As many as 1 out of 3 people who have died from disease in the last 40 years did so needlessly because of a single law passed by Congress in 1962! Here's my "insider" story.
For 19 years, I was a research scientist with the Upjohn Company, a mid-sized pharmaceutical company. I once joked that we were so busy complying with superfluous regulations, we had little time to discover new drugs. Unfortunately, it's no laughing matter.
In 2003, enough studies had been published on the 1962 Kefauver-Harris Amendments to estimate the true cost of these FDA regulations. Researchers had long suspected that they had thwarted innovation, driven up drug prices, and delayed the introduction of life-saving pharmaceuticals.
Prior to the passage of these Amendments, the FDA primarily regulated only drug safety. The Amendments gave the FDA authority over drug manufacturing, advertising, animal studies, and the design of clinical trials.
The result was predictable: the time it took to take a drug from the laboratory to the market went from 4 years to 14 years. Because patent life was 19 years or less, manufacturers had insufficient time to recover their costs before a drug went generic.
In 1984, Congress passed the Waxman-Hatch Act, which partially restored the patent years destroyed by regulation. The act estimated that regulations were responsible for a whopping 84% of the 14-year development time. Prior to 1962, about 15% of the development time was consumed by regulatory requirements.
When the AIDS epidemic arose, pharmaceutical companies began to develop treatments. However, most AIDS patients couldn't wait the 14 years that it then took to get through the regulatory red tape. A small group of concerned activists hired underground chemists to make the very drugs that we were working on.
By the time the FDA gave us permission to test our new drugs in people, virtually the entire AIDS community had already received them. Since the regulatory testing had to be done in people who hadn't yet received the drug, we had to wait for new cases to be diagnosed.
Although the actions of the AIDS activists were illegal, neither the FDA nor the pharmaceutical companies chose to prosecute. Indeed, the AIDS community demonstrated that lay individuals, working with concerned medical professionals, could manufacture, distribute, and test new therapies with a minimum of side effects!
The amendments might have saved, at best, 7,000 lives. In contrast, many more died waiting the extra 10 years for life-saving drugs. According to my calculations, about 4.7 million people died over the last 40 years while the life-saving drug they needed was tied up in regulatory red tape!
Unfortunately, that’s just the beginning. The amendments have destroyed at least half of the industry’s innovative capacity, preventing some life-saving drugs from ever reaching the market.
For example, when I filed a patent for the treatment of fibrotic liver disease with prostaglandins, an FDA examiner called me personally. “You must encourage your company to develop this product,” he insisted. “We lose 100,000 people each year to fibrotic liver disease, and we have absolutely nothing to offer.”
The studies required by the Amendments, however, were especially long, difficult, and expensive. Studies with new, breakthrough drugs often are. If we guessed wrong the first time and had to repeat years and years of studies, our patent would run out and we'd never recoup our investment. In spite of the FDA's support, we had to abandon this potentially life-saving drug.
The death toll from losing half of our innovations from 1962 to 2003 is somewhere between 4 and 16 million people depending upon the assumptions used. Adding the 4.7 million deaths due to an extra 10 years of development time suggests that as many as one out of three people who died of disease since 1962 may have done so needlessly.
The 1962 Kefauver-Harris Amendments may very well be the deadliest law that Congress ever passed.
October 11, 2005