Thursday, July 31, 2014

Unintended Consequences of FDA Regulations

Eye surgeon Dr. Brian C. Joondeph described a crazy "unintended consequence" of FDA rules designed to "protect" patients.

Here's an extended excerpt from his blog post:
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?
These FDA rules increase the "hassle factor" for patients and doctors. And cost more money in the long run.