The unintended consequences of well-meaning FDA regulations

We rely on the FDA to protect public health “by assuring the safety, efficacy, and security” of medical drugs and devices. The FDA takes its marching orders from Congress via the legislative process. One such law is the Compounding Quality Act of 2013, passed in response to a series of fatal infections due to improper compounding pharmacy processes. While such oversight is important and well meaning, the unintended consequences may be profound.

In my medical specialty of retina surgery, compounded and off-label Avastin is used in the treatment of macular degeneration, diabetic retinopathy, and other retinal conditions. At a cost of 40 times less than the FDA approved options, using compounded Avastin instead of the on-label expensive alternatives could save Medicare $3 billion per year. Studies have shown the lower cost Avastin is equivalent to the much more expensive Lucentis in treating macular degeneration. Many physicians will try Avastin as the first line of treatment in their patients and continue using it if it is working well.

As Avastin is being used “off-label” in a much smaller dose than used for its approved use in cancer treatment, it must be divided into extremely small doses suitable for injection into an eye. This is done by a compounding pharmacy. Most patients receive injections every four to six weeks for many years, with many physicians deciding at the time of the eye exam whether or not to give an injection. Most patients are elderly and/or visually impaired, meaning that a friend or family member brings them to their eye appointment.

Back to the FDA, which recently issued guidance in response to the new, compounding law. Specifically they “will require a patient-specific prescription for all drugs compounded.” While this may allow easier tracking of the rare cases when drugs are contaminated, it won’t alter the actual compounding process and won’t reduce the chance of contamination.

But once the retina surgeon examines the patient and determines that they need an injection, instead of using a preordered syringe from their inventory, they will instead have to send a prescription to the compounding pharmacy and have the patient return on a separate day for their injection. For a patient receiving monthly injections, this translates to 24 office visits rather than 12 each year. Depending on insurance, there may be a copayment for each visit. Not to mention the friend or family member doubling their driving duties and the physician further loading their already busy patient schedules. Imagine going to the family doctor for a flu shot and after a quick exam, having to return a week later for the shot after the doctor writes a prescription for it rather than simply pulling a vial of flu vaccine from the refrigerator and giving the injection.

The simple alternative for the surgeon is to abandon any intention of being a good steward of societal and patient monies by simply using the FDA approved, but far more expensive, drugs. This avoids the hassle of writing several hundred injection prescriptions each month and making patients return a week later for each injection. Good financial stewardship of government money loses appeal when the government complicates the physician’s business processes by such mandates. And when the government threatens physicians with a 30% cut in reimbursement via the SGR cuts, why should physicians jump through hoops to save Medicare a few dollars?

Brian C. Joondeph is an ophthalmologist and can be reached on Twitter @retinaldoctor.  This article originally appeared in The Daily Caller.

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    I love the unintended consequences of our good intentions as a nation.
    We demand that companies use no more than 20% of their gross sales to
    profit, everything else must go to the core business, in this case
    health care costs. How do you increase profits? You increase the total
    amount of money collected (gross sales). How do you increase gross
    sales? Increase premiums, because 20% of 100 is less than 20% of 1000,
    thus I make more money if I charge 1000 instead of 100. Yes, ACA will
    lead to lower premiums about as effectively as as ankle weights will
    help you float on water.

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