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Making Drugs Safe and Available without the FDA
The Need for Reform
Developing a new drug is a complicated process. After the compound is produced
in a laboratory, it undergoes preclinical testing on animals, clinical testing
on humans and FDA review. The time required for the process has increased
significantly since 1963 [see Figure I].2
How the FDA Delays Drugs. Many of the medical products developed today require longer and more complicated testing because of their complex nature. In addition, despite a well-orchestrated public relations campaign suggesting just the opposite, the FDA imposes delays at every stage of development.
In an October 1995 report, "FDA Drug Approval," the General Accounting Office announced that review times have fallen from 33 months to 19 months.4 In a December 12, 1995 speech at the annual meeting of the Food and Drug Law Institute, FDA Commissioner David Kessler boasted that the FDA had that year reviewed 96 percent of all pending final applications.5 Those numbers are misleading. The GAO report looked only at the last review of a final drug application and ignored the other phases of FDA review. The other phases have lengthened overall development time. For example, the number of clinical trial subjects has increased and the number of tests per subject has doubled. The FDA also has greatly increased the amount of information it demands before accepting a new drug application.6
Jeffrey Kimball, executive director of the Medical Device Manufacturers Association, says the FDA reduced its backlog of pending applications by a simple procedure: it rejected more new drug applications.7 A report by Citizens for a Sound Economy shows the FDA is taking more time to approve fewer drugs. In fiscal year 1994 the average review time was 27.3 months for the 62 new drug applications approved. But in 1995 the 33 approved new drug applications took an average of 28.6 months.8 U.S. law requires review of applications for final approval of new drugs within 180 days.9 The FDA is nowhere near meeting the statutory limit.
What is the result? Extremely long delays between the laboratory development of a drug and the time it is available to patients.10
- According to Sen. Nancy Kassebaum (R-KS), former chairman of the Senate
Labor and Human Resources Committee, which has jurisdiction over the FDA,
it takes 12 years for drug companies to develop a new drug and gain FDA
approval to market it.11
- Kenneth I. Kaitan, associate director of the Tufts Center for the Study of Drug Development, estimates that the total time to develop and gain approval for a new drug is actually 16.1 years.12
These deaths are not dramatic, and one cannot always identify a death that occurred because the FDA was slow to allow a drug on the market. There is very little peer-reviewed research on deaths caused by FDA delays.13 Nonetheless, to a certain extent quantification is possible based on FDA claims regarding the lifesaving benefits of drugs it approved and the fact that some lifesaving drugs were available in other countries years before the FDA approved them for use here. Some examples [see Figure II]:
- Misoprostol is 94 percent effective in preventing bleeding ulcers,
common in arthritis sufferers taking aspirin and similar drugs. According
to the FDA, it can potentially help 10,000 to 20,000 people every year.
For the nine and one-half months it took the FDA to approve the application
for this new drug, no one in the U.S. could use it. That means between 8,000
to 15,000 Americans may have died because Misoprostol was not available
sooner.14
- Thrombolytic therapy dissolves blood clots in heart attack victims.
Every year 700,000 people suffer heart attacks, and 9 percent of them die.
The FDA found the therapy reduced heart attack fatalities by 18 percent,
but it took two years to approve the new drug application. The result was
up to 22,000 deaths.15
- More than 1,230 U.S. deaths from overdoses of sedatives might have been prevented during the five years a safer hypnotic (benzodiazepine) was approved in Britain but not by the FDA.16
- Beta-blockers effective in preventing heart attacks and coronary death might have saved 10,000 to 20,000 lives a year during the three years when none were available in the U.S.17
- An estimated 1,000 lives were lost when FDA red tape prohibited the manufacturer from selling a defibrillator that it had already approved, according to Dr. Richard Cummins of the American Heart Association.18
Approvals Still Delayed. For more than three years the FDA has worked to reduce the amount of time it requires to approve new drugs. The FDA and Vice President Al Gore's National Performance Review proudly predict that by 1997 new drugs will receive final approval and be marketed within one year.20 Ignoring all the delays earlier in the process, what are the consequences of delaying new drugs for only one year? In the case of thrombolytic therapy, that means only 11,000 people might have died.
The FDA also imposes heavy financial burdens on Americans. Some medical manufacturers are responding to the FDA's costly delays by moving abroad. The 16-year time frame for the development and approval process has raised the average cost of drug development in the U.S. to an estimated $200 million.21 Not surprisingly, more and more medical companies are relocating portions of their business, especially to Europe, where a more rational regulatory environment makes drug development less costly.
- In a June 1994 survey by the American Electronics Association of 58
companies producing medical devices, 29 percent of the polled firms indicated
they had shifted investment overseas while 22 percent said they had shipped
personnel overseas and 40 percent said they had reduced their U.S. payroll
as a result of FDA delays.22
- A 1994 survey by the Minneapolis Star Tribune found that the most heavily regulated companies employed 7 percent of their personnel overseas in 1989 and 12 percent in 1994, and expected overseas employment to reach 16 percent by 1999.23
Taxpayers also bear a substantial burden because the FDA is funded mostly by tax dollars, not drug company fees. In 1994 the total FDA budget was $921 million, appropriations for 1995 were $975 million24 and the 1996 budget was $878 million.25