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Drug bill carries serious side effects, no benefits

Peter J. Pitts | 7/1/2019, 11:19 p.m.
Sens. John Cornyn (R-TX) and Richard Blumenthal (D-CT) claim that their new bill – the Affordable Prescriptions for Patients Act ...

Sens. John Cornyn (R-TX) and Richard Blumenthal (D-CT) claim that their new bill – the Affordable Prescriptions for Patients Act -- will expand access to needed medicines for American patients. But in reality, the bill is poised to do the exact opposite.

The bill is premised on the idea that drug companies are gaming the IP system by making incremental changes to drugs they have already patented. Sens. Cornyn and Blumenthal believe such behavior is merely a way of driving off competition from less-expensive generics, thereby inflating drug costs for patients.

The Affordable Prescriptions for Patients Act addresses this perceived abuse by empowering the Federal Trade Commission (FTC) to bring antitrust suits against pharmaceutical companies who engage in this practice.

But nearly every assumption behind the bill is flawed. For starters, the reform takes for granted that any alterations or refinements to an existing medicine automatically amounts to an anti-competitive ploy, when in fact there are countless reasons to engage in such work.

For instance, a drug firm might develop a time-release version of a medicine to make it easier and safer for patients to take. Or it might create new dosage forms entirely, allowing patients to take a pill or wear a patch instead of having the medicine administered intravenously. Similarly, researchers could find a new combination therapy that involves taking multiple already available drugs in a specific sequence.

Advances like these can drastically benefit patients, whether by improving outcomes, reducing side-effects, or simply making a drug regimen more convenient.

It's also unclear how developing a new version of an old drug impedes access to generics. After all, these improved medicines don't extend the patent on the original drug. Any firm looking to release a lower-cost generic of a drug's earlier version is free to do so.

The threat the Cornyn-Blumenthal reform poses to America's patent system is also troubling.

It takes a decade or more to bring a single new drug to market, and costs, on average, $2.6 billion. That process almost always involves numerous false starts and dead ends -- only one in ten drugs that reach clinical trials are ultimately approved.

Without the ability to protect their inventions through reliable IP laws, drug companies would have far less reason to expend the resources necessary to make genuine breakthroughs.

That would be disastrous for patients, especially those suffering from conditions for which no suitable treatment yet exists. Just think of those suffering from Alzheimer's, a disease which afflicts 10 percent of Americans over 65, and for which a new drug hasn't been approved in more than 15 years.

The Affordable Prescriptions for Patients Act would do little to expand access to generic drugs. But it would undermine an IP system that makes medical progress possible in the first place, leaving millions much worse off as a result.

Peter J. Pitts, a former FDA Associate Commissioner, is president of the Center for Medicine in the Public Interest.