Phase IV: It’s Not Over ‘Till It’s Over

Medical Patents Broker Inc.
By Kenneth Pearce, President

The Last Phase of any medical invention isn’t the approval—it’s the Post-Marketing Surveillance. Most of the time, everything moves smoothly. However, some recalls make the national news and, as a broker, I receive the weekly FDA reports that show the mistakes made. Sometimes it’s the wrong filler, the wrong strength, or even a missing active ingredient. The FDA is a busy protecting the patient.

Phase IV is about the Cross-Section of Real-World Patients

• A million plus patients can be involved: How does the treatment interact with multiple comorbidities? What about diverse age, sex, and ethnic groups? For example, with roughly 40% of the U.S. population identifying with a specific ethos, Phase IV attempts to measure whether a biologic works as effectively for everyone as it did for the hand-picked trial group. The treatment that saves millions can, unfortunately, cause hostile reactions in a few.

Phase IV is about Chasing the “One in a Million” Adverse Effect

• Vigilance Must be Maintained: The FDA uses sophisticated detection to monitor approved treatments. Some adverse reactions occur only once in 50,000 uses. It could be an outlier, but the FDA has the authority to mandate label changes or a full product recall to ensure that “one” doesn't become “many.”

Phase IV Can Lead to “New and Improved” for the Manufacturer

• Comparison Studies: How does the senior biologic stack up against the junior competitor that just launched? Favorable Phase IV reports can convince CMS and insurance carriers that the established product is significantly better. We saw this strategy keep products like warfarin sodium and digitoxin at the top for decades after their initial patents expired.
• New Indications: Monitoring can reveal that a treatment for “Condition X” is effective for “Condition Y”—even if there is no obvious scientific nexus between them. MPB’s legal counsel tells me that such a “New Use” is potentially patentable, leading to a brand new patent term for the “Y” treatment.

The President’s Viewpoint

Humans are a complex mass of cells, water, and millions of simultaneous chemical reactions. This explains why new uses for older treatments are always possible. Without Phase IV, the discovery of these lifesaving discoveries would be much rarer.

It has been called the “Practice of Medicine” for my entire life—and that’s exactly what it is: a practice. In the United States, look for the horse before chasing the Zebra. And after all of that, we find out it was the Elephant in the room all the time. We are so similar, yet so unique, that there are no absolutes. When a foreign composition of matter enters the human body, anything or nothing can change. Still, without the medical patent to fund this long-term surveillance, modern healthcare would be a very limited stage indeed.