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The FDA for the Average SBM Consumer

How the Food and Drug Administration came to be is a story that is filled with death, intrigue and dubious characters. It also, like most stories, has its share of heroes and vindications. The list of those who have died to bring us the agency we know today is long, but even today, the death-toll continues. Now this is not the horrible thing it may at first seem. People are all born with a terminal disease known as life, and they will die. The goal of Medicine is to forestall that death as long as possible and to give people good, long, healthy and safe lives. This is where the Food and Drug Administration comes into play. They help guide the pharmaceutical world in the safest manner possible.

The legal quagmire that is the Food and Drug Administration (FDA) is a result of a series of laws which it behooves the Science-Based Medical community, to understand. Many of these laws were a result of deaths, which were themselves the result of either poor safeguards, or, as we will see in one case, lack of information on the part of a company. It began with the Division of Chemistry inside the U.S. Department of Agriculture. The original concern of this group was the misbranding and adulteration of both food and drugs. The first of the laws which came into effect, to give the Bureau of Chemistry as it became known, was the Biologics Control Act of 1902. As is so often the case with FDA regulations, this was a result of deaths in the populous.

The Biologics Control Act of 1902 came about after children had died from vaccines for both diphtheria and smallpox. In the first case, a horse named Jim, who had been used to produce some 30 quarts of diphtheria antitoxin, was found to have contracted tetanus. This was after additional diphtheria antitoxin had been produced, packaged and shipped and resulted in the death of 13 children in St. Louis, Missouri. The second case, which involved a contaminated smallpox vaccine, claimed the lives of nine children in Camden, New Jersey. The BCA of 1902 directly led to the creation of the Center for Biologics Evaluation and Research or CBER. This act set the precedent for regulating drug products, specifically Biologics. 

This was followed, in 1906 by the “Wiley Act” which is also known as the Pure Food and Drug Act of 1906 which prohibited the “manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes.”1 During this time, the enforcement for this act was given to Harvey Washington Wiley (Yes, the same Wiley the Act was named after) and the USDA Bureau of Chemistry. Slowly, the Food & Drug Administration is being born. One of the first major legal tests to this was United States v. Johnson2in which the Supreme Court held that “misbranding” did not attach to the therapeutic claims of the drug product but only to the ingredients. The case involved containers of medicinal product bearing labels that stated or implied that the contents were effective in curing cancer, when the creator knew that such representations were false. To quote Justice Holmes, “One may say with some confidence that, in idiomatic English, this half at least, is confined to identity, and means a false statement as to what the ingredients are.” This ruling was a serious blow for the fledgling agency and Congress responded with the Sherley Amendment in 1912 which clarified the authority to enforce the Wiley Act based on fraud in the therapeutic claim. In 1927, the government underwent a reorganization and the Bureau of Chemistry was folded into the Food, Drug and Insecticide organization within the USDA. Three years later, this became the Food & Drug Administration.

In the 1930’s we had another major event which influenced the laws surrounding the FDA. One of the important things to understand is that the Pure Food and Drug Act of 1906 did not regulate, in any way, the safety of new drugs, and was mainly concerned with those drugs already on the market. This is where the story of Elixir Sulfanilamide enters the picture. Created in 1937 by the S. E. Massengill Company, this sulfanilamide concoction was prepared with diethylene glycol (DEG) as a solvent. DEG was at this point known to be toxic, although the exact extent of its toxicity was not known.3In September of 1937, Elixir Sulfanilamide was being sold in the U.S. Markets and by October the American Medical Association had begun receiving complaints about possible deaths resulting from it. An important name for later appears here for the first time. Frances Oldham Kelsey, during her Ph.D. in Pharmacology studies at the University of Chicago, assisted in the research project which showed that the 100 deaths from Elixir Sulfanilamide were due to the DEG which was used as a solvent.4These deaths were classified as fatal adverse events. The FDA at this time was hampered in its authority as to what action it could take. Under the Pure Food and Drug Act of 1906, the ability of the FDA to regulate this “medication” was reduced to labeling. According to the regulations, an “Elixir” was required to contain some percentage of alcohol to be permitted to be labeled as such. Elixir Sulfanilamide contained none. The end result of this was that the S. E. Massengill Company paid a small fine and their chief Chemist, Harold Watkins, committed suicide5. But, as with most regulations, it didn’t end there. Congress now passed the Food, Drug and Cosmetic Act of 1938.

The Food, Drug and Cosmetic Act of 1938 was a major leap forward for the FDA. Now, for the first time, the Agency had an ability to regulate a drug before it came onto the markets. A key part of the Act mandated that safety data had to be collected and reviewed prior to marketing of a New Chemical Entity (NCE). Additionally the FDA no longer needed to prove fraudulent intent before intervening with false or misleading labeling. These were major steps forward for the FDA and with the additional inspection authorities that the FDA gained, the Agency that we know today was basically formed. This Act also saw Homeopathic Nostrums classified as a “drug” by the FDA. They are protected under Section 201(g) and 201(j) of the act and this was the FDA’s first serious attempt at regulating these products.

In 1951 we see the next major step in the process with the Durham-Humphrey Amendment. This Amendment had the effect of basically creating a class of drug which must be taken under the supervision of a medical practitioner, the so called “prescription only” drugs. In addition, the 1940’s had seen two Amendments, the Insulin and Penicillin Amendments added a requirement for potency testing. During this time the Public Health Services Act of 1944 expanded the Agency’s scope to cover biological products as well.

This brings us to 1959 and to a tragedy on a global scale which was, through decisive action on the part of one FDA reviewer, greatly minimized in the United States. Although the tragedy would take a few years to manifest itself, 1959 saw the US Senate try to put in place regulations to have pharmaceutical companies demonstrate the efficacy of their product. There was a great deal of push back from both the public and the pharma industry, but this stopped in 1962 when thalidomide appeared.

As this is one of the true pivotal moment in the history of the FDA, we will examine it in a bit more detail. Thalidomide came on to the European Markets in 1957 and was used as a pain killer and tranquilizer6. Another key reason for its use was that it was found to combat morning sickness in pregnant women. That was to be Thalidomide’s ultimate downfall. During the 1950’s and 1960’s, after Thalidomide made it onto the Market, more than 10,000 children in 46 countries were born with deformities. This alarmed two European Doctors who began investigating the reasons7. Now we meet Frances Oldham Kelsey again. Remember her from earlier? By this time she had completed both her PhD and her M.D. and was working as a reviewer at the FDA. When Thalidomide, also known as Kevadon, came across her desk she decided that the safety documentation was not sufficient to support the requested indication of relief from morning sickness. The Application was rejected8. Richardson Merrell (Now Marion Merrell Dow), the manufacturer, then attempted to apply pressure to have their drug approved, but Dr. Kelsey remained firm in her desire for safety studies. What Richardson Merrell did manage to do was distribute 2.5 million pills to approximately 1,200 doctors in the US with the understanding that this product was not approved and still “under investigation”. As Dr. Kelsey dug deeper into the product, the 10,000 birth defects became publically known and Richardson Merrell rescinded their Application. Seventeen (17) children in the US were born with birth defects as a result of Thalidomide. Currently it is marketed in the United States by Celgene under the name Thalomid and is part of a RiskMAP known as S.T.E.P.S.

The Thalidomide incident led directly to the Kefauver-Harris Amendment of 1962. This is also known as the “Drug Efficacy Amendment”9. The main effect of this Amendment on the FDA was that they now had the authority to mandate clinical studies to show that a Drug is both safe and effective. 

As we draw to the close of the establishment of the FDA, a few more milestones should be noted. In 1976 the Medical Device Amendments expanded the FDA’s reach to cover medical devices. 1983 saw the Orphan Drug Act which makes it easier to conduct studies and research drugs for rare diseases. The Food and Drug Administration Act of 1988 makes the FDA part of the Department of Health and Human Services. Finally, in 2007, the Food and Drug Administration Amendments Act (FDAAA) put in place the ability for the FDA to being mandating Risk Management and Evaluation Strategies (R.E.M.S.) for products which have a high risk to patient populations, which was brought about, in part by the death related to Class II Extended Release Opioid Products.

This is how the FDA grew out of a few small offices to the true Agency that it is today. It has, through trial and error, learned to deal with death, unscrupulous marketing and outright contempt. The FDA will not be going anywhere soon, and with the recent appointment of Dr. Hamburg as the Commissioner the focus on Safety will once again be brought to the forefront as we are already seeing in some of the more recent enforcement actions the Agency has undertaken. 

Martin A. Lessem is a Regulatory Attorney with eight years of working in the Pharmaceutical Industry. Although currently working for a Generic manufacturer, Martin has worked for Innovator companies as well. His current area of expertise is Risk Management, specifically the new R.E.M.S. guidelines, Promotional Compliance and the Regulatory aspects of Clinical Trials. The views that he expresses in his posts are his own and do not necessarily reflect those of his current or previous companies.

Posted in: History, Medical devices, Politics and Regulation

Leave a Comment (43) ↓

43 thoughts on “The FDA for the Average SBM Consumer

  1. Todd W. says:

    Nice, brief overview of the FDA’s history. For more in depth reading, I would direct folks to the book Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation, by Philip J. Hilts. It is a very easy book to read and goes into pretty decent detail on the cultural and political contexts of the various developments in the FDA, discussing not only FDA’s high points, but its low points and darker times as well.

  2. Maz says:

    This is a great post! I am so thankful for the FDA every time I got shopping for groceries or take a prescription medication.

  3. neurondoc says:

    Nice summary of the early regulatory history of the drug side of FDA. And just so you know, there are a bunch of us FDAers who read this site regularly. :-)

  4. Chris says:

    This is where the story of Elixir Sulfanilamide enters the picture.

    This is related in The Poisoner’s Handbook. It included some very insensitive remarks from someone in the company. Unfortunately she did not include the bit about their chemist committing suicide.

  5. Chris says:

    Oh, looking at the reference to the story here, I see the insensitive comment:

    The owner of the company, when pressed to admit some measure of culpability, famously answered, “We have been supplying a legitimate professional demand and not once could have foreseen the unlooked-for results. I do not feel that there was any responsibility on our part.”

    Ms. Blum only used the last sentence (it is a very good book, and definitely for a layman like myself who is a sucker for the original CSI television program).

  6. kestrel says:

    Having a watchful eye like the FDA is a wonderful thing for the lay population. Since it seems like there are multiple people familiar with the agency here, can anyone tell me what they are doing to end the epidemic of unnecessarily prescribed Oxycodone (and related sbstances) and it’s subsequent trickle.. nay, gush, into the illegal market? I noticed it was mentioned that the FDAAA gave them oversight of some kind here but what’s being done?

    I’m talking more about affecting doctor’s prescribing habits rather than educating the public.

    Thanks.

    -kestrel

  7. relativitydrive says:

    Nice to see a fresh look at things with this perspective.

    Is there any chance you’ll be writing again about how you see (evidence based of course) the FDA (should be) evolving to regulate and protect the public? Examples are the clearly fraudulent advertising and promotion of ‘Energy Healing Therapies’, ‘Homeopathy’, ‘All Natural Remidies’ and on and on?

    Thanks,

    Alan

  8. Watcher says:

    I’m quite surprised that SD hasn’t jumped in here yet with his anti-government rhetoric yet. This seems like it would be right up his alley.

    Look no farther than @Chris’s quote to see why governmental regulation is necessary in cases where misinformation and “the bottom line” can lead to death.

  9. Probably his generator is on E.

  10. Todd W. says:

    @neurondoc

    Any openings for a non-doc?

    @kestrel

    The FDA has no authority over the practice of medicine. So, once a product is approved for market, they cannot control how it is used. What they can do is require the manufacturer to put stronger warnings on their labeling or keep tabs on the manner in which it is marketed, including promotion at conferences and the like.

    @relativitydrive

    Homeopathy is actually protected under the law. Talk to your Congresscritters to try to get the law changed. FDA’s hands a kinda tied, there. As to energy “healing” therapies, unless a drug, biologic or medical device is involved, the FDA has no jurisdiction. And as for “All Natural Remedies”, again, DSHEA kinda binds the FDA from taking action unless the product can be shown to be unsafe or, like the recent warning letter to Boyd Haley about his OSR#1, shown to fit the legal definition of the drug or to be in violation of the regulations.

    For fraudulent marketing, FTC may be the more effective route to take. It depends on the angle you want to take and if you think you can make FDA-governed regulations apply or consumer/marketing regulations apply.

  11. Martin A. Lessem, J.D. says:

    @kestrel said, “can anyone tell me what they are doing to end the epidemic of unnecessarily prescribed Oxycodone (and related sbstances) and it’s subsequent trickle.. nay, gush, into the illegal market? I noticed it was mentioned that the FDAAA gave them oversight of some kind here but what’s being done?”

    Funny you should mention this. The FDA is holding an Advisory Committee meeting about this very topic on July 22 – 23. The information for the meeting can be found here: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm214816.htm

    @relativitydrive said,” Is there any chance you’ll be writing again about how you see (evidence based of course) the FDA (should be) evolving to regulate and protect the public? Examples are the clearly fraudulent advertising and promotion of ‘Energy Healing Therapies’, ‘Homeopathy’, ‘All Natural Remidies’ and on and on?”

    I will deffinately consider this, as it is a subject-area where I work on close to a daily basis with by interactions with DDMAC. i am on vacation now (and yes, I am checking SBM on vacation) so I may take some time to work something up on Medical/Pharmaceutical Advertising. Thanks for the suggestion!

  12. kestrel says:

    “once a product is approved for market, they cannot control how it is used”

    This statement scares me considering they’re the ones who approve it for market correct?

    A quick search reveals that just like pharmacy, state boards regulate medical practices.. however the FDA can directly influence pharmacies with it’s rulings.. but not docs?

    btw, how do you properly quote here?

    Thanks.

    -kestrel

  13. Todd W. says:

    @kestrel

    The regulation of medical practice is left to the various state medical boards. FDA only has jurisdiction over the safety of medical products and their efficacy as claimed by the maker. A simplistic manner of looking at it is that FDA has oversight of the marketing aspects.

    So a manufacturer cannot market a product for X unless they have submitted the proper evidence (i.e., clinical trial data) to support the safety and efficacy of that use. However, a doctor can still use the product for X (i.e., off-label use) without FDA approval.

    Certain drugs, however, fall under non-FDA regulations. For example, something like morphine would fall under the jurisdiction of several different agencies, depending on the context. A new indication for marketing: FDA. Certain commercial claims: FTC. Distribution and use: possibly ATF/DEA.

    Drug regulation (Federal regulation in general, actually) is really freakin’ complex.

  14. Todd W. says:

    @kestrel

    Oh, and on quoting, use the blockquote html tags, like this (except use pointy brackets instead of square brackets):

    [blockquote]Quoted text.[/blockquote]

  15. LovleAnjel says:

    Great post! I was surprised to learn only 17 American kids were deformed through thalidomide. The way it’s talked about it sounds like an epidemic.

  16. chaos4zap says:

    I know that Homeopathy was grandfathered into the “Drug Efficacy Amendment”, which is why it is still sold today without any evidence for efficacy. Was homeopathy the only substance grandfathered in? Or are their others that still persist today? It is atrocious that Homeopathy is technically considered a “drug” (even though that classification is meaningless because of their exemption to prove efficacy) and supplements are not. Oh how I wish the political will were there to correct such errors.

  17. Actually, the FDA does have the power to insist that homeopathy nostrums, or at least those that were not already in the US Homeopathic Pharmacopoeia at the time of the Kefauver-Harris Amendment, be proven effective, but it chooses– perhaps reasonably, given its inability to intervene in every violation of the FDCA—not to use that power. Rather, it has allowed homeopaths themselves to determine effectiveness through “provings.” Very few new homeopathic ‘remedies’ have been added since 1962, however.

    For an interesting discussion of the homeopathy part of the FDA story, with particular attention to Sen. Royal Copeland (D-NY), the sponsor of the 1938 bill and a homeopath himself, read Suzanne White Junod’s An Alternative Perspective: Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation.

  18. qetzal says:

    @kestrel,

    Just to add to the other comments, controlling unnecessary scrips for oxycodone (or other approved narcotics) falls mainly under DEA. DEA designates certain drug substances as Schedule I, II, III, IV, or V (oxycodone is Schedule II; see here). Scheduled drugs often have additional controls that MDs and pharmacies must follow when they are prescribed and dispensed. (E.g., some require triplicate scrips, with one copy going to DEA.) FWIW, DEA also regulates how drug companies handle those scheduled substances during manufacturing. Also, at least some (most? all?) states have their own version of the DEA, on top of the federal agency.

    FDA’s role is different. They can decide whether a given drug product has adequate protections to prevent diversion and abuse (as part of their jurisdiction over drug safety). If it doesn’t they can order it withdrawn from the market, or refuse to approve it if it’s not yet on the market. They also mandate warning labels on potential for abuse, and can require the drug maker to conduct post-market surveillance to monitor potential abuse.

  19. Todd W. says:

    @chaos4zap

    There are a number of drugs that have a very long history of use, long pre-dating the creation of drug regulations, that, due to long use, were given approval to be marketed. I don’t have a full list, but some that come to mind are aspirin and a number of the opiates. Also, medical devices that were on the market before the 1976 Medical Device Amendments were grandfathered in, but FDA was given authority to, at any time, require clinical trials for such devices or to reclassify them.

    Those who actually work for FDA can correct me if I’m wrong, but that is what I recall from my classes on drug and device regulation.

  20. 1906 Pure Food and Drug Act: a great prompt for this was Upton Sinclair’s exposure of the unscrupulous meat-packing industry. We all had to read his novel, The Jungle, based on this journalistic expose, in high school as required reading.

    This is an interesting chapter in FDA history. Sinclair was a socialist. He believed that exposing yet another bad aspect of capitalism would move us, here in the united States, closer to a socialist revolution, like China, where coal miners never get killed in mining incidents. Instead of the proletariat rising up, democratic processes took effect, including the Pure Food and Drug Act, further entrenching our democratic republic/regulated-capitalism society.

    There are many self-avowed, self-identified socialists, communists, and marxists in our country’s history, but for some reason, they are rarely if never identified as such in our history books.

  21. There is a long line of case law concerning what physicians can and cannot do, but it really boils down to malpractice or fraud. So, it mainly boils down to malpractice. There, the case law is very clear that, as long as you are following care as physicians generally do provide care, OR as a “respectable minority” do, which it turns out case law has figured out is two or more people, then a physician, with a good lawyer, is on relatively safe ground from a malpractice suit.

    So, prescribing antipsychotics for pre-schoolers for whatver psychaitric malady gets pinned on them, is legal, as long as some academic psychiatrist somewhere has published an article on it.

    This website is good concerning how physician practice is regulated…
    http://www.mobar.org/journal/2000/novdec/bradford.htm

  22. Chris says:

    LoveleAngel:

    Great post! I was surprised to learn only 17 American kids were deformed through thalidomide. The way it’s talked about it sounds like an epidemic.

    I knew about that for several years, and it came in handy when some anti-vax types would spout off “remember thalidomide!” I would ask them how many Americans were affected, and they are genuinely surprised it is so low.

    On a forum a while ago a Dane made the claim that an American company was pushing its use. He was chagrined to find out the truth was completely opposite. It shows exactly how stories are distorted through retelling.

  23. Chris, Richardson Merrell was an American company.

    Thalidomide was developed and manufactured in Germany by Grünenthal, but the company that was manufacturing and marketing it in the US – the company that distributed the 2.5M pills to the 1.2k US doctors with the understanding that it was under investigation – was Richardson Merrell.

  24. Chris says:

    I stand corrected. Thank you.

  25. Chris says:

    Oh, wait… though Richardson Merrell was not promoting in Europe, that would have been Grünenthal.

  26. Grünenthal developed, marketed and sold it in Germany (2,500 thalidomide babies).

    Distillers Company Limited licensed, marketed and sold it in the UK (2,000 thalidomide babies).

    Richardson Merrell licensed and marketed (but did not sell) it in the US (17 thalidomide babies).

    That’s from Wikipedia. I don’t know who licensed and marketed it in Canada or Denmark. Possibly the same companies as above.

  27. Fifi says:

    While only 17 children may have been (recorded)as having suffered adverse effects from their mother’s taking thalidomide in the US, the numbers were much higher elsewhere. Granted you’re talking about the FDA but obviously when people learn about thalidomide they learn not just about the effect on babies in the US. I’m also curious as to a double standard about the value of a baby’s life – or at least a divergently different value put on an infant’s life by various bloggers here. In the discussion about c-sections the idea that one baby could potentially be harmed or die was cause for moral outrage, while here the fact that 17 US babies were harmed seems to be being dismissed as relatively inconsequential. I understand that you all have your own opinions and thoughts on these matters so I don’t expect conformity, I just find it interesting that the general public is seen as hysterical when they make a fuss about one baby’s life but when a blogger here does it’s seen as entirely reasonable. Of course, this is one of the big dichotomies of SBM isn’t it? Science isn’t personal but medicine is. By that I mean that the practice of science isn’t about individuals but the practice of medicine is, or at least it is when it’s done properly.

  28. Harriet Hall says:

    Fifi, No one is dismissing the harm to 17 babies. There is no double standard. Every SBM blogger cares deeply about every individual life. The whole point of science-based medicine is to establish the knowledge needed to help individuals.

    You say “the numbers were much higher elsewhere.” Yes, of course, and Martin said so in his article, citing 10,000 cases in 46 countries. Did you miss that?

    You thought you read something that wasn’t there, and you failed to read something that was there. I wonder why. Surely you are not one of those people I criticized in my “Defending Isagenix” post, people who use the comments section as a soapbox for opinions on a subject only very tenuously related to the subject of the post.

  29. Chris says:

    Fifi, no one minimizes the seventeen children disabled by thalidomide. As a matter of a fact, the company did an end run around the FDA by sending the doctors those pills.

    The company promoting thalidomide did a bad thing.

    It was the action of Dr. Kelsey and the FDA regulations that prevented the numbers of injured babies in the USA that were seen elsewhere.

  30. BillyJoe says:

    No mention of the clinician who discovered that the limb reduction deformities were caused by thalidomide and thereby prevented countless more being affected? Was that because he later disgraced himself? Does that cancel him out?

  31. Zoe237 says:

    Any comments on financial conflicts of interests within the FDA? I can’t imagine a history without mention of these COI.

    http://www.msnbc.msn.com/id/12483353/

    http://jama.ama-assn.org/cgi/content/extract/301/7/709

    Recent avandia debacle:

    ]The FDA is trying to assemble a timeline of what the FDA knew of risks associated with Avandia, these people say, and plans to call a meeting of an outside advisory committee in the next few months to look at recent information on the drug, which Glaxo reported as having global sales of £771 million ($1.2 billion) in 2009.


    Internal FDA reviews included in the Senate report show that in 2008, longtime FDA scientists David Graham and Kate Gelperin urged the FDA to get Avandia off the market. They analyzed data on side effects in dozens of Avandia studies, but their recommendations were rejected by FDA chiefs. The senators want to know why.

    http://online.wsj.com/article/SB10001424052748703791504575079791430685632.html

    And no, I’m not anti-FDA or anti-government. Love The Jungle!

  32. Zoe237 says:

    This won’t make any sense without my previous post in moderation about COI in the FDA, but

    BTW, upon a search I found two relevant posts by Dr. Gorski:

    FDA approval of drugs and transparency in clinical trial results

    It turns out that more than half of the clinical trials used to support FDA approval of drugs remain unpublished more than five years after that approval.

    http://www.sciencebasedmedicine.org/?p=215

    Threats to science-based medicine: When clinical trials for new drugs are designed by the marketing division

    http://www.sciencebasedmedicine.org/?p=192

    (If Gorski is a pharma shill, Sanofi-Aventis really ought to reevaluate their staff choices :P)

  33. BillyJoe, I would expect that William McBride was only indirectly referred to (as one of “two European Doctors”) because he wasn’t part of the history of the FDA.

  34. … not sure when Australia became part of Europe, though.

  35. BillyJoe says:

    Alison, I had the following comment typed up but somehow failed to actually post it till I came back just now and saw your post and mine still sitting in the comment box:

    Fair enough.

    …except that he is not European.

    :)

  36. Dr. Hall

    Surely you are not one of those people I criticized in my “Defending Isagenix” post, people who use the comments section as a soapbox for opinions on a subject only very tenuously related to the subject of the post.

    Oh….we’re not supposed to do that? I really need a Miss Manner’s guide to blogs.

  37. qetzal says:

    Zoe237 writes:

    Any comments on financial conflicts of interests within the FDA? I can’t imagine a history without mention of these COI.

    I don’t see why that is an essential element in a discussion of FDA’s history. It’s relevant to a discussion of FDAs problems and potential failings, sure. But this post really only addresses the history of how the FDA came to have its current form and purview. Conflicts of interest aren’t relevant to that. (Though they might be in a future write-up – if they lead to substantial alterations of FDA between now and then.)

  38. Zoe237 says:

    qetzal:

    I don’t see why that is an essential element in a discussion of FDA’s history. It’s relevant to a discussion of FDAs problems and potential failings, sure. But this post really only addresses the history of how the FDA came to have its current form and purview. Conflicts of interest aren’t relevant to that. (Though they might be in a future write-up – if they lead to substantial alterations of FDA between now and then.)

    Maybe not, since this was mostly focused on the history and laws, but the end quote referencing “unscrupulous marketing” implies that maybe the financial influences on the FDA have been important, even historically. Of course, one big story of this decade (as the internet and flow of information becomes faster) is the ties between companies and government (banking, oil, and medicine). In recent weeks we’ve seen it in tragedies in mining and oil. Perhaps a future post about the current state of the FDA and their work in this regard would be helpful? The whole point of a government “consumer protection” entity is, after all, to regulate a free for all, profit driven capitalistic system. It doesn’t work so well when there are conflicts of interests among the bureacrats themselves. One reform that I’ve seen, for example, is making sure the committee that approves the drug is different from the one who continues post approval surveillance.

    Anyway, how do you discuss an agency’s “current form and purview” without referencing its “problems and potential failings”?

    Martin A. Lessem:

    he legal quagmire that is the Food and Drug Administration (FDA) is a result of a series of laws which it behooves the Science-Based Medical community, to understand. Many of these laws were a result of deaths, which were themselves the result of either poor safeguards, or, as we will see in one case, lack of information on the part of a company.”

    I’m merely curious about the WHY behind these deaths, these poor safeguards, lack of information. It does sound like some work is being done to make the FDA more transparent. I hope it’s enough:

    Financial Disclosures by Clinical Investigators
    http://www.fda.gov/RegulatoryInformation/Guidances/ucm126832.htm

  39. Chris says:

    Zoe, how do the ethics of the FDA compare with the company that sold Elixir Sulfanilamide or the Boyd Haley’s OSR?

    Would better funding had helped? How do you think we should fund the multimillion dollar budget required to properly test drugs? Should it be public money, or the responsibility of the pharmaceutical company? How should well qualified people be recruited to the FDA when they can get better salaries in a pharmaceutical company?

    Where is that funding to make a perfect bureaucracy supposed to come from?

  40. Zoe237 says:

    Zoe, how do the ethics of the FDA compare with the company that sold Elixir Sulfanilamide or the Boyd Haley’s OSR?

    Since Boyd Haley and this unnamed company are not paid for by my tax dollars, I can’t really comment on their lack of ethics as much. The whole point is that the FDA should be regulating these instances- and sounds like they’re doing a good job with Boyd Haley (took ‘em long enough though- two years).

    Would better funding had helped? How do you think we should fund the multimillion dollar budget required to properly test drugs? Should it be public money, or the responsibility of the pharmaceutical company? How should well qualified people be recruited to the FDA when they can get better salaries in a pharmaceutical company?

    Where is that funding to make a perfect bureaucracy supposed to come from?

    Better funding would help enormously. I surely don’t pretend to have all the answers, but nor do I think we should throw up our hands and claim defeat or not question the ties between industry and the FDA.

    I’m also wondering why, for example, lower FDA people recommended to pull Avandia from the market, while FDA chiefs rejected these arguments. What’s the inside story there? I have no idea but this seemed like a good place to ask.

  41. Todd W. says:

    @Zoe237

    I’m also wondering why, for example, lower FDA people recommended to pull Avandia from the market, while FDA chiefs rejected these arguments.

    My guess (I don’t have the inside facts) is that it was largely political. Where the lower-level inspectors can often freely come to sound, science-based (or at least, informed) conclusions about whether a product should or should not be approved, the higher up the ladder you are, the more you are subject to political pressure from Congress or the President. The book I mentioned earlier, Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation, recounts how the Nixon administration stacked the leadership of FDA with party-line Republicans who would uphold the ideology of the party, rather than do what the science suggested. Anyone who disagreed was not fired, but they were often moved to positions that made their lives miserable. That way, they would just resign on their own.

    I’m not certain how prevalent that is today, but it illustrates how politics can influence what the FDA does. There have been other commissioners who have stood up to the politicos and done what is right.

  42. Zoe237 says:

    “My guess (I don’t have the inside facts) is that it was largely political. Where the lower-level inspectors can often freely come to sound, science-based (or at least, informed) conclusions about whether a product should or should not be approved, the higher up the ladder you are, the more you are subject to political pressure from Congress or the President.”

    Good point, I’ll have to pick up that book. And does this political pressure result from pharmaceutical lobbyists involved in the political process, or simply a right wing anti-government, pro corporation ethos? Probably both.

  43. Todd W. says:

    @Zoe

    I would think that the potential for political influence can come from any source. Another instance (I can’t remember if it was in that book or not) was when HIV/AIDS activists lobbied FDA to rush a potential new drug through the process so they could use it. IIRC, that was the first iteration of AZT. The activists were so desperate for some manner of treatment, that they felt the FDA was needlessly bogging down what was, in there view, a crucial treatment. Once it was approved and everyone realized what the real toxicity profile was like, they understood the delicate balancing game that FDA needs to play (quick access to new medical products vs. ensuring safety and efficacy).

    So, pressure can come from industry, Congress and the President (regardless of political party), a variety of lobbies, the public, media…lots of potential (and sometimes opposing) sources of influence. How much any one particular source prevails over others is a different question, and one that likely changes as the leadership of FDA (or even HHS) changes.

    FDA has a very difficult job to do, and, human nature being what it is, their decisions are sure to make someone mad.

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