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TITLE:
Removing Efficacy Tests from the Food and Drug Administration
MAJOR AREAS TO BE AFFECTED:
Pharmaceutical companies, hospitals, doctors, the Food and Drug Administration, Medicare and other similar government agencies and programs, health insurance providers, all American citizens in need of medical care or that have health insurance
JUSTIFICATION:
Millions of people have died in the United States due to the Food and Drug Administration’s (FDA) failure to approve drugs that would have been incredibly beneficial. Over 1,500 lives were lost because of an eight year delay on the prostrate-cancer fighting drug Prozenge. More than 3,000 people died because the FDA denied approval of interleukin-2 which was the only proven successful treatment of advanced kidney cancer. Beta-blockers that reduced the risk of heart attacks were not approved until 1981 despite the fact that they had been clinically proven since the mid-70s and were approved for this use in Europe. Studies have been done using the FDA’s own information that show that upwards of 100,000 people died premature deaths due to the six year delay.
The 1962 Kefauver-Harris Amendments added proof-of-efficacy requirements, removed time constraints on the FDA disposition of NDAs, and gave the FDA extensive powers over the clinical testing procedures drug companies used to support their applications. These amendments severely impacted the number of new drugs approved each year. The post-1962 projected average is much higher than the actual average- sixteen. The 1962 amendments caused a significant drop in the introduction of new drugs, raised costs, and did not improve safety. Even so, the amendments would be understandable if they reduced the proportion of ineffective drugs on the market. Using a variety of tests, however, little evidence has been found to suggest a decline of ineffective drugs due to the efficacy tests. The penalties imposed by the marketplace on sellers of ineffective drugs prior to 1962 were enough of a deterrent. In addition, the raised cost of FDA regulations do not vary with the number of potential users of the drug, so the decline in drug development has been especially important in the treatment of rare diseases, Rare diseases affect millions of Americans; one estimate by the American Medical Association puts the number as high as ten percent of the population. Therefore, millions of Americans have severe medical issues that are left untreated due to the increased costs brought about by stringent FDA efficacy requirements that are themselves ineffective.
The Competitive Enterprise Institute notes that in recent years thousands of patients have died because the FDA has delayed the arrival new drugs and devices that had already been available in other countries for a year or longer. These include: interleukin-2, taxotere, vasoseal, ancrod, glucophage, navelbine, lamictal, ethyol, photofrin, rilutek, citicoline, panorex, femara, transform, prostrar, and omnicath.
PROPOSAL FOR ACTION :
The Food and Drug Administration will no longer complete or require efficacy tests for a drug that has applied for approval. It will only complete or require safety testing. This will only affect the branch of the Food and Drug Administration monitoring drugs and pharmaceutical devices.
RESULTS TO BE EXPECTED :
The number of new and beneficial drugs available to patients will increase dramatically. The market will keep companies from producing ineffective drugs, just as it did before 1962 and as is still does abroad. The time and cost needed to develop drugs will rapidly decrease, thus increasing the availability of drugs to suffering individuals and also reducing the cost of healthcare. This would not only aid the general public but also the doctors, pharmaceutical companies, and hospitals as well as government agencies and programs such as Medicare.
Removing Efficacy Tests from the Food and Drug Administration
MAJOR AREAS TO BE AFFECTED:
Pharmaceutical companies, hospitals, doctors, the Food and Drug Administration, Medicare and other similar government agencies and programs, health insurance providers, all American citizens in need of medical care or that have health insurance
JUSTIFICATION:
Millions of people have died in the United States due to the Food and Drug Administration’s (FDA) failure to approve drugs that would have been incredibly beneficial. Over 1,500 lives were lost because of an eight year delay on the prostrate-cancer fighting drug Prozenge. More than 3,000 people died because the FDA denied approval of interleukin-2 which was the only proven successful treatment of advanced kidney cancer. Beta-blockers that reduced the risk of heart attacks were not approved until 1981 despite the fact that they had been clinically proven since the mid-70s and were approved for this use in Europe. Studies have been done using the FDA’s own information that show that upwards of 100,000 people died premature deaths due to the six year delay.
The 1962 Kefauver-Harris Amendments added proof-of-efficacy requirements, removed time constraints on the FDA disposition of NDAs, and gave the FDA extensive powers over the clinical testing procedures drug companies used to support their applications. These amendments severely impacted the number of new drugs approved each year. The post-1962 projected average is much higher than the actual average- sixteen. The 1962 amendments caused a significant drop in the introduction of new drugs, raised costs, and did not improve safety. Even so, the amendments would be understandable if they reduced the proportion of ineffective drugs on the market. Using a variety of tests, however, little evidence has been found to suggest a decline of ineffective drugs due to the efficacy tests. The penalties imposed by the marketplace on sellers of ineffective drugs prior to 1962 were enough of a deterrent. In addition, the raised cost of FDA regulations do not vary with the number of potential users of the drug, so the decline in drug development has been especially important in the treatment of rare diseases, Rare diseases affect millions of Americans; one estimate by the American Medical Association puts the number as high as ten percent of the population. Therefore, millions of Americans have severe medical issues that are left untreated due to the increased costs brought about by stringent FDA efficacy requirements that are themselves ineffective.
The Competitive Enterprise Institute notes that in recent years thousands of patients have died because the FDA has delayed the arrival new drugs and devices that had already been available in other countries for a year or longer. These include: interleukin-2, taxotere, vasoseal, ancrod, glucophage, navelbine, lamictal, ethyol, photofrin, rilutek, citicoline, panorex, femara, transform, prostrar, and omnicath.
PROPOSAL FOR ACTION :
The Food and Drug Administration will no longer complete or require efficacy tests for a drug that has applied for approval. It will only complete or require safety testing. This will only affect the branch of the Food and Drug Administration monitoring drugs and pharmaceutical devices.
RESULTS TO BE EXPECTED :
The number of new and beneficial drugs available to patients will increase dramatically. The market will keep companies from producing ineffective drugs, just as it did before 1962 and as is still does abroad. The time and cost needed to develop drugs will rapidly decrease, thus increasing the availability of drugs to suffering individuals and also reducing the cost of healthcare. This would not only aid the general public but also the doctors, pharmaceutical companies, and hospitals as well as government agencies and programs such as Medicare.
