Good ideas in Congress rarely have a chance. Rep. Fred Upton (R-Mich.) is sponsoring legislation to speed drug approvals, but his initial plan was largely gutted before he introduced it last month.
Drug discovery is an uncertain process. Companies consider between 5,000 and 10,000 substances for every one that ends up in the pharmacy. Of those, only one-fifth actually makes money—and must pay for everything.
As a result, the average per drug cost exceeds $1 billion, most often thought to be between $1.2 and $1.5 billion. Some estimates run more.
Naturally, the Food and Drug Administration insists that its expensive regulations are worth it. Unfortunately, while the agency undoubtedly prevents some bad pharmaceuticals from getting to market, it delays or blocks far more good products.
The average delay in winning approval of a new drug rose from seven months in 1962, when the FDA’s power was dramatically increased, to 30 months in 1967. Approval time now is estimated to run as much as 20 years.
Economist Sam Peltzman found no evidence that changing the law reduced the introduction of ineffective or unsafe pharmaceuticals. After all, companies don’t make money selling medicines that don’t work. And putting out something dangerous is a fiscal disaster. Observed Peltzman: the “penalties imposed by the marketplace on sellers of ineffective drugs prior to 1962 seem to have been enough of a deterrent to have left little room for improvement by a regulatory agency.”
Alas, the FDA increases the cost of all medicines, delays the introduction of most pharmaceuticals, and prevents some from reaching the market. That means patients suffer and even die needlessly.
Congress has applied a few bandages over the years. One was to create a process of user fees through the Prescription Drug User Fee Act. The measure was estimated to save as much as $30 billion and as many as 310,000 life years.
A special procedure for “Accelerated Approval” of drugs aimed at life-threatening conditions also was created. Unfortunately, noted Nature Biotechnology, few medicines qualified and “in recent years, FDA has been ratcheting up the requirements.”
The Wall Street Journal reported that some desperate patients today who are “frustrated by the slow pace of clinical drug trials or unable to qualify, are trying to brew their own version of an experimental compound at home and testing it on themselves.” Overall, far more people die from no drugs than from bad drugs.
The deadliest pre-1962 episode involved Elixir Sulfanilamide and killed 107 people. Around 3500 users died from Isoproterenol, an asthmatic inhaler. Vioxx was blamed for a similar number of deaths, though the claim was disputed. Most of the more recent incidents would not have been prevented from a stricter approval process.
The death toll from agency delays of medicines like beta-blockers is much greater. Analyst Dale Gieringer figured that the benefits of FDA regulation “could reasonably be put at some 5,000 casualties per decade or 10,000 per decade for worst-case scenarios. In comparison … the cost of FDA delay can be estimated at anywhere from 21,000 to 120,000 lives per decade.”
Fundamental reform is necessary. The FDA should be limited to assessing safety. Further, the agency should be stripped of approval monopoly. As a start, drugs okayed by other industrialized states should be available in America.
As I argue in the Freeman, “Patients and their health care providers also could look to private certification organizations, which today are involved in everything from building codes to electrical products to kosher food. Medical organizations already maintain pharmaceutical databases and set standards for drug treatments. They could move into testing and assessment.”
No doubt, some people would make mistakes. But they do so today. With more options, more people’s needs would be better met.
Instead of arguing over regulatory minutiae Congress should address who decides who gets treated how. Today it is Uncle Sam. Tomorrow it should be all of us.