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  • commented 6/11/13
  • tags: WMT CVS WAG RAD
  • I don't approve of generic brand drugs and believe we should go back to the major pharma companies that made the drug originally. Generic drugs have been proven to never have the correct concentration....many times the drug is not made in the intended dose, as specified on the bottle. Many times a generic drug may only be at 70 or 80% concentration. The reason for this is that the FDA does not regulate the generic companies, as they DO regulate the major pharmaceutical companies and an error, deliberate or not, could never be made. [ less... ]
    I don't approve of generic brand drugs and believe we should go back to the major pharma companies that made the drug originally. Generic drugs have been proven to never have the correct concentration....many times the drug is not made in the intended dose, as specified on the bottle. Many times a generic drug may only be at 70 or 80% concentration. The reason for this is that the FDA does not regulate the generic companies, as they DO regulate the major pharmaceutical companies and an error, deliberate or not, could never be made.
    Trefis Team commented 2 years ago
    <b>Generic drugs are regulated by FDA</b><br><br>As opposed to the common myth that if something is expensive it ought to be better, generic drugs are equally effective than their branded counterparts. This is a common misconception that generic drugs are ineffective.<br><br>Also, generic drugs are regulated by the FDA. FDA keeps a strict vigilance on every developmental aspect of the generic drugs. The following extract if from the FDA website (<a href='http://www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm134444.htm'>http://www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm134444.htm</a>).<br><br>Drug products sold in the United States are approved by the FDA whether they are brand name or generic. "Most people believe that if something costs more, it has to be better quality. In the case of generic drugs, this is not true," says Gary Buehler, Director of FDA's Office of Generic Drugs. "The standards for quality are the same for brand name and generic products."<br><br>"Much of FDA's review of generic drugs and brand name drugs is the same," Buehler explains (See "Same FDA Requirements for Brand-Name and Generic Drugs" below). There are eight major parts to the FDA's review of a firm's application to sell a generic drug:<br><br>There must be an FDA-approved brand-name drug that is the reference for the proposed generic. The generic must have the same active ingredient or ingredients and the same labeled strength as this reference product. It must have the same dosage form-tablets, patches and liquids are examples of dosage forms. It must be administered the same way, for example, swallowed as a pill or given as an injection.<br>The manufacturer must show the generic drug is "bioequivalent" to the brand-name drug (See "What Is Bioequivalence?" below).<br>The generic drug's labeling must be essentially the same as that of the approved drug.<br>The firm must fully document the generic drug's chemistry, manufacturing steps, and quality control measures. Each step of the process must be detailed for FDA review.<br>The firm must assure the FDA that the raw materials and the finished product meet USP specifications, if these have been set. The USP, or U.S. Pharmacopoeia, is the non-profit, scientific body chartered by Congress to set standards for drug purity in this country.<br>The firm must show that its generic drug maintains stability as labeled before it can be sold. Once on the market, the firm must continue to monitor the drug's stability. The firm must show that the container and its closure system won't interact with the drug. Firms making sterile drugs must submit sterility assurance data showing microbiologic integrity of these products.<br>The firm must provide a full description of the facilities it uses to manufacture, process, test, package, label and control the drug. It must certify that it complies with federal regulations about current good manufacturing practices and undergo FDA inspection of the manufacturing facility to assure compliance.<br>Before FDA approves a generic drug, it usually conducts an inspection at the proposed manufacturing site to make sure the firm is capable of meeting its application commitments and to ensure the firm can manufacture the product consistently.<br><br>"Generic competition helps keep the cost of drugs down," Buehler says. "It also encourages the research based drug companies to keep finding newer and better<br>medicines that have patent protection."<br>Myths and Facts about Generic Drugs<br><br><b>MYTH</b>: Generics take longer to act in the body.<br><b>FACT</b>: The firm seeking to sell a generic drug must show that its drug delivers the same amount of active ingredient in the same timeframe as the original product.<br><br><b>MYTH</b>: Generics are not as potent as brand-name drugs.<br><b>FACT</b>: FDA requires generics to have the same quality, strength, purity, and stability as brand-name drugs.<br><br><b>MYTH</b>: Generics are not as safe as brand-name drugs.<br><b>FACT</b>: FDA requires that all drugs be safe and effective and that their benefits outweigh their risks. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risk-benefit profile as their brand-name counterparts.<br><br><b>MYTH</b>: Brand-name drugs are made in modern manufacturing facilities, and generics are often made in substandard facilities.<br><b>FACT</b>: FDA won't permit drugs to be made in substandard facilities. FDA conducts about 3,500 inspections a year in all firms to ensure standards are met. Generic firms have facilities comparable to those of brand-name firms. In fact, brand-name firms account for an estimated 50 percent of generic drug production. They frequently make copies of their own or other brand-name drugs but sell them without the brand name.<br><br><b>MYTH</b>: Generic drugs are likely to cause more side effects.<br><b>FACT</b>: There is no evidence of this. FDA monitors reports of adverse drug reactions and has found no difference in the rates between generic and brand-name drugs.<br><br>Hope I have been able to put things in a clear perspective.
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