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FDA Issues Dietary Supplements Final Rule

Byoliveridley

The FDA issues rules that will finally make dietary supplement manufacturers conform to some rules in the manufacturing of the products.

Which ones?

  1. Accurate potency and labeling – 30 mg glucosamine will now contain something close to 30mg
  2. Impurities Testing – All the raw materials will now be tested for impurities/contaminants. They will probably follow USP guidelines.
  3. Adverse event reporting – Manufacturers/sellers will need to report adverse events. This is after the fact safety testing, wholly inadequate, but better than what we had previously.

See something missing? Efficacy!! You do not have to prove that your product actually works! Basic safety? What is the overdose level? Interactions with other medicines/supplements? Is your dosing form actually bioavailable? Meaning, if you swallow a pill, will it actually get into your bloodstream and reach the intended target?

Who knows, but standardizing, cataloging and auditing manufacturing processes is a start, I guess. 1.5 cheers for the FDA!

I would be curious to find out how these companies are going to get audited by the FDA to prove that they’re following the quality control measures they’re supposed to implement. Guess I have to read the 815 pg bundle of joy that is the actual rule to find out more. A cursory word search on audits suggests that the manufacturers do audits on their suppliers, that the quality control unit of manufacturer perform audits on their manufacturing process, but nothing about the FDA conducting audits. Of course, calling yourself a GMP (good manufacturing processes) manufacturer is usually enough to trigger an FDA audit if you’re in pharma. I wonder how the FDA will deal with this one.

FDA Issues Dietary Supplements Final Rule

The U.S. Food and Drug Administration today announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements. The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.

“This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label,” said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. “In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary supplement related adverse events to FDA.”

The regulations establish the cGMP needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints.

“The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling,” said Robert E. Brackett, Ph.D., director of FDA’s Center for Food Safety and Applied Nutrition.

Under the final rule, manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded.

The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling.

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    Who is Local?

    Byoliveridley

    “Ahmadi is still months away from getting permanent resident status, putting him in the unlucky group of middle-class British Columbians who have found themselves targeted by a tax purportedly imposed to crack down on rich real estate speculators from overseas”

    I’ve never been this hopeless

    I would not call Hamed Ahmadi unlucky, he’s a victim of the all too common policy apparatus that confuses residency with visa status. The BC non-resident tax of 15% on properties is supposed to target “foreign” (read Chinese) investors buying in Vancouver with no intentions of living there. I presume there are multiple other ways to determine residency and “localness” for the purpose of determining who lives here and who does not. The BC government, in its haste to demonstrate it was doing something, took the easy route and used visa status as a proxy.

    Hamed lives and works in BC, which meets my definition of local. While a speculation tax on non-residents is a reasonable approach, using visa status to determine residency, and providing no sensible exceptions for locals with alternative paper work is lazy and thoughtless policy making, so is not providing exceptions for people with home buying applications already in process. It’s almost as if someone looked at the polls and press and wrote the law in a day.

    In many ways, this is personal for me because I lived in the US for 10+ years under various non-permanent visas that left me vulnerable to these poorly designed, thoughtless policy measures. I lived in the same town for 10 years, was very much a local by the time I’d left, with a stable set of friends, family, work, places I shopped in, hiked to, causes I supported, volunteer work I did, and more. So, Hamed’s story could have been mine, and in some smaller ways, was mine for other parts of my life.

    “CTV News spoke with BC Liberal cabinet minister Andrew Wilkinson on Wednesday and asked several times for comment on Ahmadi’s situation. Wilkinson responded by repeating a piece of blanket advice for the people impacted. “Those who find themselves affected by the tax should seek legal advice because individual circumstances vary,” Wilkinson said.

    This is typical of policy makers who are so removed from the day to day lives of the people whose behaviour they seek to regulate. The casual assumption that regular people can afford professionals who bill at multiple hundreds of dollars an hour speaks more about the types of people these ministers hang out with than anything else. But this sounds familiar too, I needed to consult lawyers multiple times to help me with immigration paper work.

    As someone with a high level of institutional trust, and who thinks governments can affect our lives for the better with sound and thoughtful policy interventions, these types of hasty policy making are deeply disappointing. There are multiple other policy measures to make housing more affordable. The CCPA just released a comprehensive document of policies, focusing on the actual problem, the lack of affordable housing. Investment in affordable housing with a focus on cohousing and social housing, and zoning changes that reduce the protections afforded to affluent property owners would go a long way.

    Originally posted on Interrobang 04-August-2016

  • Brazil offers AIDs drug factory to Mozambique

    Byoliveridley

    Brazil is positioning itself as a major manufacturer of generics, and offering to build this factory is a very good move because it will provide AIDs treatment options for Mozambique at affordable prices (well, better prices than the pharma giants would provide, at any rate). Is there expertise available in Mozambique to staff this factory and run it at the level of quality a pharmaceutical production facility needs? I don’t know the answer, but I sure hope so. Alternatively, is there any plan for Brazil to train and equip the personnel as well? It is good news, at any rate.
    Brazil offers drug factory to AIDS-ravaged Mozambique – Yahoo News

    Brazil has offered to build a $23 million pharmaceutical plant in Mozambique that will provide drugs to treat HIV/AIDS, malaria and other diseases, Mozambique’s national newspaper said on Tuesday.

    Brazil, a leading pharmaceutical manufacturer, will monitor quality and transfer technology to the proposed plant, which would produce a range of drugs, including generic antiretroviral drugs (ARVs) to fight HIV/AIDS, Noticias reported.

    The plan was presented to the Mozambique government by Brazil’s ambassador in the southern African nation.

    Mozambique, one of the poorest nations on the continent, is struggling to find the money to rebuild its dilapidated health-care system, which was neglected during a 17-year civil war that ended in 1992.

    The former Portuguese colony has been hard hit by the AIDS epidemic, with an estimated 1.6 million of its 18 million people infected with HIV. Only a fraction of those requiring ARVs are on treatment, with most of the drugs imported from India.

    The offer to build the pharmaceutical plant was first raised by Brazilian President Luiz Inacio Lula da Silva during his 2004 official visit to Mozambique. Lula said he wanted drugs from the plant to be available to other African nations as well.

    Brazil claims the use of generic anti-retrovirals has cut its AIDS mortality rate in half.

    Mozambican Health Minister Ivo Garrido said the government would decide next month whether to approve the Brazilian proposal. “We will have to study it very carefully,” he was quoted as saying by Noticias.

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    India Rejects Obvious Patents

    Byoliveridley

    Would have been my headline. Apparently, the New York Times byline writer was more concerned about a multi billion dollar company losing a small amount of money than the fact that a different ruling in this case would have made life saving drugs unaffordable for millions of people. When did American newspapers become shills for the elite?

    Setback for Novartis in India Over Drug Patent – New York Times

    Indian companies will be free to continue making less expensive generic drugs, much of which flow to the developing world, after a court rejected a challenge to the patent law on Monday.

    Aid organizations declared the ruling a victory for the “rights of patients over patents,” but the Swiss drug company Novartis, which filed the case, warned that the ruling would discourage investments in innovation and would undermine drug companies’ efforts to improve their products.

    At issue is the degree of innovation required for a drug to be regarded as truly “new”, where there is a significant enough chance for failure that the company would never develop it unless afforded monopoly rights for 10 years. A very well known tactic by drug companies is to make a slightly different formulation of an existing drug, say an extended release form of a drug which takes a little longer to dissolve, and hence is available to the body at a different time. Under US patent law, this qualifies for full patent protection on the extended release form. By now, the science of making an extended release tablet is well known, it’s just a question of formulating the drug with a different set of inactive ingredients that take longer to dissolve, or sometimes, through a differently engineered tablet. The chemistry of this change is predictable, published and not really innovative. Why should these small changes have patent protection?

    Bonus Note: Madras is my home city, so I’m glad it was decided there!

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  • Biologic Generics Closer to Market

    Byoliveridley

    Congress Seeks Compromise on Generic Drugs – New York Times

    Biotech drugs, also known as biologic products, are typically proteins made by modifying the DNA of bacteria, yeast or mammal cells, and they are often given by injection or infusion. Supporters of the legislation received an unexpected boost when the chief medical officer of the Food and Drug Administration, Dr. Janet Woodcock, told Congress last month that the agency had the expertise and experience to decide what types of human and laboratory tests were needed to ensure that copies of a biotechnology drug worked as well as the original. Brand-name drug manufacturers have urged Congress to require human trials before allowing the sale of any products billed as comparable or equivalent to biotechnology medicines already on the market.

    It is a complex issue, and clearly, proteins and large molecules that would not be synthesized, but “grown” are subject to larger batch by batch variation, especially when the generic company does not have access to the top-secret proprietary information that genentech, or J&J used to grow their molecule. So, some level of judgment is going to be required on the part of the FDA, which has the information from both the original, and the generic manufacturers. It looks like the FDA needs to, and is prepared to deal with each generic on a case by case basis, which is how it should be.

    Protein characterization and analysis have come a long way in the last 10 years, with your fancy mass spectrometers and proteomics. It is a lot easier now to compare proteins with each other, to look for changes and differences. Mass spectrometric technology, improved electronics and huge increases in data processing and computing power make protein characterization increasingly routine. It would be up to the FDA to decide at what level of change would a protein behave so differently that its effect on humans could change significantly from the original drug, but they seem to be ready to do it.

    “Some level of clinical testing should be required in all cases,” said Dr. Susan D. Desmond-Hellmann, president for product development at Genentech. Dr. Jay P. Siegel, a senior scientist at Johnson & Johnson, said: “I would never take a biologic that had not been tested in humans. The risks are too high.”

    Yes, I would absolutely trust the word of the people who had the most to lose in this case, no conflict of interest here! To be fair, Dr. Siegel is understandably cautious. We have enough problems even with small molecules (think Vioxx!). But as I mentioned previously, it should be possible to come up with good enough metrics to decide when/where human re-testing is appropriate, instead of doing it always.

    But Dr. Woodcock (of the FDA – inserted for context) said: “Where trials are not needed, it is of questionable ethics to repeat them. The use of human subjects for trials that are not needed is not desirable.”

    People tend to forget that we’re experimenting on humans here, thanks Dr. Woodcock! Note that this is an issue where the established biologicals companies can use the safety card with impunity to protect their enormous profits. But they are not the ones who get to decide, it’s the FDA, and ultimately, Congress.

    The chief lobby for makers of biotech drugs, the Biotechnology Industry Organization, strongly opposes the bill, saying it would endanger patients and kill incentives for research and innovation.

    Oh really, how many times has this argument been raised, and proven to be false (see plutocracy-protectionary principle!). To believe this argument, we would have to believe that the 1984 generics law completely killed the small molecule industry. Not really, Glaxo, Pfizer, etc are still bigger and badder than ever.

    Assuming a multiple sclerosis treatment costs $20,000 a year (from the article). If generics come in and there’s a 10% (low end) decline in price for the treatment, the amount saved is $2000 per patient. MS is estimated to have a prevalence rate of 0.1% in North America. So, that makes 0.3 million in the US. If half of them are on this treatment (random fudge factor), you (or your insurer) will save $300 million on one disease treatment option per year (and the biologics manufacturers will lose some portion of that). This is pretty big money, no wonder they’re throwing up roadblocks!

  • Abbott Drops AIDS Drug Price in response to Thailand's hardball.

    Byoliveridley

    Moral of the story, you have to play hardball with the drug companies. Use your power as a sovereign country. You are a market to them, their threats to stop selling their drugs in your country cannot be taken seriously because if the drug is made unavailable in your country, that gives you even more right to make it yourself (or better, buy it from India!). I mean what are they going to do, invade you? The worst you will get is a scolding and lecture from the U.S ambassdor on patents and free trade, just ignore it, or better still, protest outside the embassy!

    Chemical & Engineering News: Latest News – Abbott Drops AIDS Drug Price

    Abbott Drops AIDS Drug Price, move follows compulsory licensing decision by Thailand

    Jean-François Tremblay

    Abbott Laboratories will drop its price for Kaletra, a protease inhibitor used to treat AIDS, to the equivalent of $1,000 per patient per year in 40 developing countries.

    The move, facilitated by the World Health Organization, is apparently Abbott’s response to a decision by Thailand earlier this year to resort to compulsory licensing of Kaletra, a practice that reduces health care costs in a way that pharmaceutical companies view as patent infringement (C&EN, Feb. 5, page 11).

    Following Thailand’s decision, Abbott announced that it would stop selling Kaletra and other patented drugs in Thailand, a move that the nongovernmental organization Doctors Without Borders called “a major betrayal of patients.”Abbott had already been under fire for not supplying Kaletra to several other low-income countries.

    The price of $1,000 per year per patient, Abbott says, is 55% less than the average price at which the drug is now sold in the 40 countries. The company says it wants to increase drug affordability while “preserving the system that enables the discovery of new medicines.

    Compulsory licensing is a perfectly legal option underlined by TRIPs (Agreement on Trade-Related Aspects of Intellectual Property Rights) in response to national emergencies (AIDs is a national emergency, isn’t it?). More importantly, governments in poorer countries really should invoke this provision as much as they can. Because every time they invoke it, they make big pharma come to the bargaining table.

    $1000 per patient per year is still a lot of money, though, I would encourage Thailand to play even more hardball!

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    Colonialism, Pharmaceutical style

    Byoliveridley

    Legal wrangle puts India’s generic drugs at risk – health – 29 January 2007 – New Scientist

    Tens of thousands of people being treated for AIDS will suffer if Swiss pharmaceutical company Novartis succeeds in changing India’s patent law, the humanitarian agency Medecins Sans Frontieres warned on Monday. Novartis is challenging a specific provision of India’s patent law that, if overturned, would see patents being granted far more widely, heavily restricting the availability of affordable generic medicines, MSF says.

    In 2000, antiretroviral (ARV) treatment cost was estimated at $10,000 per patient annually. But the availability of generic drugs produced mainly in India, allowed costs to plummet to about $70 per patient per year, Mwangi adds.

    You’ve got to love the friendly multinational arguing to make extra billions while people die. But I don’t think any Indian judge will overthrow Indian patent law. And there is a national interest  exemption built into most patent statutes, per the TRIPs agreements.

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