Reform the FDA, Not Patent Laws

Published August 30, 2002

The Senate’s recent passage of the Greater Access to Affordable Pharmaceuticals Act (GAAP) proves Senators are seeking an easy way around a complex issue. While attempting to bring drugs to the consumer market faster and cheaper, the Senate ignores the root cause of the expense and delay: the Food and Drug Administration (FDA).

The GAAP measure would reformulate the 1984 Hatch-Waxman Act by further limiting the intellectual property rights of pharmaceutical companies in order to increase the availability of generic drugs.

But, like all previous government attempts at market manipulation, studies indicate GAAP-style legislation could result in thwarted research and development of drug treatments, which would lead to fewer, higher-priced drugs—not more, or more affordable, drugs.

Instead of attacking patent rights, efficiently described in Hatch-Waxman and specifically protected in Article 1, Section 8 of our Constitution, legislators should be looking to reform the snail-paced drug approval process at the FDA.

On average, a new drug takes 14 years to move from the research stage to the medicine cabinet. That process costs about $800 million—for each drug. Currently, pharmaceutical firms enjoy a period during which they hold exclusive patents—property rights—to their discoveries, a reward extended to all industries, not just drugs.

It is during this time of protection that brand-name pharmaceutical companies attempt to recoup their investment, reward investors, and raise funds to invest in new medicines. Without this patent protection period, innovative pharmaceutical companies would not have the same incentive to continue their research and development of new medicines.

Personal Experience

Like the FDA, I suffer from an aging problem. Over the years, the FDA bureaucracy has become obese. As for me, I have developed osteoarthritis in my knees. Both these conditions are painful, slow you down, and have a negative effect on productivity and the quality of life.

My pain and walking difficulties became such a daily problem that I opted for a set of three shots (referred to by the FDA as a “medical device”) directly into the knee. It is a solution administered by an orthopedic surgeon via a syringe and needle (the device). A set of shots costs $500 per knee. Knee replacement, by comparison, can run about $12,000 per knee and requires extensive physical therapy. It takes about a year to full recovery.

For many people, the relief brought by the drugs-into-the-knee approach can last six months or more, and can be repeated if tolerated well the first time around. As in my case, the shots are particularly effective for younger healthy seniors with recuperative powers. Even frail seniors, whose health can be severely compromised by knee replacement surgery, consider drug treatments a miracle.

The drug treatment could have been available to me many years earlier, when the first symptoms of knee pain appeared, but for the long and costly regulatory delay. Patent protection laws didn’t slow down the process of getting that “device” to my knees. The FDA did.

FDA in Slow Motion

After some research, I learned the shots-to-the-knee approach, called Synvisc-Hylan, was developed in the Netherlands by Genzyme Biosurgery. It has been used successfully in Europe since the late 1980s. Had I known about it sooner, I could have had the shots administered years earlier while on a visit to Germany. I only learned of Synvisc-Hylan from a magazine advertisement featuring Hall of Fame golfer Nancy Lopez promoting how she “found knee pain relief.”

According to FDA review data detailed in the January 10, 2001 Federal Register (Vol. 66, Number 7), Genzyme Biosurgery and Wyeth Pharmaceuticals partnered and applied for FDA approval of Synvisc-Hylan in 1989. The approach was finally approved for use in August 1997, eight years later.

When reviewing the Synvisc-Hylan application, the FDA did not consider relevant the data from the European clinical trials of the approach. If it had, the approval process in the U.S. could have moved much more quickly.

Dr. Henry I. Miller, former FDA official and author of To America’s Health: A Proposal to Reform the Food and Drug Administration, writes, “Although few Americans are aware of it, most of the process of drug development has always been conducted by the private sector. Industry, not the FDA, performs the discovery and clinical testing of new drugs under FDA rules.”

Miller thinks the FDA evaluation process differs from its counterparts abroad in that other countries rely much more heavily on experts from the private sector, rather than a bureaucratic government agency. The approval process in the United Kingdom and European Union is thought to be more efficient than the process here in the U.S. Those countries regularly perform reviews as or more rapidly than we do here … with significantly less staff and expense.

Sheila Shulman, Peg Hewitt, and Michael Manocchia point out in their article, “Studies and Inquiries into the FDA Regulatory Process: An Historical Review,” published in the April-June 1995 of the Drug Information Journal (Vol. 29, No. 2), “Numerous independent analyses, including comparison of the FDA with drug regulators abroad, have produced recommendations for improvements that would reduce the time, the cost, complexity, and unpredictability of the research and development process.”

According to Miller, none of the recommendations reviewed by Shulman and her coauthors came close to reforming the FDA. “Even,” writes Miller, “the much-touted Food and Drug Modernization Act of 1997 did little more than codify what was already in place.”

Lessons for Legislators

Until now, I admit, I had little appreciation for the convoluted, time-consuming, and expensive process of drug invention-to-approval. You pay more attention when it’s your own health on the line.

The slow pace of the FDA put my health at risk. And Genzyme Biosurgery lost eight years of patent protection and millions of dollars in a costly delay, all of which is now reflected in the cost of their medication.

Don’t misunderstand me. I don’t blame politicians for the pain and discomfort from my failing knees. They got banged up pretty good while I was coaching youth hockey in Chicagoland.

But I do hold those politicians responsible for failing to reform the FDA while at the same time giving me a snow job about how patent laws are the problem. If anyone needs an example of good politics and lousy social policy, this is it!

What do you think? Write me at [email protected].