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A Dangerous Practice: How Drug Companies Bend FDA Rules (cont.)

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If your doctor becomes defensive when you ask about off-label use, it might be a sign that you should find another doctor, says William Soller, who is a professor in the school of pharmacy at University of California-San Francisco. Soller says it isn’t necessarily a bad sign if a doctor excuses himself/herself when you ask about off-label uses, because it typically means that he/she is going to his/her computer to find more information for you. “I want someone who will admit they don’t know something and go find out,” Soller says.

Ultimately, you want to see evidence from independent sources that supports the use of an off-label prescription. For example, if the research that supports the off-label use of a particular medication was paid for by the medication’s manufacturer, that’s a major red flag that indicates that the results are biased in favor of the drugmaker. Consequently, you should request a different prescription.

When you have doubts about a prescription, you should speak with your pharmacist. Independent experts tell us that a pharmacist often is the most qualified person to determine whether your prescription is for on-label or unnecessary off-label use, because pharmacists often are more knowledgeable about FDA approval of a medication than are the doctors who prescribe it. If the pharmacist says a prescription is for off-label use, you should ask him/her to recommend an on-label alternative, so you can have the option to request that your doctor write a new prescription.

You also can get help online. Experts say the most reliable source is dailymed.nlm.nih.gov, which is run by National Institutes of Health and has up-to-date information about all medications, including full FDA labels. If you determine that the prescription that you have is an unwanted medication that’s designed for off-label use, Fugh-Berman says you should take the prescription back to your doctor and tell him/her: “Thank you, but I prefer a time-tested drug.”

Finding out whether a low-cost and FDA-approved alternative exists is almost as difficult as finding out whether a medication is for off-label use. Although the Patient Protection and Affordable Care Act created Patient-Centered Outcomes Research Institute (PCORI), which is supposed to be a source of information about the comparative effects of different medications and treatments, it leaves out price comparisons, because lawmakers caved to lobbying by the pharmaceutical industry, experts tell us. As a result, PCORI isn’t allowed to tell people what medications cost, says Randall Stafford, who is a professor of medicine at Stanford University who specializes in evidence-based medicine and prescribing.

Unfortunately, the missed opportunity by lawmakers isn’t the only example of how the federal government could do more to protect consumers when it comes to unnecessary off-label prescriptions. Experts insist that FDA should expand its role. For example, Stafford says, FDA could do a better job of enforcing restrictions that are designed to reduce unnecessary use of off-label prescriptions. He says FDA can better anticipate which medications would be prescribed for off-label use and should monitor more aggressively the patterns of use for all medications. For instance, FDA could implement a threshold for the amount of off-label use and more heavily scrutinize that medication when it exceeds that threshold.

When we asked FDA whether it would take such additional steps to monitor and scrutinize off-label use and drugmakers, FDA spokesperson Sarah Clark-Lynn responded with a statement that didn’t address our question. She says FDA will continue to enforce existing provisions that restrict how drugmakers market off-label use of medications. We take her comments to mean that FDA won’t apply more scrutiny.

COURTING DANGER. Some experts worry that the Supreme Court could undermine the little power that FDA already exercises if the Supreme Court is asked to settle federal appeals court cases that question whether FDA’s marketing-claim restrictions for off-label prescription use violate the free speech of drug companies.

We likely won’t know until at least summer 2013 whether the issue will reach the Supreme Court. If the Supreme Court agrees to rule on the issue and then rules in favor of drugmakers, the decision would make it more difficult for FDA to rein in drugmakers who exploit off-label use of their medications, experts say.

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