Readers’ Corner: Can Physicians Write Prescriptions for Drugs that the FDA Has Not Approved?

September 13, 2011
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A reader asks us to clarify.

In response to Part One of our article on laws threatening integrative physicians and integrative medicine, Chad wrote:

Your article explains the difficulties that doctors encounter when [prescribing] compounded drugs for their patients that have not been approved by the FDA. But it also implies (quoting federal law) that it is legal for doctors to do so. This runs counter to stories I have heard about what a doctor really can and cannot [do]. Would you please provide further clarification?

Thank you, Chad, for highlighting an important area of the law as applies to doctors’ ability to prescribe “unapproved” drugs. In our article, we noted the following:

Federal law clearly states that licensed physicians may “manufacture, prepare, propagate, compound, or process drugs solely for use in the course of their professional practice” [21 USC 360(g)]. Furthermore, the Federal Food, Drug, and Cosmetic Act (FD&C) cannot regulate the therapeutic practices themselves.

There are problems, however. While practitioners might have the theoretical right to manufacture their own drugs, from the practical point of view the FDA takes a very expansive view of its authority and jurisdiction. For example, the rule stated above has been narrowly defined in at least the area of cancer treatment to apply only to intrastate activities. A report from the congressional Office of Technology Assessment, “Unconventional Cancer Treatments,” outlines the law at that time: “It is legal for physicians to prescribe treatments they manufacture that are unapproved by FDA, but only in the State in which they manufacture the treatments. It is illegal to transport unapproved drugs across State lines and laws pertaining to good manufacturing practices apply to physicians as well as to commercial medical manufacturers.”

It gets worse. The FDA holds that an “interstate commerce” test must be applied to all steps in a product’s manufacture, packaging, and distribution. This means that if any ingredient—even one test tube—used in the compounding of an unapproved drug was purchased out of state, the FDA would in its view have jurisdiction, as they would if the final product were to travel across state lines.

This report may or may not reflect the FDA’s current position on prescribing unapproved drugs as it was published several years ago, and we simply won’t know the FDA’s current thinking until they officially weigh in again. Any doctor wondering about this must consult with his or her own legal counsel and try to make sense of what is really senseless.

This is unfortunately part of a much larger problem. The FDA has shown us historically that it acts as a law unto itself, acting as executive agency, legislator, and judge all in one, although clearly forbidden to do so by the Constitution. If you don’t like it, you can sue, but the FDA has an unlimited legal budget and you don’t. That is part of the agency’s scare tactics—if you oppose us, we will bankrupt you or, if possible, put you in jail.

11 Responses to “Readers’ Corner: Can Physicians Write Prescriptions for Drugs that the FDA Has Not Approved?”

  1. SmilingAhab says:

    Just remember that private money has so infested the FDA that low-level lackeys can’t make their own decisions any more. They are a hand puppet for Big Pharma – so don’t hate the hand puppet, hate the hand.

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  2. Erika Alvarez says:

    Since we face a terrible reality that we don’t have the freedom of choice when it comes to our health is that my family and me are trying to have a plan of action autlined in the case that any of us become ill, and it is to fly overseas and seek treatment or confirm diagnosis, in a couple of countries that I know personally, we (middle class) can afford health care, which is reasonable, without insurance there. In the meantime we are working on prevention (no vaccines or meds) and cleansings of the body.
    Erika.

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  3. mark burger says:

    I beg to differ: Don’t tell people NOT to sue the FDA. How are we EVER going to make any headway? Shame on you. Here’s a recent example of a pharmacist who sued and won: US vs Franck’s Labsw, Inc. (a compounding pharmacy in Florida):

    Landmark Pharmacy Compounding Court Decision Issued
    U.S. District Court rules in favor of pharmacy compounding for veterinary patients.
    HOUSTON (September 13, 2011): Judge Timothy Corrigan of the US District Court for the Middle District of Florida has issued his ruling in US v. Franck’s Lab, Inc. This lawsuit, brought by the Food & Drug Administration against Paul Franck , RPh, FIACP of Franck‟s Lab in Ocala, Fla., alleged that the use of active pharmaceutical ingredients (APIs) in compounding veterinary preparations for non-food producing animals was illegal. The FDA stated in its case that Franck‟s Lab, Inc. – and all other pharmacists involved in compounding veterinary preparations with APIs – were in direct violation of AMDUCA, the FDA‟s CPG, and the entire Food Drug and Cosmetic Act because those preparations are “new drugs” and subject to FDA review and approval.
    Judge Corrigan’s ruling states:
    *The FDA does not have jurisdictional authority over the compounding of medications by a licensed pharmacy so long as the pharmacy‟s activities are not manufacturing. That rests with individual state Boards of Pharmacy.
    *Congress did not give FDA jurisdictional authority when it enacted the FDCA in 1938 to take enforcement action against a pharmacy that is engaged in the traditional practice of compounding.
    *The FDA cannot use its CPG for veterinary compounding issued in 2003 as the basis for enforcement action.
    *The regulations enacted by the FDA based upon AMDUCA are in error – AMDUCA did not give FDA authority to prohibit the use of bulk APIs in veterinary compounding.
    *The use of bulk APIs in compounding for humans and the prohibition of bulk APIs for compounding for non-food producing animals is an illogical position for the FDA to take and contraindicated by its own actions over the past 50+ years.
    “This ruling is a significant victory for compounding pharmacists and the veterinary patients and practitioners they serve,” says, IACP President John Herr, RPh, FIACP. “Not only does it clearly refute the FDA‟s attempts to exert unauthorized jurisdiction over compounding, it is sharply critical of the FDA‟s approach towards veterinary compounding in particular. Judge Corrigan correctly ruled that Congress never intended the FDA to prohibit the use of APIs in veterinary compounding. He also clearly stated what IACP has said for years – the FDA does not have jurisdiction over the traditional practice of pharmacy compounding. That is the sole authority of the state Boards of Pharmacy,” says Herr. “Even more important to IACP members is Judge Corrigan‟s outright dismissal of the FDA‟s arguments that compounds prepared for an individual patient on the order of that patient‟s prescriber are „new drugs‟ and should be subject to FDA‟s oversight.”
    “For more than six years, IACP has worked with our supporters and allies in Congress to have the FDA address its ill-founded 2003 Compliance Policy Guideline on veterinary compounding,” explained David G. Miller, RPh, IACP Executive Vice President & CEO. “Multiple Congressional inquiries, letters, phone calls… all of them ignored by a regulatory agency so sure of its „rightness‟ in claiming that compounders were violating laws. Well, today, they were proven wrong by the courts. The tireless efforts of our members and our staff, the courage of Paul Franck to fight the FDA itself, and the commitment of IACP to its mission of the art and science of compounding has paid off.”

    Judge Corrigan‟s ruling cites a number of landmark court cases and decisions affecting IACP members in addition to addressing the specific issue of APIs in veterinary compounding. The document numbers more than 80 pages and provides an exceptional summary of the case as well as the FDA‟s attempts to grant itself authority that Congress never intended it to have.

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  4. Why can’t I shout? This needs some shouting, as it is some very scary government intervention/anti constitutional activities! I want to shout to the heavens/rooftops etc. This has to stop! Government criminals! Usurped powers! We are a “sovereign” nation. Why are we being dictated by our servants? That my friend needs to be shouted!

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  5. natandov says:

    One solution would be for the government to bring in laws forcing FDA to submit to an independent supervisory body which would be funded by the state, to defend anyone claiming abuse of the FDA’s authority, and with the power to rein in its activities where these exceed its authority. There would need to be safeguards in place to preserve its autonomy/ independence, so it cannot be corrupted or bought by the FDA. Could a referendum be useful in this context?.

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  6. I think that the F>D>A> should be disbanded. They want to band Natural productsfrom the market ,they don’t even want people to study up on natural medicines. I think this is the craziest thing I ever heard of .Walnuts, cherries apples and all kinds of fruit have been around for hundreds of years .Why should they be bad for us? They make us healthy and big Pharma does’t want us healthy.

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  7. allison says:

    this article made me sad to the reality of how it is. I’m wondering can we unionize as a group against the FDA? Although it’s a different matter completely, I’m very proud of those NY healthworksers who unionized against mandatory swine flu vaccination. They were successful in holding it off. Doesn’t public outrage in numbers count anymore?

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  8. Harvey Branman says:

    How is that so many pharma drugs get passed and then pulled because they killed too many people. What a joke the FDA continues to be with their two-sided qualifications for drugs that are supposed to help us. As a private citizen, I could be arrested for telling someone to take vitamin C. The MD’s are owned by the drug companies. The medical schools are owned by the drug companies. Most doctors treat their patients for illness rather than advise them how to stay healthy by eating and drinking those foods and water that will keep them from getting acidic. Medical schools teach to listen for the problem and write a prescription to cover up the illness instead of looking for the root causes.

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  9. Bobbi Martin says:

    Anyone who has been aware of all the ‘Approved by the FDA” medicines that have been rushed to market in the past 15 – 20 years should also be aware of how corrupt that agency really is. If you have the money and the desire to pay them enough money you could get a large dose o straight arsenic approved or whatever ailment you wanted it approve or!! They don’t even look at , in my opinion, look at any o the medicines that Big Pharm wants approved. If these drugs were properly tested BEFORE being allowed to be put on the market there would not be so many o them being recalled because of deaths and tragic reactions to them. There needs to be ABSOLUTE transparency in ALL government agencies including where the money COMES from, who USES it, what it is used FOR, EVERY test that is run on it- including the ones that show how BAD it is, and someone needs to be in charge – say a committee – who do NOT BENEFIT from the drug getting on the market sooner rather than later, and all test results need to be communicated to health care providers so they can be discussed with the patient and an informed decision made on their use. Instead of so many malpractice suits being brought against doctors perhaps the public should start suing the drug manufacturers !!!!

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  10. Razzle says:

    Another “grey area” is the ability to prescribe medications that are currently undergoing clinical trials in an effort to achieve FDA approval.

    And also another grey area is the use of off-label prescribing of currently FDA-approved medications.

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  11. Arnie Welber says:

    Yep! That is how our dysfunctional government embedded bureaurocrats at FDA, NCI, Texas Medical Board, etc. are persercuting Stanislaw Burzynski, MD……:-)

       0 likes

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