• All roads lead to death panels – ctd.

    My last post is generating a strange amount of email (and a comment) arguing that we should let doctors make their own decisions on whether Avastin is appropriate for their patients on an individual basis.

    There’s a critical point that is getting missed.  This independent advisory commission, and the FDA’s final decision, does not tell doctors what to do.  Doctors can and still do use drugs off label.  I don’t use wikipedia often as a source, but they are the best here (emphasis mine):

    The FDA approves a drug for prescription use, and will continue to regulate the pharmaceutical industry through the work of the Division for Drug Marketing, Advertisement and Communication (DDMAC).[3] The FDA does not have the legal authority to regulate the practice of the medicine, and the physician may prescribe a drug off label. Contrary to popular notion, it is legal in the United States and in many other countries to use drugs off label, including controlled substances such as opiates. Actiq, for example, is commonly prescribed off label even though it is a Schedule II controlled substance. While it would be legal for a physician to independently decide to prescribe a drug such as Actiq off-label, it is illegal for the company to promote off-label uses to prescribers. In fact, Cephalon, the maker of Actiq, was fined for illegal promotion of the drug in September 2008.[4] Under the Food, Drug, and Cosmetic Act (FDAC) at U.S.C. 21 §§301-97, manufacturers are prohibited from directly marketing a drug for a use other than the FDA approved indication. The Food and Drug Administration Modernization Act of 1997 created an exception to the prohibition of off-label marketing. Manufacturers are now able to provide medical practitioners with off-label information in response to an unsolicited request. 21 U.S.C. §360aaa-6.

    Now, I agree that not getting FDA approval makes it less likely that insurance will cover the reimbursement for the payment.  It also prohibits the manufacturer from promoting it for breast cancer.  But I am getting a disturbing number of emails from people, who are arguing, in the same paragraph, that the government is spending too much money and that this decision is wrong because it’s being made to save money.  In the same paragraph, some of you are arguing that people don’t have a right to care and that this decision to rescind the drug’s approval is denying your right to get your care of choice.

    This decision is not pulling Avastin off the shelves.  It’s not even prohibiting doctors from proscribing Avastin for breast cancer.

    And yet – DEATH PANELS!

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    • To make an even finer point to Aaron’s message that the FDA isn’t pulling the drug from the shelves, consider that it doesn’t even directly affect whether you’ll get reimbursed by your insurer for taking Avastin for breast cancer. Commercial insurers and Medicare generally use compendia for deciding whether to cover a drug for a specific indication. Compendia list all of the indications for which there’s scientific support for taking a drug. Since the FDA review process for new indications (sNDAs) takes a long time and requires a bit of cost, payors tend to instead rely on listings in major compendia when deciding whether to cover drugs for specific off-label uses. Most of the major compendia look at clinical guidelines and academic articles for deciding on whether to list a particular indication for a drug.