Last Day at Pacific Research Institute

Colleagues and supporters:

Thank you all for your interest in my publications and proposals to reform American health care. Today is my last day as Director of Health Care Studies at Pacific Research Institute and Executive Director of the Benjamin Rush Society. I am very grateful to have had the opportunity to contribute to PRI's efforts to reform American health care in the direction of more individual choice and less government control.

I will be leaving San Francisco (by car) tomorrow to drive across the country to Washington, DC, where I will be joining the Advanced Medical Technology Association (AdvaMed), the trade association for innovative medical-device makers on August 20.

As of today, this blog will be updated very seldom (if ever). It becomes an archive, I suppose, so plunder it as you see fit!

Best wishes,

John R. Graham

Orphan Drugs & Humanitarian Devices: Current Policies Don't Meet the Challenge

An orphan drug is a drug that treats a rare disease. In the U.S., a disease from which fewer than 200,000 is defined as rare. A Humanitarian Use Device is one from which no more than 4,000 patients will benefit.

It is very difficult to attract investment in innovation in these areas, because it is very difficult for entrepreneurs to earn a profit. Starting in 1983, U.S. law has provided incentives to promote more investment. The recently signed Food and Drug Administration Safety and Innovation Act contained a number of improvements to these policies.

Unfortunately, these reforms are unlikely to achieve the goals desired by their enthusiastic supporters - the topic of this month's Health Policy Prescription, which you can read here.

A State Needs A Health Benefits Exchange Like A Fish Needs A Bicycle

Recently, former U.S. Senator Bill Frist, MD, wrote an op-ed in which he advocated collaboration with Obamacare through establishing Health Benefits Exchanges, run by politically appointed boards which will choose health plans for individuals if Obamacare survives.

Dr. Frist's recommendations would be dangerous for any state to implement, as long as Obamacare survives.

Next week, I'll be speaking at the World Congress 3rd Annual Leadership Summit on Health Insurance Exchanges. I've uploaded notes for my presentation, "A State Needs A Health Benefits Exchange Like A Fish Needs A Bicycle," here.

User Fees For Medical Devices

My latest column for Forbes.com: The Apothecary, explaining why throwing more money at the Food and Drug Administration will not improve the productivity of regulation of medical devices. Read it here.

The FDA Caused Drug Shortages; It Won't Solve Them

My latest column for the Detroit Free-Press addresses the causes and possible solutions to shortages of generic injectable sterile drugs. Read it here.

User Fees for Medical Devices: Third Time Lucky?

Congress recently re-authorized user fees for medical devices. These user fees are paid by the manufacturers to the Food and Drug Administration to finance the regulatory process of licensing new medical devices.

However, user fees have been in effect since 2003, and the FDA has taken in the cash without improving output. Indeed, productivity has declined significantly since user fees took effect.

Read this month's Health Policy Prescription here.