement, which is identical in content to his statement in the preceeding paragraph, as well as the Fuzeon example which he was responding to. I think all sides of this particular criticism are well represented in the section as it stands now. If reg is looking to improve his case, perhaps he could find an authoritative reference to a RECENT example of an important or lifesaving drug whose availability in the U.S. has been significantly delayed by the FDA (i.e. since the major revisions of their approval processes in the past 10-15 years). Rustavo 05:38, 10 March 2007 (UTC)

"Last wordism" in the criticism section
I have noticed that some contributors are constantly trying to get the "last word" on items in the criticism section, which I think contributes to the occasional awkward and repetitive nature of these entries. I think it is best to keep these to a simple "point-counterpoint" format, in which the arguments for a criticism are given in the first part of the entry, and "responses" from the FDA or counterarguments from other sources are given in the second part. Rustavo 18:50, 9 March 2007 (UTC)


 * That's funny. I've noticed the reverse. The last word is attempted to be taken by those responding to the criticisms. Regulations 19:38, 9 March 2007 (UTC)


 * Correct: 1) Point, 2) Counterpoint. If you have another suggestion, I'm all ears. Rustavo 19:43, 9 March 2007 (UTC)


 * Well, since it is a Criticism section I think it only make sense that it conclude on a critical note. Regulations 19:46, 9 March 2007 (UTC)


 * Look, restating the same thing you said in the previous paragraph just to have the "last word" does not contribute positively to the article. I don't want to start a revert war, so we will see what others think: the section in question here is "Delays in drug approval". Rustavo 22:06, 9 March 2007 (UTC)
 * Rustavo, as usual, you have a reasonable approach. Maybe if the criticisms could be numbered, that would lead to better organization.--Dr.michael.benjamin 21:54, 13 March 2007 (UTC)

horrible smell in Dr. Pepper
has anyone else noticed a horrible smell in their cans of Dr. Pepper? —Preceding unsigned comment added by 68.69.41.16 (talk) 22:37, 22 January 2011 (UTC)

Kicking
Kicking the FDA: http://content.nejm.org/cgi/content/full/358/17/1774 (A. Wood, NEJM) JFW | T@lk  07:58, 24 April 2008 (UTC)

Off Label Use
Someone had a pretty sketchy definition of off-label use in the advertising section (chocked full of opinions about how great off-label useage was). I cut most of it away--it would be a good idea for someone to write a decent definition on off-label; perhaps create a new section. —Preceding unsigned comment added by 132.189.76.18 (talk) 18:10, 9 September 2009 (UTC)

External Links (and dead link repair notification zone)
I would like to add a link to a new page on the FDA site about a major hiring push the agency is making to get the word out to people who would like to apply for jobs. Is this appropriate use of the external links section? Jan Elicker (talk) 15:34, 9 May 2008 (UTC)


 * Moved section to end per policy for talk pages. It might be appropriate to include a discussion of the current talk regarding FDA's flat budget and ballooning responsibilities (http://www.nytimes.com/2008/04/16/washington/16fda.html?ref=us is an example reference) in the main text of the article and then include this as a reference in that discussion.  A generic plug for hiring is probably violating WP:EL.Somedumbyankee (talk) 15:55, 9 May 2008 (UTC)
 * Agree with yankee analysis, the link could only be included if there was some general encyclopedic discussion of the recent staffing issues at FDA. Remember (talk) 17:13, 9 May 2008 (UTC)

I added dead link repair zone. They need to be in one place. This is it. March 1 2010 references
 * 1) 2 "FDA commissioner". US FDA. http://www.fda.gov/oc/commissioners/hamburg.html. Retrieved 2009-05-27. dead
 * 2) 3 "FDA 2008 ORA Field Activities"  (PDF). US FDA. http://www.fda.gov/oc/oms/ofm/budget/2009/Narratives/8_ORA.pdf. Retrieved 2008-09-13.   dead
 * 3) 5 Summary of FDA’s FY 2008 Budget dead
 * 4) 10 http://www.dwrf.info/documents/recent_dev_bw_quality.pdfPDF (217 KB) dead
 * 5) 15 "Therapeutic Equivalence of Generic Drugs". U.S. Food and Drug Administration. 1998. http://www.fda.gov/cder/news/nightgenlett.htm. Retrieved 2007-10- 10. dead
 * 6) 30 FDA Website: Expanded Access and Expedited Approval of New Therapies Related to HIV/AIDS dead

Mydogtrouble (talk) 17:05, 1 March 2010 (UTC)

FDA Science and Mission at Risk
A new report issued by the Report of the Subcommittee on Science and Technology prepared for the FDA Science Board entitled "FDA Science and Mission at Risk". I think this should be added into the main document. I'm new here so maybe someone else should it it? If not I'll try and draft something up. Teebs85 (talk) 16:08, 18 June 2008 (UTC)

Melamine contamination scandal
The FDA has come in for some flack for moving too slowly over contaminated Chinese food products, and for its about-turn on acceptable melamine levels for infant formula. Is this worth a line or two? Ohconfucius (talk) 13:38, 30 November 2008 (UTC)


 * Short answer: A line or two at most unless real changes are made in response to the problem. Long answer: One of the challenges for this article is how to handle the ever-changing wave of "current hot topics" that the FDA has fingers in.  Generally speaking, an encyclopedia article is written based on what has happened without addressing the "current" events, but this is a place where Wikipedia is a little different.  I guess the question is: in the long-term vision of history, will this be considered a "notable event" in the history of FDA?  Unless substantial changes are made because of it (i.e. Thalidomide and Kefauver-Harris), it may simply be forgotten.  Other than that, it's simply a "current events" item that may be of interest, and how this article deals with WP:RECENT hasn't really been dealt with, and there are good arguments both ways.  SDY (talk) 20:30, 17 December 2008 (UTC)

I think it will be remembered long term for its failure to properly regulate dangerous levels of toxins in food especially the whole aspartame debacle. 149.254.217.43 (talk) 08:34, 19 September 2009 (UTC)

Corruption
FDA scientists complain to Obama of 'corruption'. I suggest integrating this into the "criticisms" section. --Jonathan108 (talk) 11:18, 9 January 2009 (UTC)

I think this area needs to be expanded. Might I suggest the addition of certain drugs/products etc that the FDA has 'vested interests'. Some examples would be Stevia, the withdrawal of Vioxx (rofecoxib), and the debasement of the heparin supply. What about the FDA consistently annihilating the first amendment rights of American citizens to pursue alternate/natural treatment options, and research into these treatments? Can anyone find references for this uncyclopaedia? MrAnderson7 (talk) 22:34, 24 November 2009 (UTC)

United States Food and Drug Administration?
Shouldn't the page be called "United States Food and Drug Administration"? WLU (t) (c) Wikipedia's rules: simple/complex 01:43, 18 February 2009 (UTC)


 * Why? II  | (t - c) 04:02, 18 February 2009 (UTC)
 * U.S. is a short form, United States is the full name. Or it could be moved to the main article of FDA, which is the most common abbreviation.  United States has the least ambiguity as well, U.S. can stand for other things.  See here.  It's curious because FDA redirects here, and it could be a candidate for the direct name of the page, but it's not.  Might be worth a RFC just because I'm not sure.  WLU (t) (c) Wikipedia's rules: simple/complex 12:02, 18 February 2009 (UTC)
 * You could also make a fair argument for "Food and Drug Administration (United States)" since neither US nor United States is part of the common, usual, or official name of the agency. SDY (talk) 03:01, 19 February 2009 (UTC)
 * I like that solution and have moved the page. WLU (t) (c) Wikipedia's rules: simple/complex 13:34, 24 April 2009 (UTC)

(undent) Just as a side comment, "USFDA" as an abbreviation is relatively common, especially internationally, and should be kept. SDY (talk) 15:23, 24 April 2009 (UTC)
 * BTW, if you check out the FDA's redesigned web site, they now call themselves the "U.S. Food and Drug Administration" and the web page is bookmarked as "U S Food and Drug Administration Home Page". --Kentmoraga (talk) 14:41, 25 January 2010 (UTC)


 * See also discussion at Wikipedia talk:WikiProject Medicine Zodon (talk) 20:24, 24 April 2009 (UTC)

What the hell just happened?
User:WLU just moved this article with no warning and for no apparent logical reason to Food and Drug Administration (United States). That makes no sense because disambiguated names with parenthetical annotations are necessary only for things with names that are NOT UNIQUE. No other country has an agency with the exact name, so the correct name should be simply Food and Drug Administration.

Looks like WLU never studied ontology in college (or hasn't gone to college yet). --Coolcaesar (talk) 01:02, 27 April 2009 (UTC)


 * Oh---just saw the discussion linked above re this move. I agree with the view that Thailand's organization is so extremely unimportant that the article about the U.S. agency should be at the article name Food and Drug Administration. --Coolcaesar (talk) 01:06, 27 April 2009 (UTC)


 * Come on, look across the pond(s). There are other FDAs around (besides the Thai one): Saudia Arabia and China. ;-) -- Alfie±Talk 15:48, 9 July 2009 (UTC)
 * China's is the SFDA so no problem with confusion there. Remember (talk) 15:52, 9 July 2009 (UTC)
 * Correct. I just could not resist in trying to give a different perspective reading this section's heading. ;-) -- Alfie±Talk 18:20, 9 July 2009 (UTC)

Rules for generic biologics
To my knowledge FDA does not use the term "generic biologics", and uses "follow-on biologics", "follow-on protein products", or "biogenerics" (in this order) instead. The internationally most common term is "biosimilar". Can anyone from the U.S. check? —Alfie±Talk 00:01, 17 August 2009 (UTC)
 * You are right that follow-on biologics "FOBs" is the most common name for this concept in the US and I believe that this is generally what the FDA uses. Remember (talk) 00:48, 17 August 2009 (UTC)
 * Here is a site to back up that assertion: ("Follow-on Biologics & Drug Importation ($5 million) – Within the Safer Medical Products initiative, the budget proposes a new authority for the FDA to approve follow-on biologics through a regulatory pathway that protects patient safety and promotes innovation, and includes $5 million for the FDA to develop policies to allow Americans to buy drugs approved in other countries."). Remember (talk) 13:23, 17 August 2009 (UTC)

What is this agency's mission statement in pharmacology
What are the 2 recently recalled drugs and why they were recalled. What are 3 newsworthy events regarding the FDA that are relevant to pharmacolgy.

Pam —Preceding unsigned comment added by 71.245.161.50 (talk) 15:05, 3 January 2010 (UTC)
 * Sorry Pam, you're going to have to do your own homework. Fences  &amp;  Windows  02:28, 4 January 2010 (UTC)

New Page Needs Review
If you are knowledgeable about the FDA inspection process, please review a new page regarding Form 483. Thanks! --21:30, 22 January 2010 (UTC)69.174.58.44 (talk)

Insulin & Penicillin Amendment Links
Both are described on page 50, with the Insulin Amendment in 1941 and the Penicillin Amendment in 1945:

http://usautism.org/2009_new_jersey_conference/conference_proceedings_manual_nj_2009.pdf —Preceding unsigned comment added by 68.165.58.137 (talk) 21:59, 5 February 2010 (UTC)

Separate FDA drug approval page?
Would it be valuable to split out a separate "FDA drug approval" page? I find myself linking similar terms to this page often from drug articles, but it's not really an ideal link. It seems like that definitely could be a stand-alone article. Thoughts? - Draeco (talk) 04:34, 19 February 2010 (UTC)


 * It exists. See Investigational New Drug and New Drug Application.  Could be more explicitly linked, I guess.  SDY (talk) 21:51, 19 February 2010 (UTC)

Testing? What testing?
The article nowhere explains what the FDA tests. It does not mention if testing in laboratories is outsourced or to what extent. There is exactly zero in the article about food testing. It is unclear on testing of pharmaceuticals or other over-the-counter products. The article mentions "thirteen laboratories) and that's it: nothing more, such as number of employees doing testing.

The article IMPLIES ... something?! I am sure if one follows all the links one might learn more, but basic stuff like this should be clearly stated in the article!

Not to mention being bloated with bureaucratese language, such as naming an abbreviation (OCI) BEFORE explication and naming a division by abbreviation WITHOUT ANY explication (ORA, Office for Regulatory Affairs), both of which are now fixed.

I came to this article to research food safety. Are imported foods tested for poisons? Domestic foods? Chemical residues in food containers? Mydogtrouble (talk) 17:01, 1 March 2010 (UTC)

Testing-Partial Answer
The FDA has its own testing labs and when a drug is to be put on the market, the FDA attempts to replicate the testing the pharmaceutical company did to insure the quality and efficacy of the drug. If it cannot confirm testing results of the company, the product doesn't go to market and the company is advised of the FDA findings. Having been through the FDA audit process, I can assure you they are very, very thorough. The FDA also periodically audits the testing actually done by the pharmaceutical company and if the testing is found deficient, it issues a "483"-basically, a letter listing the deficiencies of the company testing. This is a highly-technical subject and probably the details are best left out of this article. Dehughes (talk) 13:39, 14 June 2010 (UTC)
 * Some procedural details found at Form FDA 483. - Rod57 (talk) 09:47, 14 November 2011 (UTC)

Article Assessment
I think that this article gives a satisfactory general overview of the FDA, particularly its organization and purpose. The history section is as bit repetitive and there should be more information on ongoing projects. I also think that the section on new drugs needs to be expanded significantly, because the FDA plays a huge role in making the US pharmaceutical industry the way it is. If the FDA was more strict regarding the production and marketing of new drugs, we as Americans would not have to pay nearly as much to fill prescriptions. Overall, I agree that this article deserves a 'B' grade.IR393aes (talk) 22:54, 30 November 2010 (UTC)
 * Was that a typo ? A stricter FDA would more likely cause increased prices ? - Rod57 (talk) 09:07, 14 November 2011 (UTC)

first approved animal
"Medical maggots represent the first living organism allowed by the Food and Drug Administration for production and marketing as a prescription medical device."

"First" in this case means "animal as device"? Certainly there have been other living things approved by the FDA as medicine. — Preceding unsigned comment added by Justanothervisitor (talk • contribs) 01:42, 24 June 2011 (UTC)

Unapproved Drugs Initiative
Unapproved Drugs Initiative does not seem to be mentioned but I can't see an obvious place to add it. - Rod57 (talk) 09:02, 14 November 2011 (UTC)

Should articles on US federal government departments contain the constitutional authority for their powers?
I think this would be useful for many reasons. — Preceding unsigned comment added by 121.208.40.196 (talk) 03:32, 30 July 2012 (UTC)

Assessment comment
Substituted at 20:34, 2 May 2016 (UTC)

Whither neutrality?
There is general agreement in the literature that the FDA is an ineffective organization that represents business interests over the health and safety of the public. The segregated criticism section needs to be merged into the body of the article and the absolutely ridiculous Koch-funded primary sources claiming that the FDA is too tough on industry needs to be deleted. Viriditas (talk) 02:24, 3 May 2013 (UTC)

Food and Drug is a Bad — Preceding unsigned comment added by 72.27.199.20 (talk) 00:20, 15 May 2014 (UTC)