Why Is The FDA Leaving Doctors In The Dark?

FDA officials apparently think that doctors aren’t smart enough to understand the labels on the medications they prescribe.

The agency recently released draft guidance for how the pharmaceutical industry should label “biosimilars,” a new class of medicines. These guidelines state that biosimilars’ labels should leave out critical information in order to avoid causing “confusion” among doctors.

Omitting this data could harm — or even kill — patients.

The FDA should reverse course — and urge drug manufacturers to give doctors all the information they need to make smart prescribing decisions and keep their patients safe.

Every prescription drug comes with a “product label.” This label isn’t the sticker on a pill bottle. It’s a detailed document that describes a medication’s safety and effectiveness, complete with data from clinical testing.

This information helps doctors understand whether a medicine is an appropriate treatment for a specific patient. In 1984, Congress passed a law that let generic drug manufacturers copy the product label of brand-name drugs word for word.

That decision made sense. The small-molecule generic drugs prevalent in that era were exact chemical replicas of the brand-name drugs they copied. That’s still true today for small-molecule drugs — store-brand ibuprofen is chemically identical to Advil. Both will affect a patient the same, so there’s no need for separate product labels.

Large-molecule drugs are different animals. These medicines are called “biologics” and are grown from living cells — generally, in a petri dish of genetically modified bacteria.

Biosimilars attempt to model biologics. But because they’re derived from different cell lines, a biosimilar will never be exactly the same as a biologic.

The differences between a biosimilar and the biologic it mimics are slight. In the majority of cases, patients fare equally well whether they receive a biologic or biosimilar. But sometimes, slight molecular differences change the way patients’ bodies react to the drug. And that can threaten their health.

Consider one prominent case in Ireland. Health officials approved a biosimilar for infliximab, a biologic that combats various forms of arthritis. According to one study, the biologic and the biosimilar had wildly different effects. Only one of every 20 people taking the original biologic required readmission to a hospital. Eight in 10 people who took the biosimilar, on the other hand, had to be re-admitted.

The folks who took the original biologic also never needed additional surgery. Almost 30 percent of those who took the biosimilar did.

Clearly, there’s a reason they’re called biosimilars — not “bio-sames.”

The FDA’s labeling guidance ignores these differences. When the agency approved its first biosimilar, Zarxio, in March of last year, it let the manufacturer base the product label off the one used by the original biologic.

That’s dangerous, because it deprives doctors of important information. For example, Zarxio’s label currently details potential adverse reactions associated with the original biologic — not for Zarxio itself. The label also swaps out data from the clinical trials that Zarxio underwent — in favor of data from those the original drug submitted to.

Worse, the label doesn’t clearly notify doctors that the data are from studies of the original drug, not Zarxio.

Doctors overwhelmingly believe that product labels should clarify such differences. Eight in ten doctors say that it’s important or very important for a biosimilar’s label to include clinical and analytical data on that biosimilar, not just on the original biologic it’s attempting to mimic.

FDA officials ought to listen.

Patients’ lives depend on doctors making informed decisions about which drugs to prescribe. They’ll only have that information if the FDA’s final guidance urges biosimilar manufacturers to include their own clinical data on the product label.

Nothing contained in this blog is to be construed as necessarily reflecting the views of the Pacific Research Institute or as an attempt to thwart or aid the passage of any legislation.

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